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"systematicReview": 0, "originalArticle": 3, "fda": 4 }, { "id": "2026-week03", "title": "【藥師文獻週報】2026 第03週", "year": 2026, "week": 3, "weekLabel": "第 3 週", "dateRange": "2026/01/12 – 01/18", "href": "2026-week03.html", "total": 12, "rct": 6, "metaAnalysis": 1, "systematicReview": 0, "originalArticle": 5, "fda": 4 }, { "id": "2026-week02", "title": "【藥師文獻週報】2026 第02週", "year": 2026, "week": 2, "weekLabel": "第 2 週", "dateRange": "2026/01/05 – 01/11", "href": "2026-week02.html", "total": 7, "rct": 3, "metaAnalysis": 2, "systematicReview": 0, "originalArticle": 2, "fda": 4 }, { "id": "2026-week01", "title": "【藥師文獻週報】2026 第01週", "year": 2026, "week": 1, "weekLabel": "第 1 週", "dateRange": "2025/12/29 – 01/04", "href": "2026-week01.html", "total": 3, "rct": 2, "metaAnalysis": 0, "systematicReview": 0, "originalArticle": 1, "fda": 4 } ], "records": [ { "id": "pmid-42586113", "kind": "article", "issueId": "2026-week33", "year": 2026, "week": 33, "weekLabel": "第 33 週", "dateRange": "2026/08/10 – 08/16", "href": "2026-week33.html", "title": "Switch to once-weekly, single-tablet islatravir-lenacapavir from daily standard of care for HIV-1 (ISLEND-2): a multicentre, randomised, open-label, active-controlled, phase 3 non-inferiority trial", "journal": "Lancet", "type": "OA", "typeLabel": "Original Article", "author": "Colson", "doi": "10.1016/S0140-6736(26)01442-X", "url": "https://doi.org/10.1016/S0140-6736(26)01442-X", "summary": "藥師重點：研究結果說明在既有病毒學抑制且無治療失敗病史的成人中，每週一次 islatravir-lenacapavir 至第 48 週具有不劣於每日標準治療的病毒控制效果，但治療相關不良事件較多且長期安全性仍待追蹤；藥師應確認轉換條件、用藥遵從性與後續病毒量監測。", "pubDate": "2026-08-12", "terms": [ "switch", "once-weekly", "single-tablet", "islatravir-lenacapavir", "from", "daily", "standard", "hiv-1", "islend-2", "multicentre" ], "drugTerms": [ "islatravir-lenacapavir", "islatravir", "lenacapavir", "mg-lenacapavir" ], "searchText": "switch to once-weekly, single-tablet islatravir-lenacapavir from daily standard of care for hiv-1 (islend-2): a multicentre, randomised, open-label, active-controlled, phase 3 non-inferiority trial lancet original article colson 10.1016/s0140-6736(26)01442-x 研究背景：延長給藥間隔的抗反轉錄病毒治療可能改善 hiv-1 病人的病毒控制與治療滿意度；islend-2 評估已病毒學抑制成人由每日標準治療轉換為每週一次 islatravir-lenacapavir 的效果與安全性。 研究方法：此第 3 期、隨機、開放標籤、活性對照、不劣性試驗於 14 個國家及地區的 100 個據點進行，納入至少 6 個月每日口服標準治療下已病毒學抑制且過去無病毒學治療失敗的 hiv-1 成人。受試者按 1:1 轉換為每週一次單錠 islatravir 2 mg-lenacapavir 300 mg，或持續每日標準治療；主要終點為第 48 週 hiv-1 rna ≥50 copies/ml，設定不劣性界值 4%。 主要結果：626 人接受治療；第 48 週 islatravir-lenacapavir 組與標準治療組 hiv-1 rna ≥50 copies/ml 分別為 0.3% 與 1.3%，差異 -1.0%（95·002% ci -3.0 至 1.1），符合不劣性標準。治療相關不良事件為 18% vs <1%，第 3 級以上不良事件為 8% vs 9%，嚴重不良事件為 7% vs 9%；兩組均有少數因不良事件停藥，且未有死亡被判定為治療相關。 藥師重點：研究結果說明在既有病毒學抑制且無治療失敗病史的成人中，每週一次 islatravir-lenacapavir 至第 48 週具有不劣於每日標準治療的病毒控制效果，但治療相關不良事件較多且長期安全性仍待追蹤；藥師應確認轉換條件、用藥遵從性與後續病毒量監測。" }, { "id": "pmid-42593775", "kind": "article", "issueId": "2026-week33", "year": 2026, "week": 33, "weekLabel": "第 33 週", "dateRange": "2026/08/10 – 08/16", "href": "2026-week33.html", "title": "Stereotactic Body Radiotherapy vs Moderately Hypofractionated IMRT for Localized Intermediate-Risk Prostate Cancer: A Randomized Clinical Trial", "journal": "JAMA", "type": "OA", "typeLabel": "Original Article", "author": "Ellis", "doi": "10.1001/jama.2026.12627", "url": "https://doi.org/10.1001/jama.2026.12627", "summary": "藥師重點：結論顯示 SBRT 可改善部分生活品質與泌尿生殖系統不良事件，但未改善無疾病存活期；藥師在放射治療照護中應依療程選擇提供泌尿、腸道及性功能症狀衛教，不宜僅因療程較短便推論疾病控制較佳。", "pubDate": "2026-08-13", "terms": [ "stereotactic", "body", "radiotherapy", "moderately", "hypofractionated", "imrt", "localized", "intermediate-risk", "prostate", "cancer" ], "drugTerms": [], "searchText": "stereotactic body radiotherapy vs moderately hypofractionated imrt for localized intermediate-risk prostate cancer: a randomized clinical trial jama original article ellis 10.1001/jama.2026.12627 研究背景：局限性中度風險前列腺癌的放射治療可透過不同分次方式縮短療程，但療程速度、生活品質與疾病控制之間的取捨仍需比較；nrg-gu005 評估 sbrt 與中度低分次 imrt。 研究方法：此第 3 期、國際性、開放標籤、隨機臨床試驗納入局限性前列腺癌患者，隨機接受 sbrt（36.25 gy，5 次；353 人）或中度低分次 imrt（70 gy，28 次或 60 gy，20 次；345 人）。主要結果為第 2 年 epic-26 尿路刺激／阻塞與腸道生活品質的最小臨床重要差異，以及第 3 年無疾病存活期。 主要結果：共 698 人隨機分組，中位追蹤 3.2 年；第 2 年尿路刺激／阻塞領域的臨床重要差異無顯著差異（35.4% vs 33.7%；p=.68），sbrt 的腸道領域差異較少（34.9% vs 43.8%；p=.03），第 3 級或第 4 級泌尿生殖系統不良事件亦較少（0.6% vs 2.5%；p=.04）。第 3 年無疾病存活期為中度低分次 imrt 92.1% 與 sbrt 88.6%（單側 log-rank p<.001），sbrt 未優於中度低分次 imrt。 藥師重點：結論顯示 sbrt 可改善部分生活品質與泌尿生殖系統不良事件，但未改善無疾病存活期；藥師在放射治療照護中應依療程選擇提供泌尿、腸道及性功能症狀衛教，不宜僅因療程較短便推論疾病控制較佳。" }, { "id": "pmid-42580772", "kind": "article", "issueId": "2026-week33", "year": 2026, "week": 33, "weekLabel": "第 33 週", "dateRange": "2026/08/10 – 08/16", "href": "2026-week33.html", "title": "Evidence based interventions for bipolar disorder across phases and age groups: living umbrella review, evaluation, analysis, and communication hub (U-REACH) project", "journal": "BMJ", "type": "SR", "typeLabel": "Systematic Review", "author": "De Prisco", "doi": "10.1136/bmj-2026-100216", "url": "https://doi.org/10.1136/bmj-2026-100216", "summary": "藥師重點：研究結果說明 EBI-BD 平台可協助依年齡、疾病階段、療效與安全性進行個別化共同決策，但不同治療的證據確定性差異很大，且此 living review 可能更新；藥師應回到原始研究確認適用族群、交互作用與監測需求。", "pubDate": "2026-08-11", "terms": [ "evidence", "interventions", "bipolar", "disorder", "across", "phases", "living", "umbrella", "evaluation", "communication" ], "drugTerms": [ "fluoxetine", "olanzapine", "quetiapine", "aripiprazole", "asenapine", "carbamazepine" ], "searchText": "evidence based interventions for bipolar disorder across phases and age groups: living umbrella review, evaluation, analysis, and communication hub (u-reach) project bmj systematic review de prisco 10.1136/bmj-2026-100216 研究背景：雙相情緒障礙的治療效果會隨年齡與疾病階段而異，臨床需要能整合不同治療策略與證據確定性的工具；u-reach 計畫建立可公開使用的 ebi-bd 資訊平台。 研究方法：此持續更新的 umbrella review 搜尋 pubmed、psycinfo 與 cochrane library，截至 2024 年 11 月 19 日納入隨機對照試驗的網絡或成對 meta-analysis，評估藥物、營養補充、心理社會、腦刺激及生理節律治療在不同年齡與雙相情緒障礙階段的單一、加強或合併治療效果。 主要結果：共納入 77 篇研究，涵蓋 116 種治療、133 個結果與 2510 項 meta-analysis；依 grade 評估，證據確定性為高 236 項、中 827 項、低 986 項及極低 461 項。不同階段的有效治療並不相同，例如成人雙相憂鬱可見 cariprazine、lamotrigine、lumateperone、lurasidone、quetiapine 等，維持期則包括 aripiprazole、lithium、olanzapine、quetiapine 等；兒童與青少年可用證據較少。 藥師重點：研究結果說明 ebi-bd 平台可協助依年齡、疾病階段、療效與安全性進行個別化共同決策，但不同治療的證據確定性差異很大，且此 living review 可能更新；藥師應回到原始研究確認適用族群、交互作用與監測需求。" }, { "id": "pmid-42594914", "kind": "article", "issueId": "2026-week33", "year": 2026, "week": 33, "weekLabel": "第 33 週", "dateRange": "2026/08/10 – 08/16", "href": "2026-week33.html", "title": "Efficacy and safety of upadacitinib in adults and adolescents for treatment of non-segmental vitiligo (Viti-Up): results of two phase 3 randomised controlled studies", "journal": "Lancet", "type": "RCT", "typeLabel": "RCT", "author": "Passeron", "doi": "10.1016/S0140-6736(26)00896-2", "url": "https://doi.org/10.1016/S0140-6736(26)00896-2", "summary": "藥師重點：結論顯示 upadacitinib 15 mg 每日可改善成人及青少年非節段型白斑的臉部與全身色素恢復，但試驗仍在進行；藥師應確認適用族群，並持續留意 herpes zoster 與 JAK inhibitor 類別相關安全性及長期資料。", "pubDate": "2026-08-15", "terms": [ "efficacy", "upadacitinib", "adults", "adolescents", "non-segmental", "vitiligo", "viti-up", "phase", "randomised", "studies" ], "drugTerms": [ "upadacitinib" ], "searchText": "efficacy and safety of upadacitinib in adults and adolescents for treatment of non-segmental vitiligo (viti-up): results of two phase 3 randomised controlled studies lancet rct passeron 10.1016/s0140-6736(26)00896-2 研究背景：非節段型白斑是因黑色素細胞流失造成皮膚脫色的自體免疫發炎疾病，系統性治療選項仍有限；本研究評估每日一次選擇性 janus kinase 抑制劑 upadacitinib 的療效與安全性。 研究方法：viti-up 包含兩項第 3 期、全球多中心、隨機、雙盲、安慰劑對照試驗，納入 12 歲以上且臉部與身體均有非節段型白斑的成人及青少年，按 2:1 分配接受 upadacitinib 15 mg 或 placebo 每日口服。主要終點為第 48 週 t-vasi 50 與 f-vasi 75。 主要結果：viti-up-1 與 viti-up-2 分別納入 308 人與 306 人；第 48 週 upadacitinib 達到 t-vasi 50 的比例為 19% 與 21%，placebo 均為 6%，達到 f-vasi 75 的比例為 25% 與 23%，placebo 為 6% 與 7%（均 p<0.001）。兩項研究均未發現判定後重大心血管事件、靜脈血栓栓塞、腸胃道穿孔、活動性結核、淋巴瘤、非黑色素瘤皮膚癌或除 herpes zoster 外的伺機性感染；安全性與 upadacitinib 整體安全性資料一致。 藥師重點：結論顯示 upadacitinib 15 mg 每日可改善成人及青少年非節段型白斑的臉部與全身色素恢復，但試驗仍在進行；藥師應確認適用族群，並持續留意 herpes zoster 與 jak inhibitor 類別相關安全性及長期資料。" }, { "id": "pmid-42586114", "kind": "article", "issueId": "2026-week33", "year": 2026, "week": 33, "weekLabel": "第 33 週", "dateRange": "2026/08/10 – 08/16", "href": "2026-week33.html", "title": "Belzutifan plus lenvatinib versus cabozantinib in patients with previously treated advanced renal cell carcinoma (LITESPARK-011): an open-label, randomised, controlled, phase 3 trial", "journal": "Lancet", "type": "OA", "typeLabel": "Original Article", "author": "Motzer", "doi": "10.1016/S0140-6736(26)01089-5", "url": "https://doi.org/10.1016/S0140-6736(26)01089-5", "summary": "藥師重點：結論顯示 belzutifan 合併 lenvatinib 可延長曾接受免疫檢查點抑制劑後腎細胞癌患者的無惡化存活期，但整體存活期尚未證實差異；藥師需監測高血壓及兩藥各自的毒性，並依病人既往治療與不良事件耐受性評估用藥。", "pubDate": "2026-08-12", "terms": [ "belzutifan", "plus", "lenvatinib", "cabozantinib", "previously", "treated", "advanced", "renal", "cell", "carcinoma" ], "drugTerms": [ "lenvatinib", "cabozantinib", "anti-pd-1", "anti-pd-l1", "belzutifan-lenvatinib" ], "searchText": "belzutifan plus lenvatinib versus cabozantinib in patients with previously treated advanced renal cell carcinoma (litespark-011): an open-label, randomised, controlled, phase 3 trial lancet original article motzer 10.1016/s0140-6736(26)01089-5 研究背景：接受 anti-pd-1 或 anti-pd-l1 治療後惡化的晚期透明細胞型腎細胞癌，後續治療的明確標準仍待建立；本研究比較 belzutifan 合併 lenvatinib 與 cabozantinib。 研究方法：litespark-011 是於 25 國 184 個醫療中心進行的第 3 期、開放標籤、隨機、活性對照試驗，納入曾接受免疫檢查點抑制劑且疾病惡化的不可切除、局部晚期或轉移性第 4 期透明細胞型腎細胞癌成人。受試者按 1:1 接受 belzutifan 120 mg 合併 lenvatinib 20 mg，或 cabozantinib 60 mg，每日口服；主要終點為無惡化存活期與整體存活期。 主要結果：共 747 人隨機分組，第二次期中分析中位追蹤 29.0 個月；belzutifan-lenvatinib 組無惡化存活期較長（14.8 vs 10.7 個月；hr 0.70，95% ci 0.59-0.84；單側 p<0.0001），但整體存活期差異未達顯著（34.9 vs 27.6 個月；hr 0.85，95% ci 0.68-1.05；單側 p=0.061）。第 3 級以上治療期間不良事件發生率相近（84% vs 83%），最常見為高血壓；治療相關不良事件分別造成 2 人與 1 人死亡。 藥師重點：結論顯示 belzutifan 合併 lenvatinib 可延長曾接受免疫檢查點抑制劑後腎細胞癌患者的無惡化存活期，但整體存活期尚未證實差異；藥師需監測高血壓及兩藥各自的毒性，並依病人既往治療與不良事件耐受性評估用藥。" }, { "id": "fda-2026-week33-2", "kind": "fda", "issueId": "2026-week33", "year": 2026, "week": 33, "weekLabel": "第 33 週", "dateRange": "2026/08/10 – 08/16", "href": "2026-week33.html", "title": "FDA Publishes Revised Draft Product-Specific Guidances for Certain Generic Peptide Products", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fda-publishes-revised-draft-product-specific-guidances-certain-generic-peptide-products", "summary": "FDA 修訂發布 17 項 peptide products 的產品特定指引草案（PSGs）；涉及仿製藥開發的實際要求，應以 FDA 原文及後續正式版本為準。", "terms": [ "publishes", "revised", "draft", "product-specific", "guidances", "certain", "generic", "peptide", "products", "psgs" ], "drugTerms": [], "searchText": "fda publishes revised draft product-specific guidances for certain generic peptide products fda drug safety 2026-07-28 fda 修訂發布 17 項 peptide products 的產品特定指引草案（psgs）；涉及仿製藥開發的實際要求，應以 fda 原文及後續正式版本為準。 https://www.fda.gov/drugs/drug-alerts-and-statements/fda-publishes-revised-draft-product-specific-guidances-certain-generic-peptide-products" }, { "id": "fda-2026-week33-1", "kind": "fda", "issueId": "2026-week33", "year": 2026, "week": 33, "weekLabel": "第 33 週", "dateRange": "2026/08/10 – 08/16", "href": "2026-week33.html", "title": "FDA Publishes New Product-Specific Guidances to Facilitate Generic Drug Development", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fda-publishes-new-product-specific-guidances-facilitate-generic-drug-development", "summary": "FDA 發布一批新的仿製藥產品特定指引草案（PSGs），說明仿製藥開發及 abbreviated new drug applications（ANDAs）證據準備可參考的方向；實際產品仍應查閱 FDA 原文與最新版本。", "terms": [ "publishes", "product-specific", "guidances", "facilitate", "generic", "development", "psgs", "abbreviated", "applications", "andas" ], "drugTerms": [], "searchText": "fda publishes new product-specific guidances to facilitate generic drug development fda drug safety 2026-08-21 fda 發布一批新的仿製藥產品特定指引草案（psgs），說明仿製藥開發及 abbreviated new drug applications（andas）證據準備可參考的方向；實際產品仍應查閱 fda 原文與最新版本。 https://www.fda.gov/drugs/drug-alerts-and-statements/fda-publishes-new-product-specific-guidances-facilitate-generic-drug-development" }, { "id": "fda-2026-week33-3", "kind": "fda", "issueId": "2026-week33", "year": 2026, "week": 33, "weekLabel": "第 33 週", "dateRange": "2026/08/10 – 08/16", "href": "2026-week33.html", "title": "FDA Approves First Generics of Gilotrif (afatinib) Tablets", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fda-approves-first-generics-gilotrif-afatinib-tablets", "summary": "FDA 核准首批 GILOTRIF（afatinib tablets）學名藥，用於腫瘤具有 FDA 檢測之非抗藥性 epidermal growth factor receptor（EGFR）突變的轉移性 non-small cell lung cancer（NSCLC）第一線治療；實際適應症與產品資訊應核對 FDA 原文。", "terms": [ "approves", "first", "generics", "gilotrif", "afatinib", "tablets", "epidermal", "growth", "factor", "receptor" ], "drugTerms": [ "afatinib" ], "searchText": "fda approves first generics of gilotrif (afatinib) tablets fda drug safety 2026-07-14 fda 核准首批 gilotrif（afatinib tablets）學名藥，用於腫瘤具有 fda 檢測之非抗藥性 epidermal growth factor receptor（egfr）突變的轉移性 non-small cell lung cancer（nsclc）第一線治療；實際適應症與產品資訊應核對 fda 原文。 https://www.fda.gov/drugs/drug-alerts-and-statements/fda-approves-first-generics-gilotrif-afatinib-tablets" }, { "id": "pmid-42561994", "kind": "article", "issueId": "2026-week32", "year": 2026, "week": 32, "weekLabel": "第 32 週", "dateRange": "2026/08/03 – 08/09", "href": "2026-week32.html", "title": "[177Lu]Lu-PSMA-617 in patients with PSMA-positive metastatic androgen pathway modulator-naive/sensitive prostate cancer (PSMAddition): a phase 3 randomised, controlled trial", "journal": "Lancet", "type": "OA", "typeLabel": "Original Article", "author": "Tagawa", "doi": "10.1016/S0140-6736(26)01092-5", "url": "https://doi.org/10.1016/S0140-6736(26)01092-5", "summary": "藥師重點：結論顯示在 PSMA-positive 轉移性 APMN/S 前列腺癌中，177Lu-PSMA-617 合併 ADT+ARPI 可延長影像學無惡化存活，但整體不良事件較多；藥師需確認 PSMA 檢測與療程條件，並監測口乾、血球減少、腸胃道不適及嚴重不良事件。", "pubDate": "2026-08-06", "terms": [ "lu-psma-617", "psma-positive", "metastatic", "androgen", "pathway", "modulator-naive", "sensitive", "prostate", "cancer", "psmaddition" ], "drugTerms": [], "searchText": "[177lu]lu-psma-617 in patients with psma-positive metastatic androgen pathway modulator-naive/sensitive prostate cancer (psmaddition): a phase 3 randomised, controlled trial lancet original article tagawa 10.1016/s0140-6736(26)01092-5 研究背景：轉移性、對雄性素途徑調節劑尚未治療或仍具敏感性的前列腺癌，現行治療通常為雄性素剝奪治療（adt）合併雄性素受體途徑抑制劑（arpi）；在 psma-positive 病灶加入 177lu-psma-617 的療效與安全性仍需隨機試驗確認。 研究方法：psmaddition 為於 20 國 169 個中心進行的第三期隨機對照試驗，納入 1144 名 psma-positive 轉移性 apmn/s 前列腺癌男性，分派接受靜脈 177lu-psma-617（7.4 gbq，每 6 週一次，最多 6 個療程，劑量允許 ±10%）合併 adt+arpi，或單用 adt+arpi；主要終點為影像學無惡化存活期。 主要結果：第二次期中分析中，177lu-psma-617 組與對照組的影像學疾病惡化或死亡分別為 24% 與 30%，加入 177lu-psma-617 可降低 28% 的惡化或死亡相對風險（hr 0.72，95% ci 0.58-0.90；p=0.0021）。第 3 級以上不良事件為 51% vs 43%，最常見為口乾（46% vs 4%，皆為第 1-2 級），另有較多血球減少與腸胃道不適。 藥師重點：結論顯示在 psma-positive 轉移性 apmn/s 前列腺癌中，177lu-psma-617 合併 adt+arpi 可延長影像學無惡化存活，但整體不良事件較多；藥師需確認 psma 檢測與療程條件，並監測口乾、血球減少、腸胃道不適及嚴重不良事件。" }, { "id": "pmid-42560689", "kind": "article", "issueId": "2026-week32", "year": 2026, "week": 32, "weekLabel": "第 32 週", "dateRange": "2026/08/03 – 08/09", "href": "2026-week32.html", "title": "Iron or Multiple Micronutrient Powder Supplements With Malaria Chemoprevention in Rural Malawian Children: The IRMA Randomized Clinical Trial", "journal": "JAMA", "type": "OA", "typeLabel": "Original Article", "author": "Phiri", "doi": "10.1001/jama.2026.12242", "url": "https://doi.org/10.1001/jama.2026.12242", "summary": "藥師重點：研究結果說明在此馬拉威幼兒族群中，普遍補充 6 個月鐵劑合併瘧疾化學預防未改善認知結果；藥師應依貧血與營養評估判斷補充需求，並持續監測血紅素、ferritin 及感染狀況，不能僅以預防性補鐵推論發展效益。", "pubDate": "2026-08-06", "terms": [ "iron", "multiple", "micronutrient", "powder", "supplements", "malaria", "chemoprevention", "rural", "malawian", "children" ], "drugTerms": [], "searchText": "iron or multiple micronutrient powder supplements with malaria chemoprevention in rural malawian children: the irma randomized clinical trial jama original article phiri 10.1001/jama.2026.12242 研究背景：貧血盛行地區常考慮對幼兒普遍補充鐵劑，但其對發展功能的效益及是否增加感染風險仍缺乏隨機試驗證據。 研究方法：irma 隨機臨床試驗於馬拉威南部 4 個農村、瘧疾流行地區中心納入 2168 名 6 個月大嬰兒，接受 6 個月鐵糖漿合併瘧疾化學預防、含鐵多種微量營養素粉劑合併瘧疾化學預防、單用瘧疾化學預防或安慰劑；主要終點為 bayley-iii 認知量表綜合分數，並評估語言、動作、貧血、ferritin 及感染。 主要結果：相較單用瘧疾化學預防，鐵糖漿合併瘧疾化學預防及含鐵粉劑合併瘧疾化學預防均未改善 bayley-iii 認知分數（md -0.52，95% ci -2.52 至 1.48；md -0.85，95% ci -2.80 至 1.09）。兩種鐵劑介入雖提高 ferritin，卻未降低貧血盛行率，也未增加瘧疾風險；單用瘧疾化學預防較安慰劑降低瘧疾發生率。 藥師重點：研究結果說明在此馬拉威幼兒族群中，普遍補充 6 個月鐵劑合併瘧疾化學預防未改善認知結果；藥師應依貧血與營養評估判斷補充需求，並持續監測血紅素、ferritin 及感染狀況，不能僅以預防性補鐵推論發展效益。" }, { "id": "pmid-42562413", "kind": "article", "issueId": "2026-week32", "year": 2026, "week": 32, "weekLabel": "第 32 週", "dateRange": "2026/08/03 – 08/09", "href": "2026-week32.html", "title": "Evaluation of patient centred digital adherence technology for tuberculosis treatment outcomes: pragmatic randomised controlled trial", "journal": "BMJ", "type": "RCT", "typeLabel": "RCT", "author": "Rubinstein", "doi": "10.1136/bmj-2026-100195", "url": "https://doi.org/10.1136/bmj-2026-100195", "summary": "藥師重點：研究結果說明結合服藥回報、衛教與支持者溝通的數位工具可能改善結核病治療完成率；藥師可協助確認病人能否使用工具、追蹤回報與失訪風險，但仍需考量數位工具參與度及低資源環境的適用性。", "pubDate": "2026-08-06", "terms": [ "evaluation", "centred", "digital", "adherence", "technology", "tuberculosis", "pragmatic", "randomised", "rubinstein", "bmj-2026-100195" ], "drugTerms": [], "searchText": "evaluation of patient centred digital adherence technology for tuberculosis treatment outcomes: pragmatic randomised controlled trial bmj rct rubinstein 10.1136/bmj-2026-100195 研究背景：結核病治療需要長期服藥，漏服與失訪可能降低治療成功率；以病人為中心的數位工具是否能改善藥物敏感性結核病的治療結果仍需評估。 研究方法：此務實型、雙臂平行隨機試驗於阿根廷 buenos aires 4 家公立醫院納入 555 名 16 歲以上新診斷患者，分派接受標準照護或標準照護合併 tb-tst。tb-tst 包含每日服藥回報、與支持者雙向訊息、衛教內容及每週尿液 isoniazid 檢測；主要終點為治癒或完成治療。 主要結果：分析納入 525 人，tb-tst 組治療成功率高於對照組（82% [208/255] vs 74% [201/270]；風險差 7.1%，95% ci 1.1%-14.1%；rr 1.10，95% ci 1.00-1.20；p=0.04）。失訪率亦較低（17% vs 24%；rr 0.70，95% ci 0.50-0.98；p=0.04），女性及 35 歲以下患者的獲益較明顯。 藥師重點：研究結果說明結合服藥回報、衛教與支持者溝通的數位工具可能改善結核病治療完成率；藥師可協助確認病人能否使用工具、追蹤回報與失訪風險，但仍需考量數位工具參與度及低資源環境的適用性。" }, { "id": "pmid-42556860", "kind": "article", "issueId": "2026-week32", "year": 2026, "week": 32, "weekLabel": "第 32 週", "dateRange": "2026/08/03 – 08/09", "href": "2026-week32.html", "title": "Comparative effectiveness of azithromycin versus roflumilast in patients with chronic obstructive pulmonary disease: emulated target trial", "journal": "BMJ", "type": "OA", "typeLabel": "Original Article", "author": "Portela", "doi": "10.1136/bmj-2026-100111", "url": "https://doi.org/10.1136/bmj-2026-100111", "summary": "藥師重點：研究結果顯示在此真實世界 COPD 族群中，azithromycin 與較低急性惡化風險相關，但研究未比較兩藥安全性，不能直接視為因果或首選治療；藥師仍需回到患者適用條件、用藥目的與完整安全性資料評估。", "pubDate": "2026-08-05", "terms": [ "comparative", "effectiveness", "azithromycin", "roflumilast", "chronic", "obstructive", "pulmonary", "emulated", "target", "portela" ], "drugTerms": [ "azithromycin" ], "searchText": "comparative effectiveness of azithromycin versus roflumilast in patients with chronic obstructive pulmonary disease: emulated target trial bmj original article portela 10.1136/bmj-2026-100111 研究背景：慢性阻塞性肺病（copd）患者可能使用 azithromycin 或 roflumilast 預防急性惡化，但兩者在日常臨床照護中的相對效果仍不確定。 研究方法：此研究以 optum clinformatics data mart 資料庫模擬目標試驗，納入 40 歲以上、病情活躍且新開始口服維持治療的 copd 患者，經傾向分數配對後形成 7550 對 azithromycin 與 roflumilast 使用者；主要終點為首次中度或重度 copd 急性惡化時間。 主要結果：兩組首次中度或重度急性惡化的未調整發生率均為每人年 1.2 次。與 roflumilast 相比，azithromycin 的首次中度或重度急性惡化風險較低（hr 0.83，95% ci 0.79-0.87；nnt 15，95% ci 12-21），敏感度及亞組分析結果大致一致。 藥師重點：研究結果顯示在此真實世界 copd 族群中，azithromycin 與較低急性惡化風險相關，但研究未比較兩藥安全性，不能直接視為因果或首選治療；藥師仍需回到患者適用條件、用藥目的與完整安全性資料評估。" }, { "id": "fda-2026-week32-2", "kind": "fda", "issueId": "2026-week32", "year": 2026, "week": 32, "weekLabel": "第 32 週", "dateRange": "2026/08/03 – 08/09", "href": "2026-week32.html", "title": "FDA Publishes Revised Draft Product-Specific Guidances for Certain Generic Peptide Products", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fda-publishes-revised-draft-product-specific-guidances-certain-generic-peptide-products", "summary": "FDA 修訂 17 項 peptide products 的產品特定指引草案（PSGs），供學名藥開發與 abbreviated new drug applications（ANDAs）準備資料時參考。藥師可留意相關 peptide products 的未來學名藥申請與替代性證據要求。", "terms": [ "publishes", "revised", "draft", "product-specific", "guidances", "certain", "generic", "peptide", "products", "psgs" ], "drugTerms": [], "searchText": "fda publishes revised draft product-specific guidances for certain generic peptide products fda drug safety 2026-07-28 fda 修訂 17 項 peptide products 的產品特定指引草案（psgs），供學名藥開發與 abbreviated new drug applications（andas）準備資料時參考。藥師可留意相關 peptide products 的未來學名藥申請與替代性證據要求。 https://www.fda.gov/drugs/drug-alerts-and-statements/fda-publishes-revised-draft-product-specific-guidances-certain-generic-peptide-products" }, { "id": "fda-2026-week32-1", "kind": "fda", "issueId": "2026-week32", "year": 2026, "week": 32, "weekLabel": "第 32 週", "dateRange": "2026/08/03 – 08/09", "href": "2026-week32.html", "title": "FDA Publishes New Product-Specific Guidances to Facilitate Generic Drug Development", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fda-publishes-new-product-specific-guidances-facilitate-generic-drug-development", "summary": "FDA 發布新一批 generic drug 的產品特定指引草案（PSGs），供學名藥開發及 abbreviated new drug applications（ANDAs）準備資料時參考。藥師可留意未來學名藥審查與相關證據要求的變化。", "terms": [ "publishes", "product-specific", "guidances", "facilitate", "generic", "development", "psgs", "abbreviated", "applications", "andas" ], "drugTerms": [], "searchText": "fda publishes new product-specific guidances to facilitate generic drug development fda drug safety 2026-08-21 fda 發布新一批 generic drug 的產品特定指引草案（psgs），供學名藥開發及 abbreviated new drug applications（andas）準備資料時參考。藥師可留意未來學名藥審查與相關證據要求的變化。 https://www.fda.gov/drugs/drug-alerts-and-statements/fda-publishes-new-product-specific-guidances-facilitate-generic-drug-development" }, { "id": "fda-2026-week32-3", "kind": "fda", "issueId": "2026-week32", "year": 2026, "week": 32, "weekLabel": "第 32 週", "dateRange": "2026/08/03 – 08/09", "href": "2026-week32.html", "title": "FDA Approves First Generics of Gilotrif (afatinib) Tablets", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fda-approves-first-generics-gilotrif-afatinib-tablets", "summary": "FDA 核准首批 GILOTRIF（afatinib tablets）學名藥，用於腫瘤具有未產生抗藥性 EGFR mutations 的轉移性非小細胞肺癌（NSCLC）第一線治療。藥師可留意品項替代、適應症與 EGFR 檢測條件。", "terms": [ "approves", "first", "generics", "gilotrif", "afatinib", "tablets", "egfr", "mutations", "nsclc", "https" ], "drugTerms": [ "afatinib" ], "searchText": "fda approves first generics of gilotrif (afatinib) tablets fda drug safety 2026-07-14 fda 核准首批 gilotrif（afatinib tablets）學名藥，用於腫瘤具有未產生抗藥性 egfr mutations 的轉移性非小細胞肺癌（nsclc）第一線治療。藥師可留意品項替代、適應症與 egfr 檢測條件。 https://www.fda.gov/drugs/drug-alerts-and-statements/fda-approves-first-generics-gilotrif-afatinib-tablets" }, { "id": "pmid-42520828", "kind": "article", "issueId": "2026-week31", "year": 2026, "week": 31, "weekLabel": "第 31 週", "dateRange": "2026/07/27 – 08/02", "href": "2026-week31.html", "title": "Ralinepag for the treatment of pulmonary arterial hypertension (ADVANCE OUTCOMES): a randomised, double-blind, placebo-controlled phase 3 study", "journal": "Lancet", "type": "OA", "typeLabel": "Original Article", "author": "McLaughlin", "doi": "10.1016/S0140-6736(26)01011-1", "url": "https://doi.org/10.1016/S0140-6736(26)01011-1", "summary": "藥師重點：結論顯示 ralinepag 可降低 PAH 臨床惡化風險，但耐受性可能限制治療持續性；藥師需協助 dose titration、監測不良反應並評估與既有 PAH 藥物的整體治療負荷。", "pubDate": "2026-07-28", "terms": [ "ralinepag", "pulmonary", "arterial", "hypertension", "advance", "randomised", "double-blind", "placebo-controlled", "phase", "lancet" ], "drugTerms": [], "searchText": "ralinepag for the treatment of pulmonary arterial hypertension (advance outcomes): a randomised, double-blind, placebo-controlled phase 3 study lancet original article mclaughlin 10.1016/s0140-6736(26)01011-1 研究背景：pulmonary arterial hypertension（pah）即使接受現代背景治療，仍可能持續惡化；口服 prostacyclin pathway 藥物 ralinepag 是否能進一步降低臨床惡化風險值得評估。 研究方法：advance outcomes 為隨機、雙盲、安慰劑對照、事件驅動的 phase 3 試驗，分析 687 名 pah 成人，於既有背景治療上加用 ralinepag 或 placebo；主要終點為首次 clinical worsening event 發生時間。 主要結果：ralinepag 組有 18% 患者發生首次 clinical worsening event，低於 placebo 組的 36%（hr 0.45，95% ci 0.33-0.62；p<0.0001）。但因不良事件停藥的比例較高（19% vs 3%）；serious adverse events 與致死性不良事件比例兩組相近。 藥師重點：結論顯示 ralinepag 可降低 pah 臨床惡化風險，但耐受性可能限制治療持續性；藥師需協助 dose titration、監測不良反應並評估與既有 pah 藥物的整體治療負荷。" }, { "id": "pmid-42525925", "kind": "article", "issueId": "2026-week31", "year": 2026, "week": 31, "weekLabel": "第 31 週", "dateRange": "2026/07/27 – 08/02", "href": "2026-week31.html", "title": "Phase 3 Trial of Weekly Oral Islatravir-Lenacapavir for HIV-1 Treatment", "journal": "NEJM", "type": "OA", "typeLabel": "Original Article", "author": "Rockstroh", "doi": "10.1056/NEJMoa2607973", "url": "https://doi.org/10.1056/NEJMoa2607973", "summary": "藥師重點：結論顯示 once-weekly oral ISL/LEN 在已穩定抑制的 HIV-1 患者可維持不劣於每日 B/F/TAF 的病毒抑制；藥師需加強每週服藥依從性、交互作用與 virologic failure 後續處置的衛教。", "pubDate": "2026-07-29", "terms": [ "phase", "weekly", "oral", "islatravir-lenacapavir", "hiv-1", "nejm", "rockstroh", "nejmoa2607973", "once-weekly", "noninferiority" ], "drugTerms": [ "islatravir-lenacapavir", "bictegravir-emtricitabine-tenofovir" ], "searchText": "phase 3 trial of weekly oral islatravir-lenacapavir for hiv-1 treatment nejm original article rockstroh 10.1056/nejmoa2607973 研究背景：hiv-1 病毒量已受抑制患者仍面臨每日服藥依從性挑戰，once-weekly 口服維持治療是否能兼顧便利性與療效，是長效治療發展的重要方向。 研究方法：此 phase 3 雙盲、主動對照、noninferiority 試驗納入 607 名已接受 b/f/taf 且病毒抑制至少 6 個月的成人，隨機改用 once-weekly oral islatravir-lenacapavir（isl/len）或持續 once-daily b/f/taf，追蹤 96 週；主要終點為第 48 週 hiv-1 rna 至少 50 copies/ml 的比例。 主要結果：第 48 週 isl/len 組無患者出現 hiv-1 rna ≥50 copies/ml，b/f/taf 組為 1 人（0.3%）；hiv-1 rna <50 copies/ml 的比例分別為 93.4% 與 92.4%。兩組因不良事件停藥與 serious adverse events 發生率相近。 藥師重點：結論顯示 once-weekly oral isl/len 在已穩定抑制的 hiv-1 患者可維持不劣於每日 b/f/taf 的病毒抑制；藥師需加強每週服藥依從性、交互作用與 virologic failure 後續處置的衛教。" }, { "id": "pmid-42526026", "kind": "article", "issueId": "2026-week31", "year": 2026, "week": 31, "weekLabel": "第 31 週", "dateRange": "2026/07/27 – 08/02", "href": "2026-week31.html", "title": "Phase 2b Trial of a NaV1.8 Inhibitor for Acute Pain", "journal": "NEJM", "type": "RCT", "typeLabel": "RCT", "author": "Singla", "doi": "10.1056/NEJMoa2602910", "url": "https://doi.org/10.1056/NEJMoa2602910", "summary": "藥師重點：研究結果說明 LTG-001 具非 opioid 止痛潛力，且高劑量可減少救援 opioid 使用；藥師需留意發燒、presyncope 等不良反應，並持續評估其與既有止痛策略的相對定位。", "pubDate": "2026-07-30", "terms": [ "phase", "nav1", "inhibitor", "acute", "pain", "nejm", "singla", "nejmoa2602910", "opioid", "ltg-001" ], "drugTerms": [ "hydrocodone", "morphine" ], "searchText": "phase 2b trial of a nav1.8 inhibitor for acute pain nejm rct singla 10.1056/nejmoa2602910 研究背景：術後急性疼痛常需使用 opioid，選擇性 nav1.8 抑制劑 ltg-001 是否可提供有效止痛並降低救援 opioid 需求，是臨床關注重點。 研究方法：此 phase 2b 雙盲、隨機、安慰劑對照試驗納入 343 名腹部整形術後中重度疼痛患者，1:1:1:1 分派至 ltg-001 低劑量、高劑量、hydrocodone bitartrate-acetaminophen 或 placebo，連續口服 48 小時；主要終點為 48 小時 spid48。 主要結果：ltg-001 低劑量與高劑量的 spid48 均顯著優於 placebo，與 placebo 的 least-squares mean difference 分別為 37.82（p=0.003）與 62.08（p<0.001）；高劑量組 opioid rescue 使用量較低（11.00 vs 18.35 mme，p=0.01），且無需救援 opioid 的比例較高（52% vs 22%，p<0.001）。高劑量組 pyrexia 與 presyncope 發生率較 placebo 高。 藥師重點：研究結果說明 ltg-001 具非 opioid 止痛潛力，且高劑量可減少救援 opioid 使用；藥師需留意發燒、presyncope 等不良反應，並持續評估其與既有止痛策略的相對定位。" }, { "id": "pmid-42530900", "kind": "article", "issueId": "2026-week31", "year": 2026, "week": 31, "weekLabel": "第 31 週", "dateRange": "2026/07/27 – 08/02", "href": "2026-week31.html", "title": "Nicotine E-Cigarettes for Cigarette Smoking Cessation: Recommendations to US-Based Clinicians", "journal": "JAMA", "type": "OA", "typeLabel": "Original Article", "author": "Leavens", "doi": "10.1001/jama.2026.13087", "url": "https://doi.org/10.1001/jama.2026.13087", "summary": "藥師重點：此文屬專家建議而非介入試驗，但可作為戒菸諮詢參考；藥師與病人討論時應強調以完全戒除香菸為目標、優先使用可追溯產品，並持續追蹤 nicotine 依賴與雙重使用風險。", "pubDate": "2026-07-30", "terms": [ "nicotine", "e-cigarettes", "cigarette", "smoking", "cessation", "recommendations", "us-based", "clinicians", "jama", "leavens" ], "drugTerms": [], "searchText": "nicotine e-cigarettes for cigarette smoking cessation: recommendations to us-based clinicians jama original article leavens 10.1001/jama.2026.13087 研究背景：成人戒菸治療除傳統 nicotine replacement therapy 外，含 nicotine 電子煙的角色仍具爭議，臨床人員對其風險與效益也常有認知落差。 研究方法：此 special communication 由 society for research on nicotine and tobacco 旗下 treatment research network 工作小組整理現有證據，提出美國臨床人員與成年吸菸者討論 nicotine e-cigarettes 用於戒菸的建議與實務做法。 主要結果：作者群指出，現有證據支持含 nicotine 電子煙在戒菸效果上優於 fda 核准的 nicotine replacement therapies，且危害低於持續吸傳統香菸；因此建議將電子煙納入各類有證據藥物戒菸選項的 shared decision-making 討論。 藥師重點：此文屬專家建議而非介入試驗，但可作為戒菸諮詢參考；藥師與病人討論時應強調以完全戒除香菸為目標、優先使用可追溯產品，並持續追蹤 nicotine 依賴與雙重使用風險。" }, { "id": "pmid-42537680", "kind": "article", "issueId": "2026-week31", "year": 2026, "week": 31, "weekLabel": "第 31 週", "dateRange": "2026/07/27 – 08/02", "href": "2026-week31.html", "title": "Multivessel coronary artery bypass grafting via small thoracotomy versus sternotomy (MIST): an investigator-initiated, international, open-label, randomised controlled trial", "journal": "Lancet", "type": "OA", "typeLabel": "Original Article", "author": "Ruel", "doi": "10.1016/S0140-6736(26)01288-2", "url": "https://doi.org/10.1016/S0140-6736(26)01288-2", "summary": "藥師重點：研究結果說明在經驗足夠團隊與適當篩選病人下，MICS CABG 可改善早期身體恢復而未見明顯安全性代價；藥師可配合術後止痛、抗栓與復原路徑管理。", "pubDate": "2026-07-31", "terms": [ "multivessel", "coronary", "artery", "bypass", "grafting", "small", "thoracotomy", "sternotomy", "mist", "investigator-initiated" ], "drugTerms": [], "searchText": "multivessel coronary artery bypass grafting via small thoracotomy versus sternotomy (mist): an investigator-initiated, international, open-label, randomised controlled trial lancet original article ruel 10.1016/s0140-6736(26)01288-2 研究背景：多支血管冠狀動脈疾病患者接受 cabg 時，經小開胸的 minimally invasive cardiac surgery（mics）可能改善術後恢復，但隨機對照證據有限。 研究方法：mist 為國際、多中心、開放標籤、隨機對照試驗，納入 170 名適合接受 mics cabg 或傳統 sternotomy cabg 的患者，主要終點為術後 1 個月 sf-36 physical component summary（pcs）分數。 主要結果：術後 1 個月 mics cabg 組的 sf-36 pcs 分數高於 sternotomy cabg 組（45.1 vs 42.2；mean difference 2.9，95% ci 0.3-5.5；p=0.031）。追蹤至 12 個月，兩組皆未發生死亡或中風，僅 mics cabg 組於 1 個月前出現 1 例 major adverse cardiac or cerebrovascular event。 藥師重點：研究結果說明在經驗足夠團隊與適當篩選病人下，mics cabg 可改善早期身體恢復而未見明顯安全性代價；藥師可配合術後止痛、抗栓與復原路徑管理。" }, { "id": "pmid-42536019", "kind": "article", "issueId": "2026-week31", "year": 2026, "week": 31, "weekLabel": "第 31 週", "dateRange": "2026/07/27 – 08/02", "href": "2026-week31.html", "title": "Initial HIV Therapy for Adults and Treatment-Associated Weight Gain: The Opti-DOR Randomized Clinical Trial", "journal": "JAMA", "type": "OA", "typeLabel": "Original Article", "author": "Woods", "doi": "10.1001/jama.2026.14762", "url": "https://doi.org/10.1001/jama.2026.14762", "summary": "藥師重點：結論顯示 doravirine/lamivudine/TDF 可在維持病毒抑制下減少體重增加，但需權衡骨密度下降與 doravirine resistance 風險；藥師應依病人心代謝與骨骼風險個別化評估。", "pubDate": "2026-07-31", "terms": [ "initial", "adults", "treatment-associated", "weight", "gain", "opti-dor", "jama", "woods", "tenofovir", "alafenamide" ], "drugTerms": [ "tenofovir", "dolutegravir", "bictegravir", "spine" ], "searchText": "initial hiv therapy for adults and treatment-associated weight gain: the opti-dor randomized clinical trial jama original article woods 10.1001/jama.2026.14762 研究背景：初始 art 尤其含 tenofovir alafenamide 與 dolutegravir 或 bictegravir 的療程常伴隨明顯體重增加，可能加重心代謝風險。 研究方法：opti-dor 為開放標籤、noninferiority 隨機試驗，於南非納入 600 名 art-naive 成人，比較 doravirine/lamivudine/tenofovir disoproxil fumarate 與 dolutegravir/emtricitabine/tenofovir alafenamide；主要終點為第 48 週 hiv rna <50 copies/ml 比例，關鍵次要終點包括體重、身體組成與安全性。 主要結果：第 48 週病毒抑制率分別為 89.0% 與 90.7%，組間差異 -1.7 個百分點（95% ci -6.6 至 3.1），符合 noninferiority。體重中位增加 3.0 kg 與 5.0 kg，差異 -2.0 kg（95% ci -3.0 至 -1.0；p<.001）；但 doravirine/lamivudine/tdf 組 hip 與 spine bone mineral density 下降較多，且 virologic failure 時有 doravirine resistance 產生。 藥師重點：結論顯示 doravirine/lamivudine/tdf 可在維持病毒抑制下減少體重增加，但需權衡骨密度下降與 doravirine resistance 風險；藥師應依病人心代謝與骨骼風險個別化評估。" }, { "id": "pmid-42532080", "kind": "article", "issueId": "2026-week31", "year": 2026, "week": 31, "weekLabel": "第 31 週", "dateRange": "2026/07/27 – 08/02", "href": "2026-week31.html", "title": "Efficacy and safety of once-weekly subcutaneous zenagamtide, a novel unimolecular GLP-1 and amylin receptor agonist, in type 2 diabetes: a multicentre, randomised, parallel, double-blind, placebo-controlled, dose-finding, phase 2 trial", "journal": "Lancet", "type": "OA", "typeLabel": "Original Article", "author": "Mora", "doi": "10.1016/S0140-6736(26)01248-1", "url": "https://doi.org/10.1016/S0140-6736(26)01248-1", "summary": "藥師重點：結論顯示 once-weekly subcutaneous zenagamtide 具劑量相關降糖效果；藥師需協助劑量遞增衛教、監測胃腸道耐受性，並留意目前仍屬早期劑量探索證據。", "pubDate": "2026-07-30", "terms": [ "efficacy", "once-weekly", "subcutaneous", "zenagamtide", "novel", "unimolecular", "glp-1", "amylin", "receptor", "agonist" ], "drugTerms": [ "glp-1", "glp-1-based" ], "searchText": "efficacy and safety of once-weekly subcutaneous zenagamtide, a novel unimolecular glp-1 and amylin receptor agonist, in type 2 diabetes: a multicentre, randomised, parallel, double-blind, placebo-controlled, dose-finding, phase 2 trial lancet original article mora 10.1016/s0140-6736(26)01248-1 研究背景：zenagamtide 為同時作用於 glp-1、amylin 與 calcitonin receptor 的新型勝肽，是否能改善第二型糖尿病控制並維持可接受安全性，值得評估。 研究方法：此多中心、隨機、雙盲、placebo 對照、dose-finding phase 2 試驗於 11 國納入 262 名第二型糖尿病成人，於 metformin 合併或不合併 sglt2 inhibitor 背景下，比較 once-weekly subcutaneous zenagamtide 六種劑量與 placebo，主要終點為第 36 週 hba1c 變化。 主要結果：第 36 週 hba1c 降幅隨劑量增加，從 0.4 mg 組的 -0.9% 到 40 mg 組的 -1.7%；相較 placebo 的 estimated treatment difference 為 -0.77% 至 -1.56%，皆達統計顯著。多數不良事件為輕至中度胃腸道症狀，261 名接受治療者中有 21 人（8%）出現 serious adverse events，未見死亡。 藥師重點：結論顯示 once-weekly subcutaneous zenagamtide 具劑量相關降糖效果；藥師需協助劑量遞增衛教、監測胃腸道耐受性，並留意目前仍屬早期劑量探索證據。" }, { "id": "pmid-42532079", "kind": "article", "issueId": "2026-week31", "year": 2026, "week": 31, "weekLabel": "第 31 週", "dateRange": "2026/07/27 – 08/02", "href": "2026-week31.html", "title": "Efficacy and safety of once-daily oral zenagamtide, a novel unimolecular GLP-1 and amylin receptor agonist, in adults with type 2 diabetes: a multicentre, randomised, parallel, double-blind, placebo-controlled, dose-finding, phase 2 trial", "journal": "Lancet", "type": "OA", "typeLabel": "Original Article", "author": "Mora", "doi": "10.1016/S0140-6736(26)01247-X", "url": "https://doi.org/10.1016/S0140-6736(26)01247-X", "summary": "藥師重點：研究結果說明 oral zenagamtide 具潛在降糖效益，但胃腸道耐受性呈劑量相關；藥師應加強服藥衛教與不良反應監測，並審慎解讀其長期安全性。", "pubDate": "2026-07-30", "terms": [ "efficacy", "once-daily", "oral", "zenagamtide", "novel", "unimolecular", "glp-1", "amylin", "receptor", "agonist" ], "drugTerms": [ "glp-1" ], "searchText": "efficacy and safety of once-daily oral zenagamtide, a novel unimolecular glp-1 and amylin receptor agonist, in adults with type 2 diabetes: a multicentre, randomised, parallel, double-blind, placebo-controlled, dose-finding, phase 2 trial lancet original article mora 10.1016/s0140-6736(26)01247-x 研究背景：若能以口服 glp-1/amylin 受體促效劑改善血糖，可能提升部分第二型糖尿病患者對治療的接受度與持續性。 研究方法：此多中心、隨機、雙盲、placebo 對照、dose-finding phase 2 試驗納入 186 名第二型糖尿病成人，比較 once-daily oral zenagamtide 6、25、50 mg 與 placebo，主要終點為第 36 週 hba1c 變化。 主要結果：第 36 週 oral zenagamtide 6、25、50 mg 的 estimated treatment difference 相較 placebo 分別為 -0.5%、-0.99%、-1.09%，皆達統計顯著。胃腸道不良事件最常見，發生率隨劑量上升；7 名使用 zenagamtide 的患者通報 serious adverse events，placebo 組未見，試驗期間無死亡。 藥師重點：研究結果說明 oral zenagamtide 具潛在降糖效益，但胃腸道耐受性呈劑量相關；藥師應加強服藥衛教與不良反應監測，並審慎解讀其長期安全性。" }, { "id": "pmid-42526472", "kind": "article", "issueId": "2026-week31", "year": 2026, "week": 31, "weekLabel": "第 31 週", "dateRange": "2026/07/27 – 08/02", "href": "2026-week31.html", "title": "Deramiocel heart-derived cellular therapy in advanced Duchenne muscular dystrophy (HOPE-3): a phase 3, randomised, double-blind, placebo-controlled trial", "journal": "Lancet", "type": "OA", "typeLabel": "Original Article", "author": "McDonald", "doi": "10.1016/S0140-6736(26)01385-1", "url": "https://doi.org/10.1016/S0140-6736(26)01385-1", "summary": "藥師重點：研究結果說明 deramiocel 可能延緩 advanced DMD 的上肢功能惡化；藥師需注意細胞治療的給藥流程、追蹤安排與長期安全性資料仍待持續累積。", "pubDate": "2026-07-29", "terms": [ "deramiocel", "heart-derived", "cellular", "advanced", "duchenne", "muscular", "dystrophy", "hope-3", "phase", "randomised" ], "drugTerms": [], "searchText": "deramiocel heart-derived cellular therapy in advanced duchenne muscular dystrophy (hope-3): a phase 3, randomised, double-blind, placebo-controlled trial lancet original article mcdonald 10.1016/s0140-6736(26)01385-1 研究背景：advanced duchenne muscular dystrophy（dmd）患者隨病程進展常出現上肢與心肌功能惡化，deramiocel 是否能延緩功能下降，是少見病治療的重要問題。 研究方法：hope-3 為 phase 3、多中心、隨機、雙盲、placebo 對照試驗，納入 106 名 10 歲以上 dmd 患者，每 3 個月門診靜脈輸注 deramiocel 或 placebo，評估 12 個月後的總 pul2.0 百分比變化。 主要結果：deramiocel 組在主要終點 total pul2.0 百分比變化上優於 placebo，least-squares mean 差異為 4.55%（95% ci 0.47-8.63；p=0.029）。整體安全性與 placebo 相近。 藥師重點：研究結果說明 deramiocel 可能延緩 advanced dmd 的上肢功能惡化；藥師需注意細胞治療的給藥流程、追蹤安排與長期安全性資料仍待持續累積。" }, { "id": "pmid-42530910", "kind": "article", "issueId": "2026-week31", "year": 2026, "week": 31, "weekLabel": "第 31 週", "dateRange": "2026/07/27 – 08/02", "href": "2026-week31.html", "title": "Dapagliflozin and Acute Kidney Injury Following Cardiac Surgery: A Randomized Clinical Trial", "journal": "JAMA", "type": "OA", "typeLabel": "Original Article", "author": "Oosterom-Eijmael", "doi": "10.1001/jama.2026.9268", "url": "https://doi.org/10.1001/jama.2026.9268", "summary": "藥師重點：結論顯示短期圍手術期使用 dapagliflozin 可能降低 elective cardiac surgery 後 AKI 風險；藥師仍需配合手術流程評估適用族群，並持續監測腎功能、血流動力與整體圍術期用藥安全。", "pubDate": "2026-07-30", "terms": [ "dapagliflozin", "acute", "kidney", "injury", "following", "cardiac", "surgery", "jama", "oosterom-eijmael", "placebo" ], "drugTerms": [ "dapagliflozin" ], "searchText": "dapagliflozin and acute kidney injury following cardiac surgery: a randomized clinical trial jama original article oosterom-eijmael 10.1001/jama.2026.9268 研究背景：心臟手術後急性腎損傷（aki）常見且影響預後，目前仍缺乏已確認有效的圍手術期預防藥物策略。 研究方法：此多中心、雙盲、placebo 對照隨機試驗於荷蘭 7 家醫院納入 784 名接受 elective cardiac surgery 的成人，術前 1 天起至術後第 2 天給予 dapagliflozin 10 mg 或 placebo 共 4 劑；主要終點為術後 7 天內依 kdigo 定義發生 aki 的比例。 主要結果：dapagliflozin 組 aki 發生率為 28%，低於 placebo 組的 52%（rr 0.54，95% ci 0.45-0.65；p<.001）。兩組心房顫動與再次手術發生率相近，分別約為 45% 與 10%-11%。 藥師重點：結論顯示短期圍手術期使用 dapagliflozin 可能降低 elective cardiac surgery 後 aki 風險；藥師仍需配合手術流程評估適用族群，並持續監測腎功能、血流動力與整體圍術期用藥安全。" }, { "id": "pmid-42526943", "kind": "article", "issueId": "2026-week31", "year": 2026, "week": 31, "weekLabel": "第 31 週", "dateRange": "2026/07/27 – 08/02", "href": "2026-week31.html", "title": "Antithrombotic treatment for migraine in patients with patent foramen ovale: multicentre, randomised, active controlled, open label trial", "journal": "BMJ", "type": "RCT", "typeLabel": "RCT", "author": "Li", "doi": "10.1136/bmj-2026-100103", "url": "https://doi.org/10.1136/bmj-2026-100103", "summary": "藥師重點：結論顯示 PFO 合併偏頭痛患者可考慮抗血栓治療作為預防選項，尤其 rivaroxaban 效果較佳；藥師仍需評估出血風險、併用藥物與是否適合長期使用抗血栓藥。", "pubDate": "2026-07-29", "terms": [ "antithrombotic", "migraine", "patent", "foramen", "ovale", "multicentre", "randomised", "active", "open", "label" ], "drugTerms": [ "clopidogrel", "rivaroxaban", "metoprolol" ], "searchText": "antithrombotic treatment for migraine in patients with patent foramen ovale: multicentre, randomised, active controlled, open label trial bmj rct li 10.1136/bmj-2026-100103 研究背景：卵圓孔未閉（pfo）合併偏頭痛患者的預防治療選擇有限，抗血栓治療是否能降低偏頭痛發作且兼顧安全性仍待釐清。 研究方法：此研究為多中心、前瞻性、隨機、開放標籤、主動對照試驗，共納入 984 名 18-64 歲且每月至少有 4 天偏頭痛的 pfo 成人，分派接受 aspirin、clopidogrel、rivaroxaban 或 metoprolol 治療 12 週，主要終點為第 9-12 週偏頭痛天數或發作次數降低至少 50% 的比例。 主要結果：aspirin、clopidogrel 與 rivaroxaban 對主要終點皆不劣於 metoprolol；反應率分別為 61.7%、66.8%、78.4% 與 61.8%。其中 rivaroxaban 的反應率優於 metoprolol，絕對差異 16.2%（98.33% ci 6.0-26.4；p<0.001），且未發生 major bleeding。 藥師重點：結論顯示 pfo 合併偏頭痛患者可考慮抗血栓治療作為預防選項，尤其 rivaroxaban 效果較佳；藥師仍需評估出血風險、併用藥物與是否適合長期使用抗血栓藥。" }, { "id": "pmid-42526949", "kind": "article", "issueId": "2026-week31", "year": 2026, "week": 31, "weekLabel": "第 31 週", "dateRange": "2026/07/27 – 08/02", "href": "2026-week31.html", "title": "Antihistamines for atopic dermatitis (eczema): systematic review and network meta-analysis of randomised trials", "journal": "BMJ", "type": "MA", "typeLabel": "Meta-analysis", "author": "Chu", "doi": "10.1136/bmj-2026-100163", "url": "https://doi.org/10.1136/bmj-2026-100163", "summary": "藥師重點：研究結果說明 routine 使用 antihistamines 治療異位性皮膚炎的臨床效益有限，藥師應避免將其視為標準止癢策略，並特別留意第一代藥物的鎮靜與認知副作用。", "pubDate": "2026-07-29", "terms": [ "antihistamines", "atopic", "dermatitis", "eczema", "network", "meta-analysis", "randomised", "trials", "bmj-2026-100163", "blockers" ], "drugTerms": [], "searchText": "antihistamines for atopic dermatitis (eczema): systematic review and network meta-analysis of randomised trials bmj meta-analysis chu 10.1136/bmj-2026-100163 研究背景：口服 antihistamines 常被加用於異位性皮膚炎止癢，但其對疾病嚴重度、搔癢與睡眠的實際效益及風險仍有爭議。 研究方法：此系統性回顧與 network meta-analysis 納入 47 項隨機試驗、共 6230 名兒童與成人，比較 h1 antihistamines、h2 blockers、mast cell stabilisers 或其合併治療作為 add-on therapy 的效果與危害，並以 grade 評估證據確定性。 主要結果：相較 placebo，第一代或第二代 h1 antihistamines 對異位性皮膚炎嚴重度與搔癢僅帶來小幅下降，平均差異分別為 -1.87 與 -0.89，均低於臨床重要差異門檻。各介入對睡眠障礙與急性惡化未見明確改善；第一代藥物可能增加 cognitive impairment，且因不良反應停藥的風險較高。 藥師重點：研究結果說明 routine 使用 antihistamines 治療異位性皮膚炎的臨床效益有限，藥師應避免將其視為標準止癢策略，並特別留意第一代藥物的鎮靜與認知副作用。" }, { "id": "fda-2026-week31-3", "kind": "fda", "issueId": "2026-week31", "year": 2026, "week": 31, "weekLabel": "第 31 週", "dateRange": "2026/07/27 – 08/02", "href": "2026-week31.html", "title": "FDA 警示具母系委內瑞拉血統病人使用 sevoflurane 等揮發性麻醉藥的神經學風險", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fda-alerts-health-care-providers-cases-neurologic-complications-general-anesthesia-linked-genetic", "summary": "FDA 正調查具母系委內瑞拉血統患者在接受 sevoflurane 等全身麻醉後發生嚴重神經學不良反應甚至死亡的案例，可能與罕見粒線體變異 MT-ND4 m.11232T>C 有關。藥師與麻醉團隊應留意相關病史，必要時評估 intravenous anesthetics 或 regional anesthesia 等替代方案。", "terms": [ "sevoflurane", "mt-nd4", "intravenous", "anesthetics", "regional", "anesthesia", "https", "drugs", "drug-alerts-and-statements", "fda-alerts-health-care-providers-cases-neurologic-complications-general-anesthesia-linked-genetic" ], "drugTerms": [], "searchText": "fda 警示具母系委內瑞拉血統病人使用 sevoflurane 等揮發性麻醉藥的神經學風險 fda drug safety 2026-07-02 fda 正調查具母系委內瑞拉血統患者在接受 sevoflurane 等全身麻醉後發生嚴重神經學不良反應甚至死亡的案例，可能與罕見粒線體變異 mt-nd4 m.11232t>c 有關。藥師與麻醉團隊應留意相關病史，必要時評估 intravenous anesthetics 或 regional anesthesia 等替代方案。 https://www.fda.gov/drugs/drug-alerts-and-statements/fda-alerts-health-care-providers-cases-neurologic-complications-general-anesthesia-linked-genetic" }, { "id": "fda-2026-week31-1", "kind": "fda", "issueId": "2026-week31", "year": 2026, "week": 31, "weekLabel": "第 31 週", "dateRange": "2026/07/27 – 08/02", "href": "2026-week31.html", "title": "FDA 發布特定 generic peptide products 修訂版 draft PSGs", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fda-publishes-revised-draft-product-specific-guidances-certain-generic-peptide-products", "summary": "FDA 發布 17 項 peptide products 修訂版 draft product-specific guidances，涵蓋 liraglutide、semaglutide、tirzepatide 等藥品的 ANDA 開發要求，更新重點包含免疫反應、雜質門檻、高階結構與生物活性評估。藥師可留意後續學名藥可近性與院內同成分產品供應變化。", "terms": [ "generic", "peptide", "products", "draft", "psgs", "product-specific", "guidances", "liraglutide", "semaglutide", "tirzepatide" ], "drugTerms": [ "liraglutide", "semaglutide", "tirzepatide" ], "searchText": "fda 發布特定 generic peptide products 修訂版 draft psgs fda drug safety 2026-07-28 fda 發布 17 項 peptide products 修訂版 draft product-specific guidances，涵蓋 liraglutide、semaglutide、tirzepatide 等藥品的 anda 開發要求，更新重點包含免疫反應、雜質門檻、高階結構與生物活性評估。藥師可留意後續學名藥可近性與院內同成分產品供應變化。 https://www.fda.gov/drugs/drug-alerts-and-statements/fda-publishes-revised-draft-product-specific-guidances-certain-generic-peptide-products" }, { "id": "fda-2026-week31-2", "kind": "fda", "issueId": "2026-week31", "year": 2026, "week": 31, "weekLabel": "第 31 週", "dateRange": "2026/07/27 – 08/02", "href": "2026-week31.html", "title": "FDA 核准首批 Gilotrif（afatinib）學名藥錠劑", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fda-approves-first-generics-gilotrif-afatinib-tablets", "summary": "FDA 核准首批 afatinib 學名藥，可用於具非抗藥性 EGFR mutation 的 metastatic NSCLC 第一線治療，以及 platinum-based chemotherapy 後進展的 metastatic squamous NSCLC。藥師需持續留意腹瀉、皮膚毒性、ILD、肝毒性與角膜炎等既有警示，並確認病人檢測與劑量資訊。", "terms": [ "gilotrif", "afatinib", "egfr", "mutation", "metastatic", "nsclc", "platinum-based", "chemotherapy", "squamous", "https" ], "drugTerms": [ "afatinib" ], "searchText": "fda 核准首批 gilotrif（afatinib）學名藥錠劑 fda drug safety 2026-07-14 fda 核准首批 afatinib 學名藥，可用於具非抗藥性 egfr mutation 的 metastatic nsclc 第一線治療，以及 platinum-based chemotherapy 後進展的 metastatic squamous nsclc。藥師需持續留意腹瀉、皮膚毒性、ild、肝毒性與角膜炎等既有警示，並確認病人檢測與劑量資訊。 https://www.fda.gov/drugs/drug-alerts-and-statements/fda-approves-first-generics-gilotrif-afatinib-tablets" }, { "id": "pmid-42492562", "kind": "article", "issueId": "2026-week30", "year": 2026, "week": 30, "weekLabel": "第 30 週", "dateRange": "2026/07/20 – 07/26", "href": "2026-week30.html", "title": "Oral step-down, optimal drug, and total duration of antibiotic treatment in African children hospitalised with severe community-acquired pneumonia (PediCAP): a factorial randomised controlled trial", "journal": "Lancet", "type": "RCT", "typeLabel": "RCT", "author": "Bielicki", "doi": "10.1016/S0140-6736(26)00879-2", "url": "https://doi.org/10.1016/S0140-6736(26)00879-2", "summary": "藥師重點：研究結果說明對無複雜因素且臨床已改善的重症社區型肺炎兒童，初始靜脈治療後可考慮轉用口服 amoxicillin，總療程 4-5 天可能足夠；藥師仍需確認病情改善、口服能力、體重劑量與再住院風險。", "pubDate": "2026-08-08", "terms": [ "oral", "step-down", "optimal", "total", "duration", "antibiotic", "african", "children", "hospitalised", "severe" ], "drugTerms": [ "amoxicillin" ], "searchText": "oral step-down, optimal drug, and total duration of antibiotic treatment in african children hospitalised with severe community-acquired pneumonia (pedicap): a factorial randomised controlled trial lancet rct bielicki 10.1016/s0140-6736(26)00879-2 研究背景：重症社區型肺炎兒童通常接受靜脈抗生素治療，臨床上仍需釐清改善後轉換口服藥物的選擇與最短有效療程。 研究方法：pedicap 為開放標籤、平行組、2×5 factorial 隨機試驗，於撒哈拉以南非洲 5 國 13 家醫院納入 2 個月至 6 歲、無複雜因素的重症社區型肺炎兒童 1101 人；比較臨床改善後轉用口服 amoxicillin 或 amoxicillin-clavulanate，以及總療程 4-8 天，主要終點為第 28 天再住院或死亡。 主要結果：口服 step-down 後，amoxicillin、amoxicillin-clavulanate 與 5 天全程靜脈治療的主要終點分別為 5.6%、6.9% 與 6.3%，兩種口服策略皆達 non-inferiority，且未顯示 amoxicillin-clavulanate 優於 amoxicillin。總療程 4-8 天皆不劣於 8 天；抗生素相關或嚴重不良事件會隨隨機分派的療程延長而增加。 藥師重點：研究結果說明對無複雜因素且臨床已改善的重症社區型肺炎兒童，初始靜脈治療後可考慮轉用口服 amoxicillin，總療程 4-5 天可能足夠；藥師仍需確認病情改善、口服能力、體重劑量與再住院風險。" }, { "id": "pmid-42492960", "kind": "article", "issueId": "2026-week30", "year": 2026, "week": 30, "weekLabel": "第 30 週", "dateRange": "2026/07/20 – 07/26", "href": "2026-week30.html", "title": "Minimal detectable change of the Patient Health Questionnaire-9, Patient Health Questionnaire-8, and Patient Health Questionnaire-2: individual patient data meta-analysis", "journal": "BMJ", "type": "MA", "typeLabel": "Meta-analysis", "author": "Wang", "doi": "10.1136/bmj-2026-100119", "url": "https://doi.org/10.1136/bmj-2026-100119", "summary": "藥師重點：研究結果說明評估抗憂鬱藥療效時，PHQ 分數小幅變化不一定代表真正改善；藥師可搭配約 6 分的 PHQ-9 變化作為一般醫療環境的參考，但仍需結合症狀、功能與治療情境判讀。", "pubDate": "2026-07-23", "terms": [ "minimal", "detectable", "change", "questionnaire-9", "questionnaire-8", "questionnaire-2", "individual", "meta-analysis", "wang", "bmj-2026-100119" ], "drugTerms": [], "searchText": "minimal detectable change of the patient health questionnaire-9, patient health questionnaire-8, and patient health questionnaire-2: individual patient data meta-analysis bmj meta-analysis wang 10.1136/bmj-2026-100119 研究背景：phq-9、phq-8 與 phq-2 常用於追蹤憂鬱症狀，但分數變化需超過測量誤差，才能判定為真正的臨床改變。 研究方法：此 individual participant data meta-analysis 整合 94-98 項研究與 42,548-44,085 名成人資料，以 random-effects meta-analysis 估算 phq-9、phq-8 與 phq-2 在不同信心水準下的 minimal detectable change（mdc）。 主要結果：在 95% 信心水準下，phq-9、phq-8 與 phq-2 的 mdc 分別為 5.72、5.51 與 2.26 分；phq-9 在住院醫療環境最高，為 6.48 分。phq-9 分數約增加 6 分，可能較能代表一般醫療環境中的真實改變；專科精神醫療可考慮較高門檻。 藥師重點：研究結果說明評估抗憂鬱藥療效時，phq 分數小幅變化不一定代表真正改善；藥師可搭配約 6 分的 phq-9 變化作為一般醫療環境的參考，但仍需結合症狀、功能與治療情境判讀。" }, { "id": "pmid-42475062", "kind": "article", "issueId": "2026-week30", "year": 2026, "week": 30, "weekLabel": "第 30 週", "dateRange": "2026/07/20 – 07/26", "href": "2026-week30.html", "title": "Implications of the 2026 Dyslipidemia Guideline for Primary Prevention Statin Therapy", "journal": "JAMA", "type": "OA", "typeLabel": "Original Article", "author": "Anderson", "doi": "10.1001/jama.2026.11246", "url": "https://doi.org/10.1001/jama.2026.11246", "summary": "藥師重點：研究結果說明 2026 dyslipidemia guideline 將 primary prevention statin 適用範圍擴大至較多低風險族群；藥師應協助確認 guideline 版本、ASCVD risk 計算、年齡與共病，並與病人討論預期效益及長期用藥需求。", "pubDate": "2026-08-18", "terms": [ "implications", "dyslipidemia", "guideline", "prevention", "statin", "jama", "anderson", "ascvd", "population", "nhanes" ], "drugTerms": [ "statin" ], "searchText": "implications of the 2026 dyslipidemia guideline for primary prevention statin therapy jama original article anderson 10.1001/jama.2026.11246 研究背景：2026 dyslipidemia guideline 更新 ascvd 風險估算與 primary prevention statin 適用族群，可能擴大需要評估或接受 statin 的成人數量。 研究方法：此橫斷面 population analysis 使用 2017-2023 年 nhanes 資料，納入 30-79 歲且無已知 ascvd 的未懷孕成人 4366 人，估算 2026 與 2018 lipid guideline 對 primary prevention statin eligibility 的影響。 主要結果：4366 名受試者代表約 1.545 億名美國成人；依 2026 guideline，估計 8750 萬人（56.6%）符合 statin eligibility，其中 2150 萬人（13.9%）為新符合。新符合者的平均 10 年 ascvd risk 為 3.1%，低於原已符合者的 6.1%；70-79 歲與 60-69 歲族群符合比例分別超過 93% 與 85%。 藥師重點：研究結果說明 2026 dyslipidemia guideline 將 primary prevention statin 適用範圍擴大至較多低風險族群；藥師應協助確認 guideline 版本、ascvd risk 計算、年齡與共病，並與病人討論預期效益及長期用藥需求。" }, { "id": "pmid-42486133", "kind": "article", "issueId": "2026-week30", "year": 2026, "week": 30, "weekLabel": "第 30 週", "dateRange": "2026/07/20 – 07/26", "href": "2026-week30.html", "title": "High-dose chemotherapy followed by autologous stem-cell transplantation versus non-myeloablative consolidation in primary CNS lymphoma (MATRix/IELSG43): a randomised phase 3 trial", "journal": "Lancet", "type": "RCT", "typeLabel": "RCT", "author": "Illerhaus", "doi": "10.1016/S0140-6736(26)00917-7", "url": "https://doi.org/10.1016/S0140-6736(26)00917-7", "summary": "藥師重點：結論顯示對完成 induction 且身體狀況適合的 PCNSL 患者，HCT-ASCT 可改善無惡化存活；藥師需留意高劑量治療後感染、肺栓塞、骨髓抑制與移植支持療法相關風險。", "pubDate": "2026-08-08", "terms": [ "high-dose", "chemotherapy", "followed", "autologous", "stem-cell", "transplantation", "non-myeloablative", "consolidation", "lymphoma", "matrix" ], "drugTerms": [ "rituximab", "methotrexate", "carboplatin" ], "searchText": "high-dose chemotherapy followed by autologous stem-cell transplantation versus non-myeloablative consolidation in primary cns lymphoma (matrix/ielsg43): a randomised phase 3 trial lancet rct illerhaus 10.1016/s0140-6736(26)00917-7 研究背景：初診原發性中樞神經系統淋巴瘤（pcnsl）的鞏固治療可採高劑量化學治療合併自體造血幹細胞移植，但相較非骨髓破壞性 chemoimmunotherapy 的療效與安全性仍不確定。 研究方法：此開放標籤、隨機、phase 3 試驗於歐洲 5 國 56 家醫院進行；患者先接受 4 個療程 matrix induction，達至少部分反應後，隨機接受 2 個療程 r-devic 或含 carmustine 與 thiotepa 的高劑量治療合併自體造血幹細胞移植（hct-asct），主要終點為 progression-free survival。 主要結果：共 368 人接受評估，230 人進入隨機分組，229 人納入分析；中位追蹤 45.3 個月後，hct-asct 組 3 年 progression-free survival 為 78%，高於 r-devic 組 51%（hr 0.43，95% ci 0.27-0.68；p=0.0003）。hct-asct 組每人平均不良事件較多（14.6 vs 9.3），治療後致死性嚴重不良事件為 5 例 vs 2 例。 藥師重點：結論顯示對完成 induction 且身體狀況適合的 pcnsl 患者，hct-asct 可改善無惡化存活；藥師需留意高劑量治療後感染、肺栓塞、骨髓抑制與移植支持療法相關風險。" }, { "id": "pmid-42485627", "kind": "article", "issueId": "2026-week30", "year": 2026, "week": 30, "weekLabel": "第 30 週", "dateRange": "2026/07/20 – 07/26", "href": "2026-week30.html", "title": "Enfortumab Vedotin and Pembrolizumab in Cisplatin-Eligible Bladder Cancer", "journal": "NEJM", "type": "RCT", "typeLabel": "RCT", "author": "Galsky", "doi": "10.1056/NEJMoa2601486", "url": "https://doi.org/10.1056/NEJMoa2601486", "summary": "藥師重點：結論顯示 perioperative enfortumab vedotin-pembrolizumab 可改善符合 cisplatin 條件之肌肉浸潤性膀胱癌患者的無事件及整體存活，但高嚴重度不良反應較多；藥師需協助評估治療適用性、免疫相關毒性與 enfortumab vedotin 的安全性監測。", "pubDate": "2026-07-23", "terms": [ "enfortumab", "vedotin", "pembrolizumab", "cisplatin-eligible", "bladder", "cancer", "nejm", "galsky", "nejmoa2601486", "cisplatin-based" ], "drugTerms": [ "enfortumab", "pembrolizumab", "vedotin-pembrolizumab", "cisplatin" ], "searchText": "enfortumab vedotin and pembrolizumab in cisplatin-eligible bladder cancer nejm rct galsky 10.1056/nejmoa2601486 研究背景：肌肉浸潤性膀胱癌目前常以 cisplatin-based chemotherapy 作為術前治療，但 perioperative enfortumab vedotin-pembrolizumab 的療效與安全性是否優於傳統治療仍待確認。 研究方法：此 phase 3、開放標籤、隨機試驗納入可接受 cisplatin 與根治性膀胱切除術的成人，分派接受 perioperative enfortumab vedotin-pembrolizumab（術前 4 個療程、術後 enfortumab vedotin 5 個療程及 pembrolizumab 13 個療程）或術前 cisplatin-gemcitabine 4 個療程後手術；主要終點為 event-free survival。 主要結果：enfortumab vedotin-pembrolizumab 組與 cisplatin-gemcitabine 組各納入 405 與 403 人；2 年 event-free survival 為 79.4% vs 66.2%（hr 0.53，95% ci 0.41-0.70；p<0.001），overall survival 為 86.9% vs 81.3%（hr 0.65，95% ci 0.48-0.89；p=0.006），pathological complete response 為 55.8% vs 32.5%。但 grade ≥3 adverse events 為 75.7% vs 67.2%。 藥師重點：結論顯示 perioperative enfortumab vedotin-pembrolizumab 可改善符合 cisplatin 條件之肌肉浸潤性膀胱癌患者的無事件及整體存活，但高嚴重度不良反應較多；藥師需協助評估治療適用性、免疫相關毒性與 enfortumab vedotin 的安全性監測。" }, { "id": "pmid-42492944", "kind": "article", "issueId": "2026-week30", "year": 2026, "week": 30, "weekLabel": "第 30 週", "dateRange": "2026/07/20 – 07/26", "href": "2026-week30.html", "title": "Early treatment with rasburicase and risk of kidney replacement therapy and death in adults with tumour lysis syndrome: emulated target trial", "journal": "BMJ", "type": "OA", "typeLabel": "Original Article", "author": "Shenoy", "doi": "10.1136/bmj-2026-100040", "url": "https://doi.org/10.1136/bmj-2026-100040", "summary": "藥師重點：研究結果說明 TLS 發生後早期使用 rasburicase 可能降低嚴重急性腎損傷或死亡風險；藥師應協助及早辨識高風險患者、確認給藥時機，並監測 uric acid、腎功能與溶血風險。", "pubDate": "2026-07-23", "terms": [ "early", "rasburicase", "kidney", "replacement", "death", "adults", "tumour", "lysis", "syndrome", "emulated" ], "drugTerms": [], "searchText": "early treatment with rasburicase and risk of kidney replacement therapy and death in adults with tumour lysis syndrome: emulated target trial bmj original article shenoy 10.1136/bmj-2026-100040 研究背景：tumour lysis syndrome（tls）可能造成高尿酸血症、急性腎損傷與死亡，rasburicase 是否應在 tls 發生後儘早使用仍需真實世界資料支持。 研究方法：此 emulated target trial 使用美國 36 家醫院 1276 名成人資料，比較 tls 發生後 12 小時內接受 rasburicase 與延後或未接受治療者；以 inverse probability of treatment weighting 調整混雜，主要終點為住院期間需 kidney replacement therapy 的急性腎損傷或死亡。 主要結果：705 人於 tls 發生後 12 小時內接受 rasburicase，中位給藥時間為 5.0 小時。早期治療組主要終點發生率為 32.7%，低於未早期治療組的 42.0%（adjusted or 0.67，95% ci 0.52-0.88；p<0.001）；90 天死亡率結果一致（adjusted or 0.71，95% ci 0.54-0.94）。 藥師重點：研究結果說明 tls 發生後早期使用 rasburicase 可能降低嚴重急性腎損傷或死亡風險；藥師應協助及早辨識高風險患者、確認給藥時機，並監測 uric acid、腎功能與溶血風險。" }, { "id": "fda-2026-week30-2", "kind": "fda", "issueId": "2026-week30", "year": 2026, "week": 30, "weekLabel": "第 30 週", "dateRange": "2026/07/20 – 07/26", "href": "2026-week30.html", "title": "FDA Publishes Revised Draft Product-Specific Guidances for Certain Generic Peptide Products", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fda-publishes-revised-draft-product-specific-guidances-certain-generic-peptide-products", "summary": "FDA 修訂 17 項 peptide products 的產品特定指引草案（PSGs），供學名藥開發與 abbreviated new drug applications（ANDAs）準備資料時參考。藥師可留意相關 peptide products 的未來學名藥申請與替代性證據要求。", "terms": [ "publishes", "revised", "draft", "product-specific", "guidances", "certain", "generic", "peptide", "products", "psgs" ], "drugTerms": [], "searchText": "fda publishes revised draft product-specific guidances for certain generic peptide products fda drug safety 2026-07-28 fda 修訂 17 項 peptide products 的產品特定指引草案（psgs），供學名藥開發與 abbreviated new drug applications（andas）準備資料時參考。藥師可留意相關 peptide products 的未來學名藥申請與替代性證據要求。 https://www.fda.gov/drugs/drug-alerts-and-statements/fda-publishes-revised-draft-product-specific-guidances-certain-generic-peptide-products" }, { "id": "fda-2026-week30-1", "kind": "fda", "issueId": "2026-week30", "year": 2026, "week": 30, "weekLabel": "第 30 週", "dateRange": "2026/07/20 – 07/26", "href": "2026-week30.html", "title": "FDA Publishes New Product-Specific Guidances to Facilitate Generic Drug Development", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fda-publishes-new-product-specific-guidances-facilitate-generic-drug-development", "summary": "FDA 發布新一批 generic drug 的產品特定指引草案（PSGs），說明如何為 abbreviated new drug applications（ANDAs）建立開發與證據資料。藥師可留意未來學名藥審查與生體相等性資料要求的變化。", "terms": [ "publishes", "product-specific", "guidances", "facilitate", "generic", "development", "psgs", "abbreviated", "applications", "andas" ], "drugTerms": [], "searchText": "fda publishes new product-specific guidances to facilitate generic drug development fda drug safety 2026-08-21 fda 發布新一批 generic drug 的產品特定指引草案（psgs），說明如何為 abbreviated new drug applications（andas）建立開發與證據資料。藥師可留意未來學名藥審查與生體相等性資料要求的變化。 https://www.fda.gov/drugs/drug-alerts-and-statements/fda-publishes-new-product-specific-guidances-facilitate-generic-drug-development" }, { "id": "fda-2026-week30-3", "kind": "fda", "issueId": "2026-week30", "year": 2026, "week": 30, "weekLabel": "第 30 週", "dateRange": "2026/07/20 – 07/26", "href": "2026-week30.html", "title": "FDA Approves First Generics of Gilotrif (afatinib) Tablets", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fda-approves-first-generics-gilotrif-afatinib-tablets", "summary": "FDA 核准首批 GILOTRIF（afatinib tablets）學名藥，用於腫瘤具有未產生抗藥性 EGFR mutations 的轉移性非小細胞肺癌（NSCLC）第一線治療。藥師可留意品項替代、適應症與 EGFR 檢測條件。", "terms": [ "approves", "first", "generics", "gilotrif", "afatinib", "tablets", "egfr", "mutations", "nsclc", "https" ], "drugTerms": [ "afatinib" ], "searchText": "fda approves first generics of gilotrif (afatinib) tablets fda drug safety 2026-07-14 fda 核准首批 gilotrif（afatinib tablets）學名藥，用於腫瘤具有未產生抗藥性 egfr mutations 的轉移性非小細胞肺癌（nsclc）第一線治療。藥師可留意品項替代、適應症與 egfr 檢測條件。 https://www.fda.gov/drugs/drug-alerts-and-statements/fda-approves-first-generics-gilotrif-afatinib-tablets" }, { "id": "pmid-42442374", "kind": "article", "issueId": "2026-week29", "year": 2026, "week": 29, "weekLabel": "第 29 週", "dateRange": "2026/07/13 – 07/19", "href": "2026-week29.html", "title": "Multidomain lifestyle intervention for the prevention of cognitive decline in at-risk older adults in Latin America (LatAm-FINGERS): a single-blind, multicentre, randomised controlled trial", "journal": "Lancet", "type": "OA", "typeLabel": "Original Article", "author": "Crivelli", "doi": "10.1016/S0140-6736(26)01278-X", "url": "https://doi.org/10.1016/S0140-6736(26)01278-X", "summary": "藥師重點：結論顯示經文化調整的多面向生活型態介入在拉丁美洲具可行性，且可進一步改善高風險高齡者的認知表現；藥師可將用藥整合、心血管風險控制與生活型態衛教納入失智預防團隊照護。", "pubDate": "2026-07-13", "terms": [ "multidomain", "lifestyle", "intervention", "prevention", "cognitive", "decline", "at-risk", "older", "adults", "latin" ], "drugTerms": [], "searchText": "multidomain lifestyle intervention for the prevention of cognitive decline in at-risk older adults in latin america (latam-fingers): a single-blind, multicentre, randomised controlled trial lancet original article crivelli 10.1016/s0140-6736(26)01278-x 研究背景：拉丁美洲失智症負擔高，且具認知退化風險的高齡族群長期在預防試驗中代表性不足，多面向生活型態介入能否在此族群落地仍待驗證。 研究方法：latam-fingers 為單盲、多中心隨機試驗，於 11 個拉丁美洲國家納入 60 至 77 歲、具高失智風險且認知表現未達最佳的受試者，1:1 分配至 2 年結構化多面向生活型態介入（sli）或較彈性的健康建議介入（fli）；主要評估可行性與 2 年全球認知綜合分數變化軌跡。 主要結果：1719 人接受評估後，1065 人進入分析並隨機分派；82.3% 完成 2 年追蹤，sli 組整體依從性為 71.6%。全球認知綜合分數每年變化在 sli 與 fli 組分別為 0.31 sd 與 0.20 sd，組間差異 0.11 sd/年（95% ci 0.06-0.15；p<0.0001）；嚴重不良事件為 9% 與 5%，且皆未被判定與介入相關。 藥師重點：結論顯示經文化調整的多面向生活型態介入在拉丁美洲具可行性，且可進一步改善高風險高齡者的認知表現；藥師可將用藥整合、心血管風險控制與生活型態衛教納入失智預防團隊照護。" }, { "id": "pmid-42461643", "kind": "article", "issueId": "2026-week29", "year": 2026, "week": 29, "weekLabel": "第 29 週", "dateRange": "2026/07/13 – 07/19", "href": "2026-week29.html", "title": "Hip Fractures: A Review", "journal": "JAMA", "type": "OA", "typeLabel": "Original Article", "author": "Johannesdottir", "doi": "10.1001/jama.2026.11895", "url": "https://doi.org/10.1001/jama.2026.11895", "summary": "藥師重點：此文強調 hip fracture 後照護不能只停在手術與止痛，藥師應主動檢視跌倒相關用藥、安排抗骨質疏鬆治療接軌，並依病人骨折風險與腎功能評估 antiresorptive 或 anabolic 藥物時機。", "pubDate": "2026-07-16", "terms": [ "fractures", "jama", "johannesdottir", "fracture", "antiresorptive", "anabolic", "bisphosphonates", "denosumab", "teriparatide", "abaloparatide" ], "drugTerms": [ "denosumab", "spine", "romosozumab" ], "searchText": "hip fractures: a review jama original article johannesdottir 10.1001/jama.2026.11895 研究背景：hip fracture 在高齡族群常導致高死亡率、失能與生活品質下降，臨床處置不僅涉及手術，也牽涉後續骨鬆治療與跌倒預防。 研究方法：此 jama review 整理 hip fracture 的流行病學、分類、危險因子、手術治療與二次骨折預防策略，內容涵蓋髖部置換、內固定、復健與 antiresorptive 或 anabolic 藥物使用。 主要結果：全球每年約有 1420 萬人發生 hip fracture；術後 1 年死亡率中位數約 22%，美國男性與女性 1 年死亡率分別為 26.9% 與 18.5%。年齡每增加 5 歲，hip fracture 風險 hr 為 1.35（95% ci 1.25-1.47）；治療除手術外，復健、跌倒風險處理及 bisphosphonates、denosumab、teriparatide、abaloparatide 或 romosozumab 等骨鬆藥物皆為關鍵組成。 藥師重點：此文強調 hip fracture 後照護不能只停在手術與止痛，藥師應主動檢視跌倒相關用藥、安排抗骨質疏鬆治療接軌，並依病人骨折風險與腎功能評估 antiresorptive 或 anabolic 藥物時機。" }, { "id": "pmid-42456137", "kind": "article", "issueId": "2026-week29", "year": 2026, "week": 29, "weekLabel": "第 29 週", "dateRange": "2026/07/13 – 07/19", "href": "2026-week29.html", "title": "Health Care-Associated Infections in U.S. Hospitals, 2023 versus 2015", "journal": "NEJM", "type": "OA", "typeLabel": "Original Article", "author": "Chea", "doi": "10.1056/NEJMoa2510881", "url": "https://doi.org/10.1056/NEJMoa2510881", "summary": "藥師重點：研究結果說明美國醫院 HAI 盛行率雖較 2015 年下降，但整體負擔仍高，且多數感染不再局限於裝置相關事件；藥師應持續強化 antimicrobial stewardship、去侵入性裝置評估與非裝置相關感染預防策略。", "pubDate": "2026-07-16", "terms": [ "care-associated", "infections", "hospitals", "nejm", "chea", "nejmoa2510881", "infection", "emerging", "program", "sites" ], "drugTerms": [], "searchText": "health care-associated infections in u.s. hospitals, 2023 versus 2015 nejm original article chea 10.1056/nejmoa2510881 研究背景：美國住院病人的 health care-associated infection（hai）盛行率曾由 2011 年的 1/25 下降至 2015 年的 1/31，疫情後醫療體系現況是否持續改善值得再評估。 研究方法：研究沿用既有盛行率調查方法，由 10 個 emerging infections program sites 於 2023 年 5 至 9 月招募 218 家醫院，抽查 13653 名住院病歷，以 national healthcare safety network 定義辨識 hai，並與 2015 年調查比較，同時推估全美 hai 負擔。 主要結果：2023 年有 355/13653 名病人出現至少 1 項 hai，盛行率為 2.6%（95% ci 2.3-2.9），低於 2015 年的 3.2%（394/12299；95% ci 2.9-3.5）。在 151 家兩次皆參與的醫院中，2023 年病人出現 hai 的機率較 2015 年低（rr 0.73，95% ci 0.63-0.85）；約 60% 感染與裝置或處置無直接關聯，估計 2023 年全美醫院仍有 518000 例 hai。 藥師重點：研究結果說明美國醫院 hai 盛行率雖較 2015 年下降，但整體負擔仍高，且多數感染不再局限於裝置相關事件；藥師應持續強化 antimicrobial stewardship、去侵入性裝置評估與非裝置相關感染預防策略。" }, { "id": "pmid-42456136", "kind": "article", "issueId": "2026-week29", "year": 2026, "week": 29, "weekLabel": "第 29 週", "dateRange": "2026/07/13 – 07/19", "href": "2026-week29.html", "title": "Extended Dual Antiplatelet Therapy for Multivessel Coronary Artery Disease", "journal": "NEJM", "type": "RCT", "typeLabel": "RCT", "author": "Tian", "doi": "10.1056/NEJMoa2517588", "url": "https://doi.org/10.1056/NEJMoa2517588", "summary": "藥師重點：結論顯示對多支血管冠狀動脈疾病且已平穩完成首年 DAPT 的特定族群，延長 clopidogrel 加 aspirin 可降低缺血事件而未明顯增加出血；藥師仍需綜合評估出血風險、併用抗凝藥與長期依從性。", "pubDate": "2026-07-16", "terms": [ "extended", "dual", "antiplatelet", "multivessel", "coronary", "artery", "nejm", "tian", "nejmoa2517588", "dapt" ], "drugTerms": [ "clopidogrel" ], "searchText": "extended dual antiplatelet therapy for multivessel coronary artery disease nejm rct tian 10.1056/nejmoa2517588 研究背景：多支血管冠狀動脈疾病患者在藥物塗層支架置放後通常接受 12 個月 dual antiplatelet therapy（dapt），但對於已平穩度過首年的病人，是否延長治療仍有爭議。 研究方法：此開放標籤、隨機試驗於中國 97 個中心納入 18 至 75 歲、接受藥物塗層支架且使用 dapt 12 個月期間未發生重大缺血或出血事件的多支血管冠狀動脈疾病患者，1:1 分配至再接受 12 個月 clopidogrel 加 aspirin，或改為 aspirin 單方；主要療效終點為心血管死亡、非致命性心肌梗塞或非致命性中風複合事件。 主要結果：共 8250 名患者隨機分派，中位追蹤 34.3 個月；36 個月主要療效終點發生率在延長 dapt 組與 aspirin 單方組分別為 5.8% 與 6.8%（hr 0.82，95% ci 0.69-0.98；p=0.03）。臨床相關或重大出血發生率為 1.4% 與 1.5%（hr 0.89，95% ci 0.61-1.30；p=0.54）。 藥師重點：結論顯示對多支血管冠狀動脈疾病且已平穩完成首年 dapt 的特定族群，延長 clopidogrel 加 aspirin 可降低缺血事件而未明顯增加出血；藥師仍需綜合評估出血風險、併用抗凝藥與長期依從性。" }, { "id": "pmid-42457242", "kind": "article", "issueId": "2026-week29", "year": 2026, "week": 29, "weekLabel": "第 29 週", "dateRange": "2026/07/13 – 07/19", "href": "2026-week29.html", "title": "Epidural analgesia in labour and neonatal and childhood outcomes: national population based cohort study", "journal": "BMJ", "type": "OA", "typeLabel": "Original Article", "author": "Kearns", "doi": "10.1136/bmj-2026-343320", "url": "https://doi.org/10.1136/bmj-2026-343320", "summary": "藥師重點：研究結果說明產程中 epidural analgesia 未見與臨床上重要的新生兒或兒童傷害風險增加有關；藥師在周產期照護可協助病人理解止痛選項，並持續監測併用止痛藥與母體血流動力學變化。", "pubDate": "2026-07-15", "terms": [ "epidural", "analgesia", "labour", "neonatal", "childhood", "national", "population", "kearns", "bmj-2026-343320", "morbidity" ], "drugTerms": [], "searchText": "epidural analgesia in labour and neonatal and childhood outcomes: national population based cohort study bmj original article kearns 10.1136/bmj-2026-343320 研究背景：生產時 epidural analgesia 的新生兒與兒童長期安全性常引發疑慮，尤其是否增加神經學併發症、感染或腦性麻痺風險仍需大型真實世界資料釐清。 研究方法：此蘇格蘭全國性人口世代研究納入 2007 至 2019 年間 495695 名單胎分娩婦女，比較產程中使用與未使用 epidural analgesia 對新生兒神經學 morbidity、其他新生兒 morbidity、敗血症、5 分鐘 apgar score <4、新生兒死亡及兒童期 cerebral palsy 的影響。 主要結果：23.2% 婦女於產程中接受 epidural analgesia；新生兒神經學 morbidity 發生率為每千出生 0.9 例。使用 epidural analgesia 與新生兒神經學 morbidity（調整後 rr 0.87，95% ci 0.68-1.12）、其他嚴重新生兒 morbidity（1.17，0.90-1.51）、新生兒敗血症（1.11，0.90-1.37）、5 分鐘 apgar score <4（0.97，0.87-1.09）、28 天內死亡（0.81，0.62-1.06）及兒童期 cerebral palsy（0.80，0.60-1.06）皆無顯著相關。 藥師重點：研究結果說明產程中 epidural analgesia 未見與臨床上重要的新生兒或兒童傷害風險增加有關；藥師在周產期照護可協助病人理解止痛選項，並持續監測併用止痛藥與母體血流動力學變化。" }, { "id": "pmid-42468541", "kind": "article", "issueId": "2026-week29", "year": 2026, "week": 29, "weekLabel": "第 29 週", "dateRange": "2026/07/13 – 07/19", "href": "2026-week29.html", "title": "Empirical treatment with valganciclovir in infants living with HIV and hospitalised with severe pneumonia in Africa: a multicentre, open-label, factorial, randomised, controlled, superiority trial", "journal": "Lancet", "type": "OA", "typeLabel": "Original Article", "author": "Moraleda", "doi": "10.1016/S0140-6736(26)00754-3", "url": "https://doi.org/10.1016/S0140-6736(26)00754-3", "summary": "藥師重點：研究結果顯示經驗性 valganciclovir 對重度 HIV-associated pneumonia 嬰兒可能帶來早期存活利益訊號，但整體 1 年結果仍需保守解讀；藥師使用時應特別監測血球下降、腎功能與與其他抗感染治療的整體耐受性。", "pubDate": "2026-07-17", "terms": [ "empirical", "valganciclovir", "infants", "living", "hospitalised", "severe", "pneumonia", "africa", "multicentre", "open-label" ], "drugTerms": [ "valganciclovir", "cotrimoxazole", "rifampicin" ], "searchText": "empirical treatment with valganciclovir in infants living with hiv and hospitalised with severe pneumonia in africa: a multicentre, open-label, factorial, randomised, controlled, superiority trial lancet original article moraleda 10.1016/s0140-6736(26)00754-3 研究背景：重度 hiv-associated pneumonia 的嬰兒死亡率仍高，若合併 cytomegalovirus 感染，經驗性使用 valganciclovir 是否可改善存活，仍缺乏隨機證據。 研究方法：empirical 為多中心、開放標籤、2×2 因子設計隨機試驗，於非洲 19 家醫院納入 28 至 365 天、因重度 hiv-associated pneumonia 住院的嬰兒，比較標準治療是否加上 15 天口服 valganciclovir；主要終點為第 15 天與 1 年 all-cause mortality。 主要結果：558 名嬰兒納入分析，valganciclovir 組與未使用組第 15 天死亡率分別為 23% 與 27%（rate ratio 0.81，95% ci 0.61-1.08；p=0.15），12 個月死亡率為 43% 與 48%（0.88，95% ci 0.74-1.05；p=0.15）。但 time-varying model 顯示第 15 天死亡風險下降（調整後 hr 0.60，95% ci 0.41-0.87；p=0.0063），嚴重不良事件未增加（or 0.64，95% ci 0.35-1.16）。 藥師重點：研究結果顯示經驗性 valganciclovir 對重度 hiv-associated pneumonia 嬰兒可能帶來早期存活利益訊號，但整體 1 年結果仍需保守解讀；藥師使用時應特別監測血球下降、腎功能與與其他抗感染治療的整體耐受性。" }, { "id": "pmid-42456135", "kind": "article", "issueId": "2026-week29", "year": 2026, "week": 29, "weekLabel": "第 29 週", "dateRange": "2026/07/13 – 07/19", "href": "2026-week29.html", "title": "Continuous or Fixed-Duration Maintenance Therapy in Multiple Myeloma", "journal": "NEJM", "type": "RCT", "typeLabel": "RCT", "author": "Kumar", "doi": "10.1056/NEJMoa2600157", "url": "https://doi.org/10.1056/NEJMoa2600157", "summary": "藥師重點：研究結果說明持續 lenalidomide 維持治療未帶來明確整體存活利益，卻伴隨較多長期毒性；藥師在維持治療階段應協助平衡療程長度、第二原發癌風險與慢性副作用監測。", "pubDate": "2026-07-16", "terms": [ "continuous", "fixed-duration", "maintenance", "multiple", "myeloma", "nejm", "kumar", "nejmoa2600157", "lenalidomide", "upfront" ], "drugTerms": [], "searchText": "continuous or fixed-duration maintenance therapy in multiple myeloma nejm rct kumar 10.1056/nejmoa2600157 研究背景：新診斷 multiple myeloma 標準治療常在誘導後持續使用 lenalidomide 維持至疾病惡化，但固定療程是否已足夠，仍缺乏長期比較證據。 研究方法：此第三期試驗納入標準風險、未接受 upfront 自體造血幹細胞移植的新診斷 multiple myeloma 患者，在 proteasome inhibitor-lenalidomide 誘導治療後，隨機分配至 lenalidomide 持續維持治療或固定 2 年療程；主要終點為 overall survival。 主要結果：516 名患者完成隨機分派，中位追蹤 86 個月；7 年 overall survival 在持續治療組與固定療程組分別為 68.6% 與 69.0%（差異 -0.4 個百分點，95% ci -9.0 至 8.3；p=0.93），未見顯著差異。7 年 progression-free survival 為 36.1% 與 29.7%，而 5 年第二原發癌累積發生率為 11.2% 與 8.3%；3 級以上非血液學不良事件在持續治療組較高（48.2% vs 31.5%）。 藥師重點：研究結果說明持續 lenalidomide 維持治療未帶來明確整體存活利益，卻伴隨較多長期毒性；藥師在維持治療階段應協助平衡療程長度、第二原發癌風險與慢性副作用監測。" }, { "id": "pmid-42457240", "kind": "article", "issueId": "2026-week29", "year": 2026, "week": 29, "weekLabel": "第 29 週", "dateRange": "2026/07/13 – 07/19", "href": "2026-week29.html", "title": "Contemporary hormonal contraception and colorectal cancer in premenopausal women: nationwide cohort study", "journal": "BMJ", "type": "OA", "typeLabel": "Original Article", "author": "Lange", "doi": "10.1136/bmj-2026-100065", "url": "https://doi.org/10.1136/bmj-2026-100065", "summary": "藥師重點：結論顯示現代 hormonal contraception 對停經前女性 colorectal cancer 風險未見明顯增加或保護效果；藥師衛教時不宜將此作為主要選藥依據，仍應回到避孕需求、血栓風險與可接受副作用做個別化評估。", "pubDate": "2026-07-15", "terms": [ "contemporary", "hormonal", "contraception", "colorectal", "cancer", "premenopausal", "women", "nationwide", "lange", "bmj-2026-100065" ], "drugTerms": [], "searchText": "contemporary hormonal contraception and colorectal cancer in premenopausal women: nationwide cohort study bmj original article lange 10.1136/bmj-2026-100065 研究背景：年輕女性 colorectal cancer 發生率上升，但現代 hormonal contraception 是否改變其風險，臨床上仍缺乏大型長期資料。 研究方法：此丹麥全國世代研究納入 1995 至 2021 年間 1956948 名 15 至 49 歲女性，依不同 hormonal contraception 類型與使用時間，比較首次診斷 colorectal cancer 的校正後發生率比。 主要結果：中位追蹤 12.5 年、共累積 2450 萬人年，期間發生 1878 例 colorectal cancer。相較從未使用者，所有目前或近期使用者的發生率比為 0.94（95% ci 0.83-1.06）；使用少於 5 年與超過 10 年者分別為 0.97（0.85-1.11）與 0.86（0.62-1.18）。不同世代複方口服避孕藥未見一致風險差異，levonorgestrel-releasing intrauterine device 的發生率比為 0.96（0.81-1.15）。 藥師重點：結論顯示現代 hormonal contraception 對停經前女性 colorectal cancer 風險未見明顯增加或保護效果；藥師衛教時不宜將此作為主要選藥依據，仍應回到避孕需求、血栓風險與可接受副作用做個別化評估。" }, { "id": "pmid-42456692", "kind": "article", "issueId": "2026-week29", "year": 2026, "week": 29, "weekLabel": "第 29 週", "dateRange": "2026/07/13 – 07/19", "href": "2026-week29.html", "title": "1-month versus 12-month dual antithrombotic therapy after percutaneous coronary intervention in patients with atrial fibrillation (OPTIMA-AF): a multicentre, open-label, hybrid non-inferiority and superiority, randomised, controlled trial", "journal": "Lancet", "type": "OA", "typeLabel": "Original Article", "author": "Sotomi", "doi": "10.1016/S0140-6736(26)00665-3", "url": "https://doi.org/10.1016/S0140-6736(26)00665-3", "summary": "藥師重點：結論顯示在以慢性冠心症為主、接受影像導引 PCI 的 atrial fibrillation 病人中，1 個月雙重抗栓後改 DOAC 單方可降低出血，且缺血結果相近；藥師仍需依支架血栓風險、腎功能與 DOAC/P2Y12 併用狀況個別化調整療程。", "pubDate": "2026-07-15", "terms": [ "month", "dual", "antithrombotic", "percutaneous", "coronary", "intervention", "atrial", "fibrillation", "optima-af", "multicentre" ], "drugTerms": [], "searchText": "1-month versus 12-month dual antithrombotic therapy after percutaneous coronary intervention in patients with atrial fibrillation (optima-af): a multicentre, open-label, hybrid non-inferiority and superiority, randomised, controlled trial lancet original article sotomi 10.1016/s0140-6736(26)00665-3 研究背景：atrial fibrillation 患者接受 pci 後需在缺血風險與出血風險間平衡 dual antithrombotic therapy 長度，但 1 個月與 12 個月策略的淨臨床效益仍不明確。 研究方法：optima-af 為多中心、開放標籤、隨機對照試驗，納入接受血管內影像導引 pci 且預計使用 doac 的 non-valvular atrial fibrillation 成人，1:1 分配至 1 個月 doac 加 p2y12 inhibitor 後改為 doac 單方，或 12 個月雙重抗栓後再改單方；主要療效終點為 12 個月全因死亡或血栓栓塞事件，主要安全終點為重大或臨床相關非重大出血。 主要結果：1079 名患者納入完整分析；主要療效終點在 1 個月與 12 個月雙重抗栓組分別為 5.4% 與 4.3%（hr 1.25，95% ci 0.73-2.17），符合不劣性。主要安全終點則為 4.5% 與 8.8%（hr 0.50，95% ci 0.30-0.81；p=0.0041），顯示較短療程可降低出血。 藥師重點：結論顯示在以慢性冠心症為主、接受影像導引 pci 的 atrial fibrillation 病人中，1 個月雙重抗栓後改 doac 單方可降低出血，且缺血結果相近；藥師仍需依支架血栓風險、腎功能與 doac/p2y12 併用狀況個別化調整療程。" }, { "id": "fda-2026-week29-1", "kind": "fda", "issueId": "2026-week29", "year": 2026, "week": 29, "weekLabel": "第 29 週", "dateRange": "2026/07/13 – 07/19", "href": "2026-week29.html", "title": "FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss", "summary": "FDA 提醒未核准或非法販售的 GLP-1 減重產品，包含部分 compounded semaglutide、tirzepatide、retatrutide 與 cagrilintide，可能有品質、劑量、冷鏈與標示不實風險，且已接獲多起不良事件通報。藥師應確認病人取得的是核准產品或合法來源，並加強劑量量測、儲存條件與網購風險衛教。", "terms": [ "concerns", "unapproved", "glp-1", "drugs", "used", "weight", "loss", "compounded", "semaglutide", "tirzepatide" ], "drugTerms": [ "glp-1", "semaglutide", "tirzepatide" ], "searchText": "fda’s concerns with unapproved glp-1 drugs used for weight loss fda drug safety 2026-06-15 fda 提醒未核准或非法販售的 glp-1 減重產品，包含部分 compounded semaglutide、tirzepatide、retatrutide 與 cagrilintide，可能有品質、劑量、冷鏈與標示不實風險，且已接獲多起不良事件通報。藥師應確認病人取得的是核准產品或合法來源，並加強劑量量測、儲存條件與網購風險衛教。 https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss" }, { "id": "fda-2026-week29-2", "kind": "fda", "issueId": "2026-week29", "year": 2026, "week": 29, "weekLabel": "第 29 週", "dateRange": "2026/07/13 – 07/19", "href": "2026-week29.html", "title": "FDA Approves First Generics of Gilotrif (afatinib) Tablets", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fda-approves-first-generics-gilotrif-afatinib-tablets", "summary": "FDA 核准第一個 afatinib 學名藥，可用於帶有非抗藥性 EGFR mutation 的轉移性 NSCLC 一線治療，以及鉑類化療後進展的轉移性鱗狀 NSCLC。藥師應確認 EGFR 檢測結果，並持續監測腹瀉、皮膚毒性、interstitial lung disease、肝毒性與胚胎胎兒毒性。", "terms": [ "approves", "first", "generics", "gilotrif", "afatinib", "tablets", "egfr", "mutation", "nsclc", "interstitial" ], "drugTerms": [ "afatinib" ], "searchText": "fda approves first generics of gilotrif (afatinib) tablets fda drug safety 2026-07-14 fda 核准第一個 afatinib 學名藥，可用於帶有非抗藥性 egfr mutation 的轉移性 nsclc 一線治療，以及鉑類化療後進展的轉移性鱗狀 nsclc。藥師應確認 egfr 檢測結果，並持續監測腹瀉、皮膚毒性、interstitial lung disease、肝毒性與胚胎胎兒毒性。 https://www.fda.gov/drugs/drug-alerts-and-statements/fda-approves-first-generics-gilotrif-afatinib-tablets" }, { "id": "fda-2026-week29-3", "kind": "fda", "issueId": "2026-week29", "year": 2026, "week": 29, "weekLabel": "第 29 週", "dateRange": "2026/07/13 – 07/19", "href": "2026-week29.html", "title": "FDA Alerts Health Care Providers to Cases of Neurologic Complications from General Anesthesia Linked to Genetic Variant in Patients of Maternal Venezuelan Ancestry", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fda-alerts-health-care-providers-cases-neurologic-complications-general-anesthesia-linked-genetic", "summary": "FDA 正在調查母系委內瑞拉血統病人接受 sevoflurane 等揮發性全身麻醉後，出現嚴重神經學不良事件與死亡的安全訊號，可能與罕見線粒體變異 MT-ND4 m.11232T>C 有關。於相關高風險族群照護時，可考慮靜脈或區域麻醉替代方案，並加強麻醉前風險辨識與 MedWatch 通報。", "terms": [ "alerts", "providers", "cases", "neurologic", "complications", "from", "general", "anesthesia", "linked", "genetic" ], "drugTerms": [], "searchText": "fda alerts health care providers to cases of neurologic complications from general anesthesia linked to genetic variant in patients of maternal venezuelan ancestry fda drug safety 2026-07-02 fda 正在調查母系委內瑞拉血統病人接受 sevoflurane 等揮發性全身麻醉後，出現嚴重神經學不良事件與死亡的安全訊號，可能與罕見線粒體變異 mt-nd4 m.11232t>c 有關。於相關高風險族群照護時，可考慮靜脈或區域麻醉替代方案，並加強麻醉前風險辨識與 medwatch 通報。 https://www.fda.gov/drugs/drug-alerts-and-statements/fda-alerts-health-care-providers-cases-neurologic-complications-general-anesthesia-linked-genetic" }, { "id": "pmid-42437322", "kind": "article", "issueId": "2026-week28", "year": 2026, "week": 28, "weekLabel": "第 28 週", "dateRange": "2026/07/06 – 07/12", "href": "2026-week28.html", "title": "YEARS Algorithm for Diagnosis of Suspected Pulmonary Embolism in Patients With Cancer: A Randomized Clinical Trial", "journal": "JAMA", "type": "OA", "typeLabel": "Original Article", "author": "Akerboom", "doi": "10.1001/jama.2026.10676", "url": "https://doi.org/10.1001/jama.2026.10676", "summary": "藥師重點：研究結果說明活動性癌症病人使用 YEARS algorithm 排除肺栓塞與直接 CTPA 同樣安全，且可減少部分影像檢查；藥師可協助辨識高風險徵象，並提醒 D-dimer、抗凝用藥與影像流程的整合。", "pubDate": "2026-07-12", "terms": [ "years", "algorithm", "diagnosis", "suspected", "pulmonary", "embolism", "cancer", "jama", "akerboom", "ctpa" ], "drugTerms": [], "searchText": "years algorithm for diagnosis of suspected pulmonary embolism in patients with cancer: a randomized clinical trial jama original article akerboom 10.1001/jama.2026.10676 研究背景：對活動性癌症且疑似肺栓塞患者，現行指引多傾向直接安排 ctpa，但 years algorithm 在此族群的安全性與效率仍缺乏隨機證據。 研究方法：hydra 為開放標籤、研究者發起、不劣性隨機試驗，於歐洲 21 家醫院納入活動性癌症且疑似急性肺栓塞患者，1:1 分配至 years diagnostic algorithm 或直接 ctpa；主要終點為排除肺栓塞後 90 天內症狀性靜脈血栓栓塞或可能與肺栓塞相關死亡。 主要結果：698 名患者隨機分派後，per-protocol 分析中 years 組主要終點為 1.8%，ctpa-only 組為 5.5%，絕對風險差 -3.7%（99.9% ci -8.8% 至 1.4%），達不劣性。years 組有 22% 病人可免做 ctpa，兩組負向 ctpa 比例無顯著差異。 藥師重點：研究結果說明活動性癌症病人使用 years algorithm 排除肺栓塞與直接 ctpa 同樣安全，且可減少部分影像檢查；藥師可協助辨識高風險徵象，並提醒 d-dimer、抗凝用藥與影像流程的整合。" }, { "id": "pmid-42425122", "kind": "article", "issueId": "2026-week28", "year": 2026, "week": 28, "weekLabel": "第 28 週", "dateRange": "2026/07/06 – 07/12", "href": "2026-week28.html", "title": "Temocillin versus carbapenems for bacteraemia due to third-generation cephalosporin-resistant Enterobacterales in Spain (ASTARTÉ): a multicentre, phase 3, open-label, non-inferiority, randomised clinical trial", "journal": "Lancet", "type": "OA", "typeLabel": "Original Article", "author": "Dezza", "doi": "10.1016/S0140-6736(26)00760-9", "url": "https://doi.org/10.1016/S0140-6736(26)00760-9", "summary": "藥師重點：結論顯示對 temocillin 與 carbapenem 皆具感受性的 3GCR-E 菌血症，temocillin 可作為 carbapenem-sparing 選項；藥師需確認藥敏結果、感染來源控制與腎功能下的劑量調整。", "pubDate": "2026-07-09", "terms": [ "temocillin", "carbapenems", "bacteraemia", "third-generation", "cephalosporin-resistant", "enterobacterales", "spain", "astart", "multicentre", "phase" ], "drugTerms": [ "temocillin", "meropenem", "ertapenem", "carbapenem" ], "searchText": "temocillin versus carbapenems for bacteraemia due to third-generation cephalosporin-resistant enterobacterales in spain (astarté): a multicentre, phase 3, open-label, non-inferiority, randomised clinical trial lancet original article dezza 10.1016/s0140-6736(26)00760-9 研究背景：第三代 cephalosporin-resistant enterobacterales（3gcr-e）菌血症常以 carbapenem 治療，但為減少抗藥性選擇壓力，窄譜 β-lactam temocillin 是否可作替代方案值得評估。 研究方法：astarté 為多中心、第三期、開放標籤、不劣性隨機試驗，於西班牙 29 家醫院納入 3gcr-e 單一菌種菌血症成人，1:1 分配至靜脈注射 temocillin 2 g every 8 h，或 meropenem 1 g every 8 h／適當時 ertapenem 1 g daily；主要終點為 mitt 族群 28 天臨床成功。 主要結果：328 名 mitt 患者中，臨床成功率 temocillin 組為 74%，carbapenem 組為 73%，差異 0.3%（95% ci -7.7 至 ∞），達預設不劣性（p=0.017）。嚴重不良事件在 temocillin 與 carbapenem 組分別為 19% 與 24%。 藥師重點：結論顯示對 temocillin 與 carbapenem 皆具感受性的 3gcr-e 菌血症，temocillin 可作為 carbapenem-sparing 選項；藥師需確認藥敏結果、感染來源控制與腎功能下的劑量調整。" }, { "id": "pmid-42413523", "kind": "article", "issueId": "2026-week28", "year": 2026, "week": 28, "weekLabel": "第 28 週", "dateRange": "2026/07/06 – 07/12", "href": "2026-week28.html", "title": "Standard-dose unfractionated heparin versus low-dose unfractionated heparin and low-molecular-weight heparin in extracorporeal life support (RATE): an open-label, randomised, non-inferiority trial", "journal": "Lancet", "type": "OA", "typeLabel": "Original Article", "author": "Minnen", "doi": "10.1016/S0140-6736(26)00851-2", "url": "https://doi.org/10.1016/S0140-6736(26)00851-2", "summary": "藥師重點：結論顯示 ECMO 抗凝目標可考慮由全劑量 UFH 下修至低劑量 UFH 或治療劑量 LMWH；藥師需配合重症團隊監測出血、血栓指標與抗凝檢驗數值，並確認轉換流程。", "pubDate": "2026-07-07", "terms": [ "standard-dose", "unfractionated", "heparin", "low-dose", "low-molecular-weight", "extracorporeal", "life", "support", "rate", "open-label" ], "drugTerms": [ "heparin" ], "searchText": "standard-dose unfractionated heparin versus low-dose unfractionated heparin and low-molecular-weight heparin in extracorporeal life support (rate): an open-label, randomised, non-inferiority trial lancet original article minnen 10.1016/s0140-6736(26)00851-2 研究背景：ecmo 病人需抗凝以降低血栓風險，但傳統全劑量 ufh 可能增加出血，較低抗凝強度是否可維持療效仍缺乏大型隨機試驗。 研究方法：此開放標籤、三組、不劣性隨機試驗於荷蘭 7 家加護病房收納接受 veno-venous 或 veno-arterial ecmo 的成人，分配至標準劑量 ufh、低劑量 ufh 或治療劑量 lmwh；主要終點為 ecmo 期間嚴重出血、嚴重血栓栓塞或 6 個月全因死亡的複合終點。 主要結果：330 名收案者中有 320 名完成 6 個月分析；複合主要終點在標準劑量 ufh、低劑量 ufh 與 lmwh 組分別為 81%、72% 與 75%，低劑量 ufh 與 lmwh 相較標準劑量 ufh 皆達不劣性。兩個低強度抗凝組的嚴重出血比例較低（58%、59% vs 65%），且未見明顯血栓併發症增加。 藥師重點：結論顯示 ecmo 抗凝目標可考慮由全劑量 ufh 下修至低劑量 ufh 或治療劑量 lmwh；藥師需配合重症團隊監測出血、血栓指標與抗凝檢驗數值，並確認轉換流程。" }, { "id": "pmid-42418774", "kind": "article", "issueId": "2026-week28", "year": 2026, "week": 28, "weekLabel": "第 28 週", "dateRange": "2026/07/06 – 07/12", "href": "2026-week28.html", "title": "Setmelanotide for the Treatment of Acquired Hypothalamic Obesity", "journal": "NEJM", "type": "RCT", "typeLabel": "RCT", "author": "Miller", "doi": "10.1056/NEJMoa2512275", "url": "https://doi.org/10.1056/NEJMoa2512275", "summary": "藥師重點：研究結果說明 setmelanotide 可改善後天性下視丘性肥胖患者的體重與飢餓感；藥師應留意胃腸道副作用、皮膚變化、兒童與成人劑量調整，以及長期治療依從性。", "pubDate": "2026-07-09", "terms": [ "setmelanotide", "acquired", "hypothalamic", "obesity", "nejm", "miller", "nejmoa2512275", "placebo" ], "drugTerms": [], "searchText": "setmelanotide for the treatment of acquired hypothalamic obesity nejm rct miller 10.1056/nejmoa2512275 研究背景：後天性下視丘性肥胖常伴隨嚴重飢餓感與體重控制困難，setmelanotide 在第二期試驗已有減重訊號，但仍需更完整驗證。 研究方法：此第三期試驗將 4 至 66 歲後天性下視丘性肥胖患者，以 2:1 隨機分派至皮下注射 setmelanotide 1.5-3.0 mg 或 placebo，每日一次治療 52 週；主要終點為 bmi 自基線的平均百分比變化，次要終點包括每週最大飢餓分數變化。 主要結果：120 名受試者中，setmelanotide 組 52 週 bmi 最小平方平均變化為 -16.5%（95% ci -19.3 至 -13.8），placebo 組為 3.3%（95% ci -0.6 至 7.2；p<0.001）；最大飢餓分數亦下降較多（-2.73 vs -1.45；p=0.009）。嚴重不良事件發生率 setmelanotide 組較高（28% vs 8%），常見不良事件為皮膚色素沉著、噁心、嘔吐與頭痛。 藥師重點：研究結果說明 setmelanotide 可改善後天性下視丘性肥胖患者的體重與飢餓感；藥師應留意胃腸道副作用、皮膚變化、兒童與成人劑量調整，以及長期治療依從性。" }, { "id": "pmid-42437501", "kind": "article", "issueId": "2026-week28", "year": 2026, "week": 28, "weekLabel": "第 28 週", "dateRange": "2026/07/06 – 07/12", "href": "2026-week28.html", "title": "Rivaroxaban Then Aspirin vs. Aspirin Alone after Total Hip or Knee Arthroplasty", "journal": "NEJM", "type": "OA", "typeLabel": "Original Article", "author": "Shivakumar", "doi": "10.1056/NEJMoa2603649", "url": "https://doi.org/10.1056/NEJMoa2603649", "summary": "藥師重點：結論顯示特定術後病人單用 aspirin 可作為 rivaroxaban 後接續 aspirin 的替代血栓預防策略；藥師仍需結合病人出血風險、既往血栓病史與術式判斷適用族群。", "pubDate": "2026-07-12", "terms": [ "rivaroxaban", "then", "aspirin", "alone", "total", "knee", "arthroplasty", "nejm", "shivakumar", "nejmoa2603649" ], "drugTerms": [ "rivaroxaban" ], "searchText": "rivaroxaban then aspirin vs. aspirin alone after total hip or knee arthroplasty nejm original article shivakumar 10.1056/nejmoa2603649 研究背景：全髖或全膝關節置換術後常需靜脈血栓預防，先前已知短期 rivaroxaban 後接續 aspirin 可行，但單用 aspirin 是否足夠仍有疑問。 研究方法：此多中心、雙盲、隨機對照不劣性試驗將接受全髖或全膝關節置換術患者分配至術後前 5 天使用 aspirin 81 mg daily 或 rivaroxaban 10 mg daily，之後兩組皆接續 aspirin；主要療效終點為 90 天內症狀性靜脈血栓栓塞，主要安全終點為出血併發症。 主要結果：5429 名患者隨機分派後，症狀性靜脈血栓栓塞在 aspirin-only 組為 0.48%，rivaroxaban-then-aspirin 組為 0.45%，風險差 0.02 個百分點（95% ci -0.34 至 0.39），符合不劣性。重大或臨床相關非重大出血則為 1.66% vs 2.04%，未見臨床上重要差異。 藥師重點：結論顯示特定術後病人單用 aspirin 可作為 rivaroxaban 後接續 aspirin 的替代血栓預防策略；藥師仍需結合病人出血風險、既往血栓病史與術式判斷適用族群。" }, { "id": "pmid-42418797", "kind": "article", "issueId": "2026-week28", "year": 2026, "week": 28, "weekLabel": "第 28 週", "dateRange": "2026/07/06 – 07/12", "href": "2026-week28.html", "title": "Meningococcal B Vaccine to Prevent Neisseria gonorrhoeae Infection", "journal": "NEJM", "type": "OA", "typeLabel": "Original Article", "author": "Seib", "doi": "10.1056/NEJMoa2516739", "url": "https://doi.org/10.1056/NEJMoa2516739", "summary": "藥師重點：研究結果說明 4CMenB 不宜視為淋病預防策略；藥師在性傳染病照護中仍應強調定期篩檢、暴露前預防、伴侶通知與症狀衛教。", "pubDate": "2026-07-08", "terms": [ "meningococcal", "vaccine", "prevent", "neisseria", "gonorrhoeae", "infection", "nejm", "seib", "nejmoa2516739", "cmenb" ], "drugTerms": [], "searchText": "meningococcal b vaccine to prevent neisseria gonorrhoeae infection nejm original article seib 10.1056/nejmoa2516739 研究背景：目前仍無預防淋病的核准疫苗，先前觀察研究曾推測 4cmenb 可能對 neisseria gonorrhoeae infection 有保護效果。 研究方法：此多中心、雙盲、安慰劑對照隨機試驗納入高風險淋病的 msm，1:1 分配接受 2 劑 4cmenb 或 placebo，並於 2 年內定期接受泌尿生殖道、肛門與口咽部位的核酸檢測；主要終點為 per-protocol 族群首次淋病感染事件。 主要結果：654 名受試者隨機分派後，587 名納入主要分析；4cmenb 組與 placebo 組淋病發生率分別為每 100 person-years 48.1 與 47.8，發生率比 1.01（95% ci 0.80-1.26；p=0.97），疫苗效益為 -0.5%。不同感染部位與有症狀、無症狀感染的次分析亦未見明顯保護效果。 藥師重點：研究結果說明 4cmenb 不宜視為淋病預防策略；藥師在性傳染病照護中仍應強調定期篩檢、暴露前預防、伴侶通知與症狀衛教。" }, { "id": "pmid-42418196", "kind": "article", "issueId": "2026-week28", "year": 2026, "week": 28, "weekLabel": "第 28 週", "dateRange": "2026/07/06 – 07/12", "href": "2026-week28.html", "title": "Lung Transplant for Refractory Lung-Limited Stage IV Non-Small Cell Lung Cancer", "journal": "JAMA", "type": "OA", "typeLabel": "Original Article", "author": "Bharat", "doi": "10.1001/jama.2026.8717", "url": "https://doi.org/10.1001/jama.2026.8717", "summary": "藥師重點：此研究提供高度選擇病人接受肺移植的早期存活訊號，但屬單中心小型資料；藥師若參與移植評估與後續照護，仍需審慎處理免疫抑制、感染預防與腫瘤復發監測。", "pubDate": "2026-07-08", "terms": [ "lung", "transplant", "refractory", "lung-limited", "stage", "non-small", "cell", "cancer", "jama", "bharat" ], "drugTerms": [], "searchText": "lung transplant for refractory lung-limited stage iv non-small cell lung cancer jama original article bharat 10.1001/jama.2026.8717 研究背景：肺部侷限、對藥物治療無效的第四期非小細胞肺癌患者常死於呼吸衰竭，肺移植雖可能移除器官層級病灶，但長期腫瘤學成效仍存疑。 研究方法：此單中心前瞻性登錄研究分析 404 名成人，其中 17 名肺部侷限第四期 nsclc 患者接受肺移植，81 名符合條件但未移植者接受藥物治療，另有 306 名非癌症肺移植患者作器官使用參考；主要終點為完成適應評估後的整體存活。 主要結果：nsclc 肺移植組 1 年整體存活率為 100.0%，單純藥物治療組為 40.8%，絕對差異 59.2 個百分點（95% ci 46.2-71.7）。與非癌症肺移植者相比，nsclc 移植組 1 年移植後存活率亦達 100% vs 88.1%；延長追蹤至 2026-01-31 時，17 名移植者中有 2 名死亡。 藥師重點：此研究提供高度選擇病人接受肺移植的早期存活訊號，但屬單中心小型資料；藥師若參與移植評估與後續照護，仍需審慎處理免疫抑制、感染預防與腫瘤復發監測。" }, { "id": "pmid-42424046", "kind": "article", "issueId": "2026-week28", "year": 2026, "week": 28, "weekLabel": "第 28 週", "dateRange": "2026/07/06 – 07/12", "href": "2026-week28.html", "title": "Formulary-Related Insurance Denials of Single-Source Branded Drugs in the United States", "journal": "JAMA", "type": "OA", "typeLabel": "Original Article", "author": "Levy", "doi": "10.1001/jama.2026.8702", "url": "https://doi.org/10.1001/jama.2026.8702", "summary": "藥師重點：研究結果說明保險處方集限制常導致治療延誤或中斷；藥師可提早處理 prior authorization、替代藥建議與病人溝通，以降低拒付對治療連續性的影響。", "pubDate": "2026-07-09", "terms": [ "formulary-related", "insurance", "denials", "single-source", "branded", "drugs", "united", "states", "jama", "levy" ], "drugTerms": [], "searchText": "formulary-related insurance denials of single-source branded drugs in the united states jama original article levy 10.1001/jama.2026.8702 研究背景：formulary exclusion、prior authorization 與 step therapy 雖可控制藥費，但也可能延誤單一來源品牌藥的治療起始。 研究方法：此回溯性全國 all-payer 世代研究使用 2018 至 2024 年 iqvia 門診藥局理賠資料，分析 117 萬人首次嘗試領取 200 萬筆單一來源品牌藥處方時，因保險處方集限制而遭拒付及其後續補藥情形。 主要結果：首次領藥嘗試中，68.0% 可直接給付，14.8% 因 formulary exclusion 遭拒，17.2% 因 prior authorization 或 step therapy 遭拒；整體拒付率自 2018 年的 24.3% 上升至 2024 年的 40.7%。在初次遭拒的處方中，48.4% 於 90 天內未能取得同治療類別任何藥物，成功補領者平均延遲 12.2 天。 藥師重點：研究結果說明保險處方集限制常導致治療延誤或中斷；藥師可提早處理 prior authorization、替代藥建議與病人溝通，以降低拒付對治療連續性的影響。" }, { "id": "pmid-42425121", "kind": "article", "issueId": "2026-week28", "year": 2026, "week": 28, "weekLabel": "第 28 週", "dateRange": "2026/07/06 – 07/12", "href": "2026-week28.html", "title": "Fixed-duration pirtobrutinib plus venetoclax-rituximab versus venetoclax-rituximab for patients with previously treated chronic lymphocytic leukaemia or small lymphocytic lymphoma (BRUIN CLL-322): an open-label, multicentre, randomised, controlled, phase 3 trial", "journal": "Lancet", "type": "OA", "typeLabel": "Original Article", "author": "Davids", "doi": "10.1016/S0140-6736(26)01204-3", "url": "https://doi.org/10.1016/S0140-6736(26)01204-3", "summary": "藥師重點：研究結果說明固定療程的 PVR 可能成為既往接受 BTK inhibitor 後復發 CLL/SLL 的新選項；藥師需特別監測腫瘤溶解症、腹瀉、心律不整風險，以及 venetoclax 漸進加量與交互作用管理。", "pubDate": "2026-07-09", "terms": [ "fixed-duration", "pirtobrutinib", "plus", "venetoclax-rituximab", "previously", "treated", "chronic", "lymphocytic", "leukaemia", "small" ], "drugTerms": [ "pirtobrutinib", "venetoclax-rituximab", "rituximab", "pirtobrutinib-rituximab" ], "searchText": "fixed-duration pirtobrutinib plus venetoclax-rituximab versus venetoclax-rituximab for patients with previously treated chronic lymphocytic leukaemia or small lymphocytic lymphoma (bruin cll-322): an open-label, multicentre, randomised, controlled, phase 3 trial lancet original article davids 10.1016/s0140-6736(26)01204-3 研究背景：曾接受 covalent btk inhibitor 的復發或難治型 cll/sll，目前固定療程標準治療為 venetoclax-rituximab（vr），加入 non-covalent btk inhibitor pirtobrutinib 是否可進一步提升療效仍待確認。 研究方法：bruin cll-322 為開放標籤、第三期隨機對照試驗，納入先前至少接受 1 線治療的 cll/sll 成人，1:1 分配至 pirtobrutinib 加 vr（pvr）或 vr；主要終點為獨立評估的無惡化存活期。 主要結果：639 名患者隨機分派後，中位追蹤 27.3 個月；pvr 相較 vr 可顯著改善無惡化存活期（hr 0.547，95% ci 0.400-0.748；p=0.0001），24 個月無惡化存活率為 87% vs 72%。兩組 3 級以上治療相關不良事件比例相近（79% vs 73%），但 pvr 組 3 級以上 tumour lysis syndrome 較少（1% vs 4%）。 藥師重點：研究結果說明固定療程的 pvr 可能成為既往接受 btk inhibitor 後復發 cll/sll 的新選項；藥師需特別監測腫瘤溶解症、腹瀉、心律不整風險，以及 venetoclax 漸進加量與交互作用管理。" }, { "id": "pmid-42418775", "kind": "article", "issueId": "2026-week28", "year": 2026, "week": 28, "weekLabel": "第 28 週", "dateRange": "2026/07/06 – 07/12", "href": "2026-week28.html", "title": "Ensartinib in Resected ALK-Positive Non-Small-Cell Lung Cancer", "journal": "NEJM", "type": "RCT", "typeLabel": "RCT", "author": "Yue", "doi": "10.1056/NEJMoa2518990", "url": "https://doi.org/10.1056/NEJMoa2518990", "summary": "藥師重點：結論顯示 ensartinib 可明顯降低完全切除後 ALK-positive NSCLC 的復發風險；藥師需追蹤皮膚毒性、長期口服依從性與術後輔助治療期間的安全性監測。", "pubDate": "2026-07-09", "terms": [ "ensartinib", "resected", "alk-positive", "non-small-cell", "lung", "cancer", "nejm", "nejmoa2518990", "nsclc", "inhibitor" ], "drugTerms": [ "ensartinib" ], "searchText": "ensartinib in resected alk-positive non-small-cell lung cancer nejm rct yue 10.1056/nejmoa2518990 研究背景：完全切除後的 alk-positive 非小細胞肺癌（nsclc）仍有復發風險，第二代 alk inhibitor ensartinib 作為術後輔助治療的效益與安全性仍需第三期試驗確認。 研究方法：此第三期、雙盲、隨機試驗納入接受輔助化療後、已完全切除的 stage ib 至 iiib alk-positive nsclc 患者，1:1 分配至 ensartinib 225 mg once daily 或 placebo，治療 24 個月；主要終點為 stage ii 至 iiib 族群的無病存活期。 主要結果：共 274 名患者隨機分派；24 個月時，stage ii 至 iiib 患者的無病存活率 ensartinib 組為 86.4%，placebo 組為 53.5%（復發或死亡 hr 0.20，95% ci 0.11-0.38；p<0.001），整體族群結果相近。3 級以上不良事件 ensartinib 組較高（35.8% vs 18.2%），以 rash 最常見。 藥師重點：結論顯示 ensartinib 可明顯降低完全切除後 alk-positive nsclc 的復發風險；藥師需追蹤皮膚毒性、長期口服依從性與術後輔助治療期間的安全性監測。" }, { "id": "pmid-42419792", "kind": "article", "issueId": "2026-week28", "year": 2026, "week": 28, "weekLabel": "第 28 週", "dateRange": "2026/07/06 – 07/12", "href": "2026-week28.html", "title": "Comparative effects of drugs for adults with overweight or obesity: systematic review and network meta-analysis", "journal": "BMJ", "type": "MA", "typeLabel": "Meta-analysis", "author": "Nong", "doi": "10.1136/bmj-2026-372161", "url": "https://doi.org/10.1136/bmj-2026-372161", "summary": "藥師重點：此結果顯示減重效益通常伴隨較高副作用與停藥風險，臨床選藥需在療效、耐受性與共病風險間做共享決策；藥師可協助病人設定期待、監測腸胃道與疲倦副作用，並評估心血管共病下的用藥優先順序。", "pubDate": "2026-07-08", "terms": [ "comparative", "drugs", "adults", "overweight", "obesity", "network", "meta-analysis", "nong", "bmj-2026-372161", "grade" ], "drugTerms": [ "tirzepatide", "cagrilintide-semaglutide", "semaglutide", "ecnoglutide", "liraglutide" ], "searchText": "comparative effects of drugs for adults with overweight or obesity: systematic review and network meta-analysis bmj meta-analysis nong 10.1136/bmj-2026-372161 研究背景：成人過重或肥胖的藥物選擇快速增加，但各藥物在減重效益、停藥率與心血管結果間的差異仍需整體比較。 研究方法：此系統性回顧與網絡統合分析納入 262 項隨機對照試驗、共 99791 名受試者，評估 19 種體重控制藥物在 24 個結局上的相對效益與風險，並結合 grade 與 bayesian dose-response 模型進行證據分級。 主要結果：相較單純生活型態介入，1 年減重幅度較大的藥物包括 tirzepatide（平均差 -14.9%）、cagrisema（-14.8%）、oral semaglutide（-10.9%）、orforglipron（-9.9%）與 subcutaneous semaglutide（-9.8%）。但多數藥物也伴隨較高停藥與腸胃道不良事件；subcutaneous semaglutide 是少數與全因死亡及心肌梗塞下降相關的藥物，tirzepatide 與 subcutaneous semaglutide 則與心衰竭風險下降相關。 藥師重點：此結果顯示減重效益通常伴隨較高副作用與停藥風險，臨床選藥需在療效、耐受性與共病風險間做共享決策；藥師可協助病人設定期待、監測腸胃道與疲倦副作用，並評估心血管共病下的用藥優先順序。" }, { "id": "pmid-42437499", "kind": "article", "issueId": "2026-week28", "year": 2026, "week": 28, "weekLabel": "第 28 週", "dateRange": "2026/07/06 – 07/12", "href": "2026-week28.html", "title": "Clinicopathologic Evaluation of Amyloid Clearance in Alzheimer Disease", "journal": "JAMA", "type": "OA", "typeLabel": "Original Article", "author": "Brown", "doi": "10.1001/jama.2026.13058", "url": "https://doi.org/10.1001/jama.2026.13058", "summary": "藥師重點：此個案提供 aducanumab 深度 amyloid 清除可能帶來下游神經病理益處的線索，但證據層級有限；藥師解讀 amyloid-targeting therapy 時，仍應提醒團隊避免由單一個案外推臨床效果。", "pubDate": "2026-07-12", "terms": [ "clinicopathologic", "evaluation", "amyloid", "clearance", "alzheimer", "jama", "brown", "amyloid-targeting", "r47h", "trem2" ], "drugTerms": [ "aducanumab" ], "searchText": "clinicopathologic evaluation of amyloid clearance in alzheimer disease jama original article brown 10.1001/jama.2026.13058 研究背景：amyloid-targeting therapy 是否能進一步減緩 tau 病理與神經退化，是阿茲海默症長期治療成效的關鍵問題。 研究方法：此臨床病理個案報告描述一名帶有 p.r47h trem2 variant、曾在隨機試驗中接受 30 劑 aducanumab 的輕度認知障礙男性，並與 14 名未治療對照比較其屍檢、amyloid/tau pet 與皮質厚度影像變化。 主要結果：病人於最後一次 aducanumab 後 4 年死亡；屍檢顯示 amyloid 清除較完整的腦區同時有較少 tau 病理，且與較慢的皮質萎縮相關（β=-0.50，95% ci -0.62 至 -0.37；p<0.001）。但 amyloid 負荷仍高的腦區，其下游病理與未治療對照相近。 藥師重點：此個案提供 aducanumab 深度 amyloid 清除可能帶來下游神經病理益處的線索，但證據層級有限；藥師解讀 amyloid-targeting therapy 時，仍應提醒團隊避免由單一個案外推臨床效果。" }, { "id": "fda-2026-week28-3", "kind": "fda", "issueId": "2026-week28", "year": 2026, "week": 28, "weekLabel": "第 28 週", "dateRange": "2026/07/06 – 07/12", "href": "2026-week28.html", "title": "FDA 最終決定撤銷 Pepaxto（melphalan flufenamide）核准", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/node/398713", "summary": "FDA 已對 Pepaxto（melphalan flufenamide）作出撤銷核准的最終決定；藥師應重新確認相關適應症、替代治療與既有病人轉換安排。", "terms": [ "pepaxto", "melphalan", "flufenamide", "https", "node" ], "drugTerms": [], "searchText": "fda 最終決定撤銷 pepaxto（melphalan flufenamide）核准 fda drug safety fda 已對 pepaxto（melphalan flufenamide）作出撤銷核准的最終決定；藥師應重新確認相關適應症、替代治療與既有病人轉換安排。 https://www.fda.gov/node/398713" }, { "id": "fda-2026-week28-4", "kind": "fda", "issueId": "2026-week28", "year": 2026, "week": 28, "weekLabel": "第 28 週", "dateRange": "2026/07/06 – 07/12", "href": "2026-week28.html", "title": "FDA 提醒注意具母系 Venezuelan ancestry 特定基因變異病人的全身麻醉神經學併發症", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fda-alerts-health-care-providers-cases-neurologic-complications-general-anesthesia-linked-genetic", "summary": "FDA 正調查 sevoflurane 與其他全身麻醉藥在具母系 Venezuelan ancestry 且帶有特定基因變異病人中的嚴重神經學不良事件風險；藥師應提醒麻醉團隊留意病史、家族背景與術前評估。", "terms": [ "venezuelan", "ancestry", "sevoflurane", "https", "drugs", "drug-alerts-and-statements", "fda-alerts-health-care-providers-cases-neurologic-complications-general-anesthesia-linked-genetic" ], "drugTerms": [], "searchText": "fda 提醒注意具母系 venezuelan ancestry 特定基因變異病人的全身麻醉神經學併發症 fda drug safety 2026-07-02 fda 正調查 sevoflurane 與其他全身麻醉藥在具母系 venezuelan ancestry 且帶有特定基因變異病人中的嚴重神經學不良事件風險；藥師應提醒麻醉團隊留意病史、家族背景與術前評估。 https://www.fda.gov/drugs/drug-alerts-and-statements/fda-alerts-health-care-providers-cases-neurologic-complications-general-anesthesia-linked-genetic" }, { "id": "fda-2026-week28-2", "kind": "fda", "issueId": "2026-week28", "year": 2026, "week": 28, "weekLabel": "第 28 週", "dateRange": "2026/07/06 – 07/12", "href": "2026-week28.html", "title": "FDA 提醒 glatiramer acetate injection 可選配 autoinjector 存在 cross-compatibility 問題", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/node/403159", "summary": "FDA 提醒 glatiramer acetate injection 可選配 autoinjector 裝置存在 cross-compatibility 問題；藥師應確認病人使用之裝置與製劑相容性，避免操作錯誤。", "terms": [ "glatiramer", "acetate", "injection", "autoinjector", "cross-compatibility", "https", "node" ], "drugTerms": [], "searchText": "fda 提醒 glatiramer acetate injection 可選配 autoinjector 存在 cross-compatibility 問題 fda drug safety fda 提醒 glatiramer acetate injection 可選配 autoinjector 裝置存在 cross-compatibility 問題；藥師應確認病人使用之裝置與製劑相容性，避免操作錯誤。 https://www.fda.gov/node/403159" }, { "id": "fda-2026-week28-5", "kind": "fda", "issueId": "2026-week28", "year": 2026, "week": 28, "weekLabel": "第 28 週", "dateRange": "2026/07/06 – 07/12", "href": "2026-week28.html", "title": "FDA 接受首個預測 drug-induced liver injury 的 in silico 工具納入 ISTAND 計畫", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fda-accepts-first-silico-drug-development-tool-under-istand-program-help-predict-drug-induced-liver", "summary": "FDA 接受首個用於預測 drug-induced liver injury 的 in silico 工具進入 ISTAND 計畫；雖非直接用藥警訊，仍反映未來藥物安全評估工具的監管方向。", "terms": [ "drug-induced", "liver", "injury", "silico", "istand", "https", "drugs", "drug-alerts-and-statements", "fda-accepts-first-silico-drug-development-tool-under-istand-program-help-predict-drug-induced-liver" ], "drugTerms": [], "searchText": "fda 接受首個預測 drug-induced liver injury 的 in silico 工具納入 istand 計畫 fda drug safety 2026-06-03 fda 接受首個用於預測 drug-induced liver injury 的 in silico 工具進入 istand 計畫；雖非直接用藥警訊，仍反映未來藥物安全評估工具的監管方向。 https://www.fda.gov/drugs/drug-alerts-and-statements/fda-accepts-first-silico-drug-development-tool-under-istand-program-help-predict-drug-induced-liver" }, { "id": "fda-2026-week28-1", "kind": "fda", "issueId": "2026-week28", "year": 2026, "week": 28, "weekLabel": "第 28 週", "dateRange": "2026/07/06 – 07/12", "href": "2026-week28.html", "title": "FDA 對未核准 GLP-1 減重產品之疑慮", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss", "summary": "FDA 提醒未核准的 GLP-1 減重產品可能涉及成分、來源與安全性疑慮；藥師應確認病人實際使用產品來源，並加強用藥與不良反應衛教。", "terms": [ "glp-1", "https", "drugs", "drug-alerts-and-statements", "fdas-concerns-unapproved-glp-1-drugs-used-weight-loss" ], "drugTerms": [ "glp-1" ], "searchText": "fda 對未核准 glp-1 減重產品之疑慮 fda drug safety 2026-06-15 fda 提醒未核准的 glp-1 減重產品可能涉及成分、來源與安全性疑慮；藥師應確認病人實際使用產品來源，並加強用藥與不良反應衛教。 https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss" }, { "id": "pmid-42392118", "kind": "article", "issueId": "2026-week27", "year": 2026, "week": 27, "weekLabel": "第 27 週", "dateRange": "2026/06/29 – 07/05", "href": "2026-week27.html", "title": "[177Lu]Lu-edotreotide versus everolimus for gastroenteropancreatic neuroendocrine tumours (COMPETE): a phase 3, multicentre, randomised, open-label, superiority trial", "journal": "Lancet", "type": "OA", "typeLabel": "Original Article", "author": "Walter", "doi": "10.1016/S0140-6736(26)00604-5", "url": "https://doi.org/10.1016/S0140-6736(26)00604-5", "summary": "藥師重點：結論顯示 [177Lu]Lu-edotreotide 在較前段治療可帶來較長無惡化存活期，且重度毒性低於 everolimus；藥師需協助安排核醫治療流程，並監測腸胃道症狀、疲倦與血液學安全性。", "pubDate": "2026-07-02", "terms": [ "lu-edotreotide", "everolimus", "gastroenteropancreatic", "neuroendocrine", "tumours", "compete", "phase", "multicentre", "randomised", "open-label" ], "drugTerms": [ "somatostatin" ], "searchText": "[177lu]lu-edotreotide versus everolimus for gastroenteropancreatic neuroendocrine tumours (compete): a phase 3, multicentre, randomised, open-label, superiority trial lancet original article walter 10.1016/s0140-6736(26)00604-5 研究背景：晚期、進展性胃腸胰神經內分泌腫瘤的治療順序尚未明確，[177lu]lu-edotreotide 與 everolimus 皆可使用，但缺乏直接比較證據。 研究方法：compete 為第三期、多中心、開放標籤優越性試驗，將 somatostatin receptor-positive、無法切除或轉移性第一至二級 gep nets 患者以 2:1 隨機分派至 [177lu]lu-edotreotide 靜脈治療（每 3 個月一次，最多 4 個療程）或 everolimus 10 mg/day，主要終點為盲態獨立中央評估的無惡化存活期。 主要結果：309 名隨機分派患者中，[177lu]lu-edotreotide 組的中位無惡化存活期為 23.9 個月，everolimus 組為 14.1 個月（hr 0.67，95% ci 0.48-0.95；p=0.022）。治療相關不良事件發生率為 82% vs 97%，3-4 級治療相關不良事件為 18% vs 40%，兩組皆無治療相關死亡。 藥師重點：結論顯示 [177lu]lu-edotreotide 在較前段治療可帶來較長無惡化存活期，且重度毒性低於 everolimus；藥師需協助安排核醫治療流程，並監測腸胃道症狀、疲倦與血液學安全性。" }, { "id": "pmid-42386316", "kind": "article", "issueId": "2026-week27", "year": 2026, "week": 27, "weekLabel": "第 27 週", "dateRange": "2026/06/29 – 07/05", "href": "2026-week27.html", "title": "Robotic versus Open Pancreatoduodenectomy (PORTAL): multicentre, single masked, phase 3, non-inferiority randomised controlled trial", "journal": "BMJ", "type": "RCT", "typeLabel": "RCT", "author": "Jin", "doi": "10.1136/bmj-2026-319692", "url": "https://doi.org/10.1136/bmj-2026-319692", "summary": "藥師重點：結論顯示機器人輔助胰十二指腸切除術在高量能中心可加速術後恢復；藥師仍應留意高成本條件下的疼痛控制、感染監測、營養支持與術後恢復流程整合。", "pubDate": "2026-07-01", "terms": [ "robotic", "open", "pancreatoduodenectomy", "portal", "multicentre", "single", "masked", "phase", "non-inferiority", "randomised" ], "drugTerms": [], "searchText": "robotic versus open pancreatoduodenectomy (portal): multicentre, single masked, phase 3, non-inferiority randomised controlled trial bmj rct jin 10.1136/bmj-2026-319692 研究背景：胰十二指腸切除術術後恢復慢且併發症負擔高，機器人輔助胰十二指腸切除術是否能在不犧牲安全性與腫瘤品質下改善恢復速度，仍需隨機試驗確認。 研究方法：此多中心、單盲、第三期不劣性隨機試驗於中國 7 家高量能中心收納 268 名可切除胰臟或壺腹周邊疾病成人，隨機接受機器人輔助或開腹胰十二指腸切除術，主要終點為術後達成功能恢復所需時間。 主要結果：修正後意向治療分析中，機器人組功能恢復的限制平均事件時間為 12.1 天，開腹組為 16.0 天，差異 -3.9 天（95% ci -5.6 至 -2.2；p<0.001）；機器人組手術時間較長，但住院天數較短，clavien-dindo 第二級以上併發症較少，整體住院成本較高。 藥師重點：結論顯示機器人輔助胰十二指腸切除術在高量能中心可加速術後恢復；藥師仍應留意高成本條件下的疼痛控制、感染監測、營養支持與術後恢復流程整合。" }, { "id": "pmid-42384870", "kind": "article", "issueId": "2026-week27", "year": 2026, "week": 27, "weekLabel": "第 27 週", "dateRange": "2026/06/29 – 07/05", "href": "2026-week27.html", "title": "Rituximab versus Ocrelizumab in Newly Diagnosed Relapsing Multiple Sclerosis", "journal": "NEJM", "type": "RCT", "typeLabel": "RCT", "author": "Torkildsen", "doi": "10.1056/NEJMoa2600993", "url": "https://doi.org/10.1056/NEJMoa2600993", "summary": "藥師重點：研究結果說明 rituximab 在抑制 MRI 疾病活動上不劣於 ocrelizumab，可作為治療選項參考；藥師仍需加強感染監測、疫苗時程安排、輸注反應處置與長期免疫抑制照護。", "pubDate": "2026-07-02", "terms": [ "rituximab", "ocrelizumab", "newly", "diagnosed", "relapsing", "multiple", "sclerosis", "nejm", "torkildsen", "nejmoa2600993" ], "drugTerms": [ "rituximab", "ocrelizumab", "anti-cd20" ], "searchText": "rituximab versus ocrelizumab in newly diagnosed relapsing multiple sclerosis nejm rct torkildsen 10.1056/nejmoa2600993 研究背景：anti-cd20 單株抗體已是復發型多發性硬化症的重要治療，但 rituximab 與 ocrelizumab 缺乏直接比較資料。 研究方法：此第三期、多中心、雙盲不劣性試驗將新診斷且近期有疾病活動的復發型多發性硬化症成人，以 3:2 隨機分配至 rituximab 或 ocrelizumab，每 6 個月給藥一次、共治療 24 個月；主要終點為第 6 至 24 個月 mri 無新發或增大的 t2 病灶。 主要結果：216 名受治療患者中，rituximab 組無新發或增大 t2 病灶的估計機率為 92.2%，ocrelizumab 組為 94.8%，風險差 -2.6 個百分點（95% ci -9.4 至 4.3），符合預設不劣性；兩組復發、失能與認知結果相近，但 rituximab 組感染發生率較高（82% vs 69%）。 藥師重點：研究結果說明 rituximab 在抑制 mri 疾病活動上不劣於 ocrelizumab，可作為治療選項參考；藥師仍需加強感染監測、疫苗時程安排、輸注反應處置與長期免疫抑制照護。" }, { "id": "pmid-42370681", "kind": "article", "issueId": "2026-week27", "year": 2026, "week": 27, "weekLabel": "第 27 週", "dateRange": "2026/06/29 – 07/05", "href": "2026-week27.html", "title": "Phase 3 Trial of Oral Infigratinib in Children with Achondroplasia", "journal": "NEJM", "type": "OA", "typeLabel": "Original Article", "author": "Savarirayan", "doi": "10.1056/NEJMoa2604565", "url": "https://doi.org/10.1056/NEJMoa2604565", "summary": "藥師重點：結論顯示每日口服 infigratinib 可改善軟骨發育不全兒童的生長速度；藥師應留意體重劑量、長期成長指標、用藥依從性與兒科家庭衛教。", "pubDate": "2026-06-28", "terms": [ "phase", "oral", "infigratinib", "children", "achondroplasia", "nejm", "savarirayan", "nejmoa2604565", "fgfr3", "pathogenic" ], "drugTerms": [ "infigratinib" ], "searchText": "phase 3 trial of oral infigratinib in children with achondroplasia nejm original article savarirayan 10.1056/nejmoa2604565 研究背景：軟骨發育不全由 fgfr3 pathogenic variants 所致，會影響骨骼生長；infigratinib 是口服 fgfr1-3 tyrosine kinase 抑制劑，可下調其致病路徑。 研究方法：研究為第三期、多中心、雙盲、安慰劑對照試驗，將 3-17 歲軟骨發育不全兒童以 2:1 隨機分派至 infigratinib 0.25 mg/kg 每日一次或 placebo，治療 52 週。主要終點為第 52 週年化身高生長速度相對基線變化；次要終點包括身高 z 分數與上下身比例。 主要結果：114 名患者隨機分派；第 52 週 infigratinib 相對 placebo 的最小平方平均差異在年化身高生長速度為 1.74 cm/year（95% ci 1.31-2.17；p<0.001），身高 z 分數差異為 0.32（96% ci 0.23-0.41；p<0.001）。兩組整體不良事件發生率相近，且無被認定與治療相關的嚴重不良事件或停藥事件。 藥師重點：結論顯示每日口服 infigratinib 可改善軟骨發育不全兒童的生長速度；藥師應留意體重劑量、長期成長指標、用藥依從性與兒科家庭衛教。" }, { "id": "pmid-42384373", "kind": "article", "issueId": "2026-week27", "year": 2026, "week": 27, "weekLabel": "第 27 週", "dateRange": "2026/06/29 – 07/05", "href": "2026-week27.html", "title": "Neonatal Survival After Serial Amnioinfusions for Anhydramnios Due to Fetal Kidney Failure: The RAFT Clinical Trial", "journal": "JAMA", "type": "OA", "typeLabel": "Original Article", "author": "Miller", "doi": "10.1001/jama.2026.8568", "url": "https://doi.org/10.1001/jama.2026.8568", "summary": "藥師重點：此策略可望減輕致命性肺發育不全，但新生兒後續腎臟併發症與照護負擔仍高；藥師參與周產期與兒腎照護時，需及早準備透析、感染預防與移植前後用藥教育。", "pubDate": "2026-07-01", "terms": [ "neonatal", "survival", "serial", "amnioinfusions", "anhydramnios", "fetal", "kidney", "failure", "raft", "jama" ], "drugTerms": [], "searchText": "neonatal survival after serial amnioinfusions for anhydramnios due to fetal kidney failure: the raft clinical trial jama original article miller 10.1001/jama.2026.8568 研究背景：胎兒腎衰竭導致的無羊水常因嚴重肺發育不全而致死，連續羊膜腔灌注雖可能改善肺部發育，但對非雙側腎缺如病例的效益與風險仍不確定。 研究方法：raft 為前瞻性、非隨機臨床試驗，於美國 13 家胎兒治療中心收納 32 對在 22 週前即出現無羊水、且非雙側腎缺如的母胎個案，於 26 週前開始進行連續羊膜腔灌注。主要終點為新生兒存活至少 14 天且成功建立透析通路。 主要結果：32 例中有 29 例活產（91%），主要終點達成率為 65.5%（95% ci 45.7%-82.1%）；14 名活產嬰兒（48%）存活至出院。常見母體併發症為早發性破水 56% 與絨毛膜羊膜分離 29%，目前存活嬰兒中已有 7 人接受腎臟移植。 藥師重點：此策略可望減輕致命性肺發育不全，但新生兒後續腎臟併發症與照護負擔仍高；藥師參與周產期與兒腎照護時，需及早準備透析、感染預防與移植前後用藥教育。" }, { "id": "pmid-42385750", "kind": "article", "issueId": "2026-week27", "year": 2026, "week": 27, "weekLabel": "第 27 週", "dateRange": "2026/06/29 – 07/05", "href": "2026-week27.html", "title": "Metabolic traits in obesity and normal BMI in industrialised countries: a multi-country analysis of national population-based studies", "journal": "Lancet", "type": "OA", "typeLabel": "Original Article", "author": "N/A", "doi": "10.1016/S0140-6736(26)00758-0", "url": "https://doi.org/10.1016/S0140-6736(26)00758-0", "summary": "藥師重點：研究結果說明較年長肥胖患者的代謝風險差距部分可透過藥物治療縮小，但年輕族群仍是照護缺口；藥師可強化早期篩檢、生活型態介入與慢性處方追蹤。", "pubDate": "2026-07-01", "terms": [ "metabolic", "traits", "obesity", "normal", "industrialised", "countries", "multi-country", "national", "population-based", "studies" ], "drugTerms": [], "searchText": "metabolic traits in obesity and normal bmi in industrialised countries: a multi-country analysis of national population-based studies lancet original article 10.1016/s0140-6736(26)00758-0 研究背景：肥胖相關的高血壓與血脂異常已有治療工具，但 bmi 所帶來的代謝風險差距是否因藥物治療而縮小，仍需跨國資料檢視。 研究方法：此跨國人口研究分析納入 1990 至 2024 年間 110 個國家代表性健康調查，共 978425 名 20-79 歲受試者，來自日本、南韓、台灣、泰國、芬蘭、英國與美國，比較不同 bmi 組別的收縮壓、non-hdl cholesterol、hdl cholesterol 與降壓、降脂藥使用情形。 主要結果：跨國合併分析顯示，肥胖或過重族群與 bmi 正常範圍的差距逐十年縮小，non-hdl cholesterol 約下降 0.05-0.07 mmol/l，收縮壓約下降 0.6-0.7 mmhg；40 歲以上肥胖者降壓與降脂藥使用增加較多，部分國家已與 bmi 正常族群代謝指標接近，但 40 歲以下肥胖年輕成人的風險差距變化不大且治療率低。 藥師重點：研究結果說明較年長肥胖患者的代謝風險差距部分可透過藥物治療縮小，但年輕族群仍是照護缺口；藥師可強化早期篩檢、生活型態介入與慢性處方追蹤。" }, { "id": "pmid-42392114", "kind": "article", "issueId": "2026-week27", "year": 2026, "week": 27, "weekLabel": "第 27 週", "dateRange": "2026/06/29 – 07/05", "href": "2026-week27.html", "title": "Dual mobility versus standard cups in total hip replacement for displaced femoral neck fractures (Duality): an international, multicentre, randomised, controlled, superiority trial", "journal": "Lancet", "type": "OA", "typeLabel": "Original Article", "author": "Hailer", "doi": "10.1016/S0140-6736(26)00759-2", "url": "https://doi.org/10.1016/S0140-6736(26)00759-2", "summary": "藥師重點：研究結果說明 dual mobility THR 可明顯降低位移性股骨頸骨折術後脫位風險；藥師於高齡骨折照護中仍應持續介入止痛、抗凝、跌倒預防與出院後用藥整合。", "pubDate": "2026-07-02", "terms": [ "dual", "mobility", "standard", "cups", "total", "replacement", "displaced", "femoral", "neck", "fractures" ], "drugTerms": [], "searchText": "dual mobility versus standard cups in total hip replacement for displaced femoral neck fractures (duality): an international, multicentre, randomised, controlled, superiority trial lancet original article hailer 10.1016/s0140-6736(26)00759-2 研究背景：位移性股骨頸骨折接受全髖關節置換術後，脫位是最常見的早期手術併發症；雙活動度髖杯是否能降低此風險，過去缺乏隨機試驗證據。 研究方法：duality 為國際、多中心、登錄型隨機優越性試驗，於瑞典與英國 44 家醫院收納 65 歲以上、適合全髖關節置換術的位移性股骨頸骨折患者，1:1 隨機分派至 dual mobility thr 或 standard thr。主要終點為 1 年內目標關節脫位。 主要結果：1600 名患者隨機分派後，1566 名納入修正後意向治療分析；dual mobility 組脫位發生率為 1.3%，standard thr 組為 4.2%，adjusted hr 0.27（95% ci 0.13-0.56；p<0.0001）。 藥師重點：研究結果說明 dual mobility thr 可明顯降低位移性股骨頸骨折術後脫位風險；藥師於高齡骨折照護中仍應持續介入止痛、抗凝、跌倒預防與出院後用藥整合。" }, { "id": "pmid-42384869", "kind": "article", "issueId": "2026-week27", "year": 2026, "week": 27, "weekLabel": "第 27 週", "dateRange": "2026/06/29 – 07/05", "href": "2026-week27.html", "title": "Adjuvant Pembrolizumab plus Belzutifan for Renal-Cell Carcinoma", "journal": "NEJM", "type": "RCT", "typeLabel": "RCT", "author": "Choueiri", "doi": "10.1056/NEJMoa2518245", "url": "https://doi.org/10.1056/NEJMoa2518245", "summary": "藥師重點：結論顯示 pembrolizumab 合併 belzutifan 可提升高復發風險族群的無病存活期，但毒性明顯增加；藥師應加強貧血、缺氧等 belzutifan 相關安全性監測，並追蹤口服治療依從性與嚴重不良事件。", "pubDate": "2026-07-02", "terms": [ "adjuvant", "pembrolizumab", "plus", "belzutifan", "renal-cell", "carcinoma", "nejm", "choueiri", "nejmoa2518245", "placebo" ], "drugTerms": [ "pembrolizumab" ], "searchText": "adjuvant pembrolizumab plus belzutifan for renal-cell carcinoma nejm rct choueiri 10.1056/nejmoa2518245 研究背景：接受腎切除後的透明細胞型腎細胞癌患者仍有復發風險，術後輔助 pembrolizumab 已能改善預後，合併 belzutifan 是否可進一步降低復發值得評估。 研究方法：此第三期、雙盲試驗將復發高風險的透明細胞型腎細胞癌患者 1:1 隨機分配至 pembrolizumab 400 mg 每 6 週一次合併 belzutifan 120 mg 每日一次，或 pembrolizumab 合併 placebo，治療最長 1 年；主要終點為研究者評估的無病存活期。 主要結果：1841 名受試者隨機分派後，中位追蹤 28.4 個月；pembrolizumab-belzutifan 組無病存活期較佳（復發或死亡 hr 0.72，95% ci 0.59-0.87；p<0.001），24 個月無病存活率為 80.7% vs 73.7%。整體存活未達顯著差異，但 3 級以上不良事件在合併 belzutifan 組較高（52.1% vs 30.2%）。 藥師重點：結論顯示 pembrolizumab 合併 belzutifan 可提升高復發風險族群的無病存活期，但毒性明顯增加；藥師應加強貧血、缺氧等 belzutifan 相關安全性監測，並追蹤口服治療依從性與嚴重不良事件。" }, { "id": "fda-2026-week27-3", "kind": "fda", "issueId": "2026-week27", "year": 2026, "week": 27, "weekLabel": "第 27 週", "dateRange": "2026/06/29 – 07/05", "href": "2026-week27.html", "title": "FDA 最終決定撤銷 Pepaxto（melphalan flufenamide）核准", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/node/398713", "summary": "FDA 已對 Pepaxto（melphalan flufenamide）作出撤銷核准的最終決定；藥師應重新確認相關適應症、替代治療與既有病人轉換安排。", "terms": [ "pepaxto", "melphalan", "flufenamide", "https", "node" ], "drugTerms": [], "searchText": "fda 最終決定撤銷 pepaxto（melphalan flufenamide）核准 fda drug safety fda 已對 pepaxto（melphalan flufenamide）作出撤銷核准的最終決定；藥師應重新確認相關適應症、替代治療與既有病人轉換安排。 https://www.fda.gov/node/398713" }, { "id": "fda-2026-week27-4", "kind": "fda", "issueId": "2026-week27", "year": 2026, "week": 27, "weekLabel": "第 27 週", "dateRange": "2026/06/29 – 07/05", "href": "2026-week27.html", "title": "FDA 提醒注意具母系 Venezuelan ancestry 特定基因變異病人的全身麻醉神經學併發症", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fda-alerts-health-care-providers-cases-neurologic-complications-general-anesthesia-linked-genetic", "summary": "FDA 正調查 sevoflurane 與其他全身麻醉藥在具母系 Venezuelan ancestry 且帶有特定基因變異病人中的嚴重神經學不良事件風險；藥師應提醒麻醉團隊留意病史、家族背景與術前評估。", "terms": [ "venezuelan", "ancestry", "sevoflurane", "https", "drugs", "drug-alerts-and-statements", "fda-alerts-health-care-providers-cases-neurologic-complications-general-anesthesia-linked-genetic" ], "drugTerms": [], "searchText": "fda 提醒注意具母系 venezuelan ancestry 特定基因變異病人的全身麻醉神經學併發症 fda drug safety 2026-07-02 fda 正調查 sevoflurane 與其他全身麻醉藥在具母系 venezuelan ancestry 且帶有特定基因變異病人中的嚴重神經學不良事件風險；藥師應提醒麻醉團隊留意病史、家族背景與術前評估。 https://www.fda.gov/drugs/drug-alerts-and-statements/fda-alerts-health-care-providers-cases-neurologic-complications-general-anesthesia-linked-genetic" }, { "id": "fda-2026-week27-2", "kind": "fda", "issueId": "2026-week27", "year": 2026, "week": 27, "weekLabel": "第 27 週", "dateRange": "2026/06/29 – 07/05", "href": "2026-week27.html", "title": "FDA 提醒 glatiramer acetate injection 可選配 autoinjector 存在 cross-compatibility 問題", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/node/403159", "summary": "FDA 提醒 glatiramer acetate injection 可選配 autoinjector 裝置存在 cross-compatibility 問題；藥師應確認病人使用之裝置與製劑相容性，避免操作錯誤。", "terms": [ "glatiramer", "acetate", "injection", "autoinjector", "cross-compatibility", "https", "node" ], "drugTerms": [], "searchText": "fda 提醒 glatiramer acetate injection 可選配 autoinjector 存在 cross-compatibility 問題 fda drug safety fda 提醒 glatiramer acetate injection 可選配 autoinjector 裝置存在 cross-compatibility 問題；藥師應確認病人使用之裝置與製劑相容性，避免操作錯誤。 https://www.fda.gov/node/403159" }, { "id": "fda-2026-week27-5", "kind": "fda", "issueId": "2026-week27", "year": 2026, "week": 27, "weekLabel": "第 27 週", "dateRange": "2026/06/29 – 07/05", "href": "2026-week27.html", "title": "FDA 接受首個預測 drug-induced liver injury 的 in silico 工具納入 ISTAND 計畫", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fda-accepts-first-silico-drug-development-tool-under-istand-program-help-predict-drug-induced-liver", "summary": "FDA 接受首個用於預測 drug-induced liver injury 的 in silico 工具進入 ISTAND 計畫；雖非直接用藥警訊，仍反映未來藥物安全評估工具的監管方向。", "terms": [ "drug-induced", "liver", "injury", "silico", "istand", "https", "drugs", "drug-alerts-and-statements", "fda-accepts-first-silico-drug-development-tool-under-istand-program-help-predict-drug-induced-liver" ], "drugTerms": [], "searchText": "fda 接受首個預測 drug-induced liver injury 的 in silico 工具納入 istand 計畫 fda drug safety 2026-06-03 fda 接受首個用於預測 drug-induced liver injury 的 in silico 工具進入 istand 計畫；雖非直接用藥警訊，仍反映未來藥物安全評估工具的監管方向。 https://www.fda.gov/drugs/drug-alerts-and-statements/fda-accepts-first-silico-drug-development-tool-under-istand-program-help-predict-drug-induced-liver" }, { "id": "fda-2026-week27-1", "kind": "fda", "issueId": "2026-week27", "year": 2026, "week": 27, "weekLabel": "第 27 週", "dateRange": "2026/06/29 – 07/05", "href": "2026-week27.html", "title": "FDA 對未核准 GLP-1 減重產品之疑慮", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss", "summary": "FDA 提醒未核准的 GLP-1 減重產品可能涉及成分、來源與安全性疑慮；藥師應確認病人實際使用產品來源，並加強用藥與不良反應衛教。", "terms": [ "glp-1", "https", "drugs", "drug-alerts-and-statements", "fdas-concerns-unapproved-glp-1-drugs-used-weight-loss" ], "drugTerms": [ "glp-1" ], "searchText": "fda 對未核准 glp-1 減重產品之疑慮 fda drug safety 2026-06-15 fda 提醒未核准的 glp-1 減重產品可能涉及成分、來源與安全性疑慮；藥師應確認病人實際使用產品來源，並加強用藥與不良反應衛教。 https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss" }, { "id": "pmid-42341302", "kind": "article", "issueId": "2026-week26", "year": 2026, "week": 26, "weekLabel": "第 26 週", "dateRange": "2026/06/22 – 06/28", "href": "2026-week26.html", "title": "Ten-Year Outcomes after CAR T-Cell Therapy for B-Cell Lymphomas", "journal": "NEJM", "type": "RCT", "typeLabel": "RCT", "author": "Ruella", "doi": "10.1056/NEJMoa2518035", "url": "https://doi.org/10.1056/NEJMoa2518035", "summary": "藥師重點：藥師照護接受 tisagenlecleucel 的 淋巴瘤 患者時，需兼顧長期緩解可能性與延遲性風險，持續追蹤 cytopenia、B-cell aplasia、感染預防與 second 主要 癌症 監測。", "pubDate": "2026-06-25", "terms": [ "ten-year", "t-cell", "b-cell", "lymphomas", "nejm", "ruella", "nejmoa2518035", "anti-cd19", "relapsed", "refractory" ], "drugTerms": [ "anti-cd19", "car-transgene" ], "searchText": "ten-year outcomes after car t-cell therapy for b-cell lymphomas nejm rct ruella 10.1056/nejmoa2518035 研究背景：anti-cd19 car t-cell 治療 已是 relapsed 或 refractory b-cell non-hodgkin 淋巴瘤 的標準治療之一，但十年以上緩解與可能治癒比例仍不明確。此研究追蹤早期接受 ctl019，也就是 tisagenlecleucel 的患者長期結果。 研究方法：研究評估 38 名 relapsed 或 refractory b-cell non-hodgkin 淋巴瘤 患者，包括 24 名 大型 b 細胞淋巴瘤 與 14 名 follicular 淋巴瘤，皆接受 cd19-directed、4-1bb-costimulated autologous car t cells。主要長期指標包含 無 淋巴瘤 存活期、無惡化存活期、整體存活期、non-relapse-related 死亡 與 second 主要 癌症。 主要結果：中位追蹤 10.1 年後，5.4 年後未再觀察到復發；10 年 無 淋巴瘤 存活期 在 大型 b 細胞淋巴瘤 為 32%，follicular 淋巴瘤 為 47%。second 主要 癌症 發生於 9 名患者，10 年累積發生率 21%；non-relapse-related 死亡率 為 18%，長期反應者中 44% 仍有 b-cell aplasia。 藥師重點：藥師照護接受 tisagenlecleucel 的 淋巴瘤 患者時，需兼顧長期緩解可能性與延遲性風險，持續追蹤 cytopenia、b-cell aplasia、感染預防與 second 主要 癌症 監測。" }, { "id": "pmid-42340733", "kind": "article", "issueId": "2026-week26", "year": 2026, "week": 26, "weekLabel": "第 26 週", "dateRange": "2026/06/22 – 06/28", "href": "2026-week26.html", "title": "Self-Directed vs Clinician-Delivered Cognitive Behavioral Therapy for Chronic Pain: A Randomized Clinical Trial", "journal": "JAMA", "type": "OA", "typeLabel": "Original Article", "author": "Heapy", "doi": "10.1001/jama.2026.7861", "url": "https://doi.org/10.1001/jama.2026.7861", "summary": "藥師重點：藥師照護慢性疼痛患者時，可將 self-directed CBT-CP 視為減少藥物依賴、擴大非藥物治療可近性的選項；尤其在 opioid 風險、鎮痛藥副作用或照護資源有限時，可主動轉介或納入衛教討論。", "pubDate": "2026-06-24", "terms": [ "self-directed", "clinician-delivered", "cognitive", "behavioral", "chronic", "pain", "jama", "heapy", "cbt-cp", "usual-practice" ], "drugTerms": [], "searchText": "self-directed vs clinician-delivered cognitive behavioral therapy for chronic pain: a randomized clinical trial jama original article heapy 10.1001/jama.2026.7861 研究背景：cognitive behavioral 治療 for chronic pain 是慢性疼痛的一線非藥物治療，但臨床取得率受人力、時間與可近性限制。此研究比較 self-directed cbt-cp 加上非同步個別回饋，是否優於 usual-practice clinician-delivered cbt-cp。 研究方法：這是一項 vha 9 個系統的 隨機、開放標籤 實務型 優越性試驗，納入 764 名 chronic musculoskeletal pain 患者。受試者 1:1 分派至 11 週 self-directed cbt-cp，含每週個別化 audio feedback，或 clinician-delivered cbt-cp 4-11 次；主要終點為 4 個月 brief pain inventory-interference score。 主要結果：4 個月時 self-directed cbt-cp 的 pain interference 較 clinician-delivered cbt-cp 低，平均 5.26 vs 6.23，平均差 -0.98，95% ci -1.31 至 -0.65，p<0.001，且 6 與 12 個月仍維持優勢。self-directed 組在其他 4 個月次要結果也較佳，且完成較多預期治療 session。 藥師重點：藥師照護慢性疼痛患者時，可將 self-directed cbt-cp 視為減少藥物依賴、擴大非藥物治療可近性的選項；尤其在 opioid 風險、鎮痛藥副作用或照護資源有限時，可主動轉介或納入衛教討論。" }, { "id": "pmid-42341796", "kind": "article", "issueId": "2026-week26", "year": 2026, "week": 26, "weekLabel": "第 26 週", "dateRange": "2026/06/22 – 06/28", "href": "2026-week26.html", "title": "Safety, pharmacokinetics, and exploratory efficacy of the oral ghrelin receptor agonist AC01 in heart failure with reduced ejection fraction (GOAL-HF1): a randomised, double-blind, placebo-controlled, phase 1b/2a study", "journal": "Lancet", "type": "OA", "typeLabel": "Original Article", "author": "Lund", "doi": "10.1016/S0140-6736(26)00904-9", "url": "https://doi.org/10.1016/S0140-6736(26)00904-9", "summary": "藥師重點：藥師應將 AC01 視為仍待大型研究驗證的早期 HFrEF 候選藥物，若進入臨床試驗或未來使用情境，需特別監測血壓、心律、血糖、troponin、NT-proBNP 與 ICD 相關安全訊號。", "pubDate": "2026-06-24", "terms": [ "pharmacokinetics", "exploratory", "efficacy", "oral", "ghrelin", "receptor", "agonist", "ac01", "heart", "failure" ], "drugTerms": [], "searchText": "safety, pharmacokinetics, and exploratory efficacy of the oral ghrelin receptor agonist ac01 in heart failure with reduced ejection fraction (goal-hf1): a randomised, double-blind, placebo-controlled, phase 1b/2a study lancet original article lund 10.1016/s0140-6736(26)00904-9 研究背景：射出分率降低型心衰竭 的核心問題之一是心肌收縮力下降，但既有 inotropes 常伴隨安全性疑慮。ac01 是口服 calcium-sensitising inotrope 與 ghrelin 受體 致效劑，本研究探索其在 hfref 的安全性、藥動學與初步療效。 研究方法：goal-hf1 為 第 1b/2a 期、隨機、雙盲、安慰劑對照 研究，納入 18-80 歲、心衰竭至少 6 個月且 ejection fraction ≤40% 的患者，且皆有 transvenous implantable cardioverter defibrillator。第 1b 期 使用 0.1、0.3、1.0、3.0 mg ac01 逐步劑量 7 天；第 2a 期 則比較 1.0 mg、3.0 mg ac01 與 安慰劑 28 天，主要終點為 safety 與 tolerability。 主要結果：共 58 名患者隨機分派，ac01 相關 不良事件 在 第 1b 期 有 12 件、第 2a 期 有 18 件，未見 ac01 相關 嚴重不良事件。治療期間出現的不良事件 在 ac01 組為 80%，安慰劑 組為 71%；常見事件包括 hypotension、non-sustained ventricular tachycardia、dyspnoea、hyperglycaemia、dizziness 或 vertigo、headache，但 ecg 未見明顯 tachycardia、新發 tachyarrhythmias、myocardial ischaemia 或 conduction abnormalities。 藥師重點：藥師應將 ac01 視為仍待大型研究驗證的早期 hfref 候選藥物，若進入臨床試驗或未來使用情境，需特別監測血壓、心律、血糖、troponin、nt-probnp 與 icd 相關安全訊號。" }, { "id": "pmid-42335922", "kind": "article", "issueId": "2026-week26", "year": 2026, "week": 26, "weekLabel": "第 26 週", "dateRange": "2026/06/22 – 06/28", "href": "2026-week26.html", "title": "Non-invasive removal of the Smart tracheal occlusion device for fetal congenital diaphragmatic hernia: a single-arm, open-label, phase 1 study", "journal": "Lancet", "type": "OA", "typeLabel": "Original Article", "author": "Russo", "doi": "10.1016/S0140-6736(26)00664-1", "url": "https://doi.org/10.1016/S0140-6736(26)00664-1", "summary": "藥師重點：藥師在高風險胎兒治療團隊中應認識 Smart-TO 仍屬早期裝置證據，需協助圍產期用藥與鎮靜/影像流程安全檢核，並提醒臨床結局仍受 CDH 肺發育不全嚴重度影響。", "pubDate": "2026-06-23", "terms": [ "non-invasive", "removal", "smart", "tracheal", "occlusion", "device", "fetal", "congenital", "diaphragmatic", "hernia" ], "drugTerms": [], "searchText": "non-invasive removal of the smart tracheal occlusion device for fetal congenital diaphragmatic hernia: a single-arm, open-label, phase 1 study lancet original article russo 10.1016/s0140-6736(26)00664-1 研究背景：fetoscopic endoluminal tracheal 阻塞 用於 congenital diaphragmatic hernia 時，傳統上需第二次介入以恢復胎兒氣道通暢。smart-to 是可在接近強磁場時自動洩氣的新型 tracheal 阻塞 device，目標是避免第二次子宮內處置。 研究方法：研究為 paris 與 leuven 兩個平行 單中心、單臂、開放標籤 首次人體試驗，納入成年孕婦、單胎 cdh 且具中重度肺發育不全等條件。smart-to balloon 於妊娠 27+0 至 31+6 週置入，預定 34+0 至 34+6 週以 mri 磁場誘發洩氣，主要終點為 balloon deflation，並評估安全性。 主要結果：48 名患者納入，47 名接受 feto，46 名成功置入 smart-to；除 1 例自發洩氣與 1 例不明原因 intrauterine fetal 死亡 外，其餘均嘗試 mri 誘發洩氣。洩氣率為 100%，95% ci 92-100；出生時所有嬰兒的空 balloon 均不在氣道內，14 名 neonatal deaths 均歸因於 pulmonary hypoplasia，無 嚴重不良事件 被認為與 smart-to 相關。 藥師重點：藥師在高風險胎兒治療團隊中應認識 smart-to 仍屬早期裝置證據，需協助圍產期用藥與鎮靜/影像流程安全檢核，並提醒臨床結局仍受 cdh 肺發育不全嚴重度影響。" }, { "id": "pmid-42341797", "kind": "article", "issueId": "2026-week26", "year": 2026, "week": 26, "weekLabel": "第 26 週", "dateRange": "2026/06/22 – 06/28", "href": "2026-week26.html", "title": "Efficacy and safety of tirofiban after successful endovascular reperfusion in acute ischaemic stroke (ATTRACTION) in China: a multicentre, double-blind, randomised controlled trial", "journal": "Lancet", "type": "OA", "typeLabel": "Original Article", "author": "Huang", "doi": "10.1016/S0140-6736(26)00983-9", "url": "https://doi.org/10.1016/S0140-6736(26)00983-9", "summary": "藥師重點：藥師評估 血管內取栓 後 tirofiban 時，應同時呈現功能獨立獲益與 顱內出血 數值較高的訊號，協助團隊依出血風險、影像與併用抗栓藥物審慎選用。", "pubDate": "2026-06-24", "terms": [ "efficacy", "tirofiban", "successful", "endovascular", "reperfusion", "acute", "ischaemic", "stroke", "attraction", "china" ], "drugTerms": [], "searchText": "efficacy and safety of tirofiban after successful endovascular reperfusion in acute ischaemic stroke (attraction) in china: a multicentre, double-blind, randomised controlled trial lancet original article huang 10.1016/s0140-6736(26)00983-9 研究背景：急性 ischaemic stroke 接受 血管內取栓 且成功 再灌流 後，仍不一定能達到功能獨立。tirofiban 是 glycoprotein iib/iiia 受體 拮抗劑，此研究評估其作為成功再灌流後輔助治療的療效與出血安全性。 研究方法：attraction 是中國 82 家醫院的 多中心、雙盲、隨機對照試驗，納入 anterior-circulation large-vessel 阻塞 且 血管內取栓 後成功 再灌流 的 急性 ischaemic stroke 患者。受試者 1:1 接受 tirofiban intra-arterial bolus 5 μg/kg 後 intravenous infusion 0.1 μg/kg/min 24 小時或 安慰劑；主要療效終點為 90 天 modified rankin scale 0-2 的 功能獨立。 主要結果：1380 名患者隨機分派，90 天 功能獨立 在 tirofiban 組為 49%，安慰劑 組為 43%，未校正 absolute 風險差 6.1 百分點，95% ci 0.8-11.3，校正 風險比 1.15，95% ci 1.03-1.27，p=0.0092。有症狀 顱內出血 48 小時內在 tirofiban 組為 12%，安慰劑 組為 9%，差異未達顯著；90 天死亡率分別為 18% 與 19%。 藥師重點：藥師評估 血管內取栓 後 tirofiban 時，應同時呈現功能獨立獲益與 顱內出血 數值較高的訊號，協助團隊依出血風險、影像與併用抗栓藥物審慎選用。" }, { "id": "pmid-42335920", "kind": "article", "issueId": "2026-week26", "year": 2026, "week": 26, "weekLabel": "第 26 週", "dateRange": "2026/06/22 – 06/28", "href": "2026-week26.html", "title": "Combined bladder-kidney transplantation: first-in-human feasibility trial", "journal": "Lancet", "type": "OA", "typeLabel": "Original Article", "author": "Nassiri", "doi": "10.1016/S0140-6736(26)00718-X", "url": "https://doi.org/10.1016/S0140-6736(26)00718-X", "summary": "藥師重點：藥師若參與 bladder-kidney transplantation 照護，需把此證據定位為極早期 feasibility 資料，重點在 tacrolimus、mycophenolate mofetil、prednisone 的免疫抑制監測、感染預防、腎功能與 rejection surveillance。", "pubDate": "2026-06-23", "terms": [ "combined", "bladder-kidney", "transplantation", "first-in-human", "feasibility", "lancet", "nassiri", "s0140-6736", "terminal", "bladder" ], "drugTerms": [], "searchText": "combined bladder-kidney transplantation: first-in-human feasibility trial lancet original article nassiri 10.1016/s0140-6736(26)00718-x 研究背景：terminal bladder 功能障礙 的腸道重建手術併發症負擔高，尤其對需免疫抑制的患者更具挑戰。vascularised 複合 bladder allograft transplantation 被提出作為重建替代方案。 研究方法：這是一項 進行中 第 0 期 feasibility 試驗，評估 deceased-donor bladder 或 combined bladder-kidney transplantation。本文報告首例 combined bladder-kidney transplantation，主要終點為技術可行性、恢復尿路連續性與 graft perfusion，以及以 不良事件 評估病人安全性。 主要結果：首例患者為 41 歲 anephric 男性，因高血壓導致 end-stage kidney 疾病 且 terminal bladder，接受 abo compatible 供者 kidney 與 bladder transplant；8 小時手術成功且無術中併發症。術後第 25 天發生 suprapubic tube tract urine leak 與 wound breakdown，經手術處理後恢復；6 個月後 egfr 維持 52-55 ml/min/1.73 m2，膀胱容量 600 ml，continence 與 spontaneous voiding 良好，serial bladder biopsies 未見 rejection。 藥師重點：藥師若參與 bladder-kidney transplantation 照護，需把此證據定位為極早期 feasibility 資料，重點在 tacrolimus、mycophenolate mofetil、prednisone 的免疫抑制監測、感染預防、腎功能與 rejection surveillance。" }, { "id": "pmid-42342272", "kind": "article", "issueId": "2026-week26", "year": 2026, "week": 26, "weekLabel": "第 26 週", "dateRange": "2026/06/22 – 06/28", "href": "2026-week26.html", "title": "Assessing early effects of Australia's Social Media Minimum Age Act on adolescents' social media use: observational study", "journal": "BMJ", "type": "OA", "typeLabel": "Original Article", "author": "Barnes", "doi": "10.1136/bmj-2026-363695", "url": "https://doi.org/10.1136/bmj-2026-363695", "summary": "藥師重點：此文與藥物治療關聯較低，但可提醒藥師在青少年心理健康、睡眠、疼痛或注意力問題衛教時，不應假設年齡限制已有效降低社群媒體暴露，仍需主動詢問使用型態與潛在風險。", "pubDate": "2026-06-24", "terms": [ "assessing", "early", "australia", "social", "media", "minimum", "adolescents", "observational", "barnes", "bmj-2026-363695" ], "drugTerms": [], "searchText": "assessing early effects of australia's social media minimum age act on adolescents' social media use: observational study bmj original article barnes 10.1136/bmj-2026-363695 研究背景：australia social media minimum age act 2024 設定 16 歲以下不得持有指定社群平台帳號，目的在降低線上傷害。此研究評估政策實施後早期對青少年社群媒體使用的影響。 研究方法：這是一項澳洲社區 observational 研究，納入 12 至未滿 17 歲青少年，於政策實施前與約 3 個月後收集資料。主要結果為過去 7 天是否每日使用社群媒體與每日使用時間，並使用 sharp regression discontinuity design 評估 16 歲門檻附近的差異。 主要結果：追蹤資料來自 408/436 名青少年；16 歲以下超過 85% 仍回報使用受法案規範的平台，且多數仍使用自己的帳號。年齡驗證、假帳號與私人瀏覽器規避情形均被回報。主要結果在 16 歲門檻未見足夠證據支持明顯 discontinuity，p 值皆 ≥0.60。 藥師重點：此文與藥物治療關聯較低，但可提醒藥師在青少年心理健康、睡眠、疼痛或注意力問題衛教時，不應假設年齡限制已有效降低社群媒體暴露，仍需主動詢問使用型態與潛在風險。" }, { "id": "pmid-42341301", "kind": "article", "issueId": "2026-week26", "year": 2026, "week": 26, "weekLabel": "第 26 週", "dateRange": "2026/06/22 – 06/28", "href": "2026-week26.html", "title": "A Pragmatic Trial of a 6-Month Strategy for Rifampicin-Resistant Tuberculosis", "journal": "NEJM", "type": "RCT", "typeLabel": "RCT", "author": "Conradie", "doi": "10.1056/NEJMoa2503687", "url": "https://doi.org/10.1056/NEJMoa2503687", "summary": "藥師重點：藥師參與 rifampicin 抗藥性 tuberculosis 治療時，可將 6 個月 bedaquiline/linezolid/delamanid 為核心的策略視為可行選項，但必須依 drug susceptibility testing 調整並嚴密監測 linezolid 毒性、QT 風險與嚴重不良事件。", "pubDate": "2026-06-25", "terms": [ "pragmatic", "month", "strategy", "rifampicin-resistant", "tuberculosis", "nejm", "conradie", "nejmoa2503687", "rifampicin", "bedaquiline" ], "drugTerms": [ "bedaquiline", "linezolid", "delamanid", "levofloxacin", "clofazimine", "rifampicin" ], "searchText": "a pragmatic trial of a 6-month strategy for rifampicin-resistant tuberculosis nejm rct conradie 10.1056/nejmoa2503687 研究背景：rifampicin 抗藥性 tuberculosis 需要更安全、有效且較短的治療策略。此研究評估包含 bedaquiline、linezolid、delamanid 及 levofloxacin 或 clofazimine 的 6 個月策略是否不劣於南非當時 9 個月 standard-of-care 處方。 研究方法：這是一項 south africa 的 第 3 期、開放標籤、實務型、隨機、controlled 不劣性 試驗，納入 6 歲以上 pulmonary rifampicin 抗藥性 tuberculosis 患者，並包含孕婦、哺乳者與部分特殊族群，但排除或依藥敏調整 fluoroquinolone-resistant tuberculosis。主要療效終點為治療結束與隨機後 76 週的 cure 或 治療 completion，非劣性界值為 10 個百分點；主要安全終點為 等級 3 以上不良事件。 主要結果：403 名受試者隨機分派，成功結果在 6 個月策略組為 86.1%，控制組為 86.0%，校正 風險差 -0.2 百分點，95% ci -6.9 至 6.5，p=0.001 for 不劣性。治療期間 等級 3 以上 不良事件 分別為 31.2% 與 37.0%，兩組各有 10 名死亡。 藥師重點：藥師參與 rifampicin 抗藥性 tuberculosis 治療時，可將 6 個月 bedaquiline/linezolid/delamanid 為核心的策略視為可行選項，但必須依 drug susceptibility testing 調整並嚴密監測 linezolid 毒性、qt 風險與嚴重不良事件。" }, { "id": "fda-2026-week26-1", "kind": "fda", "issueId": "2026-week26", "year": 2026, "week": 26, "weekLabel": "第 26 週", "dateRange": "2026/06/22 – 06/28", "href": "2026-week26.html", "title": "FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss", "summary": "FDA 提醒未經核准的 GLP-1 減重產品可能涉及成分、品質、劑量與安全性風險。藥師應確認病人取得的是 FDA 核准產品，避免使用來源不明或複方調製的 semaglutide/tirzepatide 類產品，並加強低血糖、胃腸道不良反應與劑量錯誤衛教。", "terms": [ "concerns", "unapproved", "glp-1", "drugs", "used", "weight", "loss", "semaglutide", "tirzepatide", "https" ], "drugTerms": [ "glp-1", "semaglutide", "tirzepatide" ], "searchText": "fda’s concerns with unapproved glp-1 drugs used for weight loss fda drug safety 2026-06-15 fda 提醒未經核准的 glp-1 減重產品可能涉及成分、品質、劑量與安全性風險。藥師應確認病人取得的是 fda 核准產品，避免使用來源不明或複方調製的 semaglutide/tirzepatide 類產品，並加強低血糖、胃腸道不良反應與劑量錯誤衛教。 https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss" }, { "id": "fda-2026-week26-3", "kind": "fda", "issueId": "2026-week26", "year": 2026, "week": 26, "weekLabel": "第 26 週", "dateRange": "2026/06/22 – 06/28", "href": "2026-week26.html", "title": "FDA issues final decision to withdraw approval of Pepaxto (melphalan flufenamide)", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/node/398713", "summary": "FDA 已作成撤回 Pepaxto (melphalan flufenamide) 核准的最終決定。藥師應確認院內與病人用藥清單是否仍有相關品項，避免新開立或續用，並協助腫瘤團隊轉換替代治療。", "terms": [ "issues", "final", "decision", "withdraw", "approval", "pepaxto", "melphalan", "flufenamide", "https", "node" ], "drugTerms": [], "searchText": "fda issues final decision to withdraw approval of pepaxto (melphalan flufenamide) fda drug safety fda 已作成撤回 pepaxto (melphalan flufenamide) 核准的最終決定。藥師應確認院內與病人用藥清單是否仍有相關品項，避免新開立或續用，並協助腫瘤團隊轉換替代治療。 https://www.fda.gov/node/398713" }, { "id": "fda-2026-week26-2", "kind": "fda", "issueId": "2026-week26", "year": 2026, "week": 26, "weekLabel": "第 26 週", "dateRange": "2026/06/22 – 06/28", "href": "2026-week26.html", "title": "FDA alerts patients, caregivers, and health care providers of cross-compatibility issues with autoinjector devices that are optional for use with glatiramer acetate injection", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/node/403159", "summary": "FDA 提醒 glatiramer acetate injection 的選配 autoinjector device 可能有交叉相容性問題。藥師調劑或衛教時應確認藥品廠牌、注射器與 autoinjector 是否相容，避免病人沿用不適配裝置造成注射失敗或劑量問題。", "terms": [ "alerts", "caregivers", "providers", "cross-compatibility", "issues", "autoinjector", "devices", "that", "optional", "glatiramer" ], "drugTerms": [], "searchText": "fda alerts patients, caregivers, and health care providers of cross-compatibility issues with autoinjector devices that are optional for use with glatiramer acetate injection fda drug safety fda 提醒 glatiramer acetate injection 的選配 autoinjector device 可能有交叉相容性問題。藥師調劑或衛教時應確認藥品廠牌、注射器與 autoinjector 是否相容，避免病人沿用不適配裝置造成注射失敗或劑量問題。 https://www.fda.gov/node/403159" }, { "id": "fda-2026-week26-4", "kind": "fda", "issueId": "2026-week26", "year": 2026, "week": 26, "weekLabel": "第 26 週", "dateRange": "2026/06/22 – 06/28", "href": "2026-week26.html", "title": "FDA Accepts First In Silico Drug Development Tool Under ISTAND Program to Help Predict Drug-Induced Liver Injury", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fda-accepts-first-silico-drug-development-tool-under-istand-program-help-predict-drug-induced-liver", "summary": "FDA 接受第一個 ISTAND program 下的 in silico drug development tool，用於協助預測 drug-induced liver injury。此為藥物研發與安全評估工具訊息，藥師可關注 DILI 風險預測方法進展，但臨床用藥仍需依仿單、肝功能監測與病人風險因子判讀。", "terms": [ "accepts", "first", "silico", "development", "tool", "under", "istand", "program", "help", "predict" ], "drugTerms": [], "searchText": "fda accepts first in silico drug development tool under istand program to help predict drug-induced liver injury fda drug safety 2026-06-03 fda 接受第一個 istand program 下的 in silico drug development tool，用於協助預測 drug-induced liver injury。此為藥物研發與安全評估工具訊息，藥師可關注 dili 風險預測方法進展，但臨床用藥仍需依仿單、肝功能監測與病人風險因子判讀。 https://www.fda.gov/drugs/drug-alerts-and-statements/fda-accepts-first-silico-drug-development-tool-under-istand-program-help-predict-drug-induced-liver" }, { "id": "pmid-42294841", "kind": "article", "issueId": "2026-week25", "year": 2026, "week": 25, "weekLabel": "第 25 週", "dateRange": "2026/06/15 – 06/21", "href": "2026-week25.html", "title": "Talquetamab-Daratumumab in Relapsed or Refractory Myeloma", "journal": "NEJM", "type": "OA", "typeLabel": "Original Article", "author": "Mina", "doi": "10.1056/NEJMoa2604657", "url": "https://doi.org/10.1056/NEJMoa2604657", "summary": "藥師重點：Tal-DP 與 Tal-D 均較 DPd 延長無惡化存活期；藥師需重點監測感染、血球低下、免疫治療相關反應，以及 talquetamab 相關皮膚、味覺或黏膜毒性。", "pubDate": "2026-06-13", "terms": [ "talquetamab-daratumumab", "relapsed", "refractory", "myeloma", "nejm", "mina", "nejmoa2604657", "talquetamab", "gprc5d", "bispecific" ], "drugTerms": [ "talquetamab-daratumumab", "talquetamab", "daratumumab" ], "searchText": "talquetamab-daratumumab in relapsed or refractory myeloma nejm original article mina 10.1056/nejmoa2604657 研究背景：talquetamab 為同時標靶 gprc5d 與 cd3 的 bispecific 抗體，在重度治療過的復發或難治多發性骨髓瘤已有持久反應訊號；本研究評估其合併 daratumumab 相關療法的效果。 研究方法：此第 3 期試驗將曾接受至少一線治療的復發或難治多發性骨髓瘤患者，隨機分配至 talquetamab+daratumumab+pomalidomide（tal-dp）、talquetamab+daratumumab（tal-d）或 daratumumab+pomalidomide+dexamethasone（dpd）。主要終點為獨立委員會評估的無惡化存活期。 主要結果：tal-dp、tal-d 與 dpd 組分別納入 287、287、290 人；中位追蹤 24.6 個月時，24 個月無惡化存活率為 81.3%、77.6% vs 51.2%。相較 dpd，tal-dp 的疾病惡化或死亡 hr 為 0.28（95% ci 0.20-0.40），tal-d 為 0.33（95% ci 0.24-0.46），皆 p<0.001。嚴重不良事件為 63.0%、52.6% 與 53.7%，致死性不良事件為 1.8%、4.0% 與 4.6%。 藥師重點：tal-dp 與 tal-d 均較 dpd 延長無惡化存活期；藥師需重點監測感染、血球低下、免疫治療相關反應，以及 talquetamab 相關皮膚、味覺或黏膜毒性。" }, { "id": "pmid-42315290", "kind": "article", "issueId": "2026-week25", "year": 2026, "week": 25, "weekLabel": "第 25 週", "dateRange": "2026/06/15 – 06/21", "href": "2026-week25.html", "title": "Stereotactic radiotherapy for neovascular age related macular degeneration: year 3 and 4 extended follow up results of a randomised, double masked, sham controlled, device trial (STAR)", "journal": "BMJ", "type": "RCT", "typeLabel": "RCT", "author": "Jackson", "doi": "10.1136/bmj-2026-729694", "url": "https://doi.org/10.1136/bmj-2026-729694", "summary": "藥師重點：雖然 SRT 可維持部分減少 anti-VEGF 注射的效果，但第 4 年視力較差且微血管異常較多，結果已不支持將 SRT 用於 neovascular AMD；藥師進行病人衛教時仍應以 anti-VEGF 追蹤與眼科評估為核心。", "pubDate": "2026-06-18", "terms": [ "stereotactic", "radiotherapy", "neovascular", "related", "macular", "degeneration", "year", "extended", "randomised", "double" ], "drugTerms": [ "anti-vegf" ], "searchText": "stereotactic radiotherapy for neovascular age related macular degeneration: year 3 and 4 extended follow up results of a randomised, double masked, sham controlled, device trial (star) bmj rct jackson 10.1136/bmj-2026-729694 研究背景：濕性年齡相關性黃斑部病變（neovascular amd）常需長期 anti-vegf 玻璃體內注射；star 試驗評估 立體定位放射治療（srt）在 2 年主要分析後的第 3、4 年效果。 研究方法：此英國 30 家 nhs 醫院進行的隨機、雙遮蔽、假治療對照裝置試驗，納入 411 名至少 50 歲、慢性且已治療但仍活躍的 amd 患者。受試者接受一次性 16 gray srt 或假 srt；第 4 年主要療效結果為 anti-vegf 注射次數，另一主要結果為視力變化，並評估不良事件、嚴重不良事件與微血管異常。 主要結果：srt 組 274 人、假治療組 137 人。第 4 年意向治療分析中，srt 組 4 年平均注射 19.1 次，假治療組 21.6 次，校正後減少 3.2 次（95% ci -5.7 to -0.7）；但 srt 組最終視力較假治療組差 8.3 個字母（95% ci -12.7 to -4.0）。不良事件率相近，但 reading centre 偵測到的微血管異常為 58% vs 16%。 藥師重點：雖然 srt 可維持部分減少 anti-vegf 注射的效果，但第 4 年視力較差且微血管異常較多，結果已不支持將 srt 用於 neovascular amd；藥師進行病人衛教時仍應以 anti-vegf 追蹤與眼科評估為核心。" }, { "id": "pmid-42309116", "kind": "article", "issueId": "2026-week25", "year": 2026, "week": 25, "weekLabel": "第 25 週", "dateRange": "2026/06/15 – 06/21", "href": "2026-week25.html", "title": "Patellar resurfacing in total knee replacement: 20-year clinical and economic results of a large multicentre, randomised controlled trial in the UK", "journal": "Lancet", "type": "OA", "typeLabel": "Original Article", "author": "Murray", "doi": "10.1016/S0140-6736(26)00652-5", "url": "https://doi.org/10.1016/S0140-6736(26)00652-5", "summary": "藥師重點：結果顯示主要臨床結果未達顯著差異，但 QALYs 與成本效益傾向支持髕骨表面置換；此議題主要屬骨科決策，藥師可協助術後止痛、抗凝與感染預防用藥管理。", "pubDate": "2026-06-17", "terms": [ "patellar", "resurfacing", "total", "knee", "replacement", "year", "economic", "large", "multicentre", "randomised" ], "drugTerms": [], "searchText": "patellar resurfacing in total knee replacement: 20-year clinical and economic results of a large multicentre, randomised controlled trial in the uk lancet original article murray 10.1016/s0140-6736(26)00652-5 研究背景：全膝關節置換時是否進行髕骨表面置換仍有爭議，既有隨機試驗常樣本不足且追蹤不超過 10 年；本研究提供 20 年臨床與經濟結果。 研究方法：此英國實務型、多中心、開放標籤隨機試驗於 1999 年開始，將預計接受 初次全膝關節置換術 的成人分配至進行或不進行髕骨表面置換，追蹤 20 年。主要結果為 oxford knee score（oks），次要結果包括 sf-12、eq-5d-3l、成本、成本效益與後續膝關節手術。 主要結果：1715 人隨機分組，861 人接受髕骨表面置換、854 人未接受。20 年追蹤期間 oks 邊際差為 0.76（95% ci -0.08 to 1.59；p=0.076），未達統計顯著；置換組 qalys 較高（7.295 vs 6.884；差異 0.380，95% ci 0.061-0.700；p=0.020），20 年整體醫療成本相近。 藥師重點：結果顯示主要臨床結果未達顯著差異，但 qalys 與成本效益傾向支持髕骨表面置換；此議題主要屬骨科決策，藥師可協助術後止痛、抗凝與感染預防用藥管理。" }, { "id": "pmid-42289183", "kind": "article", "issueId": "2026-week25", "year": 2026, "week": 25, "weekLabel": "第 25 週", "dateRange": "2026/06/15 – 06/21", "href": "2026-week25.html", "title": "Mezigdomide, carfilzomib, and dexamethasone versus carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma (SUCCESSOR-2): a phase 3, open-label, randomised controlled trial", "journal": "Lancet", "type": "OA", "typeLabel": "Original Article", "author": "Dimopoulos", "doi": "10.1016/S0140-6736(26)01088-3", "url": "https://doi.org/10.1016/S0140-6736(26)01088-3", "summary": "藥師重點：mezigdomide 合併 carfilzomib/dexamethasone 可明顯延長無惡化存活期，但高等級不良事件與感染較多；藥師需強化血球、感染、腎功能、心血管風險與類固醇相關副作用監測。", "pubDate": "2026-06-14", "terms": [ "mezigdomide", "carfilzomib", "dexamethasone", "relapsed", "refractory", "multiple", "myeloma", "successor-2", "phase", "open-label" ], "drugTerms": [ "anti-cd38" ], "searchText": "mezigdomide, carfilzomib, and dexamethasone versus carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma (successor-2): a phase 3, open-label, randomised controlled trial lancet original article dimopoulos 10.1016/s0140-6736(26)01088-3 研究背景：多發性骨髓瘤患者在第一次復發時常已暴露於 anti-cd38 抗體 與 lenalidomide，後續選擇受限；successor-2 評估 mezigdomide 合併 carfilzomib/dexamethasone 的療效與安全性。 研究方法：此第 3 期、開放標籤、隨機對照試驗於 26 國 160 個醫院據點進行，納入可測量且曾接受至少一線治療、最近治療期間或之後疾病惡化的成人多發性骨髓瘤患者。主要終點為 mezigdomide 1.0 mg 加 carfilzomib/dexamethasone 相較 carfilzomib/dexamethasone 的無惡化存活期。 主要結果：479 人納入分析，其中 288 人接受 mezigdomide-carfilzomib-dexamethasone，191 人接受 carfilzomib-dexamethasone。中位追蹤 10.6 個月時，無惡化存活期為 18.0 vs 8.3 個月（hr 0.48，95% ci 0.36-0.63；p<0.0001）。等級 3 或 4 不良事件為 84% vs 56%，包含 neutropenia 61% vs 9% 與感染 34% vs 16%；治療相關 等級 5 不良事件為 3% vs 1%。 藥師重點：mezigdomide 合併 carfilzomib/dexamethasone 可明顯延長無惡化存活期，但高等級不良事件與感染較多；藥師需強化血球、感染、腎功能、心血管風險與類固醇相關副作用監測。" }, { "id": "pmid-42294842", "kind": "article", "issueId": "2026-week25", "year": 2026, "week": 25, "weekLabel": "第 25 週", "dateRange": "2026/06/15 – 06/21", "href": "2026-week25.html", "title": "Lonvoguran Ziclumeran - In Vivo CRISPR Gene Editing in Hereditary Angioedema", "journal": "NEJM", "type": "OA", "typeLabel": "Original Article", "author": "Cohn", "doi": "10.1056/NEJMoa2600931", "url": "https://doi.org/10.1056/NEJMoa2600931", "summary": "藥師重點：lonvo-z 單次輸注可大幅降低遺傳性血管性水腫發作率，但仍屬新型 gene-editing 治療；藥師需留意輸注反應、長期安全性、發作紀錄與是否符合 C1 抑制劑 deficiency 族群。", "pubDate": "2026-06-13", "terms": [ "lonvoguran", "ziclumeran", "vivo", "crispr", "gene", "editing", "hereditary", "angioedema", "nejm", "cohn" ], "drugTerms": [], "searchText": "lonvoguran ziclumeran - in vivo crispr gene editing in hereditary angioedema nejm original article cohn 10.1056/nejmoa2600931 研究背景：遺傳性血管性水腫為罕見且可能危及生命的遺傳疾病，會反覆發生使人失能的腫脹發作；lonvoguran ziclumeran（lonvo-z）為單次給藥的體內 crispr gene-editing 治療候選藥物。 研究方法：此第 3 期雙盲試驗將 16 歲以上、c1 抑制劑 deficiency 的遺傳性血管性水腫患者，以 2:1 隨機分配接受單次靜脈 lonvo-z 50 mg 或 安慰劑。主要終點為輸注後第 5 至 28 週經研究者確認的每月血管性水腫發作率。 主要結果：共 80 人隨機分組，lonvo-z 組 52 人、安慰劑 組 28 人；中位追蹤 7.5 個月。第 5 至 28 週每月發作率 least-squares 平均值 為 0.26 vs 2.10，相對差異 -87%（95% ci -93 to -78；p<0.001）。輸注期間或之後不良事件為 92% vs 86%；lonvo-z 組較常見者包括輸注相關反應、頭痛、疲倦、背痛與上呼吸道感染，未通報嚴重或 等級 3 以上不良事件。 藥師重點：lonvo-z 單次輸注可大幅降低遺傳性血管性水腫發作率，但仍屬新型 gene-editing 治療；藥師需留意輸注反應、長期安全性、發作紀錄與是否符合 c1 抑制劑 deficiency 族群。" }, { "id": "pmid-42309117", "kind": "article", "issueId": "2026-week25", "year": 2026, "week": 25, "weekLabel": "第 25 週", "dateRange": "2026/06/15 – 06/21", "href": "2026-week25.html", "title": "Cervical cancer mortality trends following HPV vaccination in England, 2001-24: an analysis of population-based mortality data", "journal": "Lancet", "type": "OA", "typeLabel": "Original Article", "author": "Sasieni", "doi": "10.1016/S0140-6736(26)00918-9", "url": "https://doi.org/10.1016/S0140-6736(26)00918-9", "summary": "藥師重點：研究提供高 HPV vaccination coverage 與年輕女性子宮頸癌死亡大幅下降相關的全國層級證據；藥師可在疫苗衛教中強調青少年高涵蓋率與按時接種的重要性。", "pubDate": "2026-06-17", "terms": [ "cervical", "cancer", "mortality", "trends", "following", "vaccination", "england", "population-based", "lancet", "sasieni" ], "drugTerms": [], "searchText": "cervical cancer mortality trends following hpv vaccination in england, 2001-24: an analysis of population-based mortality data lancet original article sasieni 10.1016/s0140-6736(26)00918-9 研究背景：hpv vaccination 是消除子宮頸癌策略的重要措施，但對死亡率影響的全國層級證據仍有限；英格蘭 2008 年起推動 12-13 歲女孩 hpv vaccination，並對 14-18 歲進行 catch-up campaign。 研究方法：研究分析英格蘭 2001 至 2024 年 20-24、25-29 與 30-34 歲女性子宮頸癌死亡資料，並依出生世代 hpv vaccination coverage 估算各年齡層死亡年份中已接種比例。研究以 poisson regression 估計接種女性相較未導入疫苗時的相對風險降低。 主要結果：2020-2024 年 20-24 歲女性、12-13 歲接種率約 88-90% 的族群中，未發生子宮頸癌死亡，歷史推估預期為 23.1 例，死亡率降低 100%（95% ci 84-100）。整體至 2024 年底，hpv vaccination 與約 199.6 例子宮頸癌死亡減少相關（95% ci 125.0-274.2）。 藥師重點：研究提供高 hpv vaccination coverage 與年輕女性子宮頸癌死亡大幅下降相關的全國層級證據；藥師可在疫苗衛教中強調青少年高涵蓋率與按時接種的重要性。" }, { "id": "pmid-42308484", "kind": "article", "issueId": "2026-week25", "year": 2026, "week": 25, "weekLabel": "第 25 週", "dateRange": "2026/06/15 – 06/21", "href": "2026-week25.html", "title": "Cefazolin for Methicillin-Susceptible Staphylococcus aureus Bacteremia", "journal": "NEJM", "type": "RCT", "typeLabel": "RCT", "author": "Lee", "doi": "10.1056/NEJMoa2506905", "url": "https://doi.org/10.1056/NEJMoa2506905", "summary": "藥師重點：結果支持 cefazolin 對 MSSA 菌血症 90 天死亡率不劣於 flucloxacillin 或 cloxacillin，且急性腎損傷較少；藥師仍需依培養、susceptibility、過敏史、感染部位與腎功能調整抗生素策略。", "pubDate": "2026-06-18", "terms": [ "cefazolin", "methicillin-susceptible", "staphylococcus", "aureus", "bacteremia", "nejm", "nejmoa2506905", "mssa", "penicillin", "flucloxacillin" ], "drugTerms": [ "cefazolin", "penicillin", "flucloxacillin", "cloxacillin", "antistaphylococcal-penicillin" ], "searchText": "cefazolin for methicillin-susceptible staphylococcus aureus bacteremia nejm rct lee 10.1056/nejmoa2506905 研究背景：mssa 菌血症死亡率高，臨床上 cefazolin 與抗葡萄球菌 penicillin（flucloxacillin 或 cloxacillin）何者較適合作為首選治療仍有爭議。 研究方法：此進行中的國際 bayesian adaptive platform 試驗，以開放標籤、隨機方式比較 cefazolin 與 flucloxacillin 或 cloxacillin，用於 penicillin-resistant、methicillin-susceptible s. aureus 菌血症成人。主要結果為平台納入後 90 天全因死亡，並評估 cefazolin 的不劣性與優越性；次要安全性結果包括 14 天內急性腎損傷。 主要結果：此分析期間為 2022 年 2 月 17 日至 2024 年 8 月 7 日，已達不劣性標準。90 天死亡率為 cefazolin 組 15.0% 與抗葡萄球菌 penicillin 組 17.0%（校正 or 0.81，95% 可信區間 0.59-1.12；不劣性機率 99.2%）。急性腎損傷發生率為 13.9% vs 19.6%（校正 or 0.67，95% 可信區間 0.50-0.89；優越性機率 99.7%）。 藥師重點：結果支持 cefazolin 對 mssa 菌血症 90 天死亡率不劣於 flucloxacillin 或 cloxacillin，且急性腎損傷較少；藥師仍需依培養、susceptibility、過敏史、感染部位與腎功能調整抗生素策略。" }, { "id": "pmid-42307937", "kind": "article", "issueId": "2026-week25", "year": 2026, "week": 25, "weekLabel": "第 25 週", "dateRange": "2026/06/15 – 06/21", "href": "2026-week25.html", "title": "Bispecific Antibody Ivonescimab Added to Chemotherapy in EGFR-Variant Non-Small Cell Lung Cancer: The HARMONi-A Randomized Clinical Trial", "journal": "JAMA", "type": "OA", "typeLabel": "Original Article", "author": "Fang", "doi": "10.1001/jama.2026.7745", "url": "https://doi.org/10.1001/jama.2026.7745", "summary": "藥師重點：ivonescimab 合併 pemetrexed/carboplatin 可改善 EGFR-TKI 後惡化之 EGFR-variant NSCLC 的整體存活期，但高等級不良事件較多；藥師需監測骨髓抑制、出血/血栓、蛋白尿、高血壓與免疫相關不良事件。", "pubDate": "2026-06-17", "terms": [ "bispecific", "antibody", "ivonescimab", "added", "chemotherapy", "egfr-variant", "non-small", "cell", "lung", "cancer" ], "drugTerms": [ "ivonescimab", "carboplatin" ], "searchText": "bispecific antibody ivonescimab added to chemotherapy in egfr-variant non-small cell lung cancer: the harmoni-a randomized clinical trial jama original article fang 10.1001/jama.2026.7745 研究背景：egfr-variant nonsquamous nsclc 患者在既有 egfr-tki 治療後疾病惡化時，後續選擇有限；ivonescimab 為同時標靶 pd-1 與 vegf 的 bispecific 抗體。 研究方法：harmoni-a 為中國 55 個據點進行的隨機、雙盲、安慰劑對照第 3 期試驗，納入 322 名局部晚期或轉移性 egfr-variant nonsquamous nsclc 且曾接受 egfr-tki 的成人。受試者 1:1 接受 ivonescimab 20 mg/kg 或 安慰劑 合併 pemetrexed/carboplatin，每 3 週一次共 4 個療程後進入維持治療；本次最終分析聚焦整體存活期。 主要結果：中位追蹤 32.5 個月時，ivonescimab 加化療較單純化療改善整體存活期（中位數 16.8 vs 14.1 個月；stratified hr 0.74，95% ci 0.58-0.95；p=.02），中位整體存活期絕對差 2.7 個月。30 個月估計存活率為 29.1% vs 18.4%；等級 3 以上治療期間不良事件為 67.1% vs 54.7%。 藥師重點：ivonescimab 合併 pemetrexed/carboplatin 可改善 egfr-tki 後惡化之 egfr-variant nsclc 的整體存活期，但高等級不良事件較多；藥師需監測骨髓抑制、出血/血栓、蛋白尿、高血壓與免疫相關不良事件。" }, { "id": "pmid-42309115", "kind": "article", "issueId": "2026-week25", "year": 2026, "week": 25, "weekLabel": "第 25 週", "dateRange": "2026/06/15 – 06/21", "href": "2026-week25.html", "title": "Benzylpenicillin versus flucloxacillin or cloxacillin for the treatment of penicillin-susceptible Staphylococcus aureus bacteraemia (SNAP): an international, multicentre, open-label, non-inferiority randomised controlled trial", "journal": "Lancet", "type": "OA", "typeLabel": "Original Article", "author": "N/A", "doi": "10.1016/S0140-6736(26)00761-0", "url": "https://doi.org/10.1016/S0140-6736(26)00761-0", "summary": "藥師重點：雖未達預設不劣性門檻，但 benzylpenicillin 在死亡與急性腎損傷風險上呈有利訊號；藥師需確認 PSSA、penicillin susceptibility、感染嚴重度與當地抗生素可近性後，再協助抗生素選擇與腎功能監測。", "pubDate": "2026-06-17", "terms": [ "benzylpenicillin", "flucloxacillin", "cloxacillin", "penicillin-susceptible", "staphylococcus", "aureus", "bacteraemia", "snap", "international", "multicentre" ], "drugTerms": [ "benzylpenicillin", "flucloxacillin", "cloxacillin", "anti-staphylococcal", "penicillin" ], "searchText": "benzylpenicillin versus flucloxacillin or cloxacillin for the treatment of penicillin-susceptible staphylococcus aureus bacteraemia (snap): an international, multicentre, open-label, non-inferiority randomised controlled trial lancet original article 10.1016/s0140-6736(26)00761-0 研究背景：penicillin-susceptible s. aureus（pssa）菌血症近年重新受到重視；benzylpenicillin 可能具藥動學與不良反應優勢，但臨床仍常因未偵測 penicillin resistance 風險而使用抗葡萄球菌 penicillin。 研究方法：此研究者發起、國際、多中心、開放標籤、不劣性隨機對照試驗，納入 snap 試驗 中 pssa 菌血症成人，比較 benzylpenicillin 與 flucloxacillin 或 cloxacillin。主要結果為平台納入後 90 天全因死亡，並以 bayesian logistic regression 評估不劣性；同時追蹤急性腎損傷與嚴重不良反應。 主要結果：成人 pssa 菌血症共 493 人中，156 人分配至 benzylpenicillin，125 人分配至 flucloxacillin 或 cloxacillin。90 天死亡為 14% vs 22%（校正 or 0.67，95% 可信區間 0.35-1.28），benzylpenicillin 不劣性後驗機率 96.1%；急性腎損傷為 11% vs 22%（校正 or 0.50，95% 可信區間 0.26-0.94）。 藥師重點：雖未達預設不劣性門檻，但 benzylpenicillin 在死亡與急性腎損傷風險上呈有利訊號；藥師需確認 pssa、penicillin susceptibility、感染嚴重度與當地抗生素可近性後，再協助抗生素選擇與腎功能監測。" }, { "id": "fda-2026-week25-1", "kind": "fda", "issueId": "2026-week25", "year": 2026, "week": 25, "weekLabel": "第 25 週", "dateRange": "2026/06/15 – 06/21", "href": "2026-week25.html", "title": "FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss", "summary": "FDA 提醒未經核准的 GLP-1 減重產品可能涉及成分、品質、劑量與安全性風險。藥師應確認病人取得的是 FDA 核准產品，避免使用來源不明或複方調製的 semaglutide/tirzepatide 類產品，並加強低血糖、胃腸道不良反應與劑量錯誤衛教。", "terms": [ "concerns", "unapproved", "glp-1", "drugs", "used", "weight", "loss", "semaglutide", "tirzepatide", "https" ], "drugTerms": [ "glp-1", "semaglutide", "tirzepatide" ], "searchText": "fda’s concerns with unapproved glp-1 drugs used for weight loss fda drug safety 2026-06-15 fda 提醒未經核准的 glp-1 減重產品可能涉及成分、品質、劑量與安全性風險。藥師應確認病人取得的是 fda 核准產品，避免使用來源不明或複方調製的 semaglutide/tirzepatide 類產品，並加強低血糖、胃腸道不良反應與劑量錯誤衛教。 https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss" }, { "id": "fda-2026-week25-3", "kind": "fda", "issueId": "2026-week25", "year": 2026, "week": 25, "weekLabel": "第 25 週", "dateRange": "2026/06/15 – 06/21", "href": "2026-week25.html", "title": "FDA issues final decision to withdraw approval of Pepaxto (melphalan flufenamide)", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/node/398713", "summary": "FDA 已作成撤回 Pepaxto (melphalan flufenamide) 核准的最終決定。藥師應確認院內與病人用藥清單是否仍有相關品項，避免新開立或續用，並協助腫瘤團隊轉換替代治療。", "terms": [ "issues", "final", "decision", "withdraw", "approval", "pepaxto", "melphalan", "flufenamide", "https", "node" ], "drugTerms": [], "searchText": "fda issues final decision to withdraw approval of pepaxto (melphalan flufenamide) fda drug safety fda 已作成撤回 pepaxto (melphalan flufenamide) 核准的最終決定。藥師應確認院內與病人用藥清單是否仍有相關品項，避免新開立或續用，並協助腫瘤團隊轉換替代治療。 https://www.fda.gov/node/398713" }, { "id": "fda-2026-week25-2", "kind": "fda", "issueId": "2026-week25", "year": 2026, "week": 25, "weekLabel": "第 25 週", "dateRange": "2026/06/15 – 06/21", "href": "2026-week25.html", "title": "FDA alerts patients, caregivers, and health care providers of cross-compatibility issues with autoinjector devices that are optional for use with glatiramer acetate injection", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/node/403159", "summary": "FDA 提醒 glatiramer acetate injection 的選配 autoinjector device 可能有交叉相容性問題。藥師調劑或衛教時應確認藥品廠牌、注射器與 autoinjector 是否相容，避免病人沿用不適配裝置造成注射失敗或劑量問題。", "terms": [ "alerts", "caregivers", "providers", "cross-compatibility", "issues", "autoinjector", "devices", "that", "optional", "glatiramer" ], "drugTerms": [], "searchText": "fda alerts patients, caregivers, and health care providers of cross-compatibility issues with autoinjector devices that are optional for use with glatiramer acetate injection fda drug safety fda 提醒 glatiramer acetate injection 的選配 autoinjector device 可能有交叉相容性問題。藥師調劑或衛教時應確認藥品廠牌、注射器與 autoinjector 是否相容，避免病人沿用不適配裝置造成注射失敗或劑量問題。 https://www.fda.gov/node/403159" }, { "id": "fda-2026-week25-4", "kind": "fda", "issueId": "2026-week25", "year": 2026, "week": 25, "weekLabel": "第 25 週", "dateRange": "2026/06/15 – 06/21", "href": "2026-week25.html", "title": "FDA Accepts First In Silico Drug Development Tool Under ISTAND Program to Help Predict Drug-Induced Liver Injury", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fda-accepts-first-silico-drug-development-tool-under-istand-program-help-predict-drug-induced-liver", "summary": "FDA 接受第一個 ISTAND program 下的 in silico drug development tool，用於協助預測 drug-induced liver injury。此為藥物研發與安全評估工具訊息，藥師可關注 DILI 風險預測方法進展，但臨床用藥仍需依仿單、肝功能監測與病人風險因子判讀。", "terms": [ "accepts", "first", "silico", "development", "tool", "under", "istand", "program", "help", "predict" ], "drugTerms": [], "searchText": "fda accepts first in silico drug development tool under istand program to help predict drug-induced liver injury fda drug safety 2026-06-03 fda 接受第一個 istand program 下的 in silico drug development tool，用於協助預測 drug-induced liver injury。此為藥物研發與安全評估工具訊息，藥師可關注 dili 風險預測方法進展，但臨床用藥仍需依仿單、肝功能監測與病人風險因子判讀。 https://www.fda.gov/drugs/drug-alerts-and-statements/fda-accepts-first-silico-drug-development-tool-under-istand-program-help-predict-drug-induced-liver" }, { "id": "pmid-42274006", "kind": "article", "issueId": "2026-week24", "year": 2026, "week": 24, "weekLabel": "第 24 週", "dateRange": "2026/06/08 – 06/14", "href": "2026-week24.html", "title": "Vasopressors or Fluids in Early Septic Shock", "journal": "NEJM", "type": "OA", "typeLabel": "Original Article", "author": "Peake", "doi": "10.1056/NEJMoa2516225", "url": "https://doi.org/10.1056/NEJMoa2516225", "summary": "藥師重點：早期限制輸液並較早使用 vasopressor 未增加 90 天院外存活天數，但可減少輸液量與肺水腫；藥師協助 septic shock 復甦時應關注升壓劑啟用時機、輸液累積量與灌流目標。", "pubDate": "2026-06-11", "terms": [ "vasopressors", "fluids", "early", "septic", "shock", "nejm", "peake", "nejmoa2516225", "vasopressor", "arise" ], "drugTerms": [], "searchText": "vasopressors or fluids in early septic shock nejm original article peake 10.1056/nejmoa2516225 研究背景：septic shock 早期復甦在較多靜脈輸液與較早使用 vasopressor、限制輸液之間仍無最佳策略定論。 研究方法：arise fluids 為急診 septic shock 成人隨機試驗，將患者分配至 restricted fluid volume 加 early vasopressor 治療，或 higher fluid volume 加 later vasopressor 治療，介入至少 6 小時、最長 24 小時。主要終點為隨機分派至第 90 天 alive and out of hospital 天。 主要結果：963 名患者納入 意向治療分析，前 24 小時 vasopressor 組輸液量較 fluids 組少（中位數 差異 -1108 ml，95% ci -1395 to -850），vasopressor 使用比例高 18.9 百分點（95% ci 13.3 to 24.5）。第 90 天 alive and out of hospital 天 兩組中位數皆為 76 天（差異 0.0 天，95% ci -2.7 to 2.7，p=1.00）；pulmonary edema 較少見於 vasopressor 組（0.6% vs 5.0%，p<0.001）。 藥師重點：早期限制輸液並較早使用 vasopressor 未增加 90 天院外存活天數，但可減少輸液量與肺水腫；藥師協助 septic shock 復甦時應關注升壓劑啟用時機、輸液累積量與灌流目標。" }, { "id": "pmid-42285563", "kind": "article", "issueId": "2026-week24", "year": 2026, "week": 24, "weekLabel": "第 24 週", "dateRange": "2026/06/08 – 06/14", "href": "2026-week24.html", "title": "Updated International Patient Decision Aid Standards (IPDAS version 5.0): modified Delphi, evidence informed consensus process", "journal": "BMJ", "type": "OA", "typeLabel": "Original Article", "author": "Volk", "doi": "10.1136/bmj-2025-088116", "url": "https://doi.org/10.1136/bmj-2025-088116", "summary": "藥師重點：IPDAS 5.0 可作為藥師設計或審閱用藥決策輔助工具的品質框架，重點在於資訊平衡、降低偏差與讓病人價值偏好能被納入決策。", "pubDate": "2026-06-12", "terms": [ "updated", "international", "decision", "standards", "ipdas", "version", "modified", "delphi", "evidence", "informed" ], "drugTerms": [], "searchText": "updated international patient decision aid standards (ipdas version 5.0): modified delphi, evidence informed consensus process bmj original article volk 10.1136/bmj-2025-088116 研究背景：patient decision aids (pdas) 是協助病人在醫療選項間作知情決策的 evidence-informed tools；ipdas 上次更新在 2013 年，近年相關證據已明顯增加。 研究方法：本文報告 ipdas 5.0 更新，採 modified delphi process，經兩輪投票形成 evidence-informed consensus。共有 202 名來自 26 國的 patients/consumers、policy makers、researchers 與 clinician researchers 參與。 主要結果：ipdas 5.0 包含 7 項 qualifying criteria、10 項 essential criteria 與 54 項 enhancing criteria，分別用於判定是否為 pda、降低 biased decisions，以及提升 pda 品質。 藥師重點：ipdas 5.0 可作為藥師設計或審閱用藥決策輔助工具的品質框架，重點在於資訊平衡、降低偏差與讓病人價值偏好能被納入決策。" }, { "id": "pmid-42276088", "kind": "article", "issueId": "2026-week24", "year": 2026, "week": 24, "weekLabel": "第 24 週", "dateRange": "2026/06/08 – 06/14", "href": "2026-week24.html", "title": "The impact of Chile's multipronged food labelling and advertising law on early childhood excess weight: a cohort difference-in-differences study", "journal": "Lancet", "type": "OA", "typeLabel": "Original Article", "author": "Paraje", "doi": "10.1016/S0140-6736(26)00651-3", "url": "https://doi.org/10.1016/S0140-6736(26)00651-3", "summary": "藥師重點：此研究提供食物標示與行銷限制可能降低幼兒過重盛行的政策證據；藥師在衛教兒童肥胖與慢性病預防時，可將食品標示識讀與健康食物環境納入討論。", "pubDate": "2026-06-27", "terms": [ "impact", "chile", "multipronged", "food", "labelling", "advertising", "early", "childhood", "excess", "weight" ], "drugTerms": [], "searchText": "the impact of chile's multipronged food labelling and advertising law on early childhood excess weight: a cohort difference-in-differences study lancet original article paraje 10.1016/s0140-6736(26)00651-3 研究背景：智利 2016 food labelling and advertising law (flal) 以包裝正面黑色八角形警示標示、行銷限制與校園限制改善食物環境，但其與兒童體重結果的因果關聯仍需評估。 研究方法：研究採 世代 差異-in-differences approach，使用 chilean national board of school aid and scholarships 全國行政資料，涵蓋 2012-2017 年超過 300,000 名公立與補助學校 4-6 歲兒童。以 prekindergarten 入學年度定義 世代，比較未暴露 世代（2012、2013）與暴露於 flal 第 1 期 的 世代（2014、2015），主要結果為 excess weight（overweight 或 obesity）的二元指標。 主要結果：最終分析樣本為 321,597 名學生。暴露於 flal 第 1 期 與 excess weight 機率下降相關，kindergarten 與 first 等級 均暴露 18 個月者效果最大：女孩下降 2.85%（95% ci -0.0407 to -0.0163），男孩下降 2.40%（95% ci -0.0358 to -0.0122）；暴露 6 個月亦見下降，女孩 -1.91%（95% ci -0.0315 to -0.0068），男孩 -2.24%（95% ci -0.0345 to -0.0104）。 藥師重點：此研究提供食物標示與行銷限制可能降低幼兒過重盛行的政策證據；藥師在衛教兒童肥胖與慢性病預防時，可將食品標示識讀與健康食物環境納入討論。" }, { "id": "pmid-42253238", "kind": "article", "issueId": "2026-week24", "year": 2026, "week": 24, "weekLabel": "第 24 週", "dateRange": "2026/06/08 – 06/14", "href": "2026-week24.html", "title": "Survodutide Once Weekly for the Treatment of Adults with Obesity", "journal": "NEJM", "type": "OA", "typeLabel": "Original Article", "author": "le Roux", "doi": "10.1056/NEJMoa2600751", "url": "https://doi.org/10.1056/NEJMoa2600751", "summary": "藥師重點：survodutide 在無糖尿病肥胖成人可帶來較 安慰劑 更大的體重下降；用藥評估需留意其仍為研發中治療、劑量調整與胃腸道副作用負擔。", "pubDate": "2026-06-07", "terms": [ "survodutide", "once", "weekly", "adults", "obesity", "nejm", "roux", "nejmoa2600751", "glp-1", "glucagon" ], "drugTerms": [ "glp-1" ], "searchText": "survodutide once weekly for the treatment of adults with obesity nejm original article le roux 10.1056/nejmoa2600751 研究背景：glp-1 受體 致效劑 類藥物已改變肥胖治療，但仍有未滿足需求；survodutide 是研發中的 glucagon 受體-glp-1 受體 dual 致效劑，早期研究曾顯示減重效果。 研究方法：synchronize-1 為 第 3 期、雙盲 試驗，納入 bmi >=30 或 bmi >=27 且至少一項肥胖相關併發症、但無糖尿病的成人 725 名。受試者以 1:1:1 分配接受 每週一次 subcutaneous survodutide 調整至 3.6 mg、6.0 mg 或 安慰劑，並接受生活型態諮詢；主要終點為第 76 週體重百分比變化與達成至少 5% 減重比例。 主要結果：第 76 週 治療-處方 estimand 顯示體重變化為 survodutide 3.6 mg -12.2%（95% ci -13.6 to -10.8）、6.0 mg -13.0%（95% ci -14.4 to -11.6），安慰劑 -5.4%（95% ci -6.9 to -4.0）。達成至少 5% 減重比例為 72.6%、71.9% 與 46.3%（p<0.001 for all comparisons with 安慰劑）；胃腸道症狀為最常見不良事件，發生率 80.9%、89.7% 與 47.9%，且無死亡通報。 藥師重點：survodutide 在無糖尿病肥胖成人可帶來較 安慰劑 更大的體重下降；用藥評估需留意其仍為研發中治療、劑量調整與胃腸道副作用負擔。" }, { "id": "pmid-42269152", "kind": "article", "issueId": "2026-week24", "year": 2026, "week": 24, "weekLabel": "第 24 週", "dateRange": "2026/06/08 – 06/14", "href": "2026-week24.html", "title": "Subretinal Gene Therapy for X-Linked Retinoschisis", "journal": "NEJM", "type": "OA", "typeLabel": "Original Article", "author": "Liang", "doi": "10.1056/NEJMoa2515953", "url": "https://doi.org/10.1056/NEJMoa2515953", "summary": "藥師重點：scAAV8-hRS1 在少數患者中未見高度不良事件或眼內發炎，並有結構改善訊號；目前仍屬早期基因治療證據，臨床意義需等待更大樣本與較長追蹤確認。", "pubDate": "2026-06-11", "terms": [ "subretinal", "gene", "x-linked", "retinoschisis", "nejm", "liang", "nejmoa2515953", "pathogenic", "variation", "human" ], "drugTerms": [], "searchText": "subretinal gene therapy for x-linked retinoschisis nejm original article liang 10.1056/nejmoa2515953 研究背景：x-linked retinoschisis 是因 rs1 pathogenic variation 導致的隱性遺傳疾病，會造成進行性黃斑部退化與視力喪失。 研究方法：研究將含 human rs1 complementary dna 的 aav8 vector（scaav8-hrs1）以單次視網膜下注射給予 5-18 歲 x-linked retinoschisis 患者的一眼。主要終點為注射後 52 週安全性；次要終點包括 bcva、ss-oct 評估之視網膜結構、full-field electroretinography 與 microperimetry。 主要結果：共 12 名患者納入，scaav8-hrs1 劑量為 7.5×10^10 或 1×10^11 vector genomes。52 週內通報 56 件 不良事件，無 等級 3 以上 不良事件 或 ocular inflammation；1 名患者治療眼於 week 1 出現 macular hole。week 52 治療眼 bcva 平均增加 10.8 letters，未治療眼增加 2.4 letters；12 名患者治療眼 macular schisis cavity 於 week 13 閉合，但光感受器與 bipolar cell 功能或 macular sensitivity 未見具臨床意義變化。 藥師重點：scaav8-hrs1 在少數患者中未見高度不良事件或眼內發炎，並有結構改善訊號；目前仍屬早期基因治療證據，臨床意義需等待更大樣本與較長追蹤確認。" }, { "id": "pmid-42283370", "kind": "article", "issueId": "2026-week24", "year": 2026, "week": 24, "weekLabel": "第 24 週", "dateRange": "2026/06/08 – 06/14", "href": "2026-week24.html", "title": "Sodium Bicarbonate for Critically Ill Adults with Metabolic Acidosis and Shock", "journal": "NEJM", "type": "OA", "typeLabel": "Original Article", "author": "Serpa Neto", "doi": "10.1056/NEJMoa2600526", "url": "https://doi.org/10.1056/NEJMoa2600526", "summary": "藥師重點：在接受 vasopressor 的重症 metabolic acidosis 患者，sodium bicarbonate 未降低 30 天 重大腎臟不良事件；使用時仍應以酸鹼狀態、鈉負荷、容量狀態與腎臟替代治療需求作個別化評估。", "pubDate": "2026-06-12", "terms": [ "sodium", "bicarbonate", "critically", "adults", "metabolic", "acidosis", "shock", "nejm", "serpa", "neto" ], "drugTerms": [], "searchText": "sodium bicarbonate for critically ill adults with metabolic acidosis and shock nejm original article serpa neto 10.1056/nejmoa2600526 研究背景：重症患者 metabolic acidosis 常與器官功能障礙及死亡相關，sodium bicarbonate 可矯正 acidemia，但對接受 vasopressor 的 metabolic acidosis 患者是否改善臨床結果仍不明確。 研究方法：soda-bic 為 實務型、adaptive、雙盲、隨機試驗，於 7 國 55 個 icu 納入 metabolic acidosis 且接受 vasopressors 的成人 500 名。受試者接受 sodium bicarbonate 或 安慰劑（5% dextrose）輸注最長 5 小時，並依 ph >=7.30 與 base excess >=0 mmol/l 目標調整；主要終點為 30 天內 重大腎臟不良事件（死亡、renal-replacement 治療 或 持續性腎功能障礙）。 主要結果：30 天 重大腎臟不良事件 發生率為 sodium bicarbonate 40.2%（98/244）與 安慰劑 39.4%（100/254）（校正 差異 1.2 百分點，95% ci -7.1 to 9.4，p=0.78）。30 天內 renal-replacement 治療 為 16.8% vs 20.9%（校正 差異 -3.9 百分點，95% ci -10.6 to 2.7），院內 30 天死亡率為 25.4% vs 24.0%；sodium bicarbonate 組 4 名（1.6%）發生 adverse effect，安慰劑 無（p=0.06）。 藥師重點：在接受 vasopressor 的重症 metabolic acidosis 患者，sodium bicarbonate 未降低 30 天 重大腎臟不良事件；使用時仍應以酸鹼狀態、鈉負荷、容量狀態與腎臟替代治療需求作個別化評估。" }, { "id": "pmid-42285568", "kind": "article", "issueId": "2026-week24", "year": 2026, "week": 24, "weekLabel": "第 24 週", "dateRange": "2026/06/08 – 06/14", "href": "2026-week24.html", "title": "Reporting of Cohort and Routinely Collected Data in Randomised Controlled Trial Protocols (SPIRIT-ROUTINE): extension checklist with explanation and elaboration", "journal": "BMJ", "type": "OA", "typeLabel": "Original Article", "author": "Kearney", "doi": "10.1136/bmj-2025-087095", "url": "https://doi.org/10.1136/bmj-2025-087095", "summary": "藥師重點：此文件屬研究報告品質工具，不是臨床療效研究；閱讀使用 routinely collected 資料 的藥物試驗時，可用其檢核資料來源透明度、追蹤完整性與偏差風險。", "pubDate": "2026-06-12", "terms": [ "reporting", "routinely", "collected", "randomised", "protocols", "spirit-routine", "extension", "checklist", "explanation", "elaboration" ], "drugTerms": [], "searchText": "reporting of cohort and routinely collected data in randomised controlled trial protocols (spirit-routine): extension checklist with explanation and elaboration bmj original article kearney 10.1136/bmj-2025-087095 研究背景：使用 世代 或 routinely collected 資料（如 electronic 健康 records、registries、administrative claims）的 隨機對照試驗s 越來越常見，但資料治理、品質與取得延遲會影響可重現性與 bias 評估。 研究方法：本文介紹 spirit-routine extension，作為 spirit 2025 guideline 的延伸 checklist 與 explanation，聚焦依賴 世代 或 routinely collected 資料 sources 的試驗 protocol 報告。 主要結果：spirit-routine 旨在補足這類試驗 protocol 對資料來源、治理路徑、資料品質、追蹤與偏差評估等資訊揭露，供 investigators、funders、ethics committees、journal editors 與 peer reviewers 使用。 藥師重點：此文件屬研究報告品質工具，不是臨床療效研究；閱讀使用 routinely collected 資料 的藥物試驗時，可用其檢核資料來源透明度、追蹤完整性與偏差風險。" }, { "id": "pmid-42259339", "kind": "article", "issueId": "2026-week24", "year": 2026, "week": 24, "weekLabel": "第 24 週", "dateRange": "2026/06/08 – 06/14", "href": "2026-week24.html", "title": "Orforglipron compared with dapagliflozin in adults with type 2 diabetes and inadequate glycaemic control with metformin (ACHIEVE-2): a multicentre, randomised, non-inferiority, open-label, phase 3 trial", "journal": "Lancet", "type": "OA", "typeLabel": "Original Article", "author": "Welch", "doi": "10.1016/S0140-6736(26)00800-7", "url": "https://doi.org/10.1016/S0140-6736(26)00800-7", "summary": "藥師重點：orforglipron 顯示優於 dapagliflozin 的降 HbA1c 效果，但胃腸道事件與停藥較多；若未來進入臨床使用，劑量耐受性與病人偏好會是用藥選擇的重要考量。", "pubDate": "2026-06-08", "terms": [ "orforglipron", "dapagliflozin", "adults", "type", "diabetes", "inadequate", "glycaemic", "control", "metformin", "achieve-2" ], "drugTerms": [ "dapagliflozin", "glp-1" ], "searchText": "orforglipron compared with dapagliflozin in adults with type 2 diabetes and inadequate glycaemic control with metformin (achieve-2): a multicentre, randomised, non-inferiority, open-label, phase 3 trial lancet original article welch 10.1016/s0140-6736(26)00800-7 研究背景：第二型糖尿病常需合併治療以達血糖目標；本研究比較 口服 非胜肽 glp-1 受體 致效劑 orforglipron 與 sglt2 抑制劑 dapagliflozin 在 metformin 控制不足患者的療效與安全性。 研究方法：achieve-2 為 40 週、第 3 期、多中心、開放標籤（orforglipron dose-blinded）、隨機試驗，納入使用 metformin >=1500 mg/day、hba1c 7.0-10.5%、bmi >=23.0 kg/m2 的第二型糖尿病成人 962 名。受試者以 1:1:1:1 分配接受 每日一次 口服 orforglipron 3、12、36 mg 或 dapagliflozin 10 mg；主要終點為 week 40 hba1c 變化，不劣性 margin 為 0.3%。 主要結果：week 40 治療 處方 estimand 顯示 orforglipron 各劑量均不劣於 dapagliflozin，且 hba1c 降幅較大：orforglipron 3、12、36 mg 分別為 -1.23%、-1.50%、-1.56%，dapagliflozin 10 mg 為 -0.81%；estimated 治療 差異 分別為 -0.42%、-0.70%、-0.75%（all p<0.0001）。orforglipron 胃腸道不良事件較多（47%、46%、54% vs 12%），停藥率也較高（15%、18%、20% vs 6%），未通報 重度 hypoglycaemia。 藥師重點：orforglipron 顯示優於 dapagliflozin 的降 hba1c 效果，但胃腸道事件與停藥較多；若未來進入臨床使用，劑量耐受性與病人偏好會是用藥選擇的重要考量。" }, { "id": "pmid-42276557", "kind": "article", "issueId": "2026-week24", "year": 2026, "week": 24, "weekLabel": "第 24 週", "dateRange": "2026/06/08 – 06/14", "href": "2026-week24.html", "title": "Low concentration atropine eye drops and progression of myopia in children: multicentre placebo controlled, double masked, randomised trial in the UK (CHAMP-UK)", "journal": "BMJ", "type": "RCT", "typeLabel": "RCT", "author": "Azuara-Blanco", "doi": "10.1136/bmj-2025-086698", "url": "https://doi.org/10.1136/bmj-2025-086698", "summary": "藥師重點：結論顯示 atropine 0.01% 眼藥水在兒童近視控制可減緩屈光度與眼軸進展，藥師衛教時需提醒每日點藥依從性，並留意瞳孔放大、視覺不適與適用年齡族群。", "pubDate": "2026-06-11", "terms": [ "concentration", "atropine", "drops", "progression", "myopia", "children", "multicentre", "placebo", "double", "masked" ], "drugTerms": [ "atropine" ], "searchText": "low concentration atropine eye drops and progression of myopia in children: multicentre placebo controlled, double masked, randomised trial in the uk (champ-uk) bmj rct azuara-blanco 10.1136/bmj-2025-086698 研究背景：兒童近視進展會增加後續眼科併發症風險，低濃度 atropine 眼藥水能否在英國兒童族群安全減緩近視加深仍需評估。 研究方法：champ-uk 為英國 5 個中心進行的多中心、雙盲、安慰劑 對照、隨機優越性試驗，納入 289 名 6-12 歲、近視 -0.50 至 -10.0 d 的兒童。受試者以 2:1 分配，每日使用 preserved atropine 0.01% 或 安慰劑 眼藥水 2 年，主要終點為睫狀肌麻痺下測得的 spherical equivalent refractive error。 主要結果：atropine 0.01% 較 安慰劑 減少近視進展（平均差 0.33 d，95% ci 0.17 to 0.49 d，p<0.001），central axial length 增加也較少（平均差 0.14 mm，95% ci 0.07 to 0.21，p<0.001）。除 pupil diameter 較大外，不良事件、耐受性與其他次要結果未見差異，且無 試驗 drug 相關 嚴重不良事件。 藥師重點：結論顯示 atropine 0.01% 眼藥水在兒童近視控制可減緩屈光度與眼軸進展，藥師衛教時需提醒每日點藥依從性，並留意瞳孔放大、視覺不適與適用年齡族群。" }, { "id": "pmid-42269151", "kind": "article", "issueId": "2026-week24", "year": 2026, "week": 24, "weekLabel": "第 24 週", "dateRange": "2026/06/08 – 06/14", "href": "2026-week24.html", "title": "Interleukin-10 Autoantibodies and HLA-DRB1*01:03 in Inflammatory Bowel Disease", "journal": "NEJM", "type": "OA", "typeLabel": "Original Article", "author": "Gharahdaghi", "doi": "10.1056/NEJMoa2513654", "url": "https://doi.org/10.1056/NEJMoa2513654", "summary": "藥師重點：此研究指出 IBD 中有一小群患者帶有 neutralizing interleukin-10 autoantibodies，且與 HLA-DRB1*01:03 高度相關；目前較偏向疾病分型與機轉證據，尚不能直接推論治療選擇。", "pubDate": "2026-06-11", "terms": [ "interleukin-10", "autoantibodies", "hla-drb1", "inflammatory", "bowel", "nejm", "gharahdaghi", "nejmoa2513654", "neutralizing", "signaling" ], "drugTerms": [ "anti-interleukin-10" ], "searchText": "interleukin-10 autoantibodies and hla-drb1*01:03 in inflammatory bowel disease nejm original article gharahdaghi 10.1056/nejmoa2513654 研究背景：neutralizing interleukin-10 autoantibodies 可能模擬單基因 interleukin-10 signaling 缺陷並與 inflammatory bowel 疾病 (ibd) 相關，而 hla-drb1*01:03 是 ulcerative colitis 的重要遺傳風險因子。 研究方法：研究使用 cellular interleukin-10 reporter assay 與 confirmatory competitive enzyme-linked immunosorbent assay，檢測 oxford 與 u.k. ibd bioresource cohorts 中 ibd 患者及非 ibd controls 的血清 neutralizing interleukin-10 autoantibodies。另於部分患者進行 in vitro cytokine-release bioassay，並以 imputation 與 high-resolution sequencing 進行 hla association 分析。 主要結果：interleukin-10-neutralizing autoantibodies 見於 173/4909 名 ibd 患者（3.5%，95% ci 3.0 to 4.1），1006 名 controls 中未檢出（p<0.001）。anti-interleukin-10 seropositivity 與 hla-drb1*01:03 強烈相關，oxford 世代 or 50.0（95% ci 16.4 to 152.3，p=6.14×10^-12）、u.k. ibd bioresource or 24.7（95% ci 14.5 to 42.1，p=6.20×10^-32），high-resolution sequencing 分析 or 29.5（95% ci 12.2 to 71.1，p=4.85×10^-14）。 藥師重點：此研究指出 ibd 中有一小群患者帶有 neutralizing interleukin-10 autoantibodies，且與 hla-drb1*01:03 高度相關；目前較偏向疾病分型與機轉證據，尚不能直接推論治療選擇。" }, { "id": "pmid-42267805", "kind": "article", "issueId": "2026-week24", "year": 2026, "week": 24, "weekLabel": "第 24 週", "dateRange": "2026/06/08 – 06/14", "href": "2026-week24.html", "title": "Hospital Policy of Tranexamic Acid to Reduce Transfusion in Major Noncardiac Surgery", "journal": "NEJM", "type": "RCT", "typeLabel": "RCT", "author": "Houston", "doi": "10.1056/NEJMoa2515820", "url": "https://doi.org/10.1056/NEJMoa2515820", "summary": "藥師重點：結論顯示重大非心臟手術導入 tranexamic acid policy 可降低輸血需求，且未高於 安慰劑 的 venous thromboembolism 風險；藥師參與圍手術期用藥時仍需依手術類型、血栓風險與院內 protocol 評估。", "pubDate": "2026-06-25", "terms": [ "hospital", "policy", "tranexamic", "acid", "reduce", "transfusion", "major", "noncardiac", "surgery", "nejm" ], "drugTerms": [], "searchText": "hospital policy of tranexamic acid to reduce transfusion in major noncardiac surgery nejm rct houston 10.1056/nejmoa2515820 研究背景：重大非心臟手術中，院內常規使用 tranexamic acid 是否能在不增加 venous thromboembolism 下減少 red-cell transfusion 仍不確定。 研究方法：traction 為加拿大 10 家醫院進行的 多中心、雙盲、cluster-隨機、安慰劑對照 試驗，納入接受非心臟手術且 red-cell transfusion 高風險患者。醫院每 4 週隨機切換為全院性術中 tranexamic acid 或 安慰劑 policy，共同主要終點為住院期間 red-cell transfusion 與 90 天內 venous thromboembolism。 主要結果：8273 名患者可納入共同主要終點分析，red-cell transfusion 發生率為 tranexamic acid 7.4% vs 安慰劑 9.8%（相對風險 0.73，95% ci 0.61 to 0.86；校正 差異 -2.7 百分點，95% ci -4.2 to -1.4）。90 天 venous thromboembolism 為 2.1% vs 2.1%（相對風險 0.96，95% ci 0.65 to 1.38），符合 不劣性 標準。 藥師重點：結論顯示重大非心臟手術導入 tranexamic acid policy 可降低輸血需求，且未高於 安慰劑 的 venous thromboembolism 風險；藥師參與圍手術期用藥時仍需依手術類型、血栓風險與院內 protocol 評估。" }, { "id": "pmid-42283228", "kind": "article", "issueId": "2026-week24", "year": 2026, "week": 24, "weekLabel": "第 24 週", "dateRange": "2026/06/08 – 06/14", "href": "2026-week24.html", "title": "Gastric Residual Volume Assessment in Critically Ill Children: The GASTRIC-PICU Randomized Clinical Trial", "journal": "JAMA", "type": "OA", "typeLabel": "Original Article", "author": "Tume", "doi": "10.1001/jama.2026.10639", "url": "https://doi.org/10.1001/jama.2026.10639", "summary": "藥師重點：結果支持重症兒童腸道營養不必常規依 GRV 調整餵食，且可能提升早期營養達標；藥師與營養團隊可協助建立以臨床耐受性為主的監測流程。", "pubDate": "2026-06-12", "terms": [ "gastric", "residual", "volume", "assessment", "critically", "children", "gastric-picu", "jama", "tume", "enteral" ], "drugTerms": [], "searchText": "gastric residual volume assessment in critically ill children: the gastric-picu randomized clinical trial jama original article tume 10.1001/jama.2026.10639 研究背景：重症兒童 enteral feeding 時常規評估 gastric residual volume (grv) 很普遍，但證據有限，且高 grv 判讀可能導致餵食中斷與營養不足。 研究方法：gastric-picu 為英國 23 個 picu 與瑞士 1 個 picu 的 實務型、多中心、隨機、不劣性 試驗，納入 4700 名 0-16 歲、接受侵入性通氣並開始 enteral feeds 的兒童。受試者分配至不常規測量 grv、僅以臨床徵象評估餵食耐受性，或 常規照護 每 6 小時評估 grv；共同主要終點為 30 天 存活期 and ventilator-free 天，以及 72 小時達成能量需求比例。 主要結果：4460 名兒童納入 意向治療分析，不常規評估 grv 對 30 天 存活期 and ventilator-free 天 不劣於每 6 小時評估（兩組 中位數 25 [iqr 21-27] 天；校正 or 0.95，95% ci 0.86-1.05）。72 小時達成能量需求比例為 80.3% vs 76.8%（校正 平均差 3.2 百分點，95% ci 1.3-5.2，p<.001）。 藥師重點：結果支持重症兒童腸道營養不必常規依 grv 調整餵食，且可能提升早期營養達標；藥師與營養團隊可協助建立以臨床耐受性為主的監測流程。" }, { "id": "pmid-42274009", "kind": "article", "issueId": "2026-week24", "year": 2026, "week": 24, "weekLabel": "第 24 週", "dateRange": "2026/06/08 – 06/14", "href": "2026-week24.html", "title": "Exa-cel in Children with Transfusion-Dependent β-Thalassemia or Sickle Cell Disease", "journal": "NEJM", "type": "OA", "typeLabel": "Original Article", "author": "Frangoul", "doi": "10.1056/NEJMoa2603387", "url": "https://doi.org/10.1056/NEJMoa2603387", "summary": "藥師重點：exa-cel 在兒童族群呈現降低輸血需求或 vaso-occlusive crises 的早期結果，但治療伴隨 myeloablative conditioning 與嚴重不良事件風險；藥師重點在於調理療法毒性、感染與肝臟併發症監測。", "pubDate": "2026-06-11", "terms": [ "exa-cel", "children", "transfusion-dependent", "thalassemia", "sickle", "cell", "nejm", "frangoul", "nejmoa2603387", "exagamglogene" ], "drugTerms": [], "searchText": "exa-cel in children with transfusion-dependent β-thalassemia or sickle cell disease nejm original article frangoul 10.1056/nejmoa2603387 研究背景：exagamglogene autotemcel (exa-cel) 是以 ex vivo crispr-cas9 編輯自體 cd34+ hematopoietic cells，使其表現 fetal hemoglobin 的細胞治療；成人與青少年研究已顯示可改善 sickle cell 疾病 或 transfusion-dependent β-thalassemia 的臨床負擔。 研究方法：兩項 進行中、第 3 期、開放標籤、single-group 研究 評估 5-11 歲 transfusion-dependent β-thalassemia 或 sickle cell 疾病 兒童接受 exa-cel。治療前使用 pharmacokinetically dose-校正 busulfan 進行 myeloablative conditioning；主要終點分別為 transfusion-dependent β-thalassemia 兒童連續至少 12 個月 transfusion independence，以及 sickle cell 疾病 兒童連續至少 12 個月無 重度 vaso-occlusive crises。 主要結果：15 名 transfusion-dependent β-thalassemia 與 11 名 sickle cell 疾病 兒童接受 exa-cel，中位追蹤分別為 16.0 與 16.9 個月。追蹤至少 16 個月者中，β-thalassemia 8/8 達 transfusion independence，sickle cell 疾病 8/8 無 vaso-occlusive crises；所有兒童至少發生一次 等級 3 或 4 不良事件，2 名 β-thalassemia 兒童發生與 busulfan conditioning 相關 重度 veno-occlusive liver 疾病，其中 1 名死亡。 藥師重點：exa-cel 在兒童族群呈現降低輸血需求或 vaso-occlusive crises 的早期結果，但治療伴隨 myeloablative conditioning 與嚴重不良事件風險；藥師重點在於調理療法毒性、感染與肝臟併發症監測。" }, { "id": "pmid-42259343", "kind": "article", "issueId": "2026-week24", "year": 2026, "week": 24, "weekLabel": "第 24 週", "dateRange": "2026/06/08 – 06/14", "href": "2026-week24.html", "title": "Elecoglipron, an oral small molecule GLP-1 receptor agonist in adults with type 2 diabetes (SOLSTICE): a multicentre, phase 2b, randomised, placebo-controlled trial", "journal": "Lancet", "type": "RCT", "typeLabel": "RCT", "author": "Aroda", "doi": "10.1016/S0140-6736(26)00802-0", "url": "https://doi.org/10.1016/S0140-6736(26)00802-0", "summary": "藥師重點：研究結果支持 elecoglipron 進入 第 3 期 評估；臨床解讀時宜視為研發中新型口服 GLP-1 受體 致效劑 證據，重點放在血糖下降幅度、胃腸道耐受性與後續較大型試驗結果。", "pubDate": "2026-06-20", "terms": [ "elecoglipron", "oral", "small", "molecule", "glp-1", "receptor", "agonist", "adults", "type", "diabetes" ], "drugTerms": [ "glp-1", "semaglutide" ], "searchText": "elecoglipron, an oral small molecule glp-1 receptor agonist in adults with type 2 diabetes (solstice): a multicentre, phase 2b, randomised, placebo-controlled trial lancet rct aroda 10.1016/s0140-6736(26)00802-0 研究背景：elecoglipron 為研發中的 每日一次 口服 小分子 glp-1 受體 致效劑，設計上不受食物或水分限制，本研究評估其用於第二型糖尿病的療效、安全性與耐受性。 研究方法：solstice 為跨 9 國的 第 2b 期、隨機、雙盲、安慰劑對照 試驗，納入 18 歲以上、bmi >=23 kg/m2、hba1c 7.0-10.5% 且以生活型態、metformin 或 sglt2 抑制劑 單藥治療的第二型糖尿病成人。受試者分配至 elecoglipron 5、15、25、50 或 75 mg 不同劑量與 titration 處方、對應 安慰劑，另有 開放標籤 口服 semaglutide 14 mg；主要終點為 26 週 hba1c 百分比變化。 主要結果：404 名受試者接受至少一劑試驗治療，26 週時 elecoglipron 各劑量 hba1c 平均變化為 -0.91%（95% ci -1.25 to -0.58；5 mg）至 -1.88%（95% ci -2.23 to -1.53；75 mg 每 2 週劑量調升），安慰劑 為 -0.15%（95% ci -0.42 to 0.12）。elecoglipron 不良事件發生率為 63%-87%，安慰劑 為 63%，最常見為 nausea、constipation、diarrhoea 與 vomiting。 藥師重點：研究結果支持 elecoglipron 進入 第 3 期 評估；臨床解讀時宜視為研發中新型口服 glp-1 受體 致效劑 證據，重點放在血糖下降幅度、胃腸道耐受性與後續較大型試驗結果。" }, { "id": "pmid-42259337", "kind": "article", "issueId": "2026-week24", "year": 2026, "week": 24, "weekLabel": "第 24 週", "dateRange": "2026/06/08 – 06/14", "href": "2026-week24.html", "title": "Elecoglipron, an oral small molecule GLP-1 receptor agonist in adults with obesity or overweight (VISTA): a multicentre, phase 2, randomised, placebo-controlled clinical trial", "journal": "Lancet", "type": "RCT", "typeLabel": "RCT", "author": "Davies", "doi": "10.1016/S0140-6736(26)00748-8", "url": "https://doi.org/10.1016/S0140-6736(26)00748-8", "summary": "藥師重點：此 第 2 期 結果顯示 elecoglipron 對肥胖或過重族群具減重訊號，但仍屬劑量探索階段；藥師應關注後續 第 3 期 的持續療效、停藥率與胃腸道耐受性。", "pubDate": "2026-06-20", "terms": [ "elecoglipron", "oral", "small", "molecule", "glp-1", "receptor", "agonist", "adults", "obesity", "overweight" ], "drugTerms": [ "glp-1" ], "searchText": "elecoglipron, an oral small molecule glp-1 receptor agonist in adults with obesity or overweight (vista): a multicentre, phase 2, randomised, placebo-controlled clinical trial lancet rct davies 10.1016/s0140-6736(26)00748-8 研究背景：elecoglipron (azd5004) 為 每日一次 口服 small-molecule glp-1 受體 致效劑，本研究評估其在無第二型糖尿病、具肥胖或過重合併體重相關共病成人的體重控制效果與安全性。 研究方法：vista 為 第 2 期、雙盲、隨機、controlled dose-ranging 研究，治療期 36 週，收案地點涵蓋澳洲、加拿大、德國、日本、台灣、英國與美國。310 名 bmi >=30 kg/m2 或 bmi >=27 kg/m2 且至少一項體重相關共病的成人，分配接受 每日一次 口服 elecoglipron 5、15、50、75 mg（每週 titration 或 每 2 週劑量調整）或 匹配安慰劑；雙主要終點為第 26 週體重百分比變化與達成至少 5% 減重比例。 主要結果：第 26 週 estimated 平均值 bodyweight change 為 elecoglipron -2.6%（5 mg）至 -10.5%（75 mg 每週 titration），安慰劑 為 -0.6%；達成至少 5% 減重比例為 elecoglipron 40.4%-88.8%，安慰劑 為 15.6%。不良事件在 elecoglipron 各劑量為 84%-98%，安慰劑 為 84%，常見為 nausea、constipation、diarrhoea、headache 與 vomiting。 藥師重點：此 第 2 期 結果顯示 elecoglipron 對肥胖或過重族群具減重訊號，但仍屬劑量探索階段；藥師應關注後續 第 3 期 的持續療效、停藥率與胃腸道耐受性。" }, { "id": "pmid-42267831", "kind": "article", "issueId": "2026-week24", "year": 2026, "week": 24, "weekLabel": "第 24 週", "dateRange": "2026/06/08 – 06/14", "href": "2026-week24.html", "title": "Conservative Oxygen for Unresponsive Patients after Cardiac Arrest", "journal": "NEJM", "type": "OA", "typeLabel": "Original Article", "author": "Hodgson", "doi": "10.1056/NEJMoa2513814", "url": "https://doi.org/10.1056/NEJMoa2513814", "summary": "藥師重點：研究未顯示較保守氧氣策略可提升心跳停止後患者的功能性存活；臨床照護仍應依 ICU 氧合目標與病人狀態調整，避免將降低氧氣暴露解讀為已證實的預後改善策略。", "pubDate": "2026-06-10", "terms": [ "conservative", "oxygen", "unresponsive", "cardiac", "arrest", "nejm", "hodgson", "nejmoa2513814", "logical", "liberal" ], "drugTerms": [], "searchText": "conservative oxygen for unresponsive patients after cardiac arrest nejm original article hodgson 10.1056/nejmoa2513814 研究背景：心跳停止復甦後仍無反應且需機械通氣的患者，限制氧氣暴露是否能改善存活且保有良好功能結果仍具不確定性。 研究方法：logical 為澳洲、紐西蘭與愛爾蘭 53 個 icu 的隨機試驗，納入心跳停止後在 icu 接受機械通氣且無反應的成人。受試者分配至 conservative oxygen 治療 或 liberal oxygen 治療；兩組 spo2 下限皆為 90%，conservative 組設定 spo2 上限警示 95% 並可將 fio2 降至 0.21，主要終點為 180 天存活且 extended glasgow 結果指標 scale (gos-e) >=5。 主要結果：1840 名患者中，180 天 favorable functional 結果指標 發生率為 conservative oxygen 38.2%（313/819）與 liberal oxygen 39.7%（353/890）（相對風險 0.97，95% ci 0.87 to 1.09，p=0.65）。未通報 不良事件。 藥師重點：研究未顯示較保守氧氣策略可提升心跳停止後患者的功能性存活；臨床照護仍應依 icu 氧合目標與病人狀態調整，避免將降低氧氣暴露解讀為已證實的預後改善策略。" }, { "id": "pmid-42267821", "kind": "article", "issueId": "2026-week24", "year": 2026, "week": 24, "weekLabel": "第 24 週", "dateRange": "2026/06/08 – 06/14", "href": "2026-week24.html", "title": "Carbocisteine or Hypertonic Saline for Acute Respiratory Failure", "journal": "NEJM", "type": "OA", "typeLabel": "Original Article", "author": "Connolly", "doi": "10.1056/NEJMoa2603406", "url": "https://doi.org/10.1056/NEJMoa2603406", "summary": "藥師重點：carbocisteine 與 HTS 未縮短急性呼吸衰竭患者機械通氣時間，且各自出現明確安全性訊號；藥師在 ICU 用藥審查時應避免常規化使用，並監測出血、支氣管收縮與霧化期間低血氧。", "pubDate": "2026-06-10", "terms": [ "carbocisteine", "hypertonic", "saline", "acute", "respiratory", "failure", "nejm", "connolly", "nejmoa2603406", "mucoactive" ], "drugTerms": [], "searchText": "carbocisteine or hypertonic saline for acute respiratory failure nejm original article connolly 10.1056/nejmoa2603406 研究背景：mucoactive agents 常用於急性呼吸衰竭與機械通氣患者，但其療效與安全性證據有限。 研究方法：march 為 多中心、開放標籤、隨機、2-by-2 factorial 試驗，納入 16 歲以上、急性呼吸衰竭且分泌物不易清除的重症機械通氣患者 1956 名。受試者接受 常規照護 加 carbocisteine 750 mg three times 每日 enterally、6% 或 7% nebulized hypertonic saline (hts) 4 ml four times 每日、兩者併用或 常規照護 單用，最長 28 天；主要終點為機械通氣時間。 主要結果：carbocisteine 與 no carbocisteine 的機械通氣中位時間為 186.1 vs 172.7 小時（校正 風險比 0.96，95% ci 0.87 to 1.05，p=0.34），hts 與 no hts 為 184.5 vs 174.3 小時（校正 風險比 1.00，95% ci 0.91 to 1.10，p=0.98）。carbocisteine 增加 clinically important upper gastrointestinal 出血（風險比 6.51，95% ci 1.47 to 28.76，p=0.01），hts 增加 bronchoconstriction（風險比 5.73，95% ci 1.99 to 16.52，p=0.001）與 nebulization 期間 hypoxemia（風險比 13.29，95% ci 4.12 to 42.83，p<0.001）。 藥師重點：carbocisteine 與 hts 未縮短急性呼吸衰竭患者機械通氣時間，且各自出現明確安全性訊號；藥師在 icu 用藥審查時應避免常規化使用，並監測出血、支氣管收縮與霧化期間低血氧。" }, { "id": "pmid-42251856", "kind": "article", "issueId": "2026-week24", "year": 2026, "week": 24, "weekLabel": "第 24 週", "dateRange": "2026/06/08 – 06/14", "href": "2026-week24.html", "title": "Cagrilintide-semaglutide (CagriSema) as an add-on to basal insulin in adults with type 2 diabetes (REIMAGINE 3): a randomised, double-blind, placebo-controlled, multicentre, phase 3 study", "journal": "Lancet", "type": "OA", "typeLabel": "Original Article", "author": "Rosenstock", "doi": "10.1016/S0140-6736(26)01022-6", "url": "https://doi.org/10.1016/S0140-6736(26)01022-6", "summary": "藥師重點：在 基礎胰島素 控制不足的第二型糖尿病患者，CagriSema 作為加成治療可改善 HbA1c 並降低體重；藥師需特別評估胃腸道耐受性、胰島素併用下的血糖監測與後續實務可近性。", "pubDate": "2026-06-07", "terms": [ "cagrilintide-semaglutide", "cagrisema", "add-on", "basal", "insulin", "adults", "type", "diabetes", "reimagine", "randomised" ], "drugTerms": [ "cagrilintide-semaglutide", "semaglutide", "glp-1" ], "searchText": "cagrilintide-semaglutide (cagrisema) as an add-on to basal insulin in adults with type 2 diabetes (reimagine 3): a randomised, double-blind, placebo-controlled, multicentre, phase 3 study lancet original article rosenstock 10.1016/s0140-6736(26)01022-6 研究背景：第二型糖尿病患者使用 基礎胰島素 後仍可能血糖控制不足，且常伴隨體重增加與低血糖風險；cagrisema 為 cagrilintide 與 semaglutide 的 每週一次 組合。 研究方法：reimagine 3 為 6 國 46 中心的 雙盲、parallel-group、隨機、controlled 第 3 期a 研究，納入 hba1c 7.0-10.5%、使用穩定 每日一次 基礎胰島素 且可併用 metformin 的第二型糖尿病成人 274 名。受試者分配接受 每週一次 subcutaneous cagrilintide-semaglutide 2.4 mg each、1.0 mg each 或 dose-matched 安慰劑 40 週，主要終點為 week 40 hba1c 變化。 主要結果：week 40 hba1c 降幅顯著大於 安慰劑：cagrilintide-semaglutide 2.4 mg each -2.33%（se 0.08）、1.0 mg each -2.10%（se 0.08），安慰劑 -0.66%（se 0.11）；estimated 治療 差異 分別為 -1.68 百分點（95% ci -1.95 to -1.41，p<0.0001）與 -1.44 百分點（95% ci -1.71 to -1.17，p<0.0001）。體重下降約 10-12%，不良事件多為輕中度胃腸道事件，未通報 重度 hypoglycaemia。 藥師重點：在 基礎胰島素 控制不足的第二型糖尿病患者，cagrisema 作為加成治療可改善 hba1c 並降低體重；藥師需特別評估胃腸道耐受性、胰島素併用下的血糖監測與後續實務可近性。" }, { "id": "fda-2026-week24-1", "kind": "fda", "issueId": "2026-week24", "year": 2026, "week": 24, "weekLabel": "第 24 週", "dateRange": "2026/06/08 – 06/14", "href": "2026-week24.html", "title": "FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "concerns", "unapproved", "glp-1", "drugs", "used", "weight", "loss", "https", "drug-alerts-and-statements", "fdas-concerns-unapproved-glp-1-drugs-used-weight-loss" ], "drugTerms": [ "glp-1" ], "searchText": "fda’s concerns with unapproved glp-1 drugs used for weight loss fda drug safety 2026-06-15 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss" }, { "id": "fda-2026-week24-3", "kind": "fda", "issueId": "2026-week24", "year": 2026, "week": 24, "weekLabel": "第 24 週", "dateRange": "2026/06/08 – 06/14", "href": "2026-week24.html", "title": "FDA issues final decision to withdraw approval of Pepaxto (melphalan flufenamide)", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/node/398713", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "issues", "final", "decision", "withdraw", "approval", "pepaxto", "melphalan", "flufenamide", "https", "node" ], "drugTerms": [], "searchText": "fda issues final decision to withdraw approval of pepaxto (melphalan flufenamide) fda drug safety 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/node/398713" }, { "id": "fda-2026-week24-2", "kind": "fda", "issueId": "2026-week24", "year": 2026, "week": 24, "weekLabel": "第 24 週", "dateRange": "2026/06/08 – 06/14", "href": "2026-week24.html", "title": "FDA alerts patients, caregivers, and health care providers of cross-compatibility issues with autoinjector devices that are optional for use with glatiramer acetate injection", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/node/403159", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "alerts", "caregivers", "providers", "cross-compatibility", "issues", "autoinjector", "devices", "that", "optional", "glatiramer" ], "drugTerms": [], "searchText": "fda alerts patients, caregivers, and health care providers of cross-compatibility issues with autoinjector devices that are optional for use with glatiramer acetate injection fda drug safety 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/node/403159" }, { "id": "fda-2026-week24-4", "kind": "fda", "issueId": "2026-week24", "year": 2026, "week": 24, "weekLabel": "第 24 週", "dateRange": "2026/06/08 – 06/14", "href": "2026-week24.html", "title": "FDA Accepts First In Silico Drug Development Tool Under ISTAND Program to Help Predict Drug-Induced Liver Injury", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fda-accepts-first-silico-drug-development-tool-under-istand-program-help-predict-drug-induced-liver", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "accepts", "first", "silico", "development", "tool", "under", "istand", "program", "help", "predict" ], "drugTerms": [], "searchText": "fda accepts first in silico drug development tool under istand program to help predict drug-induced liver injury fda drug safety 2026-06-03 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/drugs/drug-alerts-and-statements/fda-accepts-first-silico-drug-development-tool-under-istand-program-help-predict-drug-induced-liver" }, { "id": "pmid-42251595", "kind": "article", "issueId": "2026-week23", "year": 2026, "week": 23, "weekLabel": "第 23 週", "dateRange": "2026/06/01 – 06/07", "href": "2026-week23.html", "title": "Treatment With 9-mg Mazdutide for Weight Reduction in Chinese Adults With Obesity: The GLORY-2 Randomized Clinical Trial", "journal": "JAMA", "type": "OA", "typeLabel": "Original Article", "author": "Gao", "doi": "10.1001/jama.2026.8142", "url": "https://doi.org/10.1001/jama.2026.8142", "summary": "藥師重點：Mazdutide 9 mg 在中國中重度 obesity 成人可帶來明顯體重下降，但胃腸道不良反應頻率高；藥師需評估 nausea/vomiting 對水分、營養與服藥順從性的影響，並提醒結果需依核准適應症與族群外推限制解讀。", "pubDate": "2026-06-07", "terms": [ "mazdutide", "weight", "reduction", "chinese", "adults", "obesity", "glory-2", "jama", "glucagon", "glp-1" ], "drugTerms": [ "glp-1" ], "searchText": "treatment with 9-mg mazdutide for weight reduction in chinese adults with obesity: the glory-2 randomized clinical trial jama original article gao 10.1001/jama.2026.8142 研究背景：obesity 是中國與全球重要公共衛生問題；mazdutide 為 每週一次 glucagon 與 glp-1 受體 dual 致效劑，本研究評估 9-mg 劑量在中國成人 obesity 的減重療效與安全性。 研究方法：glory-2 為 雙盲、安慰劑對照、第 3 期 隨機臨床試驗，於中國 27 家醫院收錄 bmi ≥30、可有或無 type 2 diabetes 的成人。受試者以 2:1 接受 mazdutide 9 mg once 每週 subcutaneous injection 或 安慰劑，並搭配 reduced calorie diet 與 increased physical activity 60 週；co-主要 結果指標 為體重百分比變化與 ≥5% weight reduction。 主要結果：461 人接受治療；week 60 體重變化為 -16.65% vs -1.50%，組間差 -15.15%（95% ci -17.22% to -13.09%；p<.001）。達 ≥5% weight reduction 為 84.3% vs 33.1%，組間差 51.6%（95% ci 43.0% to 60.1%；p<.001）；停藥不良事件為 2.9% vs 0%，常見事件為 vomiting 53.1%、nausea 46.9%、diarrhea 39.4%，多為輕至中度。 藥師重點：mazdutide 9 mg 在中國中重度 obesity 成人可帶來明顯體重下降，但胃腸道不良反應頻率高；藥師需評估 nausea/vomiting 對水分、營養與服藥順從性的影響，並提醒結果需依核准適應症與族群外推限制解讀。" }, { "id": "pmid-42242770", "kind": "article", "issueId": "2026-week23", "year": 2026, "week": 23, "weekLabel": "第 23 週", "dateRange": "2026/06/01 – 06/07", "href": "2026-week23.html", "title": "Systematic estimates of global causes of neonatal and under 5 mortality in 2000-24: secondary data analysis using bayesian multinomial logistic regression", "journal": "BMJ", "type": "OA", "typeLabel": "Original Article", "author": "Perin", "doi": "10.1136/bmj-2025-088686", "url": "https://doi.org/10.1136/bmj-2025-088686", "summary": "藥師重點：結果顯示新生兒照護、呼吸道感染、周產期照護與 malaria 仍是 under 5 死亡率 的核心負擔；藥師可用於抗感染藥物、疫苗、孕產用藥與兒科劑量安全的公共衛生規劃。", "pubDate": "2026-06-04", "terms": [ "estimates", "global", "causes", "neonatal", "under", "mortality", "bayesian", "multinomial", "logistic", "regression" ], "drugTerms": [], "searchText": "systematic estimates of global causes of neonatal and under 5 mortality in 2000-24: secondary data analysis using bayesian multinomial logistic regression bmj original article perin 10.1136/bmj-2025-088686 研究背景：neonatal 與 under 5 死亡的主要原因隨地區與時間改變而不同；掌握 cause-specific 死亡率 可協助設定兒童健康介入優先順序。 研究方法：此 次要 資料 分析 使用 bayesian multinomial logistic regression model，整合系統性文獻、who 死亡率 database、dhs、mics、hdss 等資料，估計 195 國 2000-2024 年 neonates 與 under 5 cause-specific 死亡率。 主要結果：2024 年 under 5 deaths 估計 4.9 百萬；主要死因為 preterm birth complications 0.82 百萬（90% ui 0.76 to 0.88）、lower respiratory infections 0.66 百萬、intrapartum related 事件 0.48 百萬 與 malaria 0.45 百萬。多數主要死因下降速度自 2016 年後放緩。 藥師重點：結果顯示新生兒照護、呼吸道感染、周產期照護與 malaria 仍是 under 5 死亡率 的核心負擔；藥師可用於抗感染藥物、疫苗、孕產用藥與兒科劑量安全的公共衛生規劃。" }, { "id": "pmid-42223087", "kind": "article", "issueId": "2026-week23", "year": 2026, "week": 23, "weekLabel": "第 23 週", "dateRange": "2026/06/01 – 06/07", "href": "2026-week23.html", "title": "Selpercatinib in Early-Stage RET Fusion-Positive Non-Small-Cell Lung Cancer", "journal": "NEJM", "type": "OA", "typeLabel": "Original Article", "author": "Wu", "doi": "10.1056/NEJMoa2602628", "url": "https://doi.org/10.1056/NEJMoa2602628", "summary": "藥師重點：結果顯示 adjuvant selpercatinib 可延長 stage II-IIIA RET fusion-陽性 NSCLC 的 無事件存活期；藥師需確認 RET fusion 檢測、治療期間肝功能監測、交互作用與長達 3 年治療的順從性管理。", "pubDate": "2026-05-31", "terms": [ "selpercatinib", "early-stage", "fusion-positive", "non-small-cell", "lung", "cancer", "nejm", "nejmoa2602628", "fusion", "advanced" ], "drugTerms": [ "selpercatinib" ], "searchText": "selpercatinib in early-stage ret fusion-positive non-small-cell lung cancer nejm original article wu 10.1056/nejmoa2602628 研究背景：selpercatinib 為高選擇性、可進入中樞神經系統的 ret 抑制劑，已用於 ret fusion-陽性 advanced 或 轉移性 nsclc；其在早期根治治療後作為 adjuvant 治療 的效益尚未確定。 研究方法：libretto-432 為 第 3 期、雙盲 試驗，納入 ret fusion-陽性 nsclc 且已接受 curative-intent definitive 治療 的患者。受試者隨機接受 adjuvant selpercatinib 或 安慰劑 最多 3 年；主要終點為 stage ii 或 iiia 患者的 investigator-assessed 無事件存活期。 主要結果：151 人隨機分組；stage ii 或 iiia 的 2-year 無事件存活期 為 92% vs 61%（hr 0.17，95% ci 0.06 to 0.51；p<0.001）。stage ib/ii/iiia 全體 2-year 無事件存活期 為 94% vs 70%（hr 0.17，95% ci 0.06 to 0.49；p<0.001）；selpercatinib 組 alt 與 ast 升高 等級 ≥3 分別為 17% 與 19%。 藥師重點：結果顯示 adjuvant selpercatinib 可延長 stage ii-iiia ret fusion-陽性 nsclc 的 無事件存活期；藥師需確認 ret fusion 檢測、治療期間肝功能監測、交互作用與長達 3 年治療的順從性管理。" }, { "id": "pmid-42234540", "kind": "article", "issueId": "2026-week23", "year": 2026, "week": 23, "weekLabel": "第 23 週", "dateRange": "2026/06/01 – 06/07", "href": "2026-week23.html", "title": "Phase 3 Trial of Secukinumab in Polymyalgia Rheumatica", "journal": "NEJM", "type": "OA", "typeLabel": "Original Article", "author": "Stone", "doi": "10.1056/NEJMoa2602567", "url": "https://doi.org/10.1056/NEJMoa2602567", "summary": "藥師重點：Secukinumab 加 prednisone taper 可提高復發性 polymyalgia rheumatica 的持續緩解並降低類固醇累積劑量；藥師需追蹤感染、fungal infection、過敏反應與 steroid taper 期間症狀復燃。", "pubDate": "2026-06-03", "terms": [ "phase", "secukinumab", "polymyalgia", "rheumatica", "nejm", "stone", "nejmoa2602567", "glucocorticoids", "selective", "interleukin-17a" ], "drugTerms": [ "secukinumab" ], "searchText": "phase 3 trial of secukinumab in polymyalgia rheumatica nejm original article stone 10.1056/nejmoa2602567 研究背景：polymyalgia rheumatica 常以肩臀疼痛與僵硬表現，glucocorticoids 為第一線治療但復發與類固醇毒性常見；secukinumab 為 selective interleukin-17a 抑制劑。 研究方法：replenish 收錄 recently relapsed polymyalgia rheumatica 患者，以 1:1:1 分配至 secukinumab 300 mg、secukinumab 150 mg 或 安慰劑 52 週。所有患者並接受 24 週 prednisone taper；主要終點為 week 52 sustained 緩解，次要終點包括 annual cumulative glucocorticoid dose 與安全性。 主要結果：381 人隨機分組；week 52 sustained 緩解 為 41.2%、40.6% vs 20.4%，兩種 secukinumab 劑量相較 安慰劑 均 p<0.001。平均值 校正 annual cumulative glucocorticoid dose 為 1603.7 mg、1683.2 mg vs 2093.0 mg；嚴重不良事件 為 13.5%、15.9% vs 14.2%，nasopharyngitis、hypersensitivity reactions、urinary tract infections、fungal infections 較常見於 secukinumab 組。 藥師重點：secukinumab 加 prednisone taper 可提高復發性 polymyalgia rheumatica 的持續緩解並降低類固醇累積劑量；藥師需追蹤感染、fungal infection、過敏反應與 steroid taper 期間症狀復燃。" }, { "id": "pmid-42225112", "kind": "article", "issueId": "2026-week23", "year": 2026, "week": 23, "weekLabel": "第 23 週", "dateRange": "2026/06/01 – 06/07", "href": "2026-week23.html", "title": "Perioperative serplulimab with neoadjuvant chemotherapy versus perioperative chemotherapy in PD-L1-positive gastric cancer (ASTRUM-006): a randomised, double-blind, multicentre, phase 3 study", "journal": "Lancet", "type": "RCT", "typeLabel": "RCT", "author": "Shen", "doi": "10.1016/S0140-6736(26)00974-8", "url": "https://doi.org/10.1016/S0140-6736(26)00974-8", "summary": "藥師重點：結論顯示 perioperative serplulimab 加 SOX 可延長 PD-L1 陽性 可切除胃癌族群的 無事件存活期；臨床導入前需確認 PD-L1 CPS、手術時程、免疫相關不良事件與 oxaliplatin/S-1 相關毒性監測。", "pubDate": "2026-06-20", "terms": [ "perioperative", "serplulimab", "neoadjuvant", "chemotherapy", "pd-l1-positive", "gastric", "cancer", "astrum-006", "randomised", "double-blind" ], "drugTerms": [ "serplulimab", "oxaliplatin" ], "searchText": "perioperative serplulimab with neoadjuvant chemotherapy versus perioperative chemotherapy in pd-l1-positive gastric cancer (astrum-006): a randomised, double-blind, multicentre, phase 3 study lancet rct shen 10.1016/s0140-6736(26)00974-8 研究背景：可切除胃癌或 gastro-oesophageal junction adenocarcinoma 的圍手術期 chemo-immunotherapy 效果仍不一致；astrum-006 評估 pd-l1 陽性 族群中 serplulimab 合併 sox 的效益與安全性。 研究方法：此隨機、雙盲、多中心 第 3 期 試驗收錄 18-70 歲、pd-l1 cps ≥5、局部晚期且可切除之胃或 gastro-oesophageal junction adenocarcinoma。受試者以 1:1 接受 neoadjuvant serplulimab 4.5 mg/kg 或 安慰劑 加 sox 三個 cycle，之後 serplulimab 組接受 adjuvant serplulimab 最多 17 cycles，對照組接受 adjuvant sox 五個 cycles；主要終點為 無事件存活期。 主要結果：588 人隨機分組；pd-l1 cps ≥10 族群 中位數 無事件存活期 為 nr vs 42.0 個月（hr 0.65，95% ci 0.47-0.90；p=0.0082）。intention-to-treat 族群 亦為 nr vs 35.9 個月（hr 0.73，95% ci 0.56-0.94；p=0.015）；等級 3 以上 治療相關不良事件 為 47% vs 59%。 藥師重點：結論顯示 perioperative serplulimab 加 sox 可延長 pd-l1 陽性 可切除胃癌族群的 無事件存活期；臨床導入前需確認 pd-l1 cps、手術時程、免疫相關不良事件與 oxaliplatin/s-1 相關毒性監測。" }, { "id": "pmid-42223077", "kind": "article", "issueId": "2026-week23", "year": 2026, "week": 23, "weekLabel": "第 23 週", "dateRange": "2026/06/01 – 06/07", "href": "2026-week23.html", "title": "Perioperative Apalutamide in High-Risk Localized Prostate Cancer", "journal": "NEJM", "type": "OA", "typeLabel": "Original Article", "author": "Taplin", "doi": "10.1056/NEJMoa2603878", "url": "https://doi.org/10.1056/NEJMoa2603878", "summary": "藥師重點：Perioperative apalutamide 加 ADT 可改善高風險局部攝護腺癌手術相關結果，但不良事件較多；藥師需追蹤 rash、內分泌治療相關代謝與骨骼風險、跌倒風險及 perioperative 用藥銜接。", "pubDate": "2026-05-31", "terms": [ "perioperative", "apalutamide", "high-risk", "localized", "prostate", "cancer", "nejm", "taplin", "nejmoa2603878", "radical" ], "drugTerms": [], "searchText": "perioperative apalutamide in high-risk localized prostate cancer nejm original article taplin 10.1056/nejmoa2603878 研究背景：高風險局部或局部晚期攝護腺癌即使接受 radical prostatectomy，5 年內仍可能復發；本研究評估 perioperative adt 加 apalutamide 是否可改善手術後腫瘤學結果。 研究方法：proteus 為 第 3 期、雙盲、安慰劑對照 試驗，新診斷高風險 localized 或 locally advanced prostate 癌症 患者以 1:1 接受 adt 加 apalutamide 240 mg per day 或 adt 加 安慰劑。治療於 radical prostatectomy with pelvic lymph-node dissection 前後各 6 cycles（每 cycle 28 天），dual 主要終點s 為 pathological 完全反應/minimal residual 疾病 複合 與 無轉移存活期。 主要結果：2109 人隨機分組，中位追蹤 61.7 個月；pathological 完全反應 或 minimal residual 疾病 為 8.9% vs 1.0%（or 10.17，95% ci 5.27 to 19.64；p<0.001）。5 年 無轉移存活期 為 78.2% vs 73.5%（hr 0.80，95% ci 0.67 to 0.96；p=0.02）；等級 3 或 4 不良事件 為 39.6% vs 31.0%，差異主要來自 rash。 藥師重點：perioperative apalutamide 加 adt 可改善高風險局部攝護腺癌手術相關結果，但不良事件較多；藥師需追蹤 rash、內分泌治療相關代謝與骨骼風險、跌倒風險及 perioperative 用藥銜接。" }, { "id": "pmid-42223064", "kind": "article", "issueId": "2026-week23", "year": 2026, "week": 23, "weekLabel": "第 23 週", "dateRange": "2026/06/01 – 06/07", "href": "2026-week23.html", "title": "PARP and Androgen-Signaling Inhibition plus ADT in Metastatic Prostate Cancer", "journal": "NEJM", "type": "OA", "typeLabel": "Original Article", "author": "Agarwal", "doi": "10.1056/NEJMoa2604126", "url": "https://doi.org/10.1056/NEJMoa2604126", "summary": "藥師重點：Talazoparib 加 enzalutamide 可延長具 DNA repair gene alterations 的 轉移性 APMS prostate 癌症 影像無惡化存活，但整體存活仍屬 interim 結果；藥師需確認基因檢測結果並密切監測 anemia、neutropenia、疲倦與劑量調整需求。", "pubDate": "2026-05-30", "terms": [ "parp", "androgen-signaling", "inhibition", "plus", "metastatic", "prostate", "cancer", "nejm", "agarwal", "nejmoa2604126" ], "drugTerms": [], "searchText": "parp and androgen-signaling inhibition plus adt in metastatic prostate cancer nejm original article agarwal 10.1056/nejmoa2604126 研究背景：talazoparib 加 enzalutamide 先前在 androgen pathway modulation-resistant 轉移性 prostate 癌症 顯示效益，且 homologous recombination repair gene alterations 族群受益較明顯；本研究評估較早期 apms 轉移性 prostate 癌症 的治療角色。 研究方法：此 進行中 第 3 期、雙盲 試驗 收錄帶有 homologous recombination repair gene alterations 的 轉移性 androgen pathway modulation-sensitive prostate 癌症 患者。受試者以 1:1 接受 talazoparib 0.5 mg 加 enzalutamide 160 mg 每日一次，或 安慰劑 加 enzalutamide 160 mg 每日一次；主要終點為 investigator-assessed imaging-based 無惡化存活期，key 次要終點 為 整體存活期。 主要結果：599 人隨機分組；3 年 無惡化存活期 為 77% vs 56%（hr for 疾病 progression or 死亡 0.48，95% ci 0.36 to 0.65；p<0.001）。interim 整體存活期 3 年為 78% vs 72%（hr for 死亡 0.77，95% ci 0.56 to 1.04）；嚴重不良事件 為 42% vs 32%，talazoparib 組 等級 3 以上 anemia 為 51%，並有 2 例 治療-related deaths。 藥師重點：talazoparib 加 enzalutamide 可延長具 dna repair gene alterations 的 轉移性 apms prostate 癌症 影像無惡化存活，但整體存活仍屬 interim 結果；藥師需確認基因檢測結果並密切監測 anemia、neutropenia、疲倦與劑量調整需求。" }, { "id": "pmid-42251769", "kind": "article", "issueId": "2026-week23", "year": 2026, "week": 23, "weekLabel": "第 23 週", "dateRange": "2026/06/01 – 06/07", "href": "2026-week23.html", "title": "Orforglipron Added to Titrated Insulin Glargine in Type 2 Diabetes: The ACHIEVE-5 Randomized Clinical Trial", "journal": "JAMA", "type": "OA", "typeLabel": "Original Article", "author": "Giorgino", "doi": "10.1001/jama.2026.9512", "url": "https://doi.org/10.1001/jama.2026.9512", "summary": "藥師重點：Orforglipron 併用 insulin glargine 可改善 HbA1c 並減重，且摘要未見臨床顯著低血糖增加；藥師需監測胃腸道耐受性、insulin 劑量調整、低血糖衛教與口服 GLP-1 類藥物服藥順從性。", "pubDate": "2026-06-07", "terms": [ "orforglipron", "added", "titrated", "insulin", "glargine", "type", "diabetes", "achieve-5", "jama", "giorgino" ], "drugTerms": [ "glp-1" ], "searchText": "orforglipron added to titrated insulin glargine in type 2 diabetes: the achieve-5 randomized clinical trial jama original article giorgino 10.1001/jama.2026.9512 研究背景：orforglipron 為 口服 nonpeptide glp-1 受體 致效劑；其加到已滴定 insulin glargine 後對第二型糖尿病血糖與體重的影響尚需 第 3 期 評估。 研究方法：achieve-5 為 40 週、隨機、雙盲、第 3 期 研究，於 5 國 72 個中心收錄使用 insulin glargine、可併用 metformin 或 sglt2 抑制劑 但控制不足的第二型糖尿病成人。受試者以 1:1:1:1 接受 orforglipron 3 mg、12 mg、36 mg 每日一次 或 安慰劑，皆併用 titrated insulin glargine；主要終點為 week 40 hba1c 變化。 主要結果：546 人隨機分組；week 40 hba1c 變化為 -1.58%、-1.88%、-1.82% vs -0.79%，相對 安慰劑 差異分別為 -0.78%、-1.08%、-1.03%（p<.001 for all）。體重變化為 -2.6%、-4.8%、-5.4% vs 0.2%；常見不良事件為輕至中度 gastrointestinal 事件，未增加 clinically significant hypoglycemia。 藥師重點：orforglipron 併用 insulin glargine 可改善 hba1c 並減重，且摘要未見臨床顯著低血糖增加；藥師需監測胃腸道耐受性、insulin 劑量調整、低血糖衛教與口服 glp-1 類藥物服藥順從性。" }, { "id": "pmid-42246654", "kind": "article", "issueId": "2026-week23", "year": 2026, "week": 23, "weekLabel": "第 23 週", "dateRange": "2026/06/01 – 06/07", "href": "2026-week23.html", "title": "Obinutuzumab or Tacrolimus in Primary Membranous Nephropathy", "journal": "NEJM", "type": "OA", "typeLabel": "Original Article", "author": "Fervenza", "doi": "10.1056/NEJMoa2602678", "url": "https://doi.org/10.1056/NEJMoa2602678", "summary": "藥師重點：Obinutuzumab 在 主要 membranous nephropathy 誘導 complete 緩解 優於 tacrolimus；藥師需監測 infusion reaction、感染、neutropenia、疫苗接種時機與免疫抑制背景治療。", "pubDate": "2026-06-05", "terms": [ "obinutuzumab", "tacrolimus", "membranous", "nephropathy", "nejm", "fervenza", "nejmoa2602678", "type", "anti-cd20", "majesty" ], "drugTerms": [ "obinutuzumab", "anti-cd20" ], "searchText": "obinutuzumab or tacrolimus in primary membranous nephropathy nejm original article fervenza 10.1056/nejmoa2602678 研究背景：obinutuzumab 為 type ii anti-cd20 抗體，已用於血液腫瘤與自體免疫疾病；主要 membranous nephropathy 中其相較 tacrolimus 的療效與安全性仍需評估。 研究方法：majesty 為 第 3 期試驗，將 主要 membranous nephropathy 成人以 1:1 分配接受 intravenous obinutuzumab 或 口服 tacrolimus。主要終點為 week 104 complete 緩解，定義為 urinary protein-to-creatinine 比值 ≤0.3 且 egfr 穩定；並評估 緩解、egfr decline、promis fatigue t score 與安全性。 主要結果：142 人隨機分組；week 104 complete 緩解 為 37% vs 6%，校正 差異 31 百分點（95% ci 18 to 44；p<0.001）。complete/partial 緩解 與 week 76 complete 緩解 亦支持 obinutuzumab；等級 3 以上 不良事件 為 22% vs 19%，嚴重不良事件 為 17% vs 14%，obinutuzumab 相關反應包括 輸注相關反應、respiratory tract infections 與 neutropenia。 藥師重點：obinutuzumab 在 主要 membranous nephropathy 誘導 complete 緩解 優於 tacrolimus；藥師需監測 infusion reaction、感染、neutropenia、疫苗接種時機與免疫抑制背景治療。" }, { "id": "pmid-42233621", "kind": "article", "issueId": "2026-week23", "year": 2026, "week": 23, "weekLabel": "第 23 週", "dateRange": "2026/06/01 – 06/07", "href": "2026-week23.html", "title": "Obexelimab for the Treatment of IgG4-Related Disease", "journal": "NEJM", "type": "OA", "typeLabel": "Original Article", "author": "Della-Torre", "doi": "10.1056/NEJMoa2601337", "url": "https://doi.org/10.1056/NEJMoa2601337", "summary": "藥師重點：Obexelimab 可能作為 IgG4-related 疾病 的 steroid-sparing 選項；藥師需協助規劃 steroid taper、感染風險與疫苗評估，並追蹤 hypersensitivity、diarrhea 與疾病 flare。", "pubDate": "2026-06-02", "terms": [ "obexelimab", "igg4-related", "nejm", "della-torre", "nejmoa2601337", "glucocorticoid", "cd19", "riib", "coengagement", "b-cell" ], "drugTerms": [ "obexelimab" ], "searchText": "obexelimab for the treatment of igg4-related disease nejm original article della-torre 10.1056/nejmoa2601337 研究背景：igg4-related 疾病 為可侵犯多器官的慢性纖維發炎性疾病，glucocorticoid 雖為治療基石，但長期毒性與停藥後復發是臨床限制；obexelimab 透過 cd19 與 fcγriib coengagement 抑制 b-cell activity。 研究方法：indigo 為 第 3 期、雙盲、隨機、安慰劑對照 試驗，active igg4-related 疾病 患者接受 subcutaneous obexelimab 250 mg once 每週 或 安慰劑 共 52 週。兩組 glucocorticoids 皆依標準化 schedule 於 week 8 taper 至停用；主要終點為需 rescue 治療 的首次 flare 時間。 主要結果：194 人隨機分組；obexelimab 延長首次需救援治療的 flare 時間（hr 0.44，95% ci 0.28 to 0.71；p<0.001），flare 發生率為 26.8% vs 54.6%。complete 緩解 為 37.1% vs 19.6%（p=0.005），cumulative glucocorticoid rescue dose 為 329.5 mg vs 929.8 mg（p=0.004）；嚴重不良事件 為 10.3% vs 18.6%。 藥師重點：obexelimab 可能作為 igg4-related 疾病 的 steroid-sparing 選項；藥師需協助規劃 steroid taper、感染風險與疫苗評估，並追蹤 hypersensitivity、diarrhea 與疾病 flare。" }, { "id": "pmid-42235014", "kind": "article", "issueId": "2026-week23", "year": 2026, "week": 23, "weekLabel": "第 23 週", "dateRange": "2026/06/01 – 06/07", "href": "2026-week23.html", "title": "Kidney Transplantation in Two Highly Sensitized Candidates after CAR T-Cell Therapy", "journal": "NEJM", "type": "OA", "typeLabel": "Original Article", "author": "Bhoj", "doi": "10.1056/NEJMoa2513428", "url": "https://doi.org/10.1056/NEJMoa2513428", "summary": "藥師重點：此報告提示 CAR T-cell desensitization 可能擴大高度 HLA sensitized 患者的移植機會，但證據仍限於 2 例 safety run-in；藥師應回原文確認 lymphodepletion、感染預防、免疫抑制銜接、CRS/ICANS 與移植後 rejection surveillance。", "pubDate": "2026-06-04", "terms": [ "kidney", "transplantation", "highly", "sensitized", "candidates", "t-cell", "nejm", "bhoj", "nejmoa2513428", "sensitization" ], "drugTerms": [ "anti-hla" ], "searchText": "kidney transplantation in two highly sensitized candidates after car t-cell therapy nejm original article bhoj 10.1056/nejmoa2513428 研究背景：高度 hla sensitization 會明顯限制 end-stage kidney 疾病 患者接受 kidney transplantation 的機會，既有 desensitization 對 calculated panel-reactive 抗體 score ≥99.9% 族群效果不穩定。 研究方法：本文為 多中心 第 1 期 臨床 研究 的 safety run-in 世代 報告，評估 combined cd19-targeted 與 bcma-targeted car t cells 用於清除 preformed anti-hla 抗體 的細胞來源。摘要描述兩位高度 sensitized 候選者在 dual car t-cell 治療 desensitization 後接受 kidney transplantation。 主要結果：摘要指出兩位高度 sensitized 候選者在 dual car t-cell 治療 後完成 kidney transplantation，但未提供完整抗體下降幅度、移植後腎功能、排斥或感染等量化結果。研究登錄為 nct06056102，屬早期安全性與可行性訊號。 藥師重點：此報告提示 car t-cell desensitization 可能擴大高度 hla sensitized 患者的移植機會，但證據仍限於 2 例 safety run-in；藥師應回原文確認 lymphodepletion、感染預防、免疫抑制銜接、crs/icans 與移植後 rejection surveillance。" }, { "id": "pmid-42218899", "kind": "article", "issueId": "2026-week23", "year": 2026, "week": 23, "weekLabel": "第 23 週", "dateRange": "2026/06/01 – 06/07", "href": "2026-week23.html", "title": "Ivonescimab plus chemotherapy versus tislelizumab plus chemotherapy in advanced squamous non-small-cell lung cancer (HARMONi-6): interim overall survival analysis of a randomised, double-blind, phase 3 trial in China", "journal": "Lancet", "type": "RCT", "typeLabel": "RCT", "author": "Lu", "doi": "10.1016/S0140-6736(26)00966-9", "url": "https://doi.org/10.1016/S0140-6736(26)00966-9", "summary": "藥師重點：ivonescimab 加化療在此中國族群較 tislelizumab 加化療延長 整體存活期，但 VEGF blockade 相關出血訊號較高；藥師需評估出血風險、抗凝/抗血小板併用、免疫相關不良事件與化療骨髓抑制。", "pubDate": "2026-06-27", "terms": [ "ivonescimab", "plus", "chemotherapy", "tislelizumab", "advanced", "squamous", "non-small-cell", "lung", "cancer", "harmoni-6" ], "drugTerms": [ "ivonescimab", "tislelizumab", "paclitaxel", "carboplatin" ], "searchText": "ivonescimab plus chemotherapy versus tislelizumab plus chemotherapy in advanced squamous non-small-cell lung cancer (harmoni-6): interim overall survival analysis of a randomised, double-blind, phase 3 trial in china lancet rct lu 10.1016/s0140-6736(26)00966-9 研究背景：ivonescimab 為同時作用於 pd-1 與 vegf 的 bispecific 抗體；harmoni-6 先前顯示其合併化療可延長 advanced squamous nsclc 的 無惡化存活期，本次報告預先設定的 interim 整體存活期 分析。 研究方法：harmoni-6 為中國 50 家醫院執行的 雙盲、隨機、第 3 期試驗，收錄未治療、不可切除 stage iiib/iiic 或 stage iv squamous nsclc，ecog 0-1、年齡 18-75 歲患者。受試者接受 ivonescimab 或 tislelizumab 合併 paclitaxel/carboplatin 四個 cycles，之後以對應單藥維持；整體存活期 為 key 次要終點。 主要結果：532 人隨機分組；資料截止時死亡 84/266 vs 120/265。中位數 整體存活期 為 27.9 個月 vs 23.7 個月（hr for 死亡 0.66，95% ci 0.50-0.87；pone-sided=0.0017），達預設邊界；等級 3 以上 治療相關不良事件 為 69% vs 59%，等級 3 以上 haemorrhage 為 3% vs 1%。 藥師重點：ivonescimab 加化療在此中國族群較 tislelizumab 加化療延長 整體存活期，但 vegf blockade 相關出血訊號較高；藥師需評估出血風險、抗凝/抗血小板併用、免疫相關不良事件與化療骨髓抑制。" }, { "id": "pmid-42250272", "kind": "article", "issueId": "2026-week23", "year": 2026, "week": 23, "weekLabel": "第 23 週", "dateRange": "2026/06/01 – 06/07", "href": "2026-week23.html", "title": "Insulin Costs and Use by Medicare Beneficiaries After the Inflation Reduction Act Out-of-Pocket Cap", "journal": "JAMA", "type": "OA", "typeLabel": "Original Article", "author": "Myerson", "doi": "10.1001/jama.2026.5975", "url": "https://doi.org/10.1001/jama.2026.5975", "summary": "藥師重點：自付額上限可降低並穩定 insulin 花費，主要改善原本負擔較高者的使用；藥師在用藥諮詢時可主動評估費用障礙、換藥風險、續方中斷與低收入或高自付病人的援助資源。", "pubDate": "2026-06-06", "terms": [ "insulin", "costs", "medicare", "beneficiaries", "inflation", "reduction", "out-of-pocket", "jama", "myerson", "cost" ], "drugTerms": [], "searchText": "insulin costs and use by medicare beneficiaries after the inflation reduction act out-of-pocket cap jama original article myerson 10.1001/jama.2026.5975 研究背景：美國 inflation reduction act 於 2023 年將 medicare 受益者 insulin out-of-pocket cost 限制為每 30-day supply $35；其對 insulin 可近性與使用量的實際影響需評估。 研究方法：此 interrupted time series 分析 使用 2021-2023 年美國資料，比較 medicare part d insulin users 在政策實施前後的額外變化。主要結果包括每 30-day insulin supply 自付費用、30-day insulin fills、基礎胰島素 adherence（proportion of 天 covered）與 persistence。 主要結果：納入 2,860,394 名 insulin users；政策後幾乎沒有 insulin fills 超過上限，2021-2022 年則有 13% 可能超過。每 30-day supply cost 由 $22.95 降至 $18.16，差異 -$4.79（95% ci -$4.84 to -$4.74）；整體 insulin fills、adherence 與 persistence 未增加，但 基準值 cost top decile（>$58/30-day supply）者 fills 增加 0.8 fills/year，proportion of 天 covered 增加 2.7 百分點。 藥師重點：自付額上限可降低並穩定 insulin 花費，主要改善原本負擔較高者的使用；藥師在用藥諮詢時可主動評估費用障礙、換藥風險、續方中斷與低收入或高自付病人的援助資源。" }, { "id": "pmid-42242779", "kind": "article", "issueId": "2026-week23", "year": 2026, "week": 23, "weekLabel": "第 23 週", "dateRange": "2026/06/01 – 06/07", "href": "2026-week23.html", "title": "Global, regional, and national levels and trends in under 5, infant, and neonatal mortality during 1990-2024 with scenario based projections to 2030: modelling study", "journal": "BMJ", "type": "OA", "typeLabel": "Original Article", "author": "Sharrow", "doi": "10.1136/bmj-2025-088684", "url": "https://doi.org/10.1136/bmj-2025-088684", "summary": "藥師重點：結果提醒兒童死亡改善速度已放緩，尤其 neonatal period 與高死亡地區需加強照護；藥師可將此作為疫苗、感染治療、孕產與新生兒用藥安全及轉介資源規劃的背景資料。", "pubDate": "2026-06-04", "terms": [ "global", "regional", "national", "levels", "trends", "under", "infant", "neonatal", "mortality", "scenario" ], "drugTerms": [], "searchText": "global, regional, and national levels and trends in under 5, infant, and neonatal mortality during 1990-2024 with scenario based projections to 2030: modelling study bmj original article sharrow 10.1136/bmj-2025-088684 研究背景：neonatal、infant 與 under 5 死亡率 仍是全球兒童健康核心指標；本研究估計 1990-2024 年 200 個國家與地區趨勢，並推估 2025-2030 年不同情境下死亡數。 研究方法：此 modelling 研究 使用 country-specific household surveys、vital registration、sample vital registration systems、unaids、災害與衝突資料庫及 world 族群 prospects 2024 等來源。研究納入全國代表性資料，並排除疑似品質不足或危機干擾的調查資料。 主要結果：2024 年估計 4.9 百萬（90% ui 4.7 to 5.2 百萬）名兒童於 5 歲前死亡，其中 neonatal deaths 為 2.3 百萬。2015-2024 年 under 5 死亡率 比率 年下降 1.5%，低於 2000-2015 年的 3.9%；若近期趨勢持續，2025-2030 年 under 5 deaths 預估 27.3 百萬，近半發生於 neonatal period。 藥師重點：結果提醒兒童死亡改善速度已放緩，尤其 neonatal period 與高死亡地區需加強照護；藥師可將此作為疫苗、感染治療、孕產與新生兒用藥安全及轉介資源規劃的背景資料。" }, { "id": "pmid-42242781", "kind": "article", "issueId": "2026-week23", "year": 2026, "week": 23, "weekLabel": "第 23 週", "dateRange": "2026/06/01 – 06/07", "href": "2026-week23.html", "title": "Global, regional, and national levels and trends in older child, adolescent, and youth (5-24 years) all cause mortality from 1990 to 2024: modelling study", "journal": "BMJ", "type": "OA", "typeLabel": "Original Article", "author": "You", "doi": "10.1136/bmj-2025-088685", "url": "https://doi.org/10.1136/bmj-2025-088685", "summary": "藥師重點：此研究屬人口健康監測，不能外推為個別藥物療效；藥師可用於青少年與青年風險溝通、預防照護資源配置，以及辨識高死亡負擔地區的用藥與公共衛生需求。", "pubDate": "2026-06-04", "terms": [ "global", "regional", "national", "levels", "trends", "older", "child", "adolescent", "youth", "years" ], "drugTerms": [], "searchText": "global, regional, and national levels and trends in older child, adolescent, and youth (5-24 years) all cause mortality from 1990 to 2024: modelling study bmj original article you 10.1136/bmj-2025-088685 研究背景：隨著 5 歲以下死亡下降，5-24 歲兒童、青少年與青年死亡的公共衛生重要性增加；本研究估計 1990-2024 年 200 個國家與地區的 全因死亡率 趨勢。 研究方法：此 modelling 研究 建立 死亡率 databases，整合 vital registration、sample vital registration、household surveys 與 族群 censuses 等全國代表性資料，估計 5-24 歲各年齡層 死亡率 risk 並評估區域與國家趨勢。 主要結果：2024 年全球估計 5-24 歲死亡 2.1 百萬（90% ui 2.1 to 2.4 百萬），占 25 歲以下死亡 31%，高於 1990 年的 21%。死亡風險於 10-14 歲最低，15-19 與 20-24 歲上升；1990-2024 年 5-9 歲死亡下降 64%，20-24 歲僅下降 33%，且 2015 年後進展放緩。 藥師重點：此研究屬人口健康監測，不能外推為個別藥物療效；藥師可用於青少年與青年風險溝通、預防照護資源配置，以及辨識高死亡負擔地區的用藥與公共衛生需求。" }, { "id": "pmid-42246672", "kind": "article", "issueId": "2026-week23", "year": 2026, "week": 23, "weekLabel": "第 23 週", "dateRange": "2026/06/01 – 06/07", "href": "2026-week23.html", "title": "Finerenone in Persons with Chronic Kidney Disease without Diabetes", "journal": "NEJM", "type": "OA", "typeLabel": "Original Article", "author": "Heerspink", "doi": "10.1056/NEJMoa2604625", "url": "https://doi.org/10.1056/NEJMoa2604625", "summary": "藥師重點：Finerenone 在非糖尿病 CKD 族群可減緩 eGFR 下降，但 potassium 監測仍是用藥安全核心；藥師需確認 RAAS 抑制劑 背景治療、eGFR 起始條件、albuminuria 範圍與高血鉀處置計畫。", "pubDate": "2026-06-04", "terms": [ "finerenone", "persons", "chronic", "kidney", "diabetes", "nejm", "heerspink", "nejmoa2604625", "type", "find-ckd" ], "drugTerms": [], "searchText": "finerenone in persons with chronic kidney disease without diabetes nejm original article heerspink 10.1056/nejmoa2604625 研究背景：finerenone 已在 type 2 diabetes 合併 ckd 患者顯示腎臟與心血管效益；find-ckd 評估其在沒有糖尿病但有 albuminuria 的 ckd 成人是否同樣能減緩腎功能下降。 研究方法：研究收錄無糖尿病、egfr 25 to <90 ml per minute per 1.73 m2 且 urinary albumin-to-creatinine 比值 200 to ≤3500 的 ckd 成人，且皆使用 renin-angiotensin system 抑制劑。受試者接受 finerenone 10 或 20 mg 每日 或 安慰劑；主要終點為 基準值 至 month 32 的 total egfr slope。 主要結果：1584 人隨機分組；egfr 年變化率為 finerenone -3.3 vs 安慰劑 -4.0 ml per minute per 1.73 m2，差異 0.7（95% ci 0.3 to 1.1；p<0.001）。複合 kidney or 心血管 結果指標 風險較低（hr 0.77，95% ci 0.60 to 0.99；p=0.04）；hyperkalemia 為 17.0% vs 13.3%，因 hyperkalemia 停藥為 1.5% vs 0.1%。 藥師重點：finerenone 在非糖尿病 ckd 族群可減緩 egfr 下降，但 potassium 監測仍是用藥安全核心；藥師需確認 raas 抑制劑 背景治療、egfr 起始條件、albuminuria 範圍與高血鉀處置計畫。" }, { "id": "pmid-42246414", "kind": "article", "issueId": "2026-week23", "year": 2026, "week": 23, "weekLabel": "第 23 週", "dateRange": "2026/06/01 – 06/07", "href": "2026-week23.html", "title": "Finerenone in Patients With Chronic Kidney Disease Due to Glomerular Diseases: A Randomized Clinical Trial", "journal": "JAMA", "type": "OA", "typeLabel": "Original Article", "author": "Neuen", "doi": "10.1001/jama.2026.9923", "url": "https://doi.org/10.1001/jama.2026.9923", "summary": "藥師重點：此 exploratory 分析 支持 finerenone 可作為 glomerular 疾病 相關 CKD 的腎功能保護背景證據；藥師需注意這不是主要族群單獨確證試驗，仍需依 eGFR、albuminuria、serum potassium 與 RAAS blockade 情形個別評估。", "pubDate": "2026-06-05", "terms": [ "finerenone", "chronic", "kidney", "glomerular", "diseases", "jama", "neuen", "failure", "prespecified", "exploratory" ], "drugTerms": [], "searchText": "finerenone in patients with chronic kidney disease due to glomerular diseases: a randomized clinical trial jama original article neuen 10.1001/jama.2026.9923 研究背景：glomerular diseases 是 ckd 與 kidney failure 的重要原因；finerenone 在 ckd 中可降低腎功能惡化風險，但 glomerular diseases 族群資料較有限。 研究方法：此研究為 第 3 期 隨機、雙盲、安慰劑對照 試驗 的 prespecified exploratory 次族群 分析，聚焦 investigator-reported glomerular 疾病 之 nondiabetic ckd 患者。整體 試驗 納入特定 egfr 與 albuminuria 範圍者，介入為 finerenone 10 mg 或 20 mg 每日一次 vs 安慰劑；評估 total egfr slope、albuminuria 變化與 kidney failure 或 sustained ≥40% egfr decline。 主要結果：1584 人中 903 人有 glomerular 疾病，其中 immunoglobulin a nephropathy 46.1%、focal segmental glomerulosclerosis 23.8%、membranous nephropathy 10.0%。至 month 32 total egfr slope 為 -3.50 vs -4.23 ml/min/1.73 m2 per year，差異 0.73（95% ci 0.22-1.24）；month 12 albuminuria 降低 42%（95% ci 35%-48%），kidney failure 或 ≥40% egfr decline 風險較低（hr 0.74，95% ci 0.57-0.97）。 藥師重點：此 exploratory 分析 支持 finerenone 可作為 glomerular 疾病 相關 ckd 的腎功能保護背景證據；藥師需注意這不是主要族群單獨確證試驗，仍需依 egfr、albuminuria、serum potassium 與 raas blockade 情形個別評估。" }, { "id": "pmid-42242773", "kind": "article", "issueId": "2026-week23", "year": 2026, "week": 23, "weekLabel": "第 23 週", "dateRange": "2026/06/01 – 06/07", "href": "2026-week23.html", "title": "Estimates of global causes of death for children and adolescents aged 5-19 in 2000-24: secondary data analysis using bayesian multinomial logistic regression", "journal": "BMJ", "type": "OA", "typeLabel": "Original Article", "author": "Eilerts-Spinelli", "doi": "10.1136/bmj-2025-088687", "url": "https://doi.org/10.1136/bmj-2025-088687", "summary": "藥師重點：此研究可協助藥師在青少年照護中重視外傷預防、malaria/感染控制、癌症支持療法與自傷風險轉介；解讀時需記得其為模型估計，不代表單一介入效果。", "pubDate": "2026-06-04", "terms": [ "estimates", "global", "causes", "death", "children", "adolescents", "aged", "bayesian", "multinomial", "logistic" ], "drugTerms": [], "searchText": "estimates of global causes of death for children and adolescents aged 5-19 in 2000-24: secondary data analysis using bayesian multinomial logistic regression bmj original article eilerts-spinelli 10.1136/bmj-2025-088687 研究背景：了解 5-19 歲兒童與青少年死因分布，有助於將預防與醫療資源放在道路傷害、感染、腫瘤與心理健康等主要負擔。 研究方法：此 次要 資料 分析 使用 bayesian multinomial logistic regression model，整合 pubmed、embase、who 死亡率 database、dhs、mics 等資料來源，估計 195 國 2000-2024 年 cause-specific 死亡率 fractions。 主要結果：2024 年全球 5-19 歲死亡約 1.4 百萬；主要死因為 road traffic injuries 113,138（90% ui 106,901 to 119,375）、malaria 99,219（85,840 to 112,597）與 neoplasms 87,827（81,143 to 94,511）。15-19 歲女性以 self-harm 死亡較突出，男性則以 road traffic injuries 最高；高死亡地區多數 communicable、maternal、perinatal、nutritional conditions 的下降自 2015 年後放緩。 藥師重點：此研究可協助藥師在青少年照護中重視外傷預防、malaria/感染控制、癌症支持療法與自傷風險轉介；解讀時需記得其為模型估計，不代表單一介入效果。" }, { "id": "pmid-42250575", "kind": "article", "issueId": "2026-week23", "year": 2026, "week": 23, "weekLabel": "第 23 週", "dateRange": "2026/06/01 – 06/07", "href": "2026-week23.html", "title": "Efficacy and safety of retatrutide, a GIP, GLP-1, and glucagon receptor agonist, in people with type 2 diabetes and inadequate glycaemic control with diet and exercise (TRANSCEND-T2D-1): a double-blind, randomised, phase 3 trial", "journal": "Lancet", "type": "RCT", "typeLabel": "RCT", "author": "Bajaj", "doi": "10.1016/S0140-6736(26)00967-0", "url": "https://doi.org/10.1016/S0140-6736(26)00967-0", "summary": "藥師重點：結論顯示 retatrutide 單藥在早期、以生活型態控制不足的第二型糖尿病族群可改善 HbA1c 並降低體重；用藥評估需特別關注胃腸道耐受性、體重快速下降、低血糖風險與未來核准適應症。", "pubDate": "2026-06-13", "terms": [ "efficacy", "retatrutide", "glp-1", "glucagon", "receptor", "agonist", "people", "type", "diabetes", "inadequate" ], "drugTerms": [ "glp-1" ], "searchText": "efficacy and safety of retatrutide, a gip, glp-1, and glucagon receptor agonist, in people with type 2 diabetes and inadequate glycaemic control with diet and exercise (transcend-t2d-1): a double-blind, randomised, phase 3 trial lancet rct bajaj 10.1016/s0140-6736(26)00967-0 研究背景：retatrutide 是 gip、glp-1 與 glucagon triple hormone 受體 致效劑，正在開發用於第二型糖尿病、肥胖及相關併發症；本研究評估其作為單一療法用於飲食與運動控制仍不足之第二型糖尿病患者。 研究方法：transcend-t2d-1 為 40 週、第 3 期、隨機、雙盲、安慰劑對照試驗，於美國、墨西哥與印度 48 個中心收錄 hba1c 7.0%-9.5%、bmi 至少 23 kg/m2 的成人。受試者以 1:1:1:1 分配接受每週一次皮下注射 retatrutide 4 mg、9 mg、12 mg 或 安慰劑，主要終點為 week 40 hba1c 變化。 主要結果：共 537 人隨機分組；week 40 hba1c 變化為 retatrutide -1.69%、-1.86%、-1.94%，安慰劑 為 -0.81%，相對 安慰劑 差異分別為 -0.88%、-1.04%、-1.12%（all p<0.0001）。體重變化為 -11.5%、-13.9%、-15.3% vs -2.6%；常見不良事件多為輕至中度胃腸道事件，未通報 重度 hypoglycaemia。 藥師重點：結論顯示 retatrutide 單藥在早期、以生活型態控制不足的第二型糖尿病族群可改善 hba1c 並降低體重；用藥評估需特別關注胃腸道耐受性、體重快速下降、低血糖風險與未來核准適應症。" }, { "id": "pmid-42248158", "kind": "article", "issueId": "2026-week23", "year": 2026, "week": 23, "weekLabel": "第 23 週", "dateRange": "2026/06/01 – 06/07", "href": "2026-week23.html", "title": "Efficacy and safety of finerenone in patients with chronic kidney disease: an individual participant data pooled analysis (INFINITY)", "journal": "Lancet", "type": "MA", "typeLabel": "Meta-analysis", "author": "Neuen", "doi": "10.1016/S0140-6736(26)01009-3", "url": "https://doi.org/10.1016/S0140-6736(26)01009-3", "summary": "藥師重點：此 pooled 分析 支持 finerenone 在較廣 CKD 族群可能兼具腎臟與心血管保護；處方審查需把 eGFR、albuminuria、RAAS blockade、SGLT2 抑制劑 併用與 serum potassium 監測列為重點。", "pubDate": "2026-06-13", "terms": [ "efficacy", "finerenone", "chronic", "kidney", "individual", "participant", "pooled", "infinity", "lancet", "meta-analysis" ], "drugTerms": [], "searchText": "efficacy and safety of finerenone in patients with chronic kidney disease: an individual participant data pooled analysis (infinity) lancet meta-analysis neuen 10.1016/s0140-6736(26)01009-3 研究背景：mineralocorticoid 受體 過度活化是多種 ckd 進展的共同路徑；finerenone 已在 type 2 diabetes 相關 ckd 顯示腎臟與心血管效益，但不同病因與不同 egfr、albuminuria 層級的整體證據仍需整合。 研究方法：infinity 為 個別參與者資料統合分析，納入 fidelio-dkd、figaro-dkd 與 find-ckd 三項隨機、雙盲、安慰劑對照 試驗，共評估 ckd 患者使用 finerenone 的相對效果。主要腎臟結果為 kidney failure 或 sustained ≥57% egfr decline；主要心血管結果為 心衰竭 住院 或 心血管 死亡。 主要結果：三項研究共 14,574 人；finerenone 降低 複合 kidney 結果指標（22.3 vs 28.8 事件 per 1000 patient-years；hr 0.76，95% ci 0.68-0.86）與 kidney failure 單用（hr 0.85，95% ci 0.74-0.99）。複合 心血管 結果指標 亦下降（hr 0.80，95% ci 0.70-0.91）；hyperkalaemia 較 安慰劑 常見，但導致住院的絕對發生率低。 藥師重點：此 pooled 分析 支持 finerenone 在較廣 ckd 族群可能兼具腎臟與心血管保護；處方審查需把 egfr、albuminuria、raas blockade、sglt2 抑制劑 併用與 serum potassium 監測列為重點。" }, { "id": "pmid-42223072", "kind": "article", "issueId": "2026-week23", "year": 2026, "week": 23, "weekLabel": "第 23 週", "dateRange": "2026/06/01 – 06/07", "href": "2026-week23.html", "title": "Daraxonrasib or Chemotherapy in Previously Treated Metastatic Pancreatic Cancer", "journal": "NEJM", "type": "OA", "typeLabel": "Original Article", "author": "O'Reilly", "doi": "10.1056/NEJMoa2605555", "url": "https://doi.org/10.1056/NEJMoa2605555", "summary": "藥師重點：Daraxonrasib 在先前治療過 mPDAC 顯示較化療延長存活，尤其需依 RAS mutation profile 判讀；藥師需留意口服標靶治療的給藥順從性、毒性型態與與傳統化療不同的停藥/調整標準。", "pubDate": "2026-05-31", "terms": [ "daraxonrasib", "chemotherapy", "previously", "treated", "metastatic", "pancreatic", "cancer", "nejm", "reilly", "nejmoa2605555" ], "drugTerms": [], "searchText": "daraxonrasib or chemotherapy in previously treated metastatic pancreatic cancer nejm original article o'reilly 10.1056/nejmoa2605555 研究背景：先前治療過的 轉移性 pancreatic ductal adenocarcinoma（mpdac）治療選擇有限，且 ras pathway 活化是 pdac 重要驅動因子；daraxonrasib 為 口服 ras(on) multiselective 抑制劑。 研究方法：rasolute 302 為 第 3 期、international、開放標籤、隨機試驗，將先前治療過的 mpdac 患者分配至 daraxonrasib 或 investigator's choice chemotherapy。dual 主要終點s 為 ras g12 族群 的 整體存活期 與 無惡化存活期，並評估 overall 族群 與安全性。 主要結果：500 人隨機分組，其中 91.8% 有 ras g12 mutations；ras g12 族群 中位數 整體存活期 為 13.2 vs 6.6 個月，overall 族群 為 13.2 vs 6.7 個月，兩者 hr 均為 0.40（p<0.001）。ras g12 族群 中位數 無惡化存活期 為 7.3 vs 3.5 個月；等級 3 以上 不良事件 為 61.8% vs 69.6%，治療-related discontinuation 為 1.2% vs 11.2%。 藥師重點：daraxonrasib 在先前治療過 mpdac 顯示較化療延長存活，尤其需依 ras mutation profile 判讀；藥師需留意口服標靶治療的給藥順從性、毒性型態與與傳統化療不同的停藥/調整標準。" }, { "id": "pmid-42242268", "kind": "article", "issueId": "2026-week23", "year": 2026, "week": 23, "weekLabel": "第 23 週", "dateRange": "2026/06/01 – 06/07", "href": "2026-week23.html", "title": "Atrasentan in patients with IgA nephropathy (ALIGN): final 2·5-year results from a randomised, double-blind, placebo-controlled, phase 3 trial", "journal": "Lancet", "type": "RCT", "typeLabel": "RCT", "author": "Heerspink", "doi": "10.1016/S0140-6736(26)00960-8", "url": "https://doi.org/10.1016/S0140-6736(26)00960-8", "summary": "藥師重點：結果支持 atrasentan 在標準 RAAS blockade 背景下可能延緩 IgA nephropathy 腎功能惡化；藥師需追蹤水腫、體液滯留、血壓、腎功能與是否併用 SGLT2 抑制劑。", "pubDate": "2026-06-13", "terms": [ "atrasentan", "nephropathy", "align", "final", "year", "from", "randomised", "double-blind", "placebo-controlled", "phase" ], "drugTerms": [ "atrasentan" ], "searchText": "atrasentan in patients with iga nephropathy (align): final 2·5-year results from a randomised, double-blind, placebo-controlled, phase 3 trial lancet rct heerspink 10.1016/s0140-6736(26)00960-8 研究背景：atrasentan 為 selective endothelin a 受體 拮抗劑，先前 align interim 分析 已顯示可降低 iga nephropathy 蛋白尿；本研究進一步評估 2.5 年治療後是否能減緩 egfr 下降。 研究方法：align 為 133 個中心、20 國參與的 第 3 期、隨機、雙盲、安慰劑對照試驗，收錄 biopsy-proven iga nephropathy、egfr ≥30 ml/min per 1.73 m2、且在 renin-angiotensin system inhibition 下尿蛋白 ≥1.0 g/day 的成人。受試者接受 口服 atrasentan 0.75 mg 每日一次 或 安慰劑 132 週，主要分析 main stratum week 136 egfr 變化。 主要結果：404 人隨機分組；main stratum week 136 egfr 變化為 atrasentan -7.5 vs 安慰劑 -9.9 ml/min per 1.73 m2，組間差 2.4 ml/min per 1.73 m2（95% ci -0.1 to 4.8；p=0.057）。week 132 組間差為 2.6 ml/min per 1.73 m2（95% ci 0.1-5.0），total egfr slope 差為 1.4 ml/min per 1.73 m2 per year；fluid retention 不良事件 為 14% vs 12%。 藥師重點：結果支持 atrasentan 在標準 raas blockade 背景下可能延緩 iga nephropathy 腎功能惡化；藥師需追蹤水腫、體液滯留、血壓、腎功能與是否併用 sglt2 抑制劑。" }, { "id": "pmid-42235013", "kind": "article", "issueId": "2026-week23", "year": 2026, "week": 23, "weekLabel": "第 23 週", "dateRange": "2026/06/01 – 06/07", "href": "2026-week23.html", "title": "All-Oral Treatment of Newly Diagnosed Acute Myeloid Leukemia", "journal": "NEJM", "type": "OA", "typeLabel": "Original Article", "author": "Roboz", "doi": "10.1056/NEJMoa2510223", "url": "https://doi.org/10.1056/NEJMoa2510223", "summary": "藥師重點：全口服 decitabine-cedazuridine 加 venetoclax 可能降低不適合 intensive chemotherapy 之 AML 患者的給藥負擔；藥師需強化服藥時程、骨髓抑制監測、感染預防與 venetoclax 相關交互作用管理。", "pubDate": "2026-06-04", "terms": [ "all-oral", "newly", "diagnosed", "acute", "myeloid", "leukemia", "nejm", "roboz", "nejmoa2510223", "intensive" ], "drugTerms": [ "azacitidine" ], "searchText": "all-oral treatment of newly diagnosed acute myeloid leukemia nejm original article roboz 10.1056/nejmoa2510223 研究背景：75 歲以上或不適合 intensive induction chemotherapy 的新診斷 aml 患者，常用 azacitidine 或 decitabine 加 venetoclax，但注射給藥造成病人與照護端負擔；口服 decitabine-cedazuridine 提供口服替代可能。 研究方法：ascertain-v 為 第 1 期-2、開放標籤、多中心、non隨機試驗，收錄新診斷 aml 且 ≥75 歲或不適合 intensive chemotherapy 的患者，給予 口服 decitabine-cedazuridine 加 口服 venetoclax。主要終點包括 venetoclax pharmacokinetic interaction 指標與 完全反應；第 2b 期 在 blast clearance 後鼓勵 schedule adjustments 以降低 myelosuppression。 主要結果：共 189 人納入；未觀察到 decitabine-cedazuridine 與 venetoclax 的 drug-drug interactions。pivotal 第 2b 期 完全反應 為 47%（95% ci 36 to 57），完全反應 或 incomplete hematologic recovery 為 63%（95% ci 53 to 73），中位數 整體存活期 為 15.5 個月；等級 3 以上常見事件為 anemia 30%、neutropenia 26%、febrile neutropenia 25%。 藥師重點：全口服 decitabine-cedazuridine 加 venetoclax 可能降低不適合 intensive chemotherapy 之 aml 患者的給藥負擔；藥師需強化服藥時程、骨髓抑制監測、感染預防與 venetoclax 相關交互作用管理。" }, { "id": "fda-2026-week23-1", "kind": "fda", "issueId": "2026-week23", "year": 2026, "week": 23, "weekLabel": "第 23 週", "dateRange": "2026/06/01 – 06/07", "href": "2026-week23.html", "title": "FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss", "summary": "FDA 提醒未經核准的 GLP-1 減重產品可能涉及成分、品質、劑量與安全性風險。藥師應確認病人取得的是 FDA 核准產品，避免使用來源不明或複方調製的 semaglutide/tirzepatide 類產品，並加強低血糖、胃腸道不良反應與劑量錯誤衛教。", "terms": [ "concerns", "unapproved", "glp-1", "drugs", "used", "weight", "loss", "semaglutide", "tirzepatide", "https" ], "drugTerms": [ "glp-1", "semaglutide", "tirzepatide" ], "searchText": "fda’s concerns with unapproved glp-1 drugs used for weight loss fda drug safety 2026-06-15 fda 提醒未經核准的 glp-1 減重產品可能涉及成分、品質、劑量與安全性風險。藥師應確認病人取得的是 fda 核准產品，避免使用來源不明或複方調製的 semaglutide/tirzepatide 類產品，並加強低血糖、胃腸道不良反應與劑量錯誤衛教。 https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss" }, { "id": "fda-2026-week23-3", "kind": "fda", "issueId": "2026-week23", "year": 2026, "week": 23, "weekLabel": "第 23 週", "dateRange": "2026/06/01 – 06/07", "href": "2026-week23.html", "title": "FDA issues final decision to withdraw approval of Pepaxto (melphalan flufenamide)", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/node/398713", "summary": "FDA 已作成撤回 Pepaxto (melphalan flufenamide) 核准的最終決定。藥師應確認院內與病人用藥清單是否仍有相關品項，避免新開立或續用，並協助腫瘤團隊轉換替代治療。", "terms": [ "issues", "final", "decision", "withdraw", "approval", "pepaxto", "melphalan", "flufenamide", "https", "node" ], "drugTerms": [], "searchText": "fda issues final decision to withdraw approval of pepaxto (melphalan flufenamide) fda drug safety fda 已作成撤回 pepaxto (melphalan flufenamide) 核准的最終決定。藥師應確認院內與病人用藥清單是否仍有相關品項，避免新開立或續用，並協助腫瘤團隊轉換替代治療。 https://www.fda.gov/node/398713" }, { "id": "fda-2026-week23-2", "kind": "fda", "issueId": "2026-week23", "year": 2026, "week": 23, "weekLabel": "第 23 週", "dateRange": "2026/06/01 – 06/07", "href": "2026-week23.html", "title": "FDA alerts patients, caregivers, and health care providers of cross-compatibility issues with autoinjector devices that are optional for use with glatiramer acetate injection", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/node/403159", "summary": "FDA 提醒 glatiramer acetate injection 的選配 autoinjector device 可能有交叉相容性問題。藥師調劑或衛教時應確認藥品廠牌、注射器與 autoinjector 是否相容，避免病人沿用不適配裝置造成注射失敗或劑量問題。", "terms": [ "alerts", "caregivers", "providers", "cross-compatibility", "issues", "autoinjector", "devices", "that", "optional", "glatiramer" ], "drugTerms": [], "searchText": "fda alerts patients, caregivers, and health care providers of cross-compatibility issues with autoinjector devices that are optional for use with glatiramer acetate injection fda drug safety fda 提醒 glatiramer acetate injection 的選配 autoinjector device 可能有交叉相容性問題。藥師調劑或衛教時應確認藥品廠牌、注射器與 autoinjector 是否相容，避免病人沿用不適配裝置造成注射失敗或劑量問題。 https://www.fda.gov/node/403159" }, { "id": "fda-2026-week23-4", "kind": "fda", "issueId": "2026-week23", "year": 2026, "week": 23, "weekLabel": "第 23 週", "dateRange": "2026/06/01 – 06/07", "href": "2026-week23.html", "title": "FDA Accepts First In Silico Drug Development Tool Under ISTAND Program to Help Predict Drug-Induced Liver Injury", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fda-accepts-first-silico-drug-development-tool-under-istand-program-help-predict-drug-induced-liver", "summary": "FDA 接受第一個 ISTAND program 下的 in silico drug development tool，用於協助預測 drug-induced liver injury。此為藥物研發與安全評估工具訊息，藥師可關注 DILI 風險預測方法進展，但臨床用藥仍需依仿單、肝功能監測與病人風險因子判讀。", "terms": [ "accepts", "first", "silico", "development", "tool", "under", "istand", "program", "help", "predict" ], "drugTerms": [], "searchText": "fda accepts first in silico drug development tool under istand program to help predict drug-induced liver injury fda drug safety 2026-06-03 fda 接受第一個 istand program 下的 in silico drug development tool，用於協助預測 drug-induced liver injury。此為藥物研發與安全評估工具訊息，藥師可關注 dili 風險預測方法進展，但臨床用藥仍需依仿單、肝功能監測與病人風險因子判讀。 https://www.fda.gov/drugs/drug-alerts-and-statements/fda-accepts-first-silico-drug-development-tool-under-istand-program-help-predict-drug-induced-liver" }, { "id": "pmid-42202319", "kind": "article", "issueId": "2026-week22", "year": 2026, "week": 22, "weekLabel": "第 22 週", "dateRange": "2026/05/25 – 05/31", "href": "2026-week22.html", "title": "Zanidatamab with and without Tislelizumab in HER2-Positive Gastroesophageal Cancer", "journal": "NEJM", "type": "RCT", "typeLabel": "RCT", "author": "Shitara", "doi": "10.1056/NEJMoa2517729", "url": "https://doi.org/10.1056/NEJMoa2517729", "summary": "藥師重點：Zanidatamab 合併化療可延長 無惡化存活期，加入 tislelizumab 於期中分析亦顯示 整體存活期 優勢；臨床評估時需確認 HER2 狀態、免疫治療適用性，並主動監測 diarrhea 與高等級不良事件。", "pubDate": "2026-05-28", "terms": [ "zanidatamab", "tislelizumab", "her2-positive", "gastroesophageal", "cancer", "nejm", "shitara", "nejmoa2517729", "dual", "her2-targeted" ], "drugTerms": [ "zanidatamab", "tislelizumab", "anti-programmed", "trastuzumab" ], "searchText": "zanidatamab with and without tislelizumab in her2-positive gastroesophageal cancer nejm rct shitara 10.1056/nejmoa2517729 研究背景：zanidatamab 為 dual her2-targeted bispecific 抗體，先前 第 2 期 研究顯示其合併化療、可加或不加 tislelizumab，作為 her2-陽性 gastroesophageal adenocarcinoma 第一線治療具潛在療效與可接受安全性。 研究方法：此 開放標籤 第 3 期試驗 以 1:1:1 隨機分派未治療且 centrally confirmed her2-陽性 advanced gastroesophageal adenocarcinoma 患者，接受 zanidatamab-tislelizumab-chemotherapy、zanidatamab-chemotherapy 或 trastuzumab-chemotherapy。兩項主要終點為 無惡化存活期 與 整體存活期。 主要結果：中位追蹤 25.9 個月，無惡化存活期 於 zanidatamab-tislelizumab-chemotherapy 與 zanidatamab-chemotherapy 均較 trastuzumab-chemotherapy 延長（12.4 個月、12.4 個月 vs 8.1 個月；hr 0.63，95% ci 0.51-0.78；hr 0.65，95% ci 0.52-0.81；兩者 p<0.001）。整體存活期 於 zanidatamab-tislelizumab-chemotherapy 較長（26.4 vs 19.2 個月；hr 0.72，95% ci 0.57-0.90；p=0.004），等級 3 以上不良事件為 83.3%、73.8%、74.5%，最常見為 diarrhea。 藥師重點：zanidatamab 合併化療可延長 無惡化存活期，加入 tislelizumab 於期中分析亦顯示 整體存活期 優勢；臨床評估時需確認 her2 狀態、免疫治療適用性，並主動監測 diarrhea 與高等級不良事件。" }, { "id": "pmid-42212933", "kind": "article", "issueId": "2026-week22", "year": 2026, "week": 22, "weekLabel": "第 22 週", "dateRange": "2026/05/25 – 05/31", "href": "2026-week22.html", "title": "Teclistamab in Multiple Myeloma with One to Three Previous Lines of Therapy", "journal": "NEJM", "type": "OA", "typeLabel": "Original Article", "author": "Touzeau", "doi": "10.1056/NEJMoa2603870", "url": "https://doi.org/10.1056/NEJMoa2603870", "summary": "藥師重點：Teclistamab 在 1-3 線後 multiple myeloma 顯示 無惡化存活期 與 整體存活期 優勢，但感染、CRS 與 ICANS 是用藥照護核心；藥師需確認預防性抗感染、免疫球蛋白補充、住院或門診監測流程與病人衛教。", "pubDate": "2026-05-29", "terms": [ "teclistamab", "multiple", "myeloma", "three", "previous", "lines", "nejm", "touzeau", "nejmoa2603870", "targeting" ], "drugTerms": [ "teclistamab", "anti-cd38" ], "searchText": "teclistamab in multiple myeloma with one to three previous lines of therapy nejm original article touzeau 10.1056/nejmoa2603870 研究背景：teclistamab 為 targeting b-cell maturation antigen 與 cd3 的 bispecific 抗體，其作為 復發或難治性 multiple myeloma 較早線單藥治療的療效仍需確認。 研究方法：研究將曾接受 1-3 線治療且包含 anti-cd38 monoclonal 抗體 與 lenalidomide 的 復發或難治性 multiple myeloma 患者，隨機分派接受 teclistamab 或醫師選擇的 pvd（pomalidomide、bortezomib、dexamethasone）或 kd（carfilzomib、dexamethasone）。建議使用 antimicrobial prophylaxis 與 immune globulin replacement；主要終點為 independent review committee 評估的 無惡化存活期。 主要結果：teclistamab 296 人、pvd 或 kd 297 人；中位追蹤 17.3 個月期中分析顯示，18 個月 無惡化存活期 為 69.8% vs 26.9%（hr for 疾病 progression or 死亡 0.29，95% ci 0.23-0.38；p<0.001）。完全反應 or better 為 65.9% vs 16.8%（p<0.001），18 個月 整體存活期 為 79.2% vs 68.6%（hr for 死亡 0.60，95% ci 0.43-0.83；p=0.002）；等級 3 或 4 不良事件 為 84.9% vs 76.3%，等級 3 或 4 infection 為 41.6% vs 29.0%，crs 66.0%，icans 4.1%。 藥師重點：teclistamab 在 1-3 線後 multiple myeloma 顯示 無惡化存活期 與 整體存活期 優勢，但感染、crs 與 icans 是用藥照護核心；藥師需確認預防性抗感染、免疫球蛋白補充、住院或門診監測流程與病人衛教。" }, { "id": "pmid-42217458", "kind": "article", "issueId": "2026-week22", "year": 2026, "week": 22, "weekLabel": "第 22 週", "dateRange": "2026/05/25 – 05/31", "href": "2026-week22.html", "title": "Tafasitamab plus lenalidomide and R-CHOP versus R-CHOP for first-line treatment of patients with high-risk diffuse large B-cell lymphoma (frontMIND): a global, phase 3, randomised, double-blind, placebo-controlled trial", "journal": "Lancet", "type": "RCT", "typeLabel": "RCT", "author": "Lenz", "doi": "10.1016/S0140-6736(26)00866-4", "url": "https://doi.org/10.1016/S0140-6736(26)00866-4", "summary": "藥師重點：Tafa-len-R-CHOP 帶來 無惡化存活期 優勢，但 整體存活期 尚未成熟且高等級與致死性不良事件增加；若作為第一線候選策略，需特別評估感染、血球抑制、lenalidomide 相關風險與病人高風險定義是否符合。", "pubDate": "2026-06-20", "terms": [ "tafasitamab", "plus", "lenalidomide", "r-chop", "first-line", "high-risk", "diffuse", "large", "b-cell", "lymphoma" ], "drugTerms": [ "tafasitamab", "rituximab", "anti-cd19" ], "searchText": "tafasitamab plus lenalidomide and r-chop versus r-chop for first-line treatment of patients with high-risk diffuse large b-cell lymphoma (frontmind): a global, phase 3, randomised, double-blind, placebo-controlled trial lancet rct lenz 10.1016/s0140-6736(26)00866-4 研究背景：約 40% high-risk dlbcl 患者無法以第一線 r-chop 治癒，frontmind 評估在 r-chop 加入 tafasitamab 與 lenalidomide（tafa-len-r-chop）是否可改善高風險 aggressive b-cell 淋巴瘤 預後。 研究方法：frontmind 為 global 第 3 期、隨機、雙盲、安慰劑對照 研究，於 298 個中心收錄 18-80 歲、初治 high-intermediate-risk 或 high-risk dlbcl 或 hgbl 患者。899 人以 1:1 分派接受 6 個 21 天療程 tafa-len-r-chop 或 r-chop；主要終點為 investigator-assessed 無惡化存活期，安全性為次要終點。 主要結果：中位追蹤 35.2 個月，tafa-len-r-chop 相較 r-chop 改善 無惡化存活期（hr 0.75，95% ci 0.59-0.96；p=0.0194），2 年 無惡化存活期 為 71.1% vs 62.9%。整體存活期 期中 hr 為 0.85（95% ci 0.63-1.14）；等級 3 以上 治療期間出現的不良事件 較高（87% vs 76%），fatal 治療期間出現的不良事件 為 6% vs 4%，但整體死亡數為 19% vs 22%。 藥師重點：tafa-len-r-chop 帶來 無惡化存活期 優勢，但 整體存活期 尚未成熟且高等級與致死性不良事件增加；若作為第一線候選策略，需特別評估感染、血球抑制、lenalidomide 相關風險與病人高風險定義是否符合。" }, { "id": "pmid-42202318", "kind": "article", "issueId": "2026-week22", "year": 2026, "week": 22, "weekLabel": "第 22 週", "dateRange": "2026/05/25 – 05/31", "href": "2026-week22.html", "title": "Stem-Cell-Derived Biologic Ventricular Assist Tissue in Heart Failure", "journal": "NEJM", "type": "OA", "typeLabel": "Original Article", "author": "Zimmermann", "doi": "10.1056/NEJMoa2513525", "url": "https://doi.org/10.1056/NEJMoa2513525", "summary": "藥師重點：BioVAT 為早期探索性心臟再肌化治療，3 個月指標改善需放在 開放標籤、小樣本與高事件負擔下解讀；若進入臨床研究照護，藥師需特別關注 immunosuppression、感染、腎功能與裝置或移植相關用藥銜接。", "pubDate": "2026-05-28", "terms": [ "stem-cell-derived", "biologic", "ventricular", "assist", "tissue", "heart", "failure", "nejm", "zimmermann", "nejmoa2513525" ], "drugTerms": [], "searchText": "stem-cell-derived biologic ventricular assist tissue in heart failure nejm original article zimmermann 10.1056/nejmoa2513525 研究背景：biologic ventricular assist tissue (biovat) 由 allogeneic induced pluripotent stem cells 分化的 cardiomyocytes 與 stromal cells 製成，用於 reduced left ventricular ejection fraction 心衰竭 的 cardiac remuscularization。 研究方法：此 開放標籤 第 1 期-2 研究 評估 biovat transplantation 用於 left ventricular ejection fraction ≤35% 且至少一處左心室 hypokinetic 或 dyskinetic segment 的心衰竭患者。20 人接受 5、10 或 20 engineered-heart-muscle units，所有患者均接受 immunosuppression；安全性以 procedure-related 不良事件 評估，主要療效終點包括 target heart-wall thickness、left ventricular ejection fraction 與 kccq-oss 變化。 主要結果：20 人接受治療，研究期間 3 人死亡（vasoplegia、covid-19、aortic dissection 各 1 人），1 人接受 heart transplantation，4 人因 lvad、renal failure 或 urothelial carcinoma 停用 immunosuppression。在 16 名接受安全最高劑量 20 units 的患者中，12 人完成 3 個月 interim 追蹤；target-wall thickness 增加 4.5 mm（90% ci 3.7-5.4；p<0.001），left ventricular ejection fraction 增加 3.9 百分點（90% ci 0.9-6.8；p=0.04），kccq-oss 增加 6.7 分（90% ci 1.0-12.5；p=0.06），所有患者至少有 1 件 不良事件。 藥師重點：biovat 為早期探索性心臟再肌化治療，3 個月指標改善需放在 開放標籤、小樣本與高事件負擔下解讀；若進入臨床研究照護，藥師需特別關注 immunosuppression、感染、腎功能與裝置或移植相關用藥銜接。" }, { "id": "pmid-42214392", "kind": "article", "issueId": "2026-week22", "year": 2026, "week": 22, "weekLabel": "第 22 週", "dateRange": "2026/05/25 – 05/31", "href": "2026-week22.html", "title": "Sacituzumab tirumotecan plus pembrolizumab versus pembrolizumab in PD-L1-positive advanced non-small-cell lung cancer (OptiTROP-Lung05): interim analysis of a randomised, open-label, phase 3 trial", "journal": "Lancet", "type": "RCT", "typeLabel": "RCT", "author": "Xiong", "doi": "10.1016/S0140-6736(26)00968-2", "url": "https://doi.org/10.1016/S0140-6736(26)00968-2", "summary": "藥師重點：Sac-TMT 加 pembrolizumab 在 PD-L1 陽性、無 targetable genomic alterations 的 advanced NSCLC 期中分析顯示明顯 無惡化存活期 優勢，但毒性較高且試驗仍在進行；用藥評估需確認 PD-L1 TPS、驅動基因狀態與 ADC 相關不良事件監測。", "pubDate": "2026-06-27", "terms": [ "sacituzumab", "tirumotecan", "plus", "pembrolizumab", "pd-l1-positive", "advanced", "non-small-cell", "lung", "cancer", "optitrop-lung05" ], "drugTerms": [ "sacituzumab", "pembrolizumab" ], "searchText": "sacituzumab tirumotecan plus pembrolizumab versus pembrolizumab in pd-l1-positive advanced non-small-cell lung cancer (optitrop-lung05): interim analysis of a randomised, open-label, phase 3 trial lancet rct xiong 10.1016/s0140-6736(26)00968-2 研究背景：sacituzumab tirumotecan (sac-tmt) 為 trop2-targeting 抗體-drug conjugate，早期研究顯示合併 pd-1/pd-l1 抑制劑 作為 nsclc 第一線治療具抗腫瘤活性。 研究方法：optitrop-lung05 為中國 68 家醫院進行的 隨機、開放標籤 第 3 期試驗，收錄 locally advanced 或 轉移性 nsclc、無 targetable genomic alterations 且 pd-l1 tps ≥1% 的患者。413 人以 1:1 分派接受 sac-tmt 4 mg/kg（天 1, 15, 29）加 pembrolizumab 400 mg（第 1 天）或 pembrolizumab 單用，每 6 週靜脈給藥；主要終點為 盲性獨立中央審查 評估的 無惡化存活期。 主要結果：中位追蹤 10.5 個月時，sac-tmt 加上 pembrolizumab 的 中位數 無惡化存活期 尚未達到，pembrolizumab 單用 為 5.7 個月（stratified hr 0.35，95% ci 0.26-0.47；p<0.0001）。無惡化存活期 效益在 pd-l1 tps 1-49%（hr 0.28，95% ci 0.19-0.41）與 tps ≥50%（hr 0.47，95% ci 0.29-0.77）均一致；等級 3 以上 治療期間出現的不良事件 為 55% vs 31%。 藥師重點：sac-tmt 加 pembrolizumab 在 pd-l1 陽性、無 targetable genomic alterations 的 advanced nsclc 期中分析顯示明顯 無惡化存活期 優勢，但毒性較高且試驗仍在進行；用藥評估需確認 pd-l1 tps、驅動基因狀態與 adc 相關不良事件監測。" }, { "id": "pmid-42206582", "kind": "article", "issueId": "2026-week22", "year": 2026, "week": 22, "weekLabel": "第 22 週", "dateRange": "2026/05/25 – 05/31", "href": "2026-week22.html", "title": "Phase 3 Results of Bepirovirsen Treatment for Chronic Hepatitis B Virus Infection", "journal": "NEJM", "type": "RCT", "typeLabel": "RCT", "author": "Hou", "doi": "10.1056/NEJMoa2515131", "url": "https://doi.org/10.1056/NEJMoa2515131", "summary": "藥師重點：Bepirovirsen 在特定 noncirrhotic HBV 且 HBsAg 範圍受限族群中提高 functional cure 率；實務上需嚴格確認 NA 停藥條件，並監測 ALT 上升、HBV DNA 與 HBsAg 變化。", "pubDate": "2026-06-25", "terms": [ "phase", "bepirovirsen", "chronic", "hepatitis", "virus", "infection", "nejm", "nejmoa2515131", "targeting", "transcripts" ], "drugTerms": [], "searchText": "phase 3 results of bepirovirsen treatment for chronic hepatitis b virus infection nejm rct hou 10.1056/nejmoa2515131 研究背景：bepirovirsen 為 targeting hbv transcripts 的 antisense oligonucleotide，固定療程後若能維持 hbv dna 低於 lloq 且 hbsag loss，可達 functional cure 的治療目標。 研究方法：b-well 1 與 b-well 2 為兩項 replicate、雙盲 第 3 期試驗s，收錄 noncirrhotic chronic hbv infection 且正在穩定使用 nucleoside or nucleotide analogue (na) 治療、hbsag >100 至 3000 iu/ml 的成人。患者以 2:1 分派接受 subcutaneous bepirovirsen 300 mg 每週 或 安慰劑 24 週，符合條件者於 48 週停用 na；主要終點為 week 72 functional cure。 主要結果：week 72 functional cure 在 b-well 1 為 20%（127/650）vs 0%（0/328），b-well 2 為 19%（106/570）vs 0%（0/286）。pooled 分析 顯示 不良事件 為 91% vs 73%，嚴重不良事件 為 7% vs 4%；治療期間 等級 3 以上 不良事件 為 16% vs 3%，bepirovirsen 組最常見 等級 3 event 為 alanine aminotransferase 上升（6%）。 藥師重點：bepirovirsen 在特定 noncirrhotic hbv 且 hbsag 範圍受限族群中提高 functional cure 率；實務上需嚴格確認 na 停藥條件，並監測 alt 上升、hbv dna 與 hbsag 變化。" }, { "id": "pmid-42203255", "kind": "article", "issueId": "2026-week22", "year": 2026, "week": 22, "weekLabel": "第 22 週", "dateRange": "2026/05/25 – 05/31", "href": "2026-week22.html", "title": "Outcome switching in cohort studies of interventions: meta-epidemiological study", "journal": "BMJ", "type": "OA", "typeLabel": "Original Article", "author": "Song", "doi": "10.1136/bmj-2025-087975", "url": "https://doi.org/10.1136/bmj-2025-087975", "summary": "藥師重點：閱讀介入性 世代研究 時，不能只看發表論文的主要結果，應回查登錄紀錄與預設終點；此研究提醒藥物效果與安全性證據解讀需留意 selective reporting 風險。", "pubDate": "2026-05-27", "terms": [ "switching", "studies", "interventions", "meta-epidemiological", "song", "bmj-2025-087975", "prespecification", "longitudinal", "clinicaltrials", "measurement" ], "drugTerms": [], "searchText": "outcome switching in cohort studies of interventions: meta-epidemiological study bmj original article song 10.1136/bmj-2025-087975 研究背景：觀察性 世代 研究 常被用來評估介入效果，但 結果指標 switching 與 結果指標 prespecification 不完整可能造成選擇性報告偏差。 研究方法：此 longitudinal meta-epidemiological 研究 比對 clinicaltrials.gov 登錄資料與期刊發表結果，納入 2014-2016 年起始、於 2024 年前發表結果的 controlled 世代 研究 of interventions。主要評估 結果指標 switching 比例與 主要 結果指標 是否完整預先指定，包括 measurement variable、分析 metric、aggregation method 與 time point。 主要結果：9965 筆登錄資料中納入 124 篇研究，僅 30 篇（24%）完整預先指定 主要 結果指標。結果指標 switching 發生於 60 篇（48%），僅 2 篇提供解釋；常見型態包括 omission（n=32，26%）、downgrading（n=32，26%）與 introduction of new 主要 結果指標（n=25，20%）。在有 結果指標 switching 且結果被報告的 57 篇中，77%（44/57）偏向 statistically significant results。 藥師重點：閱讀介入性 世代研究 時，不能只看發表論文的主要結果，應回查登錄紀錄與預設終點；此研究提醒藥物效果與安全性證據解讀需留意 selective reporting 風險。" }, { "id": "pmid-42187087", "kind": "article", "issueId": "2026-week22", "year": 2026, "week": 22, "weekLabel": "第 22 週", "dateRange": "2026/05/25 – 05/31", "href": "2026-week22.html", "title": "In Vivo Base Editing of PCSK9 with VERVE-102 for Hypercholesterolemia", "journal": "NEJM", "type": "OA", "typeLabel": "Original Article", "author": "Vafai", "doi": "10.1056/NEJMoa2601283", "url": "https://doi.org/10.1056/NEJMoa2601283", "summary": "藥師重點：VERVE-102 單次給藥可降低 PCSK9 與 LDL 膽固醇，但目前僅為小型 第 1 期 劑量遞增研究；臨床採用前仍需確認長期安全性，並特別留意輸注反應與肝功能變化。", "pubDate": "2026-05-25", "terms": [ "vivo", "base", "editing", "pcsk9", "verve-102", "hypercholesterolemia", "nejm", "vafai", "nejmoa2601283", "loss-of-function" ], "drugTerms": [], "searchText": "in vivo base editing of pcsk9 with verve-102 for hypercholesterolemia nejm original article vafai 10.1056/nejmoa2601283 研究背景：pcsk9 loss-of-function variants 與較低 ldl 膽固醇 及較少 ascvd 事件 相關；verve-102 是設計用於肝臟持久 inactivate pcsk9 的 investigational base-editing 治療。 研究方法：此 第 1 期、開放標籤、single-ascending-dose 研究 對 heterozygous familial hyper膽固醇emia 或 premature 冠狀動脈 動脈 疾病 成人給予單次 intravenous verve-102，劑量為 0.3-1.0 mg total rna/kg。verve-102 含 adenine base-editor mrna 與 targeting pcsk9 的 guide rna，封裝於含 n-acetylgalactosamine 的 lipid nanoparticle；主要評估安全性與 pcsk9、ldl 膽固醇 變化。 主要結果：35 人接受 verve-102 且至少追蹤 28 天，未發生 dose-limiting toxic effects；觀察到 mild-to-moderate 輸注相關反應 與暫時性 alanine aminotransferase 上升，1 名胃食道逆流患者發生 aspiration pneumonitis。pcsk9 平均下降呈劑量相關，從 0.3 mg/kg 的 51% 至 1.0 mg/kg 的 88%；ldl 膽固醇 對應下降 9% 至 62%，最高劑量絕對下降 78 mg/dl，15 人追蹤至少 1 年仍維持下降。 藥師重點：verve-102 單次給藥可降低 pcsk9 與 ldl 膽固醇，但目前僅為小型 第 1 期 劑量遞增研究；臨床採用前仍需確認長期安全性，並特別留意輸注反應與肝功能變化。" }, { "id": "pmid-42212913", "kind": "article", "issueId": "2026-week22", "year": 2026, "week": 22, "weekLabel": "第 22 週", "dateRange": "2026/05/25 – 05/31", "href": "2026-week22.html", "title": "First-Line Sunvozertinib in NSCLC with EGFR Exon 20 Insertion Mutations", "journal": "NEJM", "type": "OA", "typeLabel": "Original Article", "author": "Zhou", "doi": "10.1056/NEJMoa2604461", "url": "https://doi.org/10.1056/NEJMoa2604461", "summary": "藥師重點：Sunvozertinib 作為 EGFR exon 20 insertion advanced nonsquamous NSCLC 第一線治療可延長 無惡化存活期；用藥前需確認分子檢測結果，治療中監測 creatine kinase、diarrhea、anemia 與整體高等級不良事件。", "pubDate": "2026-05-29", "terms": [ "first-line", "sunvozertinib", "nsclc", "egfr", "exon", "insertion", "mutations", "nejm", "zhou", "nejmoa2604461" ], "drugTerms": [ "sunvozertinib" ], "searchText": "first-line sunvozertinib in nsclc with egfr exon 20 insertion mutations nejm original article zhou 10.1056/nejmoa2604461 研究背景：sunvozertinib 已獲加速核准用於 advanced nsclc with egfr exon 20 insertion mutations 後線治療，但作為第一線治療的療效與安全性仍需資料支持。 研究方法：此 international 第 3 期試驗 以 1:1 將 advanced nonsquamous nsclc 且具 egfr exon 20 insertions 的患者分派至 sunvozertinib 或 chemotherapy（carboplatin-pemetrexed）。主要終點為 盲性獨立中央審查 評估的 無惡化存活期，疾病進展後允許 crossover 至 sunvozertinib。 主要結果：共 324 人隨機分派，sunvozertinib 163 人、chemotherapy 161 人；中位數 無惡化存活期 為 10.3 vs 7.5 個月（hr for 疾病 progression or 死亡 0.65，95% ci 0.50-0.85；p<0.001），12 個月 無惡化存活期 為 46.1% vs 26.7%，整體存活期 資料尚未成熟（38.9% maturity）。objective 反應 為 58.9% vs 31.1%，中位數 duration of 反應 為 11.2 vs 7.1 個月；等級 3 以上 不良事件 為 75.5% vs 56.7%，sunvozertinib 常見為 serum creatine kinase 上升、diarrhea 與 anemia，未有研究者認定與 sunvozertinib 相關死亡。 藥師重點：sunvozertinib 作為 egfr exon 20 insertion advanced nonsquamous nsclc 第一線治療可延長 無惡化存活期；用藥前需確認分子檢測結果，治療中監測 creatine kinase、diarrhea、anemia 與整體高等級不良事件。" }, { "id": "pmid-42214397", "kind": "article", "issueId": "2026-week22", "year": 2026, "week": 22, "weekLabel": "第 22 週", "dateRange": "2026/05/25 – 05/31", "href": "2026-week22.html", "title": "Efficacy and safety of the CD40 ligand inhibitor dapirolizumab pegol in systemic lupus erythematosus (PHOENYCS GO): a randomised, double-blind, placebo-controlled, phase 3 trial", "journal": "Lancet", "type": "RCT", "typeLabel": "RCT", "author": "Clowse", "doi": "10.1016/S0140-6736(26)00691-4", "url": "https://doi.org/10.1016/S0140-6736(26)00691-4", "summary": "藥師重點：Dapirolizumab pegol 在標準治療外可改善 SLE 疾病活動度，但仍屬需進一步定位的治療選項；若未來使用，需留意輸注過敏、感染風險與血栓栓塞相關事件。", "pubDate": "2026-06-06", "terms": [ "efficacy", "cd40", "ligand", "inhibitor", "dapirolizumab", "pegol", "systemic", "lupus", "erythematosus", "phoenycs" ], "drugTerms": [ "dapirolizumab" ], "searchText": "efficacy and safety of the cd40 ligand inhibitor dapirolizumab pegol in systemic lupus erythematosus (phoenycs go): a randomised, double-blind, placebo-controlled, phase 3 trial lancet rct clowse 10.1016/s0140-6736(26)00691-4 研究背景：dapirolizumab pegol 為 cd40 ligand 抑制劑，本 第 3 期試驗 評估其用於 systemic lupus erythematosus (sle) 患者的疾病活動度改善與安全性。 研究方法：phoenycs go 為 48 週、隨機、雙盲、安慰劑對照 第 3 期試驗，於 25 國 177 個中心收錄 16 歲以上、使用 standard-of-care 後仍為 moderate-to-重度 active sle 的患者。患者以 2:1 分派接受 intravenous dapirolizumab pegol 24 mg/kg 或 安慰劑，每 4 週一次並併用 standard of care；主要終點為 week 48 bicla 反應。 主要結果：full-分析 set 為 315 人；week 48 bicla 反應 為 dapirolizumab pegol 50%（103/208）vs 安慰劑 35%（37/107）（p=0.011；差異 14.6，95% ci 3.3-25.8）。治療期間出現的不良事件 為 83% vs 75%，serious 治療期間出現的不良事件 為 10% vs 15%；dapirolizumab pegol 組 infusion hypersensitivity 3%，serious infections 4%，另有 1 件 myocardial infarction 與 1 件 gangrene-related sepsis 死亡。 藥師重點：dapirolizumab pegol 在標準治療外可改善 sle 疾病活動度，但仍屬需進一步定位的治療選項；若未來使用，需留意輸注過敏、感染風險與血栓栓塞相關事件。" }, { "id": "pmid-42208561", "kind": "article", "issueId": "2026-week22", "year": 2026, "week": 22, "weekLabel": "第 22 週", "dateRange": "2026/05/25 – 05/31", "href": "2026-week22.html", "title": "Efficacy and safety of ocrelizumab in primary progressive multiple sclerosis, including older patients and those with more advanced disease (ORATORIO-HAND): a multicentre, double-blind, randomised, placebo-controlled, phase 3b study", "journal": "Lancet", "type": "RCT", "typeLabel": "RCT", "author": "Giovannoni", "doi": "10.1016/S0140-6736(26)00617-3", "url": "https://doi.org/10.1016/S0140-6736(26)00617-3", "summary": "藥師重點：結果支持 ocrelizumab 可延緩較廣泛 PPMS 族群的失能進展，且對手部功能有臨床意義；用藥時仍需依 B-cell depletion 治療常規監測感染、疫苗接種時機與輸注相關反應。", "pubDate": "2026-05-30", "terms": [ "efficacy", "ocrelizumab", "progressive", "multiple", "sclerosis", "including", "older", "those", "more", "advanced" ], "drugTerms": [ "ocrelizumab" ], "searchText": "efficacy and safety of ocrelizumab in primary progressive multiple sclerosis, including older patients and those with more advanced disease (oratorio-hand): a multicentre, double-blind, randomised, placebo-controlled, phase 3b study lancet rct giovannoni 10.1016/s0140-6736(26)00617-3 研究背景：oratorio 已顯示 ocrelizumab 可降低 主要 progressive multiple sclerosis (ppms) 失能惡化風險，本研究進一步評估較年長、失能較重 ppms 患者，特別是手部功能保存的效果。 研究方法：oratorio-hand 為 多中心、雙盲、隨機、安慰劑對照 第 3 期b 研究，於 22 國 138 個中心收錄 18-65 歲、edss 3.0-8.0 的 ppms 患者。1013 人以 1:1 分派接受 intravenous ocrelizumab 600 mg 或 安慰劑，每 6 個月一次至 144 週；共同主要評估為 12-week 複合 confirmed disability progression (12w-ccdp)，包含 9-hole peg test 或 edss。 主要結果：12w-ccdp 發生率為 ocrelizumab 33%（165/505）vs 安慰劑 40%（205/508）（hr 0.70，95% ci 0.57-0.86；相對風險 reduction=30%；p=0.0007）。mri-active 次族群 亦有顯著風險降低（risk reduction=55%；p<0.0001）；整體安全性相近，ocrelizumab 感染較多（48% vs 45%），排除 covid-19 後為 38% vs 37%，嚴重不良事件 與 serious infections 相近。 藥師重點：結果支持 ocrelizumab 可延緩較廣泛 ppms 族群的失能進展，且對手部功能有臨床意義；用藥時仍需依 b-cell depletion 治療常規監測感染、疫苗接種時機與輸注相關反應。" }, { "id": "pmid-42208564", "kind": "article", "issueId": "2026-week22", "year": 2026, "week": 22, "weekLabel": "第 22 週", "dateRange": "2026/05/25 – 05/31", "href": "2026-week22.html", "title": "Efficacy and safety of intravenous prasinezumab in individuals with early-stage Parkinson's disease on stable symptomatic monotherapy (PADOVA): a phase 2b, multicentre, randomised, double-blind, placebo-controlled study", "journal": "Lancet", "type": "RCT", "typeLabel": "RCT", "author": "Nikolcheva", "doi": "10.1016/S0140-6736(26)00865-2", "url": "https://doi.org/10.1016/S0140-6736(26)00865-2", "summary": "藥師重點：PADOVA 未達主要療效終點，prasinezumab 目前仍屬需進一步驗證的疾病修飾治療候選；若納入試驗或後續使用，應與既有 levodopa 或 MAO-B 抑制劑 治療目標區分，避免把探索性訊號解讀為已確立療效。", "pubDate": "2026-05-30", "terms": [ "efficacy", "intravenous", "prasinezumab", "individuals", "early-stage", "parkinson", "stable", "symptomatic", "monotherapy", "padova" ], "drugTerms": [ "prasinezumab" ], "searchText": "efficacy and safety of intravenous prasinezumab in individuals with early-stage parkinson's disease on stable symptomatic monotherapy (padova): a phase 2b, multicentre, randomised, double-blind, placebo-controlled study lancet rct nikolcheva 10.1016/s0140-6736(26)00865-2 研究背景：prasinezumab 先前在 early-stage parkinson's 疾病 顯示可能延緩 mds-updrs part iii 運動惡化，本研究評估其在已穩定使用 有症狀 medication 族群中的療效與安全性。 研究方法：padova 為 第 2b 期、多中心、雙盲、安慰劑對照 隨機試驗，收錄 50-85 歲、診斷 3 個月至 3 年、hoehn and yahr stage 1 或 2 且穩定用藥的 early-stage parkinson's 疾病 患者。586 人以 1:1 分派接受 intravenous prasinezumab 1500 mg 或 安慰劑，每 4 週一次至少 76 週；主要終點為 confirmed motor progression event（off-medication mds-updrs part iii 增加 ≥5 分）的時間。 主要結果：主要終點未達顯著差異，prasinezumab 相較 安慰劑 的 motor progression hr 為 0.84（95% ci 0.69-1.01；p=0.066），中位時間為 61.1 週 vs 49.7 週。嚴重不良事件 發生率相近（12% vs 12%），3 件死亡均判定與 研究 drug 無關。 藥師重點：padova 未達主要療效終點，prasinezumab 目前仍屬需進一步驗證的疾病修飾治療候選；若納入試驗或後續使用，應與既有 levodopa 或 mao-b 抑制劑 治療目標區分，避免把探索性訊號解讀為已確立療效。" }, { "id": "pmid-42208560", "kind": "article", "issueId": "2026-week22", "year": 2026, "week": 22, "weekLabel": "第 22 週", "dateRange": "2026/05/25 – 05/31", "href": "2026-week22.html", "title": "Efficacy and safety of a bodyweight-adjusted higher dose of ocrelizumab in relapsing (MUSETTE) and primary progressive (GAVOTTE) multiple sclerosis: two multicentre, randomised, double-blind, parallel-group phase 3b trials", "journal": "Lancet", "type": "RCT", "typeLabel": "RCT", "author": "Hauser", "doi": "10.1016/S0140-6736(26)00147-9", "url": "https://doi.org/10.1016/S0140-6736(26)00147-9", "summary": "藥師重點：高劑量 ocrelizumab 未進一步改善 RMS 或 PPMS 失能進展控制，摘要資料不支持單因體重或暴露量考量而升高劑量；臨床仍應以核准劑量與既有監測流程為主。", "pubDate": "2026-05-30", "terms": [ "efficacy", "bodyweight-adjusted", "higher", "dose", "ocrelizumab", "relapsing", "musette", "progressive", "gavotte", "multiple" ], "drugTerms": [ "ocrelizumab", "anti-cd20" ], "searchText": "efficacy and safety of a bodyweight-adjusted higher dose of ocrelizumab in relapsing (musette) and primary progressive (gavotte) multiple sclerosis: two multicentre, randomised, double-blind, parallel-group phase 3b trials lancet rct hauser 10.1016/s0140-6736(26)00147-9 研究背景：ocrelizumab 為 anti-cd20 monoclonal 抗體，600 mg 劑量已用於 rms 與 ppms；先前 post-hoc 分析提示較高 exposure 可能與較佳 b-cell depletion 和較低失能惡化相關，因此需前瞻性評估高劑量是否更有效。 研究方法：musette 與 gavotte 為兩項 多中心、雙盲 第 3 期 controlled 試驗，比較 bodyweight-校正 高劑量 ocrelizumab（<75 kg 為 1200 mg，≥75 kg 為 1800 mg）與 600 mg ocrelizumab。rms 與 ppms 患者以 2:1 隨機分派，每 24 週輸注一次；主要終點為 12-week 複合 confirmed disability progression (ccdp)。 主要結果：musette 納入 860 人，12-week ccdp 為 34% vs 37%（hr 0.93，95% ci 0.73-1.18；p=0.53）；gavotte 納入 753 人，12-week ccdp 為 47% vs 49%（hr 0.95，95% ci 0.76-1.18；p=0.64）。高劑量與 600 mg 的 不良事件、嚴重不良事件 與 fatalities 比率相近，未發現新的安全性訊號。 藥師重點：高劑量 ocrelizumab 未進一步改善 rms 或 ppms 失能進展控制，摘要資料不支持單因體重或暴露量考量而升高劑量；臨床仍應以核准劑量與既有監測流程為主。" }, { "id": "pmid-42202320", "kind": "article", "issueId": "2026-week22", "year": 2026, "week": 22, "weekLabel": "第 22 週", "dateRange": "2026/05/25 – 05/31", "href": "2026-week22.html", "title": "Decompression with or without Duraplasty for Chiari I and Syringomyelia", "journal": "NEJM", "type": "RCT", "typeLabel": "RCT", "author": "Limbrick", "doi": "10.1056/NEJMoa2402821", "url": "https://doi.org/10.1056/NEJMoa2402821", "summary": "藥師重點：PFD-D 未顯著降低手術併發症，雖有較大的 syrinx 縮小與較少再次 decompression 訊號，但仍需更大型研究確認；圍手術照護時應依神經外科判斷監測併發症與追蹤影像變化。", "pubDate": "2026-05-28", "terms": [ "decompression", "duraplasty", "chiari", "syringomyelia", "nejm", "limbrick", "nejmoa2402821", "type", "malformation", "posterior" ], "drugTerms": [], "searchText": "decompression with or without duraplasty for chiari i and syringomyelia nejm rct limbrick 10.1056/nejmoa2402821 研究背景：兒童 chiari type i malformation 合併 syringomyelia 可透過 posterior fossa decompression (pfd) 改善症狀，但是否需加做 duraplasty 以改善預後仍不明確。 研究方法：此多中心、cluster-隨機對照試驗 於 38 個中心收錄 21 歲以下、cerebellar tonsillar ectopia 至少 5 mm 且 syrinx 直徑 3.0-9.9 mm 的患者，比較 pfd with duraplasty (pfd-d) 與 pfd 單用。主要終點為 6 個月內手術併發症，次要終點包括臨床改善、syrinx 縮小、再次 decompression 與生活品質變化。 主要結果：共 162 人納入分析，pfd-d 78 人、pfd 單用 84 人；6 個月內併發症為 14% vs 6%（校正 勝算比 2.59，95% ci 0.86-7.84；p=0.11）。24 個月時臨床改善為 58% vs 46%，syrinx 平均縮小 3.08±2.33 mm vs 1.22±1.79 mm，再次 decompression 為 3% vs 14%，健康相關生活品質變化相近。 藥師重點：pfd-d 未顯著降低手術併發症，雖有較大的 syrinx 縮小與較少再次 decompression 訊號，但仍需更大型研究確認；圍手術照護時應依神經外科判斷監測併發症與追蹤影像變化。" }, { "id": "pmid-42208563", "kind": "article", "issueId": "2026-week22", "year": 2026, "week": 22, "weekLabel": "第 22 週", "dateRange": "2026/05/25 – 05/31", "href": "2026-week22.html", "title": "Comparison of [18F]flortaucipir and [18F]MK6240 for the detection of tau pathology in Alzheimer's disease (HEAD): a multicentre, prospective, cross-sectional, within-participant study", "journal": "Lancet", "type": "OA", "typeLabel": "Original Article", "author": "Povala", "doi": "10.1016/S0140-6736(26)00417-4", "url": "https://doi.org/10.1016/S0140-6736(26)00417-4", "summary": "藥師重點：Tau PET tracer 選擇會影響 tau pathology 判讀與臨床試驗分層，進而影響 Alzheimer's 疾病 治療資格或監測決策；解讀影像報告時需確認使用的 tracer，避免將不同 tracer 結果直接互相比較。", "pubDate": "2026-05-30", "terms": [ "comparison", "flortaucipir", "mk6240", "detection", "pathology", "alzheimer", "head", "multicentre", "prospective", "cross-sectional" ], "drugTerms": [], "searchText": "comparison of [18f]flortaucipir and [18f]mk6240 for the detection of tau pathology in alzheimer's disease (head): a multicentre, prospective, cross-sectional, within-participant study lancet original article povala 10.1016/s0140-6736(26)00417-4 研究背景：tau pet imaging 是 alzheimer's 疾病 診斷、分期與治療選擇的重要 biomarker，本研究評估不同 pet tracer 是否會改變 tau pathology 偵測結果。 研究方法：head 為 prospective、多中心、non-隨機、within-participant comparison 研究，比較 [18f]flortaucipir (tauvid) 與 investigational [18f]mk6240。682 名完成流程者接受 tau pet、amyloid-β (aβ) pet 與認知評估，兩種 tau pet 於 45 天內完成；共同主要終點為區分 alzheimer's 疾病-related cognitive impairment 的準確度，以及 mtl 與 neocortical tau positivity 頻率。 主要結果：[18f]mk6240 區分 alzheimer's 疾病 與 non-alzheimer's 疾病 impairment 的 auc 高於 [18f]flortaucipir（0.93，95% ci 0.89-0.95 vs 0.86，0.75-0.91；p<0.0001）。認知正常者中，[18f]mk6240 偵測 mtl-陽性 較多（54 [15%] vs 23 [6%]）；aβ-陽性 次族群 prevalence 比值 2.43（95% ci 1.50-3.94；p=0.0003）。認知受損者 neocortical tau positivity 亦較高（80 [28%] vs 46 [16%]）。 藥師重點：tau pet tracer 選擇會影響 tau pathology 判讀與臨床試驗分層，進而影響 alzheimer's 疾病 治療資格或監測決策；解讀影像報告時需確認使用的 tracer，避免將不同 tracer 結果直接互相比較。" }, { "id": "pmid-42217468", "kind": "article", "issueId": "2026-week22", "year": 2026, "week": 22, "weekLabel": "第 22 週", "dateRange": "2026/05/25 – 05/31", "href": "2026-week22.html", "title": "Cancer Diagnostic Delay Rates Associated With a Population-Based Screening Trial Evaluating a Cell-Free DNA Multicancer Early Detection Test", "journal": "JAMA", "type": "OA", "typeLabel": "Original Article", "author": "Mann", "doi": "10.1001/jama.2026.6803", "url": "https://doi.org/10.1001/jama.2026.6803", "summary": "藥師重點：MCED screening 試驗 參與地區短期內出現 modest diagnostic delay 增加，提醒導入大型篩檢或早期偵測計畫時需同步監測診斷量能；此結果不太可能實質影響該 MCED 試驗 主要結果解讀，但可作為系統層級風險管理依據。", "pubDate": "2026-05-30", "terms": [ "cancer", "diagnostic", "delay", "rates", "population-based", "screening", "evaluating", "cell-free", "multicancer", "early" ], "drugTerms": [], "searchText": "cancer diagnostic delay rates associated with a population-based screening trial evaluating a cell-free dna multicancer early detection test jama original article mann 10.1001/jama.2026.6803 研究背景：人口層級 screening 試驗 可能增加有限醫療資源需求，但許多試驗未評估 intervention rollout 對既有照護流程的 spillover effects。 研究方法：此 橫斷面研究 分析英格蘭 21 個 癌症 alliance regions，其中 8 個參與 nhs-galleri cell-free dna-based multicancer early detection (mced) screening 試驗。研究以 差異-in-differences event 研究 比較 試驗 start 前 6 個月至後 3 年的 diagnostic delay rates，主要聚焦 head and neck、lung 與 upper gastrointestinal cancers。 主要結果：共記錄 1,875,236 筆疑似 head and neck、lung 或 upper gastrointestinal cancers 轉診。試驗 開始後前 6 個月，參與地區 diagnostic delay rates 由 28.6% 增至 29.6%，未參與地區由 28.9% 降至 26.3%，校正 差異-in-differences estimate 為 3.4 百分點（95% ci 1.9-5.0；p<.001）；第二個 6 個月仍增加 4.8 百分點（95% ci 1.9-7.7；p=.003），其後不再具統計顯著。前 6 個月疑似癌症轉診率亦較高（23.8 per 100,000 族群；95% ci 0.9-46.8；p=.04）。 藥師重點：mced screening 試驗 參與地區短期內出現 modest diagnostic delay 增加，提醒導入大型篩檢或早期偵測計畫時需同步監測診斷量能；此結果不太可能實質影響該 mced 試驗 主要結果解讀，但可作為系統層級風險管理依據。" }, { "id": "pmid-42208562", "kind": "article", "issueId": "2026-week22", "year": 2026, "week": 22, "weekLabel": "第 22 週", "dateRange": "2026/05/25 – 05/31", "href": "2026-week22.html", "title": "Alzheimer's disease neuropathology plasma biomarkers and cognition in midlife: a community-based cohort study", "journal": "Lancet", "type": "OA", "typeLabel": "Original Article", "author": "Jiang", "doi": "10.1016/S0140-6736(26)00515-5", "url": "https://doi.org/10.1016/S0140-6736(26)00515-5", "summary": "藥師重點：中年 plasma biomarkers 可提供早期 Alzheimer's 疾病 風險分層訊號，但陽性比例低且為關聯性資料；臨床解讀時不宜作為單一診斷依據，仍需結合認知評估、影像或其他 biomarker。", "pubDate": "2026-05-30", "terms": [ "alzheimer", "neuropathology", "plasma", "biomarkers", "cognition", "midlife", "community-based", "lancet", "jiang", "s0140-6736" ], "drugTerms": [], "searchText": "alzheimer's disease neuropathology plasma biomarkers and cognition in midlife: a community-based cohort study lancet original article jiang 10.1016/s0140-6736(26)00515-5 研究背景：alzheimer's 疾病 neuropathology 以 aβ 與 p-tau 累積為特徵，過去多在老年臨床樣本評估；中年社區族群中 plasma biomarkers 與認知結果的關聯仍較少資料。 研究方法：此 community-based 世代研究 分析 cardia 研究 year 35（2020-22）具 plasma biomarkers 的參與者，排除無認知測量與 probable dementia 者後納入 1350 人。研究測量 aβ42、aβ40、p-tau217，計算 p-tau217/aβ42 與 aβ42/40，並依 amyloid pet-validated cutpoints 定義 alzheimer's 疾病 neuropathology status，評估其與認知 z scores 及 accelerated decline 的關聯。 主要結果：平均年齡 61 歲，女性 58%，black 45%、white 55%。alzheimer's 疾病 neuropathology positivity 依 p-tau217/aβ42 為 6%、aβ42/40 為 15%、p-tau217 為 4%；陽性狀態與較差 processing speed（standardised cognitive 差異 -0.54 至 -0.25；p values 0.0001-0.0048）及 executive function（-0.42 至 -0.19；p values 0.0070-0.049）相關，並與 verbal memory 與 processing speed accelerated decline odds 增加相關（例如 aβ42/40 verbal memory or 4.31，95% ci 1.71-10.9；p-tau217 processing speed or 3.98，95% ci 1.71-9.3）。 藥師重點：中年 plasma biomarkers 可提供早期 alzheimer's 疾病 風險分層訊號，但陽性比例低且為關聯性資料；臨床解讀時不宜作為單一診斷依據，仍需結合認知評估、影像或其他 biomarker。" }, { "id": "pmid-42202772", "kind": "article", "issueId": "2026-week22", "year": 2026, "week": 22, "weekLabel": "第 22 週", "dateRange": "2026/05/25 – 05/31", "href": "2026-week22.html", "title": "Adverse Pregnancy Outcomes and Sedentary Behavior, Light-Intensity Physical Activity, and Daily Steps", "journal": "JAMA", "type": "OA", "typeLabel": "Original Article", "author": "Barone Gibbs", "doi": "10.1001/jama.2026.6986", "url": "https://doi.org/10.1001/jama.2026.6986", "summary": "藥師重點：孕期衛教可鼓勵減少久坐、增加低強度活動與步數，作為生活型態風險降低策略；但此為觀察性研究，不能直接證明介入效果，若有妊娠併發症或活動限制仍需回到產科評估。", "pubDate": "2026-05-27", "terms": [ "adverse", "pregnancy", "sedentary", "behavior", "light-intensity", "physical", "activity", "daily", "steps", "jama" ], "drugTerms": [], "searchText": "adverse pregnancy outcomes and sedentary behavior, light-intensity physical activity, and daily steps jama original article barone gibbs 10.1001/jama.2026.6986 研究背景：中高強度身體活動已被建議用於降低不良妊娠結果風險，但久坐、light-intensity physical activity (lpa) 與 每日 steps 的關聯仍未明確。 研究方法：此 世代研究 於 2021-2025 年收錄 470 名妊娠未滿 13 週的孕婦志願者，使用大腿配戴 accelerometer 於各孕期量測 sedentary behavior (sed)、lpa 與 每日 steps。主要結果包含 hypertensive 疾患 of pregnancy、gestational diabetes、preterm birth 與 small for gestational age，並以 multivariable logistic regression 估計 absolute risks (ars) 與 rr。 主要結果：174 人（37.0%）發生不良妊娠結果，86 人（18.3%）有 hypertensive 疾患 of pregnancy。相較 low sed（ar 19.0%），high sed（ar 42.3%；rr 2.22，95% ci 1.12-4.43）與 very high sed（ar 41.6%；rr 2.19，95% ci 1.09-4.40）風險較高；very high lpa 相較 low lpa 風險較低（ar 21.1%；rr 0.52，95% ci 0.30-0.93），moderate 與 high 每日 steps 亦較 low steps 低。 藥師重點：孕期衛教可鼓勵減少久坐、增加低強度活動與步數，作為生活型態風險降低策略；但此為觀察性研究，不能直接證明介入效果，若有妊娠併發症或活動限制仍需回到產科評估。" }, { "id": "pmid-42207501", "kind": "article", "issueId": "2026-week22", "year": 2026, "week": 22, "weekLabel": "第 22 週", "dateRange": "2026/05/25 – 05/31", "href": "2026-week22.html", "title": "Adverse Effects and Treatment Discontinuation of Blood Pressure-Lowering Drugs and Combinations: A Network Meta-Analysis", "journal": "JAMA", "type": "MA", "typeLabel": "Meta-analysis", "author": "Wang", "doi": "10.1001/jama.2026.6214", "url": "https://doi.org/10.1001/jama.2026.6214", "summary": "藥師重點：不同降血壓藥類與組合的耐受性差異可作為換藥或合併治療討論依據，特別是咳嗽、水腫、頭暈與停藥風險；但結果來自短期 試驗-level network 統合分析，不宜直接外推到個別病人的長期治療。", "pubDate": "2026-06-23", "terms": [ "adverse", "discontinuation", "blood", "pressure-lowering", "drugs", "combinations", "network", "meta-analysis", "jama", "wang" ], "drugTerms": [], "searchText": "adverse effects and treatment discontinuation of blood pressure-lowering drugs and combinations: a network meta-analysis jama meta-analysis wang 10.1001/jama.2026.6214 研究背景：降血壓藥物不良反應會影響治療持續性與血壓控制，本研究比較 5 大類降壓藥與組合療法在短期臨床試驗中的停藥與常見不良反應。 研究方法：此 network 統合分析 納入自資料庫建立至 2024-12-31 的 雙盲 隨機臨床試驗s，評估 ace 抑制劑、arbs、β-blockers、ccbs、thiazide 或 thiazide-like diuretics 及其組合，追蹤 4-26 週。主要結果為因 不良事件 (aes) 停用隨機治療，並以 ors 與 95% 可信區間s (cris) 彙整。 主要結果：共納入 716 試驗、159,362 人，平均追蹤 8.6 週。相較 安慰劑，因 aes 停藥增加於 ccbs（or 1.43，95% cri 1.23-1.67；rd 1.2%）、ace 抑制劑 加上 ccbs（or 1.46，95% cri 1.13-1.87；rd 1.1%）與 β-blockers 加上 thiazide diuretics（or 1.58，95% cri 1.04-2.47；rd 1.7%）；arb monotherapy（or 0.73，95% cri 0.61-0.86）與 arbs 加上 ccbs（or 0.61，95% cri 0.47-0.79）停藥較 安慰劑 少。 藥師重點：不同降血壓藥類與組合的耐受性差異可作為換藥或合併治療討論依據，特別是咳嗽、水腫、頭暈與停藥風險；但結果來自短期 試驗-level network 統合分析，不宜直接外推到個別病人的長期治療。" }, { "id": "fda-2026-week22-1", "kind": "fda", "issueId": "2026-week22", "year": 2026, "week": 22, "weekLabel": "第 22 週", "dateRange": "2026/05/25 – 05/31", "href": "2026-week22.html", "title": "FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "concerns", "unapproved", "glp-1", "drugs", "used", "weight", "loss", "https", "drug-alerts-and-statements", "fdas-concerns-unapproved-glp-1-drugs-used-weight-loss" ], "drugTerms": [ "glp-1" ], "searchText": "fda’s concerns with unapproved glp-1 drugs used for weight loss fda drug safety 2026-06-15 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss" }, { "id": "fda-2026-week22-3", "kind": "fda", "issueId": "2026-week22", "year": 2026, "week": 22, "weekLabel": "第 22 週", "dateRange": "2026/05/25 – 05/31", "href": "2026-week22.html", "title": "FDA issues final decision to withdraw approval of Pepaxto (melphalan flufenamide)", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/node/398713", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "issues", "final", "decision", "withdraw", "approval", "pepaxto", "melphalan", "flufenamide", "https", "node" ], "drugTerms": [], "searchText": "fda issues final decision to withdraw approval of pepaxto (melphalan flufenamide) fda drug safety 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/node/398713" }, { "id": "fda-2026-week22-2", "kind": "fda", "issueId": "2026-week22", "year": 2026, "week": 22, "weekLabel": "第 22 週", "dateRange": "2026/05/25 – 05/31", "href": "2026-week22.html", "title": "FDA alerts patients, caregivers, and health care providers of cross-compatibility issues with autoinjector devices that are optional for use with glatiramer acetate injection", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/node/403159", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "alerts", "caregivers", "providers", "cross-compatibility", "issues", "autoinjector", "devices", "that", "optional", "glatiramer" ], "drugTerms": [], "searchText": "fda alerts patients, caregivers, and health care providers of cross-compatibility issues with autoinjector devices that are optional for use with glatiramer acetate injection fda drug safety 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/node/403159" }, { "id": "fda-2026-week22-4", "kind": "fda", "issueId": "2026-week22", "year": 2026, "week": 22, "weekLabel": "第 22 週", "dateRange": "2026/05/25 – 05/31", "href": "2026-week22.html", "title": "FDA Accepts First In Silico Drug Development Tool Under ISTAND Program to Help Predict Drug-Induced Liver Injury", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fda-accepts-first-silico-drug-development-tool-under-istand-program-help-predict-drug-induced-liver", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "accepts", "first", "silico", "development", "tool", "under", "istand", "program", "help", "predict" ], "drugTerms": [], "searchText": "fda accepts first in silico drug development tool under istand program to help predict drug-induced liver injury fda drug safety 2026-06-03 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/drugs/drug-alerts-and-statements/fda-accepts-first-silico-drug-development-tool-under-istand-program-help-predict-drug-induced-liver" }, { "id": "pmid-42167272", "kind": "article", "issueId": "2026-week21", "year": 2026, "week": 21, "weekLabel": "第 21 週", "dateRange": "2026/05/18 – 05/24", "href": "2026-week21.html", "title": "Updated trends in the global prevalence and burden of mental disorders, 1990-2023: a systematic analysis for the Global Burden of Disease Study 2023", "journal": "Lancet", "type": "SR", "typeLabel": "Systematic Review", "author": "N/A", "doi": "10.1016/S0140-6736(26)00519-2", "url": "https://doi.org/10.1016/S0140-6736(26)00519-2", "summary": "藥師重點：此研究凸顯精神疾病負擔持續增加且分布不均，對藥師的意義在於慢性用藥追蹤、可近性、轉介與族群照護規劃；其資料不應直接外推為個別精神科藥物療效比較。", "pubDate": "2026-05-23", "terms": [ "updated", "trends", "global", "prevalence", "burden", "mental", "disorders", "lancet", "s0140-6736", "anxiety" ], "drugTerms": [], "searchText": "updated trends in the global prevalence and burden of mental disorders, 1990-2023: a systematic analysis for the global burden of disease study 2023 lancet systematic review 10.1016/s0140-6736(26)00519-2 研究背景：gbd 2023 估計 375 種疾病與傷害的盛行率、發生率與健康負擔，其中包含 12 類 mental 疾患；本研究評估 1990-2023 年不同性別、年齡、地區與 sdi 分層的趨勢。 研究方法：研究納入 anxiety 疾患、重大 depressive 疾患、dysthymia、bipolar 疾患、schizophrenia、autism spectrum 疾患、conduct 疾患、adhd、anorexia nervosa、bulimia nervosa、idiopathic developmental intellectual disability 與 other mental 疾患。作者以文獻資料與 bayesian meta-regression 估計 prevalence，並以 disability weights 計算 ylds；anorexia nervosa 另估計 deaths、ylls 與 dalys。 主要結果：2023 年全球 mental 疾患 prevalent cases 估計為 1.17 billion（95% uncertainty 區間 1.06-1.31），age-standardised prevalence 比率 為 14210.7 per 100000 族群，較 1990 年 prevalent cases 增加 95.5%（75.0-121.2），age-standardised prevalence 比率 增加 24.2%（11.4-41.4）。2023 年 mental 疾患 造成 171 百萬（127-228）dalys，占全因 dalys 的 6.1%（4.8-7.6），並為全球 ylds 第一大原因（17.3%）。 藥師重點：此研究凸顯精神疾病負擔持續增加且分布不均，對藥師的意義在於慢性用藥追蹤、可近性、轉介與族群照護規劃；其資料不應直接外推為個別精神科藥物療效比較。" }, { "id": "pmid-42150581", "kind": "article", "issueId": "2026-week21", "year": 2026, "week": 21, "weekLabel": "第 21 週", "dateRange": "2026/05/18 – 05/24", "href": "2026-week21.html", "title": "Safety and efficacy of astegolimab for COPD with frequent exacerbations regardless of baseline blood eosinophil counts (ALIENTO and ARNASA): randomised, double-blind, placebo-controlled, phase 2b and 3 trials", "journal": "Lancet", "type": "RCT", "typeLabel": "RCT", "author": "Papi", "doi": "10.1016/S0140-6736(26)00637-9", "url": "https://doi.org/10.1016/S0140-6736(26)00637-9", "summary": "藥師重點：研究結果支持 ST2/IL-33 pathway 可能成為頻繁急性惡化 COPD 的治療標的，但兩個試驗與給藥間隔的結果不完全一致；若未來進入臨床使用，藥師需特別確認適用族群、與吸入維持治療併用情境及感染或呼吸道不良事件監測。", "pubDate": "2026-05-23", "terms": [ "efficacy", "astegolimab", "copd", "frequent", "exacerbations", "regardless", "baseline", "blood", "eosinophil", "counts" ], "drugTerms": [ "astegolimab", "anti-st2" ], "searchText": "safety and efficacy of astegolimab for copd with frequent exacerbations regardless of baseline blood eosinophil counts (aliento and arnasa): randomised, double-blind, placebo-controlled, phase 2b and 3 trials lancet rct papi 10.1016/s0140-6736(26)00637-9 研究背景：il-33/st2 pathway 與 copd 急性惡化時的 neutrophilic 與 eosinophilic inflammation 有關；astegolimab 為 anti-st2 human igg2 monoclonal 抗體，本研究評估其用於頻繁急性惡化 copd 患者的療效與安全性。 研究方法：aliento 為 第 2b 期、arnasa 為 第 3 期，皆為隨機、雙盲、安慰劑對照試驗，納入目前或曾吸菸且有頻繁急性惡化病史的 copd 患者，不依 基準值 blood eosinophils 分層排除。受試者以 1:1:1 分配接受 subcutaneous astegolimab 476 mg 每 2 週、每 4 週 或 安慰劑，並持續使用最佳化吸入維持治療 52 週，主要終點為中重度急性惡化年化發生率。 主要結果：aliento 納入 1301 人，arnasa 納入 1375 人；相較 安慰劑，aliento 中 astegolimab 每 2 週 的 校正 比率 比值 為 0.85（95% ci 0.72-1.00；p=0.049），每 4 週 為 0.93（95% ci 0.79-1.10；p=0.38）。arnasa 中 每 2 週 為 0.85（95% ci 0.72-1.01；p=0.068），每 4 週 為 0.82（95% ci 0.70-0.98；p=0.024）；不良事件與死亡在各組大致平衡，兩試驗合計 3 例死亡（0.1%）被研究者認為與治療相關。 藥師重點：研究結果支持 st2/il-33 pathway 可能成為頻繁急性惡化 copd 的治療標的，但兩個試驗與給藥間隔的結果不完全一致；若未來進入臨床使用，藥師需特別確認適用族群、與吸入維持治療併用情境及感染或呼吸道不良事件監測。" }, { "id": "pmid-42150044", "kind": "article", "issueId": "2026-week21", "year": 2026, "week": 21, "weekLabel": "第 21 週", "dateRange": "2026/05/18 – 05/24", "href": "2026-week21.html", "title": "Prehospital Resuscitation with Type O Whole Blood for Trauma and Hemorrhage", "journal": "NEJM", "type": "RCT", "typeLabel": "RCT", "author": "Sperry", "doi": "10.1056/NEJMoa2602167", "url": "https://doi.org/10.1056/NEJMoa2602167", "summary": "藥師重點：結果未顯示到院前 Type O whole blood 較 blood components 降低 30 天死亡率；急救與大量輸血流程仍需依院內血品供應、輸血反應監測、凝血狀態與創傷團隊決策執行。", "pubDate": "2026-06-18", "terms": [ "prehospital", "resuscitation", "type", "whole", "blood", "trauma", "hemorrhage", "nejm", "sperry", "nejmoa2602167" ], "drugTerms": [], "searchText": "prehospital resuscitation with type o whole blood for trauma and hemorrhage nejm rct sperry 10.1056/nejmoa2602167 研究背景：創傷性出血與休克患者在到院前輸血可降低死亡風險，但 whole blood 是否優於血液成分輸注，以及血品儲存時間是否影響結果仍不確定。 研究方法：towar 為 實務型、多中心、第 3 期、cluster-隨機試驗，將 44 個 air medical bases 以 2:1 分配至到院前使用最多 2 units type o whole blood，或依臨床需要使用 blood components（plasma、red cells 或兩者）。主要終點為隨機分派後 30 天全因死亡，另以觀察性子研究評估 whole blood 儲存天數與預後關係。 主要結果：符合資格者 1020 人，其中 whole blood 組 715 人、component 組 305 人；主要分析分別納入 695 與 298 人。30 天死亡率 whole blood 組為 25.9%，component 組為 20.5%（校正 勝算比 1.24；95% ci 0.87-1.76；p=0.24），兩組不良事件無明顯差異；whole blood 儲存 15-21 天與 1-14 天的 30 天死亡率相近（校正 勝算比 0.99；95% ci 0.74-1.32）。 藥師重點：結果未顯示到院前 type o whole blood 較 blood components 降低 30 天死亡率；急救與大量輸血流程仍需依院內血品供應、輸血反應監測、凝血狀態與創傷團隊決策執行。" }, { "id": "pmid-42149993", "kind": "article", "issueId": "2026-week21", "year": 2026, "week": 21, "weekLabel": "第 21 週", "dateRange": "2026/05/18 – 05/24", "href": "2026-week21.html", "title": "Phase 3 Trials of Inhaled Treprostinil for Idiopathic Pulmonary Fibrosis", "journal": "NEJM", "type": "OA", "typeLabel": "Original Article", "author": "Nathan", "doi": "10.1056/NEJMoa2501488", "url": "https://doi.org/10.1056/NEJMoa2501488", "summary": "藥師重點：inhaled treprostinil 在 IPF 患者可減緩 FVC 下降並降低 臨床 worsening，但咳嗽與停藥比例需納入給藥衛教與追蹤；使用時也應確認吸入技巧、給藥頻次負擔、背景 antifibrotic 治療 與病人可耐受性。", "pubDate": "2026-05-18", "terms": [ "phase", "trials", "inhaled", "treprostinil", "idiopathic", "pulmonary", "fibrosis", "nejm", "nathan", "nejmoa2501488" ], "drugTerms": [], "searchText": "phase 3 trials of inhaled treprostinil for idiopathic pulmonary fibrosis nejm original article nathan 10.1056/nejmoa2501488 研究背景：inhaled treprostinil 用於 特發性肺纖維化（ipf）的兩項 第 3 期 隨機試驗，是基於其可能具 antifibrotic mechanism 的臨床與臨床前證據；本文報告 teton-1 與合併試驗資料。 研究方法：teton-1 為 雙盲 試驗，將 ipf 患者隨機分配至 inhaled treprostinil 或 安慰劑（12 breaths four times 每日）。主要終點為 week 52 forced vital capacity（fvc）變化；次要終點依序包括 臨床 worsening、急性 exacerbation of ipf、存活期、percentage of predicted fvc、quality of life 與 diffusion capacity of the lungs for carbon monoxide。 主要結果：598 人接受至少一劑 treprostinil（n=299）或 安慰劑（n=299），其中 434 人完成 week 52 評估；77.6% 併用 background antifibrotic 治療。week 52 fvc 中位數 change 為 -43.3 ml vs -196.2 ml（差異 130.1 ml；95% ci 82.2-178.1；p<0.001）；臨床 worsening 為 31.8% vs 44.5%（風險比 0.67；95% ci 0.52-0.88；p=0.003）。最常見不良事件為 cough（54.8% vs 33.1%），停藥率為 40.5% vs 32.8%。 藥師重點：inhaled treprostinil 在 ipf 患者可減緩 fvc 下降並降低 臨床 worsening，但咳嗽與停藥比例需納入給藥衛教與追蹤；使用時也應確認吸入技巧、給藥頻次負擔、背景 antifibrotic 治療 與病人可耐受性。" }, { "id": "pmid-42155503", "kind": "article", "issueId": "2026-week21", "year": 2026, "week": 21, "weekLabel": "第 21 週", "dateRange": "2026/05/18 – 05/24", "href": "2026-week21.html", "title": "Johns Hopkins Center for Humanitarian Health-Lancet Commission on health, conflict, and forced displacement: health in a world of crises and impunity", "journal": "Lancet", "type": "OA", "typeLabel": "Original Article", "author": "Spiegel", "doi": "10.1016/S0140-6736(26)00564-7", "url": "https://doi.org/10.1016/S0140-6736(26)00564-7", "summary": "藥師重點：此篇目前只能確認主題與文章類型，不能外推為具體藥品可近性、疫苗或慢性病照護建議；若要用於院內藥訊，建議人工讀全文後再補上可執行的藥事照護重點。", "pubDate": "2026-05-23", "terms": [ "johns", "hopkins", "center", "humanitarian", "health-lancet", "commission", "conflict", "forced", "displacement", "world" ], "drugTerms": [], "searchText": "johns hopkins center for humanitarian health-lancet commission on health, conflict, and forced displacement: health in a world of crises and impunity lancet original article spiegel 10.1016/s0140-6736(26)00564-7 研究背景：此文題名指向 健康、conflict 與 forced displacement 的 lancet commission 報告，但 pubmed abstract 僅註明可於 supplementary materials 查看 french、spanish 與 arabic 版本。 研究方法：摘要未提供研究方法、資料來源、委員會流程或分析架構，無法僅依摘要判斷其證據整理方式。 主要結果：摘要未提供主要結果、數據或政策建議內容，需回到全文或 supplementary materials 才能確認重點。 藥師重點：此篇目前只能確認主題與文章類型，不能外推為具體藥品可近性、疫苗或慢性病照護建議；若要用於院內藥訊，建議人工讀全文後再補上可執行的藥事照護重點。" }, { "id": "pmid-42149700", "kind": "article", "issueId": "2026-week21", "year": 2026, "week": 21, "weekLabel": "第 21 週", "dateRange": "2026/05/18 – 05/24", "href": "2026-week21.html", "title": "Cryobiopsy vs Forceps for Bronchoscopic Lung Biopsy: The FROSTBITE-2 Randomized Clinical Trial", "journal": "JAMA", "type": "RCT", "typeLabel": "RCT", "author": "Thiboutot", "doi": "10.1001/jama.2026.7908", "url": "https://doi.org/10.1001/jama.2026.7908", "summary": "藥師重點：此研究與用藥療效無直接關聯，但會影響肺部疾病診斷品質與後續治療決策；藥師參與跨團隊討論時，可留意病人抗凝血或抗血小板用藥、切片後出血風險與檢體診斷成功率對用藥選擇的影響。", "pubDate": "2026-06-16", "terms": [ "cryobiopsy", "forceps", "bronchoscopic", "lung", "biopsy", "frostbite-2", "jama", "thiboutot", "crush", "artifact" ], "drugTerms": [], "searchText": "cryobiopsy vs forceps for bronchoscopic lung biopsy: the frostbite-2 randomized clinical trial jama rct thiboutot 10.1001/jama.2026.7908 研究背景：傳統 bronchoscopic biopsy 多使用 forceps，但檢體可能較小且受 crush artifact 影響；1.1-mm cryoprobe 可取得較大且較完整的經支氣管切片檢體。 研究方法：frostbite-2 為開放標示、結果評估者遮蔽、多中心隨機臨床試驗，於美國 9 個醫學中心納入 500 名 18 歲以上、因肺結節或腫塊、肺移植或 diffuse parenchymal lung 疾病 預定接受 transbronchial biopsy 的患者。受試者以 1:1 分配至 1.1-mm cryoprobe（n=250）或 2.0-mm forceps（n=250），主要終點為組織學檢體可產生特定診斷的 diagnostic yield。 主要結果：主要分析納入 490 人；cryoprobe 組 diagnostic yield 高於 forceps 組（217/245 [88.6%] vs 193/245 [78.8%]；absolute 差異 9.8%；95% ci 3.3%-16.3%；p=.003）。肺結節或腫塊與肺移植族群亦較高，但 diffuse parenchymal lung 疾病 未達顯著差異；forceps 組有 4 例需 chest tube 的 pneumothorax（1.6%），cryoprobe 組無此事件，兩組皆無 significant 出血 或 respiratory failure。 藥師重點：此研究與用藥療效無直接關聯，但會影響肺部疾病診斷品質與後續治療決策；藥師參與跨團隊討論時，可留意病人抗凝血或抗血小板用藥、切片後出血風險與檢體診斷成功率對用藥選擇的影響。" }, { "id": "pmid-42167298", "kind": "article", "issueId": "2026-week21", "year": 2026, "week": 21, "weekLabel": "第 21 週", "dateRange": "2026/05/18 – 05/24", "href": "2026-week21.html", "title": "Coronary microvascular dysfunction and cardiovascular outcomes (Multicenter FLOW-CMD Registry): a prospective, multicentre cohort study in South Korea", "journal": "Lancet", "type": "OA", "typeLabel": "Original Article", "author": "Lee", "doi": "10.1016/S0140-6736(26)00666-5", "url": "https://doi.org/10.1016/S0140-6736(26)00666-5", "summary": "藥師重點：冠狀動脈 microvascular 功能障礙 與較高心血管事件風險相關，可提醒藥師在疑似缺血性心臟病患者中重視整體風險控制；實務上仍需依原文族群與診斷條件，配合血壓、血脂、抗血小板或抗缺血用藥的個別化評估。", "pubDate": "2026-06-06", "terms": [ "coronary", "microvascular", "dysfunction", "cardiovascular", "multicenter", "flow-cmd", "registry", "prospective", "multicentre", "south" ], "drugTerms": [], "searchText": "coronary microvascular dysfunction and cardiovascular outcomes (multicenter flow-cmd registry): a prospective, multicentre cohort study in south korea lancet original article lee 10.1016/s0140-6736(26)00666-5 研究背景：冠狀動脈 microvascular 功能障礙 常與 epicardial 冠狀動脈 動脈 疾病 共存，但在接受 invasive 冠狀動脈 angiography 患者中的盛行率與預後資料仍有限。 研究方法：多中心 flow-cmd registry 為南韓 7 家 tertiary hospitals 的前瞻性多中心 世代研究，納入 18 歲以上、因臨床需要接受 invasive 冠狀動脈 angiography 的連續患者，並以 冠狀動脈 physiological assessment 系統性評估。obstructive epicardial 冠狀動脈 動脈 疾病 依 stenosis 與 fractional flow reserve 定義；冠狀動脈 microvascular 功能障礙 定義為 冠狀動脈 flow reserve below 2.0 且 index of microcirculatory resistance ≥25，主要終點為 all-cause 死亡、myocardial infarction、clinically driven repeat revascularisation 或 hospitalisation for 心衰竭 的 複合。 主要結果：5764 人接受篩選，1003 人納入；冠狀動脈 microvascular 功能障礙 見於 obstructive epicardial 冠狀動脈 動脈 疾病 患者 123/573（21.5%），以及無 obstructive epicardial 冠狀動脈 動脈 疾病 患者 40/430（9.3%）。中位追蹤 1.9 年，主要終點在 microvascular 功能障礙 組 26 人發生（2-year kaplan-meier estimate 18.8%），preserved microvascular function 組 70 人發生（10.5%）；風險比 1.91（95% ci 1.22-2.99；p=0.0047）。 藥師重點：冠狀動脈 microvascular 功能障礙 與較高心血管事件風險相關，可提醒藥師在疑似缺血性心臟病患者中重視整體風險控制；實務上仍需依原文族群與診斷條件，配合血壓、血脂、抗血小板或抗缺血用藥的個別化評估。" }, { "id": "pmid-42156120", "kind": "article", "issueId": "2026-week21", "year": 2026, "week": 21, "weekLabel": "第 21 週", "dateRange": "2026/05/18 – 05/24", "href": "2026-week21.html", "title": "Concordance between target trial emulation and randomised controlled trials: systematic review and meta-analysis", "journal": "BMJ", "type": "MA", "typeLabel": "Meta-analysis", "author": "Wang", "doi": "10.1136/bmj-2025-086810", "url": "https://doi.org/10.1136/bmj-2025-086810", "summary": "藥師重點：target 試驗 emulation 可補足部分 RCT 不足，但目前整體僅達中等一致性；以此類證據支持用藥決策時，需回頭檢視族群定義、暴露與 結果指標 模擬品質、基礎風險平衡及資料來源限制。", "pubDate": "2026-05-19", "terms": [ "concordance", "between", "target", "emulation", "randomised", "trials", "meta-analysis", "wang", "bmj-2025-086810", "medline" ], "drugTerms": [], "searchText": "concordance between target trial emulation and randomised controlled trials: systematic review and meta-analysis bmj meta-analysis wang 10.1136/bmj-2025-086810 研究背景：target 試驗 emulation 常用於以觀察性資料模擬隨機試驗問題，但其結果與對應 rct 的一致性，以及哪些設計因素會影響成功程度仍需釐清。 研究方法：此 系統性回顧與統合分析 搜尋 medline、embase、scopus、psycinfo 與 web of science（2010-2025），納入明確模擬健康介入 rct 的觀察性研究。研究以 21 項預先定義的 emulation design features 評估 paired target 試驗 emulation 與 benchmarking rct 的一致性，包括 pearson correlation coefficients、standardised 差異 agreement 與 比值 of ratios。 主要結果：共納入 107 組 target 試驗 emulation-rct pairs，pearson correlation coefficient 為 0.59（95% ci 0.45-0.70），standardised 差異 agreement 為 79%（85/107），summary 比值 of ratios 為 0.96（95% ci 0.92-1.01；i2=36%）。在 63 組較接近原試驗設計的 emulations 中，一致性較高（pearson correlation coefficient 0.83；95% ci 0.73-0.89）；claims 資料、基準值 族群 characteristics 不平衡與 結果指標 emulation quality 較低者，一致性較差。 藥師重點：target 試驗 emulation 可補足部分 rct 不足，但目前整體僅達中等一致性；以此類證據支持用藥決策時，需回頭檢視族群定義、暴露與 結果指標 模擬品質、基礎風險平衡及資料來源限制。" }, { "id": "pmid-42161415", "kind": "article", "issueId": "2026-week21", "year": 2026, "week": 21, "weekLabel": "第 21 週", "dateRange": "2026/05/18 – 05/24", "href": "2026-week21.html", "title": "Calcium, vitamin D, or combined supplementation to prevent fractures and falls: systematic review and meta-analysis", "journal": "BMJ", "type": "MA", "typeLabel": "Meta-analysis", "author": "Massé", "doi": "10.1136/bmj-2025-088050", "url": "https://doi.org/10.1136/bmj-2025-088050", "summary": "藥師重點：結果不支持將 calcium 或 vitamin D 補充視為一般成人預防骨折與跌倒的主要策略；建議仍需依飲食攝取、缺乏風險、腎功能、結石或高血鈣風險，以及是否需 osteoporosis 藥物治療個別評估。", "pubDate": "2026-05-20", "terms": [ "calcium", "vitamin", "combined", "supplementation", "prevent", "fractures", "falls", "meta-analysis", "mass", "bmj-2025-088050" ], "drugTerms": [], "searchText": "calcium, vitamin d, or combined supplementation to prevent fractures and falls: systematic review and meta-analysis bmj meta-analysis massé 10.1136/bmj-2025-088050 研究背景：calcium、vitamin d 或兩者合併常用於預防骨折與跌倒，但對未接受 osteoporosis 藥物治療成人的實際效益仍有爭議。 研究方法：此 系統性回顧與統合分析 納入 rct，比較 calcium、vitamin d 或合併補充與 安慰劑 或未治療；受試者為 ≥18 歲且未接受 osteoporosis 藥物治療的成人。主要終點為 any fracture，次要終點包括 hip fracture、non-vertebral fracture、vertebral fracture、falling 及總跌倒次數，並以 等級 評估證據確定性。 主要結果：共納入 69 試驗、153902 人，多數為 community dwelling（87%）且非骨折或跌倒高風險（73%）。對 any fracture，calcium 的 風險比 為 0.91（95% ci 0.81-1.01；moderate certainty），vitamin d 為 1.00（95% ci 0.95-1.06；high certainty），合併補充為 0.91（95% ci 0.84-0.99；high certainty）；其他骨折與跌倒結果大多顯示 little to no effect，高風險或住宿照護族群證據有限。 藥師重點：結果不支持將 calcium 或 vitamin d 補充視為一般成人預防骨折與跌倒的主要策略；建議仍需依飲食攝取、缺乏風險、腎功能、結石或高血鈣風險，以及是否需 osteoporosis 藥物治療個別評估。" }, { "id": "pmid-42167774", "kind": "article", "issueId": "2026-week21", "year": 2026, "week": 21, "weekLabel": "第 21 週", "dateRange": "2026/05/18 – 05/24", "href": "2026-week21.html", "title": "CRT-Estimands Framework: consensus based extension of the ICH E9(R1) addendum for cluster randomised trials", "journal": "BMJ", "type": "OA", "typeLabel": "Original Article", "author": "Kahan", "doi": "10.1136/bmj-2025-089050", "url": "https://doi.org/10.1136/bmj-2025-089050", "summary": "藥師重點：此文不是個別藥物療效研究，但可協助藥師閱讀 cluster 試驗 時確認 estimand 是否對應臨床問題；在解讀用藥、照護流程或政策介入研究時，應留意隨機化單位、干預層級與 intercurrent 事件 的處理方式。", "pubDate": "2026-05-21", "terms": [ "crt-estimands", "framework", "consensus", "extension", "addendum", "cluster", "randomised", "trials", "kahan", "bmj-2025-089050" ], "drugTerms": [], "searchText": "crt-estimands framework: consensus based extension of the ich e9(r1) addendum for cluster randomised trials bmj original article kahan 10.1136/bmj-2025-089050 研究背景：ich e9(r1) addendum 提供 estimands 架構以明確定義臨床試驗欲估計的治療效果，但原架構主要聚焦 individually 隨機試驗s；群集隨機試驗s 因隨機化單位為群體，需更清楚描述研究問題與估計目標。 研究方法：本文為 consensus based methodological article，發展 crt-estimands framework 作為 ich e9(r1) addendum 在 群集隨機試驗s 的延伸。文章以屬性、解釋與範例說明如何定義 cluster 試驗 的 estimands，目標是提升研究問題與試驗結果解讀的一致性。 主要結果：crt-estimands framework 要求研究者在 群集隨機試驗s 中清楚描述估計目標相關屬性，包含群體與個人層級的介入、intercurrent 事件、結果指標、族群 與 治療 effect 描述。採用此架構可使 clinicians、patients 與 policy makers 更容易判斷試驗結果是否符合其決策問題。 藥師重點：此文不是個別藥物療效研究，但可協助藥師閱讀 cluster 試驗 時確認 estimand 是否對應臨床問題；在解讀用藥、照護流程或政策介入研究時，應留意隨機化單位、干預層級與 intercurrent 事件 的處理方式。" }, { "id": "pmid-42149992", "kind": "article", "issueId": "2026-week21", "year": 2026, "week": 21, "weekLabel": "第 21 週", "dateRange": "2026/05/18 – 05/24", "href": "2026-week21.html", "title": "Azithromycin for Preschoolers with Wheezing in the Emergency Department", "journal": "NEJM", "type": "OA", "typeLabel": "Original Article", "author": "Denninghoff", "doi": "10.1056/NEJMoa2516505", "url": "https://doi.org/10.1056/NEJMoa2516505", "summary": "藥師重點：結果不支持對急診中重度喘鳴的學齡前兒童常規使用 azithromycin 以降低症狀嚴重度；藥師應協助抗生素 stewardship，確認是否有明確細菌感染證據，並留意 macrolide 不良反應與抗藥性風險。", "pubDate": "2026-05-18", "terms": [ "azithromycin", "preschoolers", "wheezing", "emergency", "department", "nejm", "denninghoff", "nejmoa2516505", "illnesses", "recurrent" ], "drugTerms": [ "azithromycin" ], "searchText": "azithromycin for preschoolers with wheezing in the emergency department nejm original article denninghoff 10.1056/nejmoa2516505 研究背景：學齡前兒童 wheezing illnesses 是住院常見原因，臨床上常使用抗生素；既有觀察性研究發現 recurrent wheezing 兒童鼻咽檢體較常分離出 streptococcus pneumoniae、moraxella catarrhalis 與 haemophilus influenzae。 研究方法：此多中心試驗納入 18-59 個月、因 moderate-to-重度 急性 wheezing 至急診就醫的兒童，隨機接受 azithromycin 12 mg/kg 每日一次 或 安慰劑，共 5 天。主要終點為 5 天 asthma flare-up diary for young children（adyc）總分，並分別於 pathogenic bacteria 陽性 世代 與 negative 世代 評估；次要終點包括急診停留時間、住院時間，以及 72 小時內再急診或住院。 主要結果：840 名兒童隨機分派，其中 521 人 pathogenic bacteria 陽性；試驗在期中分析後因 futility 停止。adyc score 在 陽性 世代 中 azithromycin 與 安慰劑 無顯著差異（中位數 9.59 vs 9.72；p=0.70），negative 世代 亦無差異（中位數 9.30 vs 9.10；p=0.69）；陽性 世代 中 bacterial clearance 為 58.7% vs 11.4%，但次要臨床結果、bacterial resistance 發展與 不良事件 大致相似。 藥師重點：結果不支持對急診中重度喘鳴的學齡前兒童常規使用 azithromycin 以降低症狀嚴重度；藥師應協助抗生素 stewardship，確認是否有明確細菌感染證據，並留意 macrolide 不良反應與抗藥性風險。" }, { "id": "pmid-42150112", "kind": "article", "issueId": "2026-week21", "year": 2026, "week": 21, "weekLabel": "第 21 週", "dateRange": "2026/05/18 – 05/24", "href": "2026-week21.html", "title": "4% Tetrasodium EDTA to Prevent Central Venous Access Device-Associated Complications: A Randomized Clinical Trial", "journal": "JAMA", "type": "RCT", "typeLabel": "RCT", "author": "Ornowska", "doi": "10.1001/jama.2026.6025", "url": "https://doi.org/10.1001/jama.2026.6025", "summary": "藥師重點：4% t-EDTA lock 可降低 ICU 成人 CVAD 相關複合事件，主要訊號來自減少需 alteplase 的阻塞；導入前需確認院內 lock solution 濃度、管路相容性、透析管路例外流程與調製給藥安全。", "pubDate": "2026-06-23", "terms": [ "tetrasodium", "edta", "prevent", "central", "venous", "access", "device-associated", "complications", "jama", "ornowska" ], "drugTerms": [], "searchText": "4% tetrasodium edta to prevent central venous access device-associated complications: a randomized clinical trial jama rct ornowska 10.1001/jama.2026.6025 研究背景：cvad 可能造成 catheter-associated bloodstream infection、catheter 阻塞 與 catheter-related venous thrombosis；4% tetrasodium edta 具抗凝血、抗菌與抗 biofilm 特性，可作為未使用管腔的 locking fluid。 研究方法：此 實務型、triple-blind、多中心、cluster-隨機 crossover 試驗 於加拿大 6 家醫院 icu 進行，納入 18 歲以上、已有 cvad 且至少 1 個 lumen 未使用的患者。icu 在 3.5 個月期間使用 2.5 ml 4% t-edta 或 control locking fluid（saline 或 hemodialysis lines 使用 4% citrate），之後 crossover；主要終點為 cvad-associated bloodstream infection、需 alteplase 的 catheter 阻塞，或因 阻塞 移除 catheter 的 複合 incidence 比率。 主要結果：分析納入 1468 人，t-edta 組 696 人、control 組 772 人。主要複合終點發生率為 13.1 vs 19.9 per 1000 catheter-天（74 vs 126 事件），校正 比率 比值 0.68（95% ci 0.47-0.96；p=.03）；個別組成中，僅需 alteplase 的 cvad 阻塞 明顯較低（66 vs 112 事件；比率 比值 0.66；95% ci 0.46-0.96）。 藥師重點：4% t-edta lock 可降低 icu 成人 cvad 相關複合事件，主要訊號來自減少需 alteplase 的阻塞；導入前需確認院內 lock solution 濃度、管路相容性、透析管路例外流程與調製給藥安全。" }, { "id": "fda-2026-week21-1", "kind": "fda", "issueId": "2026-week21", "year": 2026, "week": 21, "weekLabel": "第 21 週", "dateRange": "2026/05/18 – 05/24", "href": "2026-week21.html", "title": "FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss", "summary": "FDA 提醒未經核准的 GLP-1 減重產品可能涉及成分、品質、劑量與安全性風險。藥師應確認病人取得的是 FDA 核准產品，避免使用來源不明或複方調製的 semaglutide/tirzepatide 類產品，並加強低血糖、胃腸道不良反應與劑量錯誤衛教。", "terms": [ "concerns", "unapproved", "glp-1", "drugs", "used", "weight", "loss", "semaglutide", "tirzepatide", "https" ], "drugTerms": [ "glp-1", "semaglutide", "tirzepatide" ], "searchText": "fda’s concerns with unapproved glp-1 drugs used for weight loss fda drug safety 2026-06-15 fda 提醒未經核准的 glp-1 減重產品可能涉及成分、品質、劑量與安全性風險。藥師應確認病人取得的是 fda 核准產品，避免使用來源不明或複方調製的 semaglutide/tirzepatide 類產品，並加強低血糖、胃腸道不良反應與劑量錯誤衛教。 https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss" }, { "id": "fda-2026-week21-3", "kind": "fda", "issueId": "2026-week21", "year": 2026, "week": 21, "weekLabel": "第 21 週", "dateRange": "2026/05/18 – 05/24", "href": "2026-week21.html", "title": "FDA issues final decision to withdraw approval of Pepaxto (melphalan flufenamide)", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/node/398713", "summary": "FDA 已作成撤回 Pepaxto (melphalan flufenamide) 核准的最終決定。藥師應確認院內與病人用藥清單是否仍有相關品項，避免新開立或續用，並協助腫瘤團隊轉換替代治療。", "terms": [ "issues", "final", "decision", "withdraw", "approval", "pepaxto", "melphalan", "flufenamide", "https", "node" ], "drugTerms": [], "searchText": "fda issues final decision to withdraw approval of pepaxto (melphalan flufenamide) fda drug safety fda 已作成撤回 pepaxto (melphalan flufenamide) 核准的最終決定。藥師應確認院內與病人用藥清單是否仍有相關品項，避免新開立或續用，並協助腫瘤團隊轉換替代治療。 https://www.fda.gov/node/398713" }, { "id": "fda-2026-week21-2", "kind": "fda", "issueId": "2026-week21", "year": 2026, "week": 21, "weekLabel": "第 21 週", "dateRange": "2026/05/18 – 05/24", "href": "2026-week21.html", "title": "FDA alerts patients, caregivers, and health care providers of cross-compatibility issues with autoinjector devices that are optional for use with glatiramer acetate injection", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/node/403159", "summary": "FDA 提醒 glatiramer acetate injection 的選配 autoinjector device 可能有交叉相容性問題。藥師調劑或衛教時應確認藥品廠牌、注射器與 autoinjector 是否相容，避免病人沿用不適配裝置造成注射失敗或劑量問題。", "terms": [ "alerts", "caregivers", "providers", "cross-compatibility", "issues", "autoinjector", "devices", "that", "optional", "glatiramer" ], "drugTerms": [], "searchText": "fda alerts patients, caregivers, and health care providers of cross-compatibility issues with autoinjector devices that are optional for use with glatiramer acetate injection fda drug safety fda 提醒 glatiramer acetate injection 的選配 autoinjector device 可能有交叉相容性問題。藥師調劑或衛教時應確認藥品廠牌、注射器與 autoinjector 是否相容，避免病人沿用不適配裝置造成注射失敗或劑量問題。 https://www.fda.gov/node/403159" }, { "id": "fda-2026-week21-4", "kind": "fda", "issueId": "2026-week21", "year": 2026, "week": 21, "weekLabel": "第 21 週", "dateRange": "2026/05/18 – 05/24", "href": "2026-week21.html", "title": "FDA Accepts First In Silico Drug Development Tool Under ISTAND Program to Help Predict Drug-Induced Liver Injury", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fda-accepts-first-silico-drug-development-tool-under-istand-program-help-predict-drug-induced-liver", "summary": "FDA 接受第一個 ISTAND program 下的 in silico drug development tool，用於協助預測 drug-induced liver injury。此為藥物研發與安全評估工具訊息，藥師可關注 DILI 風險預測方法進展，但臨床用藥仍需依仿單、肝功能監測與病人風險因子判讀。", "terms": [ "accepts", "first", "silico", "development", "tool", "under", "istand", "program", "help", "predict" ], "drugTerms": [], "searchText": "fda accepts first in silico drug development tool under istand program to help predict drug-induced liver injury fda drug safety 2026-06-03 fda 接受第一個 istand program 下的 in silico drug development tool，用於協助預測 drug-induced liver injury。此為藥物研發與安全評估工具訊息，藥師可關注 dili 風險預測方法進展，但臨床用藥仍需依仿單、肝功能監測與病人風險因子判讀。 https://www.fda.gov/drugs/drug-alerts-and-statements/fda-accepts-first-silico-drug-development-tool-under-istand-program-help-predict-drug-induced-liver" }, { "id": "pmid-42119587", "kind": "article", "issueId": "2026-week20", "year": 2026, "week": 20, "weekLabel": "第 20 週", "dateRange": "2026/05/11 – 05/17", "href": "2026-week20.html", "title": "Tirzepatide for maintenance of bodyweight reduction in people with obesity in the USA (SURMOUNT-MAINTAIN): a multicentre, double-blind, randomised, placebo-controlled trial", "journal": "Lancet", "type": "RCT", "typeLabel": "RCT", "author": "Horn", "doi": "10.1016/S0140-6736(26)00656-2", "url": "https://doi.org/10.1016/S0140-6736(26)00656-2", "summary": "藥師重點：tirzepatide 停用後體重回升明顯，持續 MTD 維持效果最佳，降至 5 mg 可能作為不中斷治療的替代策略；藥師需追蹤胃腸道耐受性、劑量調整、復胖幅度與病人長期治療期待。", "pubDate": "2026-06-06", "terms": [ "tirzepatide", "maintenance", "bodyweight", "reduction", "people", "obesity", "surmount-maintain", "multicentre", "double-blind", "randomised" ], "drugTerms": [ "tirzepatide" ], "searchText": "tirzepatide for maintenance of bodyweight reduction in people with obesity in the usa (surmount-maintain): a multicentre, double-blind, randomised, placebo-controlled trial lancet rct horn 10.1016/s0140-6736(26)00656-2 研究背景：肥胖治療後體重維持對長期健康與生活品質重要，但停用藥物後常有復胖；surmount-maintain 評估 tirzepatide mtd 持續治療、降至 5 mg 或改 安慰劑 對體重維持的影響。 研究方法：此 第 3 期b 安慰劑對照 試驗 共 112 週，包含 60 週 開放標籤 weight-loss period 與 52 週 雙盲 maintenance period，於美國 20 個中心進行。完成 once 每週 subcutaneous tirzepatide mtd（10 mg 或 15 mg）初始減重後，bmi ≥30 kg/m2 或 bmi ≥27 kg/m2 且有體重相關共病的成人，3:3:2 隨機分派至持續 mtd、降至 tirzepatide 5 mg 或 安慰劑；主要終點為 基準值 至 week 112 的 bodyweight percentage change。 主要結果：441 人進入初始期，378 人於 week 60 隨機分派；week 112 相對 基準值 體重變化為 mtd -21.9%（95% ci -23.5 to -20.3）、tirzepatide 5 mg -16.6%（95% ci -18.0 to -15.1）、安慰劑 -9.9%（95% ci -11.1 to -8.8），與 安慰劑 比較皆 p<0.0001。因復胖超過 50% 而接受 rescue 治療 者為 8%、25%、67%；tirzepatide 最常見 不良事件 為多屬輕中度且多發生於劑量調整期的 gastrointestinal 事件。 藥師重點：tirzepatide 停用後體重回升明顯，持續 mtd 維持效果最佳，降至 5 mg 可能作為不中斷治療的替代策略；藥師需追蹤胃腸道耐受性、劑量調整、復胖幅度與病人長期治療期待。" }, { "id": "pmid-42114550", "kind": "article", "issueId": "2026-week20", "year": 2026, "week": 20, "weekLabel": "第 20 週", "dateRange": "2026/05/11 – 05/17", "href": "2026-week20.html", "title": "Ticagrelor with aspirin dual antiplatelet therapy combined with intravenous thrombolysis in patients with ischaemic stroke in China (TAPIS): a multicentre, double-blind, randomised controlled trial", "journal": "Lancet", "type": "RCT", "typeLabel": "RCT", "author": "Wang", "doi": "10.1016/S0140-6736(26)00757-9", "url": "https://doi.org/10.1016/S0140-6736(26)00757-9", "summary": "藥師重點：中度缺血性中風 thrombolysis 後早期 DAPT 可能提升 90 天良好功能結果，但 有症狀 顱內出血 的 CI 較寬，不能排除小幅增加風險；藥師需協助確認溶栓時間、抗血小板起始時點與顱內出血監測。", "pubDate": "2026-05-16", "terms": [ "ticagrelor", "aspirin", "dual", "antiplatelet", "combined", "intravenous", "thrombolysis", "ischaemic", "stroke", "china" ], "drugTerms": [], "searchText": "ticagrelor with aspirin dual antiplatelet therapy combined with intravenous thrombolysis in patients with ischaemic stroke in china (tapis): a multicentre, double-blind, randomised controlled trial lancet rct wang 10.1016/s0140-6736(26)00757-9 研究背景：急性缺血性中風接受 intravenous thrombolysis 後，早期加入口服 dapt 的效益與出血風險仍未定論；tapis 評估發病 6 小時內 aspirin 加 ticagrelor 的輔助效果。 研究方法：tapis 為中國 60 家醫院進行的 隨機、雙盲、安慰劑對照 試驗，收錄接受 intravenous thrombolysis、nihss score 4-10 的缺血性中風患者。患者 1:1 接受 aspirin 加上 ticagrelor 或 安慰劑，於發病 6 小時內、thrombolysis 前中後皆可起始；ticagrelor 或 安慰劑 持續至 第 7 天，兩組 第 2 天-90 皆 開放標籤 aspirin，主要療效終點為 90 天 modified rankin scale score 0-1。 主要結果：1382 人隨機分派至 early dapt 690 人或 安慰劑 692 人。90 天 excellent functional 結果指標 為 68.7% vs 62.0%（風險比 1.11，95% ci 1.03-1.20；p=0.0089）；36 小時內 有症狀 顱內出血 為 0.9% vs 0.7%（風險比 1.20，95% ci 0.37-3.93；p=0.76）。 藥師重點：中度缺血性中風 thrombolysis 後早期 dapt 可能提升 90 天良好功能結果，但 有症狀 顱內出血 的 ci 較寬，不能排除小幅增加風險；藥師需協助確認溶栓時間、抗血小板起始時點與顱內出血監測。" }, { "id": "pmid-42127391", "kind": "article", "issueId": "2026-week20", "year": 2026, "week": 20, "weekLabel": "第 20 週", "dateRange": "2026/05/11 – 05/17", "href": "2026-week20.html", "title": "Telitacicept for IgA Nephropathy - Interim Analysis of a Phase 3 Trial", "journal": "NEJM", "type": "RCT", "typeLabel": "RCT", "author": "Lv", "doi": "10.1056/NEJMoa2514415", "url": "https://doi.org/10.1056/NEJMoa2514415", "summary": "藥師重點：telitacicept 在高進展風險 IgA nephropathy 可明顯降低蛋白尿，且期中資料未出現新的安全性訊號；用藥評估仍需追蹤感染風險、免疫相關不良反應與較長期 eGFR 結果。", "pubDate": "2026-05-14", "terms": [ "telitacicept", "nephropathy", "interim", "phase", "nejm", "nejmoa2514415", "baff", "april", "biopsy-proven", "proteinuria" ], "drugTerms": [], "searchText": "telitacicept for iga nephropathy - interim analysis of a phase 3 trial nejm rct lv 10.1056/nejmoa2514415 研究背景：iga nephropathy 的進展與 baff、april 相關，telitacicept 可同時中和 baff 與 april，可能降低持續蛋白尿與疾病進展風險。 研究方法：此研究為預先規劃期中分析的 多中心、雙盲、隨機、安慰劑對照 第 3 期試驗，收錄 biopsy-proven iga nephropathy 且在支持治療後仍有 proteinuria ≥1.0 g/day 的成人。患者 1:1 接受 telitacicept 240 mg subcutaneous once 每週 或 安慰劑，主要終點為 week 39 相對基線的 24-hour urinary protein-to-creatinine 比值 幾何平均比值，並評估安全性。 主要結果：共 318 人隨機分派，每組 159 人；week 39 的 24-hour urinary protein-to-creatinine 比值 變化為 telitacicept -58.9% vs 安慰劑 -8.8%，相對差異 -55.0%（95% ci -61.3 to -47.6；p<0.001）。egfr 相對基線變化為 -1.0% vs -7.7%；不良事件 較常見於 telitacicept（89.3% vs 78.6%），但 嚴重不良事件 較少（2.5% vs 8.2%），未見非預期安全性訊號。 藥師重點：telitacicept 在高進展風險 iga nephropathy 可明顯降低蛋白尿，且期中資料未出現新的安全性訊號；用藥評估仍需追蹤感染風險、免疫相關不良反應與較長期 egfr 結果。" }, { "id": "pmid-42134355", "kind": "article", "issueId": "2026-week20", "year": 2026, "week": 20, "weekLabel": "第 20 週", "dateRange": "2026/05/11 – 05/17", "href": "2026-week20.html", "title": "Quantifying relative health impact across Gavi, the Vaccine Alliance's portfolio in 117 countries at the subregional level: a modelling study", "journal": "Lancet", "type": "OA", "typeLabel": "Original Article", "author": "Gaythorpe", "doi": "10.1016/S0140-6736(26)00555-6", "url": "https://doi.org/10.1016/S0140-6736(26)00555-6", "summary": "藥師重點：疫苗 impact ratios 可作為免疫政策規劃與資源配置的輔助指標，但不應單獨決定疫苗優先順序；仍需合併疾病負擔、接種可近性、成本、供應與地方流行病學資料。", "pubDate": "2026-05-16", "terms": [ "quantifying", "relative", "impact", "across", "gavi", "vaccine", "alliance", "portfolio", "countries", "subregional" ], "drugTerms": [], "searchText": "quantifying relative health impact across gavi, the vaccine alliance's portfolio in 117 countries at the subregional level: a modelling study lancet original article gaythorpe 10.1016/s0140-6736(26)00555-6 研究背景：在醫療資源受限下，各疫苗對死亡與 disability-校正 life-years 的相對影響可協助國家免疫計畫排序；本研究估計 gavi 支持疫苗組合在 117 個 low-income and middle-income countries 的 疫苗 impact ratios。 研究方法：此 modelling 研究 使用 疫苗 impact modelling consortium 模型，定義 疫苗 impact 比值 為每 1000 vaccinations 可避免的 deaths 或 disability-校正 life-years。模型採標準化人口資料與疫苗覆蓋率假設，包含 no-vaccination counterfactual，並納入 structural、parameter 與 stochastic uncertainty；分析 2000-2030 年接種（cholera 為 2000-2040 年）的 14 種 疫苗-preventable diseases。 主要結果：整體估計 human papillomavirus 疫苗 每 1000 vaccinations 可避免 deaths 最高（11.24，95% uncertainty 區間 10.88-11.64），其次為 measles 疫苗（6.09，4.90-7.07）。其他疫苗的 impact ratios 依 subregion 與 immunisation activity type 而異，且因不確定性範圍重疊，疫苗間排序需保守解讀。 藥師重點：疫苗 impact ratios 可作為免疫政策規劃與資源配置的輔助指標，但不應單獨決定疫苗優先順序；仍需合併疾病負擔、接種可近性、成本、供應與地方流行病學資料。" }, { "id": "pmid-42128454", "kind": "article", "issueId": "2026-week20", "year": 2026, "week": 20, "weekLabel": "第 20 週", "dateRange": "2026/05/11 – 05/17", "href": "2026-week20.html", "title": "Prophylactic tranexamic acid for the prevention of postpartum haemorrhage in women with placenta praevia: multicentre, double blind, randomised, placebo controlled, phase 3 trial", "journal": "BMJ", "type": "RCT", "typeLabel": "RCT", "author": "Zhang", "doi": "10.1136/bmj-2026-089636", "url": "https://doi.org/10.1136/bmj-2026-089636", "summary": "藥師重點：tranexamic acid 1 g 作為 placenta praevia 剖腹產且已使用 oxytocin 的輔助預防，可小幅降低 postpartum haemorrhage；藥師需確認給藥時點、血栓風險與腎功能等禁忌或慎用條件。", "pubDate": "2026-05-13", "terms": [ "prophylactic", "tranexamic", "acid", "prevention", "postpartum", "haemorrhage", "women", "placenta", "praevia", "multicentre" ], "drugTerms": [], "searchText": "prophylactic tranexamic acid for the prevention of postpartum haemorrhage in women with placenta praevia: multicentre, double blind, randomised, placebo controlled, phase 3 trial bmj rct zhang 10.1136/bmj-2026-089636 研究背景：placenta praevia 剖腹產婦女有較高 postpartum haemorrhage 風險，預防性 tranexamic acid 是否能在 oxytocin 基礎上進一步減少出血仍需大型試驗確認。 研究方法：此研究為中國 24 個產科單位進行的隨機、雙盲、安慰劑對照 第 3 期試驗，收錄 1732 名 placenta praevia 且接受 caesarean delivery 的婦女。受試者在臍帶夾閉後 5 分鐘內接受 prophylactic oxytocin，並靜脈輸注 tranexamic acid 1 g 或 安慰劑；主要終點為估算失血量 ≥1000 ml 或產後 2 天內輸注紅血球。 主要結果：主要終點資料可評估率為 99.8%（1691/1694），placenta accreta spectrum 佔 17.9%。postpartum haemorrhage 發生率為 tranexamic acid 29.7% vs 安慰劑 35.1%（相對風險 0.85，95.2% ci 0.75 to 0.96；p=0.01）；嚴重不良事件 兩組皆為 0.5%（相對風險 1.01，95% ci 0.25 to 4.00）。 藥師重點：tranexamic acid 1 g 作為 placenta praevia 剖腹產且已使用 oxytocin 的輔助預防，可小幅降低 postpartum haemorrhage；藥師需確認給藥時點、血栓風險與腎功能等禁忌或慎用條件。" }, { "id": "pmid-42126852", "kind": "article", "issueId": "2026-week20", "year": 2026, "week": 20, "weekLabel": "第 20 週", "dateRange": "2026/05/11 – 05/17", "href": "2026-week20.html", "title": "Pragmatic Parental Support to Mitigate Burnout Among Pregnant and Postpartum Trainees: A Randomized Clinical Trial", "journal": "JAMA", "type": "RCT", "typeLabel": "RCT", "author": "Rubio-Chavez", "doi": "10.1001/jama.2026.5663", "url": "https://doi.org/10.1001/jama.2026.5663", "summary": "藥師重點：此研究屬職場支持介入，顯示結構化 parental support package 可減少產後 burnout 增幅；對醫療團隊管理的意義在於支持方案需涵蓋實際育兒、哺乳與 mentorship，而非僅靠個人調適。", "pubDate": "2026-06-09", "terms": [ "pragmatic", "parental", "support", "mitigate", "burnout", "pregnant", "postpartum", "trainees", "jama", "rubio-chavez" ], "drugTerms": [], "searchText": "pragmatic parental support to mitigate burnout among pregnant and postpartum trainees: a randomized clinical trial jama rct rubio-chavez 10.1001/jama.2026.5663 研究背景：醫師訓練期間的 occupational burnout 會影響照護品質、留任與健康，懷孕與產後 trainees 因職場支持不足與家庭角色轉換而風險較高。 研究方法：此 實務型、隨機、controlled、parallel-group 臨床 試驗 於美國東北部 7 個訓練機構進行，收錄懷孕 ≥12 週的 residents 與 fellows，排除 nonbirthing parents。156 名受試者 1:1 分派至 parental support package 或 usual support；介入包含 smart bassinet、wearable breast pump、virtual perinatal support 與 faculty mentorship，主要終點為懷孕期間至產後 24 週 stanford professional fulfillment index burnout 分數變化。 主要結果：143 人納入主要分析，中位數 age 32 years。burnout score 變化在 parental support package 組為 2.96 至 3.03，usual support 組為 3.13 至 3.79（校正 between-group 差異 in change -0.58，95% ci -1.10 to -0.07；p=.03；d=0.65）；差異主要來自 interpersonal disengagement（-0.70，95% ci -1.24 to -0.15；p=.01），emotional exhaustion 未達統計顯著差異。 藥師重點：此研究屬職場支持介入，顯示結構化 parental support package 可減少產後 burnout 增幅；對醫療團隊管理的意義在於支持方案需涵蓋實際育兒、哺乳與 mentorship，而非僅靠個人調適。" }, { "id": "pmid-42127296", "kind": "article", "issueId": "2026-week20", "year": 2026, "week": 20, "weekLabel": "第 20 週", "dateRange": "2026/05/11 – 05/17", "href": "2026-week20.html", "title": "Neuroepithelial Tumor with AAV Integration after Intracisternal Magna Vector Delivery", "journal": "NEJM", "type": "OA", "typeLabel": "Original Article", "author": "Ahrens-Nicklas", "doi": "10.1056/NEJMoa2601608", "url": "https://doi.org/10.1056/NEJMoa2601608", "summary": "藥師重點：此個案提供 AAV gene 治療 後罕見腫瘤與 vector integration 的安全性訊號；藥師在基因治療追蹤中需重視長期腫瘤監測、神經學變化通報與個案層級風險溝通。", "pubDate": "2026-06-04", "terms": [ "neuroepithelial", "tumor", "integration", "intracisternal", "magna", "vector", "delivery", "nejm", "ahrens-nicklas", "nejmoa2601608" ], "drugTerms": [], "searchText": "neuroepithelial tumor with aav integration after intracisternal magna vector delivery nejm original article ahrens-nicklas 10.1056/nejmoa2601608 研究背景：recombinant adeno-associated virus (aav) vectors 多數不整合入基因體，但 neonatal murine models 曾顯示罕見 genomic integration 可能與 oncogenesis 相關。 研究方法：本文報告 1 名 重度 mucopolysaccharidosis type i (mpsi, hurler subtype) 5 歲男童，在接受 intracisternal magna aav serotype 9 gene 治療 4 年後發生 neuroepithelial tumor，並進行腫瘤切除與分子分析。 主要結果：患者 主要 tumor 成功切除，術後仍保有優於年齡的 advanced cognitive function，顯示 mpsi 可能獲得緩解。腫瘤分子分析發現 rearranged aav vector elements clonal integration 至 plag1，並表現 chimeric aav-plag1 transcript。 藥師重點：此個案提供 aav gene 治療 後罕見腫瘤與 vector integration 的安全性訊號；藥師在基因治療追蹤中需重視長期腫瘤監測、神經學變化通報與個案層級風險溝通。" }, { "id": "pmid-42107373", "kind": "article", "issueId": "2026-week20", "year": 2026, "week": 20, "weekLabel": "第 20 週", "dateRange": "2026/05/11 – 05/17", "href": "2026-week20.html", "title": "Impact of introducing RTS,S/AS01E malaria vaccine on mortality in young children in Ghana, Kenya, and Malawi: an observational evaluation of a cluster-randomised implementation programme", "journal": "Lancet", "type": "OA", "typeLabel": "Original Article", "author": "Mwapasa", "doi": "10.1016/S0140-6736(26)00248-5", "url": "https://doi.org/10.1016/S0140-6736(26)00248-5", "summary": "藥師重點：RTS,S 導入 routine immunisation programme 與幼兒死亡率下降相關，效果約為避免八分之一死亡，但第 4 劑 uptake 偏低；疫苗政策與衛教應強調完整接種時程、地區瘧疾負擔與持續監測。", "pubDate": "2026-05-09", "terms": [ "impact", "introducing", "as01e", "malaria", "vaccine", "mortality", "young", "children", "ghana", "kenya" ], "drugTerms": [], "searchText": "impact of introducing rts,s/as01e malaria vaccine on mortality in young children in ghana, kenya, and malawi: an observational evaluation of a cluster-randomised implementation programme lancet original article mwapasa 10.1016/s0140-6736(26)00248-5 研究背景：rts,s/as01e malaria 疫苗 已納入多個 sub-saharan african countries 兒童免疫計畫，是否能降低幼兒死亡率是公共衛生推動的重要依據。 研究方法：此研究為 ghana、kenya 與 malawi 的 cluster-隨機 implementation programme 觀察性評估，158 個行政單位 cluster 1:1 分配為 2019 年導入 rts,s 或延後導入。rts,s 採 4 劑時程，主要評估符合接種 3 劑資格兒童的非傷害性 all-cause post-neonatal 死亡率，並追蹤 重度 malaria admissions、疫苗 uptake 與安全性，總評估期間 46 個月。 主要結果：46 個月期間，第 1、2、3、4 劑 rts,s 接種人數分別為 1,289,504、1,158,850、1,068,039 與 436,527；2022 年 coverage 為第 1 劑 82.8%、第 3 劑 71.1%、第 4 劑 39.9%。符合第 3 劑資格兒童中，排除 injury 的死亡為導入區 5576 例 vs 比較區 6152 例，死亡率 比率 比值 0.87（95% ci 0.77-0.97；p=0.016）。 藥師重點：rts,s 導入 routine immunisation programme 與幼兒死亡率下降相關，效果約為避免八分之一死亡，但第 4 劑 uptake 偏低；疫苗政策與衛教應強調完整接種時程、地區瘧疾負擔與持續監測。" }, { "id": "pmid-42127390", "kind": "article", "issueId": "2026-week20", "year": 2026, "week": 20, "weekLabel": "第 20 週", "dateRange": "2026/05/11 – 05/17", "href": "2026-week20.html", "title": "Ensitrelvir for Covid-19 Postexposure Prophylaxis in Household Contacts", "journal": "NEJM", "type": "RCT", "typeLabel": "RCT", "author": "Hayden", "doi": "10.1056/NEJMoa2509306", "url": "https://doi.org/10.1056/NEJMoa2509306", "summary": "藥師重點：ensitrelvir 於家戶暴露後 72 小時內短期給藥可降低接觸者發病風險；實務上需確認當地核准適應症、起始時間窗、CYP 相關交互作用與高風險族群優先性。", "pubDate": "2026-05-14", "terms": [ "ensitrelvir", "covid-19", "postexposure", "prophylaxis", "household", "contacts", "nejm", "hayden", "nejmoa2509306", "sars-cov-2" ], "drugTerms": [ "ensitrelvir" ], "searchText": "ensitrelvir for covid-19 postexposure prophylaxis in household contacts nejm rct hayden 10.1056/nejmoa2509306 研究背景：ensitrelvir 為口服 sars-cov-2 3c-like protease 抑制劑，已於日本用於 mild-to-moderate covid-19；covid-19 家戶接觸者暴露後預防仍缺乏核准抗病毒藥物選項。 研究方法：此研究為 雙盲、隨機、安慰劑對照 試驗，收錄 sars-cov-2 檢測陰性、但為 covid-19 index patient 家戶接觸者的受試者。受試者在 index patient 症狀開始 72 小時內接受 ensitrelvir（第 1 天 375 mg，天 2-5 125 mg 每日）或 安慰劑；主要終點為 第 10 天 前出現實驗室確認且症狀持續 ≥48 小時的 covid-19。 主要結果：modified intention-to-treat 族群 包含 ensitrelvir 1030 人與 安慰劑 1011 人，平均年齡 42.4 歲，37.0% 至少有 1 項 重度 covid-19 risk factor。covid-19 發生率為 2.9% vs 9.0%（風險比 0.33，95% ci 0.22 to 0.49；p<0.001）；不良事件 為 15.1% vs 15.5%，嚴重不良事件 兩組皆 0.2%，無 covid-19 相關住院或死亡。 藥師重點：ensitrelvir 於家戶暴露後 72 小時內短期給藥可降低接觸者發病風險；實務上需確認當地核准適應症、起始時間窗、cyp 相關交互作用與高風險族群優先性。" }, { "id": "pmid-42107374", "kind": "article", "issueId": "2026-week20", "year": 2026, "week": 20, "weekLabel": "第 20 週", "dateRange": "2026/05/11 – 05/17", "href": "2026-week20.html", "title": "Enpatoran, a Toll-like receptor 7/8 inhibitor, in moderate-to-severe systemic lupus erythematosus: findings from Cohort B of a multicentre, international, double-blind, placebo-controlled dose-finding phase 2 trial", "journal": "Lancet", "type": "RCT", "typeLabel": "RCT", "author": "Morand", "doi": "10.1016/S0140-6736(26)00463-0", "url": "https://doi.org/10.1016/S0140-6736(26)00463-0", "summary": "藥師重點：enpatoran 在中重度 SLE 顯示 BICLA 反應 改善訊號，但未證實明確劑量反應；若後續納入治療討論，需留意疾病活動度評估、glucocorticoid tapering 背景與長期安全性資料仍待確認。", "pubDate": "2026-05-09", "terms": [ "enpatoran", "toll-like", "receptor", "inhibitor", "moderate-to-severe", "systemic", "lupus", "erythematosus", "findings", "from" ], "drugTerms": [], "searchText": "enpatoran, a toll-like receptor 7/8 inhibitor, in moderate-to-severe systemic lupus erythematosus: findings from cohort b of a multicentre, international, double-blind, placebo-controlled dose-finding phase 2 trial lancet rct morand 10.1016/s0140-6736(26)00463-0 研究背景：tlr7/8 會活化先天與後天免疫反應，與 systemic lupus erythematosus (sle) 致病機轉有關；willow 世代 b 評估口服 tlr7/8 抑制劑 enpatoran 用於中重度活動性 sle 的效果。 研究方法：此研究為多國、多中心、隨機、雙盲、安慰劑對照、dose-finding 第 2 期 試驗，收錄 18-75 歲、病程至少 6 個月且用藥穩定的中重度 sle 患者。受試者接受 enpatoran 25 mg、50 mg、100 mg 或 安慰劑 每日兩次 24 週，主要評估 week 24 的 bicla 反應 dose-反應 relationship，並追蹤不良事件。 主要結果：世代 b safety 族群 共 354 人；week 24 未達成 bicla 反應 具統計顯著 dose-反應 的主要目標（p=0.14）。各劑量 bicla 反應 皆高於 安慰劑（25 mg 58%，or 2.2，95% ci 1.1-4.0；50 mg 49%，or 1.5，95% ci 0.8-2.8；100 mg 49%，or 1.6，95% ci 0.9-2.8；安慰劑 39%），最常見 治療-emergent 不良事件 為 diarrhoea，嚴重不良事件 約 1-4%。 藥師重點：enpatoran 在中重度 sle 顯示 bicla 反應 改善訊號，但未證實明確劑量反應；若後續納入治療討論，需留意疾病活動度評估、glucocorticoid tapering 背景與長期安全性資料仍待確認。" }, { "id": "pmid-42107392", "kind": "article", "issueId": "2026-week20", "year": 2026, "week": 20, "weekLabel": "第 20 週", "dateRange": "2026/05/11 – 05/17", "href": "2026-week20.html", "title": "Endovascular thrombectomy for patients with large-core ischaemic stroke presenting up to 24 h after onset (ATLAS): a systematic review and individual patient data meta-analysis with central imaging adjudication", "journal": "Lancet", "type": "MA", "typeLabel": "Meta-analysis", "author": "Sarraj", "doi": "10.1016/S0140-6736(26)00876-7", "url": "https://doi.org/10.1016/S0140-6736(26)00876-7", "summary": "藥師重點：large-core ischaemic stroke 發病 24 h 內接受 血管內取栓 整體可改善功能結果並降低死亡率，但 core volume ≥150 mL 尤其超過 6 h 者證據較有限；抗栓、血壓與出血風險管理仍需依影像條件與中風團隊決策調整。", "pubDate": "2026-05-23", "terms": [ "endovascular", "thrombectomy", "large-core", "ischaemic", "stroke", "presenting", "onset", "atlas", "individual", "meta-analysis" ], "drugTerms": [], "searchText": "endovascular thrombectomy for patients with large-core ischaemic stroke presenting up to 24 h after onset (atlas): a systematic review and individual patient data meta-analysis with central imaging adjudication lancet meta-analysis sarraj 10.1016/s0140-6736(26)00876-7 研究背景：large-core ischaemic stroke 患者常被排除於 血管內取栓 之外；atlas 以 individual patient 資料 統合分析 整合近期試驗，評估發病 24 小時內此族群的效益與安全性。 研究方法：研究搜尋 2018 年 3 月 1 日至 2025 年 3 月 1 日 pubmed 與 embase 的隨機試驗，納入 aspects ≤5 或 estimated ischaemic core ≥50 ml 且發病 24 h 內的 large-core ischaemic stroke。共取得 eligible 試驗 的 individual patient-level 資料，經 central imaging core laboratory 重新判讀 aspects 與 core volume；主要終點為 90 天 mrs distribution，並評估 死亡率、neurological worsening 與 有症狀 intracerebral haemorrhage。 主要結果：共納入 6 個試驗、1886 人；90 天 mrs distribution 在 血管內取栓 組較 medical management 組佳（中位數 score 4 vs 5；agenor 1.63，95% ci 1.42-1.88；p<0.0001）。血管內取栓 組 90 天死亡率較低（31.1% vs 37.3%；arr 0.82，95% ci 0.70-0.97；p=0.022），有症狀 顱內出血 無顯著差異（1.1% vs 1.0%；風險差 -0.17 百分點，95% ci -1.01 to 0.67）。core volume ≥150 ml 者估計值仍偏向 血管內取栓，但 95% ci 較寬。 藥師重點：large-core ischaemic stroke 發病 24 h 內接受 血管內取栓 整體可改善功能結果並降低死亡率，但 core volume ≥150 ml 尤其超過 6 h 者證據較有限；抗栓、血壓與出血風險管理仍需依影像條件與中風團隊決策調整。" }, { "id": "pmid-42127389", "kind": "article", "issueId": "2026-week20", "year": 2026, "week": 20, "weekLabel": "第 20 週", "dateRange": "2026/05/11 – 05/17", "href": "2026-week20.html", "title": "Endovascular Treatment of Medium-Vessel-Occlusion Strokes", "journal": "NEJM", "type": "RCT", "typeLabel": "RCT", "author": "Hu", "doi": "10.1056/NEJMoa2514120", "url": "https://doi.org/10.1056/NEJMoa2514120", "summary": "藥師重點：medium-vessel 阻塞 且中重度缺損患者接受 血管內取栓 可提高 90 天功能獨立機率，但伴隨較高 有症狀 intracranial hemorrhage；藥師在急性中風團隊中需協助掌握 thrombolysis 併用、抗栓恢復時點與出血監測。", "pubDate": "2026-05-14", "terms": [ "endovascular", "medium-vessel-occlusion", "strokes", "nejm", "nejmoa2514120", "medium-vessel", "blinded", "assessment", "nihss", "score" ], "drugTerms": [], "searchText": "endovascular treatment of medium-vessel-occlusion strokes nejm rct hu 10.1056/nejmoa2514120 研究背景：medium-vessel 阻塞 急性缺血性中風接受 血管內取栓 的效益在不同試驗中不一致，對中重度神經缺損患者是否改善功能恢復仍需確認。 研究方法：此中國 48 家中心 開放標籤 隨機試驗 採 blinded 結果指標 assessment，收錄發病 24 小時內、nihss score ≥6 且因 medium-vessel 阻塞 造成中重度中風的成人。患者 1:1 分派至 血管內取栓 加 medical management 或 medical management 單用；因 proportional-odds assumption 不成立，預先規劃改以 90 天 modified rankin scale score 0-2 的 功能獨立 為主要終點。 主要結果：血管內取栓 組 280 人、control 組 283 人，中位數 age 71 years，中位數 nihss score 10。90 天 功能獨立 為 58.6% vs 46.6%（校正 比率 比值 1.24，95% ci 1.07 to 1.44；p=0.004）；有症狀 intracranial hemorrhage 為 4.7% vs 2.2%，90-day 死亡率 為 11.1% vs 10.2%。 藥師重點：medium-vessel 阻塞 且中重度缺損患者接受 血管內取栓 可提高 90 天功能獨立機率，但伴隨較高 有症狀 intracranial hemorrhage；藥師在急性中風團隊中需協助掌握 thrombolysis 併用、抗栓恢復時點與出血監測。" }, { "id": "pmid-42120081", "kind": "article", "issueId": "2026-week20", "year": 2026, "week": 20, "weekLabel": "第 20 週", "dateRange": "2026/05/11 – 05/17", "href": "2026-week20.html", "title": "Efficacy of dual antiplatelet therapy for three months versus 12 months after coronary artery bypass grafting: multicentre, double blinded, randomised controlled trial", "journal": "BMJ", "type": "RCT", "typeLabel": "RCT", "author": "Yuan", "doi": "10.1136/bmj-2025-088939", "url": "https://doi.org/10.1136/bmj-2025-088939", "summary": "藥師重點：CABG 後 saphenous vein graft 患者使用 3 個月 ticagrelor 加 aspirin 後轉 aspirin，可維持 graft 阻塞 非劣性並降低出血；臨床仍需依缺血風險、出血風險與外科醫囑調整 DAPT 期間。", "pubDate": "2026-05-12", "terms": [ "efficacy", "dual", "antiplatelet", "three", "months", "coronary", "artery", "bypass", "grafting", "multicentre" ], "drugTerms": [], "searchText": "efficacy of dual antiplatelet therapy for three months versus 12 months after coronary artery bypass grafting: multicentre, double blinded, randomised controlled trial bmj rct yuan 10.1136/bmj-2025-088939 研究背景：冠狀動脈繞道手術後使用 dapt 可降低 saphenous vein graft 阻塞，但延長治療也可能增加出血風險；本研究比較 3 個月與 12 個月 dapt 的療效與安全性。 研究方法：此研究為中國 13 家心臟手術中心進行的多中心、雙盲、隨機、不劣性 試驗，收錄 2300 名 18-80 歲、接受 elective 主要 cabg 且至少有 1 條 saphenous vein graft 的患者。受試者接受 ticagrelor 90 mg 每日兩次 加 aspirin 100 mg 每日一次 共 12 個月，或前 3 個月 dapt 後改為 安慰劑 加 aspirin 9 個月；主要終點為 1 年 graft 阻塞 與 barc type 2、3 或 5 出血。 主要結果：modified intention-to-treat set 共 2290 人；1 年 saphenous vein graft 阻塞 為 10.8% vs 11.2%（absolute 差異 -0.31%，95% ci -3.13% to 2.52%；p=0.008 for 不劣性）。barc type 2、3 或 5 出血 為 8.3% vs 13.2%（absolute 差異 -4.67%，95% ci -7.18% to -2.16%；p<0.001），macce 兩組相近。 藥師重點：cabg 後 saphenous vein graft 患者使用 3 個月 ticagrelor 加 aspirin 後轉 aspirin，可維持 graft 阻塞 非劣性並降低出血；臨床仍需依缺血風險、出血風險與外科醫囑調整 dapt 期間。" }, { "id": "pmid-42134354", "kind": "article", "issueId": "2026-week20", "year": 2026, "week": 20, "weekLabel": "第 20 週", "dateRange": "2026/05/11 – 05/17", "href": "2026-week20.html", "title": "Efficacy and safety of cefepime-nacubactam and aztreonam-nacubactam compared with imipenem-cilastatin for complicated urinary tract infection or acute uncomplicated pyelonephritis (Integral-1): a double-blind, randomised phase 3 trial", "journal": "Lancet", "type": "RCT", "typeLabel": "RCT", "author": "Takahashi", "doi": "10.1016/S0140-6736(26)00596-9", "url": "https://doi.org/10.1016/S0140-6736(26)00596-9", "summary": "藥師重點：cefepime-nacubactam 與 aztreonam-nacubactam 可作為 Gram-negative cUTI 或 急性 uncomplicated pyelonephritis 的潛在選項，尤其涉及抗藥性菌株時；實務採用前需依培養敏感性、腎功能劑量調整與院內抗菌藥物管理規範評估。", "pubDate": "2026-05-16", "terms": [ "efficacy", "cefepime-nacubactam", "aztreonam-nacubactam", "imipenem-cilastatin", "complicated", "urinary", "tract", "infection", "acute", "uncomplicated" ], "drugTerms": [ "cefepime-nacubactam", "imipenem-cilastatin", "cefepime", "imipenem", "cilastatin", "meropenem" ], "searchText": "efficacy and safety of cefepime-nacubactam and aztreonam-nacubactam compared with imipenem-cilastatin for complicated urinary tract infection or acute uncomplicated pyelonephritis (integral-1): a double-blind, randomised phase 3 trial lancet rct takahashi 10.1016/s0140-6736(26)00596-9 研究背景：nacubactam (op0595) 為新型 diazabicyclooctane β-lactamase 抑制劑，可與 cefepime 或 aztreonam 併用；本研究評估其治療 cuti 或 急性 uncomplicated pyelonephritis 的療效與安全性。 研究方法：integral-1 為 global、第 3 期、多中心、隨機、雙盲 試驗，收錄 ≥18 歲 cuti 或 急性 uncomplicated pyelonephritis 成人。患者 2:1:1 接受 cefepime 2 g + nacubactam 1 g、aztreonam 2 g + nacubactam 1 g，或 imipenem 1 g + cilastatin 1 g，每 8 小時靜脈給藥 5-14 天；主要終點為 test of cure 時 臨床 and microbiological 複合 success。 主要結果：614 人隨機分派，431 人納入主要療效分析；複合 success 為 cefepime-nacubactam 82%、aztreonam-nacubactam 72%、imipenem-cilastatin 61%。相較 imipenem-cilastatin，cefepime-nacubactam 差異 21.3%（95% ci 10.9 to 32.0，達 non-inferior and superior），aztreonam-nacubactam 差異 11.4%（95% ci -1.2 to 23.7，達 non-inferior）；治療期間出現的不良事件 為 33%、30%、43%，無 治療-related deaths。 藥師重點：cefepime-nacubactam 與 aztreonam-nacubactam 可作為 gram-negative cuti 或 急性 uncomplicated pyelonephritis 的潛在選項，尤其涉及抗藥性菌株時；實務採用前需依培養敏感性、腎功能劑量調整與院內抗菌藥物管理規範評估。" }, { "id": "pmid-42134863", "kind": "article", "issueId": "2026-week20", "year": 2026, "week": 20, "weekLabel": "第 20 週", "dateRange": "2026/05/11 – 05/17", "href": "2026-week20.html", "title": "Analysing complex interventions using component network meta-analysis", "journal": "BMJ", "type": "OA", "typeLabel": "Original Article", "author": "Veroniki", "doi": "10.1136/bmj-2024-083075", "url": "https://doi.org/10.1136/bmj-2024-083075", "summary": "藥師重點：解讀複合介入的 systematic review 時，CNMA 可協助判斷哪個成分可能貢獻療效，但結果高度依賴模型假設與資料連通性；用於藥事或照護方案決策前需確認 component 定義與交互作用設定。", "pubDate": "2026-05-14", "terms": [ "analysing", "complex", "interventions", "component", "network", "meta-analysis", "veroniki", "bmj-2024-083075", "components", "cnma" ], "drugTerms": [], "searchText": "analysing complex interventions using component network meta-analysis bmj original article veroniki 10.1136/bmj-2024-083075 研究背景：network 統合分析 常用於比較複雜介入，但當介入由多個 components 組成時，傳統方法不易估計各 component 的個別效果或交互作用。 研究方法：本文為方法學文章，介紹 component network 統合分析 (cnma) 的建模方式，並以實例說明 additive cnma 與 interaction cnma 如何估計 component effects。 主要結果：cnma 可在複雜介入中估計個別 component 的 additive effect，也可透過 interaction cnma 評估 component 在彼此存在時效果是否改變；但模型建立與解讀較複雜，需要 clinicians、methodologists 與 statisticians 的 multidisciplinary team。 藥師重點：解讀複合介入的 systematic review 時，cnma 可協助判斷哪個成分可能貢獻療效，但結果高度依賴模型假設與資料連通性；用於藥事或照護方案決策前需確認 component 定義與交互作用設定。" }, { "id": "pmid-42134356", "kind": "article", "issueId": "2026-week20", "year": 2026, "week": 20, "weekLabel": "第 20 週", "dateRange": "2026/05/11 – 05/17", "href": "2026-week20.html", "title": "Addition of autologous stem-cell transplantation to an ibrutinib-containing first-line treatment in patients aged 18-65 years with mantle cell lymphoma (TRIANGLE): 4·5-year follow-up of a three-arm, randomised, open-label, phase 3 superiority trial of the European MCL Network", "journal": "Lancet", "type": "RCT", "typeLabel": "RCT", "author": "Dreyling", "doi": "10.1016/S0140-6736(26)00362-4", "url": "https://doi.org/10.1016/S0140-6736(26)00362-4", "summary": "藥師重點：年輕 mantle cell 淋巴瘤 患者使用 ibrutinib 合併免疫化療並維持治療可改善長期結果，但在此 處方 中加入 ASCT 未增加效益且毒性較高；藥師需關注 ibrutinib 相關感染、出血、心血管風險與維持治療期間交互作用。", "pubDate": "2026-05-16", "terms": [ "addition", "autologous", "stem-cell", "transplantation", "ibrutinib-containing", "first-line", "aged", "years", "mantle", "cell" ], "drugTerms": [ "ibrutinib", "rituximab", "cisplatin", "oxaliplatin" ], "searchText": "addition of autologous stem-cell transplantation to an ibrutinib-containing first-line treatment in patients aged 18-65 years with mantle cell lymphoma (triangle): 4·5-year follow-up of a three-arm, randomised, open-label, phase 3 superiority trial of the european mcl network lancet rct dreyling 10.1016/s0140-6736(26)00362-4 研究背景：triangle 早期結果顯示 ibrutinib 加入年輕 mantle cell 淋巴瘤 第一線免疫化療可改善 failure-free 存活期；延長追蹤後，本研究評估在 ibrutinib-containing 處方 中再加入 asct 是否仍有額外效益。 研究方法：triangle 為 13 個歐洲國家與以色列、165 個中心進行的 three-arm、隨機、開放標籤 第 3 期 優越性試驗，收錄 18-65 歲、未治療 stage ii-iv mantle cell 淋巴瘤 且適合 asct 的患者。患者分派至標準免疫化療後 asct（group a）、標準治療加 ibrutinib 並 asct（group a + i），或 ibrutinib-containing 處方 但省略 asct（group i）；主要終點為 failure-free 存活期，並評估 整體存活期 與安全性。 主要結果：870 人隨機分派，中位數 追蹤 54.9 個月。4-year failure-free 存活期 在 group a + i 與 group i 為 82% vs 81%（hr 0.86，one-sided 98.33% ci 0.00-1.27；one-sided p=0.21），未顯示 asct 額外優勢；group a + i 仍優於 group a（82% vs 70%；hr 0.63；one-sided p=0.0026）。4-year 整體存活期 為 group a + i 88% vs group a 81%（hr 0.59，95% ci 0.38-0.92），group i 90% vs group a 81%（hr 0.57，95% ci 0.36-0.90）；等級 3-5 haematological 疾患 與 infections 在 group a + i 較多。 藥師重點：年輕 mantle cell 淋巴瘤 患者使用 ibrutinib 合併免疫化療並維持治療可改善長期結果，但在此 處方 中加入 asct 未增加效益且毒性較高；藥師需關注 ibrutinib 相關感染、出血、心血管風險與維持治療期間交互作用。" }, { "id": "pmid-42119585", "kind": "article", "issueId": "2026-week20", "year": 2026, "week": 20, "weekLabel": "第 20 週", "dateRange": "2026/05/11 – 05/17", "href": "2026-week20.html", "title": "A case of acute necrotising encephalitis secondary to human herpesvirus 6 infection", "journal": "Lancet", "type": "OA", "typeLabel": "Original Article", "author": "Shinaman", "doi": "10.1016/S0140-6736(26)00252-7", "url": "https://doi.org/10.1016/S0140-6736(26)00252-7", "summary": "藥師重點：此病例提醒 急性 necrotising encephalitis 需快速辨識並及早介入免疫治療；藥師可協助 corticosteroids、IVIG 與 plasma exchange 相關用藥審核，並留意癲癇控制、感染線索與高死亡或中重度失能風險。", "pubDate": "2026-05-12", "terms": [ "case", "acute", "necrotising", "encephalitis", "human", "herpesvirus", "infection", "lancet", "shinaman", "s0140-6736" ], "drugTerms": [], "searchText": "a case of acute necrotising encephalitis secondary to human herpesvirus 6 infection lancet original article shinaman 10.1016/s0140-6736(26)00252-7 研究背景：急性 necrotising encephalitis 可與 human herpesvirus 6 infection 相關，常以發燒、癲癇、意識改變與局部神經缺損表現，且預後不佳。 研究方法：本文為 lancet 臨床 rounds case report，描述 1 名 11 個月大女嬰因 human herpesvirus 6 infection 併發 急性 necrotising encephalitis，並整理診斷檢查、影像特徵與治療重點。 主要結果：病例出現顱內壓升高、癲癇與張力增加；檢查可見血清學異常如 thrombocytopenia 與 liver 功能障礙，cerebrospinal fluid 可有蛋白升高但無 white blood cell pleocytosis，mri t2-weighted images 可見雙側 thalami、basal ganglia、subcortical white matter、cerebellum 與 brainstem 訊號變化及 diffusion restriction。文中指出治療需快速啟動 immunosuppression，包括 corticosteroids、intravenous immunoglobulin 與 plasma exchange。 藥師重點：此病例提醒 急性 necrotising encephalitis 需快速辨識並及早介入免疫治療；藥師可協助 corticosteroids、ivig 與 plasma exchange 相關用藥審核，並留意癲癇控制、感染線索與高死亡或中重度失能風險。" }, { "id": "fda-2026-week20-1", "kind": "fda", "issueId": "2026-week20", "year": 2026, "week": 20, "weekLabel": "第 20 週", "dateRange": "2026/05/11 – 05/17", "href": "2026-week20.html", "title": "FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "concerns", "unapproved", "glp-1", "drugs", "used", "weight", "loss", "https", "drug-alerts-and-statements", "fdas-concerns-unapproved-glp-1-drugs-used-weight-loss" ], "drugTerms": [ "glp-1" ], "searchText": "fda’s concerns with unapproved glp-1 drugs used for weight loss fda drug safety 2026-06-15 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss" }, { "id": "fda-2026-week20-3", "kind": "fda", "issueId": "2026-week20", "year": 2026, "week": 20, "weekLabel": "第 20 週", "dateRange": "2026/05/11 – 05/17", "href": "2026-week20.html", "title": "FDA issues final decision to withdraw approval of Pepaxto (melphalan flufenamide)", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/node/398713", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "issues", "final", "decision", "withdraw", "approval", "pepaxto", "melphalan", "flufenamide", "https", "node" ], "drugTerms": [], "searchText": "fda issues final decision to withdraw approval of pepaxto (melphalan flufenamide) fda drug safety 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/node/398713" }, { "id": "fda-2026-week20-2", "kind": "fda", "issueId": "2026-week20", "year": 2026, "week": 20, "weekLabel": "第 20 週", "dateRange": "2026/05/11 – 05/17", "href": "2026-week20.html", "title": "FDA alerts patients, caregivers, and health care providers of cross-compatibility issues with autoinjector devices that are optional for use with glatiramer acetate injection", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/node/403159", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "alerts", "caregivers", "providers", "cross-compatibility", "issues", "autoinjector", "devices", "that", "optional", "glatiramer" ], "drugTerms": [], "searchText": "fda alerts patients, caregivers, and health care providers of cross-compatibility issues with autoinjector devices that are optional for use with glatiramer acetate injection fda drug safety 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/node/403159" }, { "id": "fda-2026-week20-4", "kind": "fda", "issueId": "2026-week20", "year": 2026, "week": 20, "weekLabel": "第 20 週", "dateRange": "2026/05/11 – 05/17", "href": "2026-week20.html", "title": "FDA Accepts First In Silico Drug Development Tool Under ISTAND Program to Help Predict Drug-Induced Liver Injury", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fda-accepts-first-silico-drug-development-tool-under-istand-program-help-predict-drug-induced-liver", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "accepts", "first", "silico", "development", "tool", "under", "istand", "program", "help", "predict" ], "drugTerms": [], "searchText": "fda accepts first in silico drug development tool under istand program to help predict drug-induced liver injury fda drug safety 2026-06-03 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/drugs/drug-alerts-and-statements/fda-accepts-first-silico-drug-development-tool-under-istand-program-help-predict-drug-induced-liver" }, { "id": "pmid-42070573", "kind": "article", "issueId": "2026-week19", "year": 2026, "week": 19, "weekLabel": "第 19 週", "dateRange": "2026/05/04 – 05/10", "href": "2026-week19.html", "title": "Substantial increases in cervical cancer inequalities worldwide without enhanced human papillomavirus vaccination and screening efforts: a global modelling study", "journal": "Lancet", "type": "OA", "typeLabel": "Original Article", "author": "Brisson", "doi": "10.1016/S0140-6736(26)00410-1", "url": "https://doi.org/10.1016/S0140-6736(26)00410-1", "summary": "藥師重點：模型結果指出若不強化 HPV vaccination 與 screening，全球子宮頸癌不平等可能擴大；公共衛生與臨床端應把疫苗接種、篩檢與治療連結視為一組策略，而非單靠單一措施。", "pubDate": "2026-05-02", "terms": [ "substantial", "increases", "cervical", "cancer", "inequalities", "worldwide", "enhanced", "human", "papillomavirus", "vaccination" ], "drugTerms": [], "searchText": "substantial increases in cervical cancer inequalities worldwide without enhanced human papillomavirus vaccination and screening efforts: a global modelling study lancet original article brisson 10.1016/s0140-6736(26)00410-1 研究背景：who 提出子宮頸癌消除目標，包括 90% 女童接種、70% 女性篩檢與 90% 癌前病變及癌症治療；但 lmics 與 hics 之間的 hpv vaccination 與 screening 落差仍大。 研究方法：此 global modelling 研究 使用 hpv-advise model，推估 67 個 lmics 與 42 個 hics 在不同 hpv vaccination 與 screening 情境下的 age-standardised cervical 癌症 incidence。研究比較 status quo 與 5 種 lmics 強化預防策略，並以 rrlmic/hic=asrlmics/asrhics 衡量不平等程度。 主要結果：在 status quo 下，模型預估 lmics 子宮頸癌發生率僅下降 23%，而 hics 會在 2048 年達到 elimination（age-standardised cervical 癌症 incidence 97.5%。sputum minidock mtb sensitivity 與 xpert mtb/rif ultra 接近（差異 -2.8 百分點，95% ci -6.0 to 0.5），且高於 smear microscopy；system usability scale 中位數 score 75（iqr 65-80），未通報與 index test 相關 不良事件。 藥師重點：研究結果顯示 minidock mtb 在多國臨床場域達到 who near-point-of-care tuberculosis diagnostics 的準確性目標，且可用性良好；若未來導入臨床，藥師與感染管制團隊需確認檢體類型、陰性結果解讀、與既有 xpert mtb/rif ultra 或培養流程的銜接。" }, { "id": "pmid-42035778", "kind": "article", "issueId": "2026-week18", "year": 2026, "week": 18, "weekLabel": "第 18 週", "dateRange": "2026/04/27 – 05/03", "href": "2026-week18.html", "title": "Pharmacological blood-pressure lowering for the prevention of cardiovascular disease and death across the full spectrum of chronic kidney disease severity: an individual-participant data meta-analysis", "journal": "Lancet", "type": "MA", "typeLabel": "Meta-analysis", "author": "Zeng", "doi": "10.1016/S0140-6736(26)00367-3", "url": "https://doi.org/10.1016/S0140-6736(26)00367-3", "summary": "藥師重點：研究結果說明 CKD 患者接受降血壓治療的心血管相對效益大致與非 CKD 族群相近，且跨 CKD 分期與蛋白尿狀態一致；但 CKD 合併 diabetes 者效益可能較小，藥師應協助個別化評估血壓目標、腎功能、電解質與多重用藥風險。", "pubDate": "2026-04-25", "terms": [ "pharmacological", "blood-pressure", "lowering", "prevention", "cardiovascular", "death", "across", "full", "spectrum", "chronic" ], "drugTerms": [], "searchText": "pharmacological blood-pressure lowering for the prevention of cardiovascular disease and death across the full spectrum of chronic kidney disease severity: an individual-participant data meta-analysis lancet meta-analysis zeng 10.1016/s0140-6736(26)00367-3 研究背景：慢性腎臟病（ckd）患者，特別是較晚期 ckd，常因安全性考量而在降血壓治療 rct 中代表性不足，使心血管風險管理證據有限。 研究方法：本研究為 individual-participant 資料 one-stage 統合分析，納入 血壓 lowering 治療 trialists' collaboration 資料集中符合條件的 rct。符合條件者須有每組至少 1000 person-years 追蹤、基線血壓與 creatinine 資料及 time-to-event 結果指標；主要終點為 主要心血管事件，包括致死或非致死 stroke、ischaemic heart 疾病，或 心衰竭 住院/死亡。 主要結果：52 項 rct 中，共 46 項、285,124 名受試者符合資格；59,185 名（20.7%）基線有 ckd，86,067 名（30.2%）有 type 2 diabetes。中位追蹤 4.4 年，收縮壓 每下降 5 mm hg，可降低 ckd 患者 重大 心血管 疾病 風險（hr 0.91，95% ci 0.87-0.94），無 ckd 者為 hr 0.90（95% ci 0.88-0.93；pinteraction>0.99）。效果在 ckd 各期、proteinuria 狀態與不同血壓分類大致一致；但合併 diabetes 的 ckd 患者效果較弱（hr 0.96，95% ci 0.90-1.02），未合併 diabetes 者為 hr 0.88（95% ci 0.84-0.93；pinteraction=0.044）。 藥師重點：研究結果說明 ckd 患者接受降血壓治療的心血管相對效益大致與非 ckd 族群相近，且跨 ckd 分期與蛋白尿狀態一致；但 ckd 合併 diabetes 者效益可能較小，藥師應協助個別化評估血壓目標、腎功能、電解質與多重用藥風險。" }, { "id": "pmid-42054679", "kind": "article", "issueId": "2026-week18", "year": 2026, "week": 18, "weekLabel": "第 18 週", "dateRange": "2026/04/27 – 05/03", "href": "2026-week18.html", "title": "Mim8 Bispecific Antibody Prophylaxis in Hemophilia A with or without Inhibitors", "journal": "NEJM", "type": "RCT", "typeLabel": "RCT", "author": "Mancuso", "doi": "10.1056/NEJMoa2517384", "url": "https://doi.org/10.1056/NEJMoa2517384", "summary": "藥師重點：結論顯示 Mim8 prophylaxis 在 hemophilia A 伴或不伴 抑制劑 患者，可較 on-demand 治療 及原先 clotting factor concentrate prophylaxis 降低需治療出血事件；用藥評估時需關注給藥頻率、體重分層劑量、注射部位反應，以及與既有凝血因子或 bypassing agents 的實務銜接。", "pubDate": "2026-04-30", "terms": [ "mim8", "bispecific", "antibody", "prophylaxis", "hemophilia", "inhibitors", "nejm", "mancuso", "nejmoa2517384", "denecimig" ], "drugTerms": [ "anti-mim8" ], "searchText": "mim8 bispecific antibody prophylaxis in hemophilia a with or without inhibitors nejm rct mancuso 10.1056/nejmoa2517384 研究背景：mim8（denecimig）為模擬 activated factor viii 的 bispecific 抗體，設計用於 hemophilia a 伴或不伴 factor viii 抑制劑 患者的出血預防。 研究方法：此 第 3 期 隨機試驗 收錄 12 歲以上 hemophilia a 患者。原本接受 on-demand 治療 者以 1:1:1 分配至持續 on-demand 治療、mim8 once 每週 或 mim8 once monthly；原本於 run-in phase 接受 clotting factor concentrates prophylaxis 者以 1:1 分配至 mim8 once 每週 或 once monthly。主要終點為需以凝血因子產品治療之出血事件年化率。 主要結果：在 pretrial on-demand 治療 世代，mim8 once 每週 與 once monthly 的 estimated 平均值 annualized treated 出血 比率 分別為 0.57（95% ci 0.25-1.30）與 0.20（95% ci 0.06-0.71），對照 on-demand 治療 為 15.76（95% ci 10.70-23.20），relative decrease 分別為 96.4% 與 98.7%（兩者 p<0.001）。在 pretrial prophylaxis 世代，mim8 once 每週 與 once monthly 相較 run-in 期 factor prophylaxis 亦降低 treated 出血 比率（54.0% 與 42.8%；兩者 p=0.006）。injection-site reactions 發生於 103/4005 次注射（2.6%），未通報 thromboembolic event 或 臨床 evidence of neutralizing anti-mim8 抗體。 藥師重點：結論顯示 mim8 prophylaxis 在 hemophilia a 伴或不伴 抑制劑 患者，可較 on-demand 治療 及原先 clotting factor concentrate prophylaxis 降低需治療出血事件；用藥評估時需關注給藥頻率、體重分層劑量、注射部位反應，以及與既有凝血因子或 bypassing agents 的實務銜接。" }, { "id": "pmid-42060283", "kind": "article", "issueId": "2026-week18", "year": 2026, "week": 18, "weekLabel": "第 18 週", "dateRange": "2026/04/27 – 05/03", "href": "2026-week18.html", "title": "Management of Chronic Subdural Hematoma With Adjunctive Embolization of Middle Meningeal Artery: The EMMA-Can Randomized Clinical Trial", "journal": "JAMA", "type": "RCT", "typeLabel": "RCT", "author": "Shankar", "doi": "10.1001/jama.2026.4910", "url": "https://doi.org/10.1001/jama.2026.4910", "summary": "藥師重點：研究結果顯示，手術引流後加做 EMMA 可降低單側慢性硬腦膜下血腫 90 天有症狀復發；但死亡率與 嚴重不良事件 數字仍需搭配完整原文與神經外科判斷解讀，藥師可協助釐清抗栓藥物、出血風險與圍手術期用藥管理。", "pubDate": "2026-05-26", "terms": [ "management", "chronic", "subdural", "hematoma", "adjunctive", "embolization", "middle", "meningeal", "artery", "emma-can" ], "drugTerms": [], "searchText": "management of chronic subdural hematoma with adjunctive embolization of middle meningeal artery: the emma-can randomized clinical trial jama rct shankar 10.1001/jama.2026.4910 研究背景：慢性硬腦膜下血腫在手術引流後仍可能復發，middle meningeal 動脈 adjunctive embolization（emma）是否能降低復發風險仍需隨機試驗證據。 研究方法：emma-can 為加拿大 9 個 tertiary care centers 進行的 隨機、開放標籤、blinded-end point 試驗，收錄接受手術引流的成人單側、有症狀慢性硬腦膜下血腫（≥10 mm）患者。介入組於術後 72 小時內使用 onyx-18 進行 emma，對照組僅接受手術引流；主要終點為 90 天 ct 偵測到的有症狀復發。 主要結果：192 名隨機分配者中，186 名完成試驗，兩組各 93 名，平均年齡 71.8 歲。90 天有症狀復發發生於 emma 組 4 名（4.3%）與對照組 26 名（28%），風險差 -23.7（95% ci -34.1 to -13.9；p<.001）。影像學復發為 14% vs 49.5%；死亡率為 4.3% vs 1.1%，嚴重不良事件 為 8.6% vs 5.4%。 藥師重點：研究結果顯示，手術引流後加做 emma 可降低單側慢性硬腦膜下血腫 90 天有症狀復發；但死亡率與 嚴重不良事件 數字仍需搭配完整原文與神經外科判斷解讀，藥師可協助釐清抗栓藥物、出血風險與圍手術期用藥管理。" }, { "id": "pmid-42055584", "kind": "article", "issueId": "2026-week18", "year": 2026, "week": 18, "weekLabel": "第 18 週", "dateRange": "2026/04/27 – 05/03", "href": "2026-week18.html", "title": "Benzodiazepine or Z-hypnotic use during pregnancy and risk of psychiatric disorders in children: population based cohort study", "journal": "BMJ", "type": "OA", "typeLabel": "Original Article", "author": "Cho", "doi": "10.1136/bmj-2025-088671", "url": "https://doi.org/10.1136/bmj-2025-088671", "summary": "藥師重點：結論顯示，在控制家庭共享因素後，孕期 benzodiazepines 或 Z-hypnotics 暴露未與子代精神疾病整體風險增加相關；但部分暴露時點與較長 Z-hypnotic 使用仍無法完全排除小幅風險，孕期用藥諮詢應維持最低有效劑量、最短必要療程並評估非藥物選項。", "pubDate": "2026-04-29", "terms": [ "benzodiazepine", "z-hypnotic", "pregnancy", "psychiatric", "disorders", "children", "population", "bmj-2025-088671", "benzodiazepines", "z-hypnotics" ], "drugTerms": [ "benzodiazepine" ], "searchText": "benzodiazepine or z-hypnotic use during pregnancy and risk of psychiatric disorders in children: population based cohort study bmj original article cho 10.1136/bmj-2025-088671 研究背景：孕期使用 benzodiazepines 或 z-hypnotics 是否增加子代精神疾病風險仍有疑慮，且需區分藥物暴露與家庭、遺傳及適應症相關因素的影響。 研究方法：此南韓 national 健康 information database 族群 based 世代研究 納入 2010-2022 年所有活產兒並追蹤至 2023 年，比較孕期暴露 benzodiazepines 或 z-hypnotics、未暴露，以及母親曾使用但孕期未暴露者。研究以 propensity score overlap weighting 平衡共變項，並進行 sibling controlled 分析；主要評估子代整體與 12 類特定 psychiatric 疾患。 主要結果：共納入 3,809,949 名活產兒，其中 94,482 名（2.5%）孕期暴露 benzodiazepines 或 z-hypnotics。與未暴露或 past users 相比，初步分析顯示孕期暴露與較高 psychiatric 疾患 風險相關，但在 sibling controlled 分析 後關聯減弱（hr 0.99，95% ci 0.94-1.04），個別 psychiatric 疾患 亦未見風險增加。部分 次族群 的點估計略高，例如孕期後半段暴露或 z-hypnotic 暴露 ≥30 天，但 sibling 分析 的 信賴區間s 較寬且包含 null。 藥師重點：結論顯示，在控制家庭共享因素後，孕期 benzodiazepines 或 z-hypnotics 暴露未與子代精神疾病整體風險增加相關；但部分暴露時點與較長 z-hypnotic 使用仍無法完全排除小幅風險，孕期用藥諮詢應維持最低有效劑量、最短必要療程並評估非藥物選項。" }, { "id": "pmid-42055586", "kind": "article", "issueId": "2026-week18", "year": 2026, "week": 18, "weekLabel": "第 18 週", "dateRange": "2026/04/27 – 05/03", "href": "2026-week18.html", "title": "Accelerated continuous theta burst stimulation targeting left primary motor cortex for children with autism spectrum disorder: multicentre randomised sham controlled trial", "journal": "BMJ", "type": "RCT", "typeLabel": "RCT", "author": "Tan", "doi": "10.1136/bmj-2025-086295", "url": "https://doi.org/10.1136/bmj-2025-086295", "summary": "藥師重點：研究結果說明五天 a-cTBS protocol 對 4-10 歲自閉症類群障礙兒童的社交溝通量表有短期改善訊號，且不良事件多為輕中度；臨床解讀仍需留意介入設備、操作人員訓練、追蹤僅一個月，以及此研究並非藥物治療試驗。", "pubDate": "2026-04-29", "terms": [ "accelerated", "continuous", "theta", "burst", "stimulation", "targeting", "left", "motor", "cortex", "children" ], "drugTerms": [], "searchText": "accelerated continuous theta burst stimulation targeting left primary motor cortex for children with autism spectrum disorder: multicentre randomised sham controlled trial bmj rct tan 10.1136/bmj-2025-086295 研究背景：自閉症類群障礙兒童的社交溝通困難仍缺乏可快速執行且具安全性資料的介入方式；本研究評估五天 accelerated continuous theta burst stimulation（a-ctbs）是否能改善社交溝通表現。 研究方法：此多中心、隨機、sham controlled 試驗 於中國三所學術醫院進行，收錄 200 名 4-10 歲、自閉症類群障礙且 full scale intelligence quotient ≥50 的兒童。受試者以 1:1 分配至 active a-ctbs 或 sham，連續五天每日 10 次刺激，目標為 left 主要 motor cortex；主要終點為 srs-2 自基線至治療後與一個月追蹤的變化。 主要結果：198 名兒童納入 modified 意向治療分析，193 名完成完整介入。相較 sham，a-ctbs 組治療後 srs-2 分數下降較多（-6.25，95% ci -8.69 to -3.81；cohen's d -0.92；p<0.001），一個月追蹤仍有差異（-6.17，95% ci -8.65 to -3.70；cohen's d -0.90；p<0.001）。語言能力次要終點亦較有利（cohen's d 0.12-0.47；all p<0.02），通報不良事件皆為輕至中度且未需介入即緩解。 藥師重點：研究結果說明五天 a-ctbs protocol 對 4-10 歲自閉症類群障礙兒童的社交溝通量表有短期改善訊號，且不良事件多為輕中度；臨床解讀仍需留意介入設備、操作人員訓練、追蹤僅一個月，以及此研究並非藥物治療試驗。" }, { "id": "fda-2026-week18-1", "kind": "fda", "issueId": "2026-week18", "year": 2026, "week": 18, "weekLabel": "第 18 週", "dateRange": "2026/04/27 – 05/03", "href": "2026-week18.html", "title": "FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "concerns", "unapproved", "glp-1", "drugs", "used", "weight", "loss", "https", "drug-alerts-and-statements", "fdas-concerns-unapproved-glp-1-drugs-used-weight-loss" ], "drugTerms": [ "glp-1" ], "searchText": "fda’s concerns with unapproved glp-1 drugs used for weight loss fda drug safety 2026-06-15 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss" }, { "id": "fda-2026-week18-3", "kind": "fda", "issueId": "2026-week18", "year": 2026, "week": 18, "weekLabel": "第 18 週", "dateRange": "2026/04/27 – 05/03", "href": "2026-week18.html", "title": "FDA issues final decision to withdraw approval of Pepaxto (melphalan flufenamide)", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/node/398713", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "issues", "final", "decision", "withdraw", "approval", "pepaxto", "melphalan", "flufenamide", "https", "node" ], "drugTerms": [], "searchText": "fda issues final decision to withdraw approval of pepaxto (melphalan flufenamide) fda drug safety 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/node/398713" }, { "id": "fda-2026-week18-2", "kind": "fda", "issueId": "2026-week18", "year": 2026, "week": 18, "weekLabel": "第 18 週", "dateRange": "2026/04/27 – 05/03", "href": "2026-week18.html", "title": "FDA alerts patients, caregivers, and health care providers of cross-compatibility issues with autoinjector devices that are optional for use with glatiramer acetate injection", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/node/403159", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "alerts", "caregivers", "providers", "cross-compatibility", "issues", "autoinjector", "devices", "that", "optional", "glatiramer" ], "drugTerms": [], "searchText": "fda alerts patients, caregivers, and health care providers of cross-compatibility issues with autoinjector devices that are optional for use with glatiramer acetate injection fda drug safety 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/node/403159" }, { "id": "fda-2026-week18-4", "kind": "fda", "issueId": "2026-week18", "year": 2026, "week": 18, "weekLabel": "第 18 週", "dateRange": "2026/04/27 – 05/03", "href": "2026-week18.html", "title": "FDA Accepts First In Silico Drug Development Tool Under ISTAND Program to Help Predict Drug-Induced Liver Injury", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fda-accepts-first-silico-drug-development-tool-under-istand-program-help-predict-drug-induced-liver", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "accepts", "first", "silico", "development", "tool", "under", "istand", "program", "help", "predict" ], "drugTerms": [], "searchText": "fda accepts first in silico drug development tool under istand program to help predict drug-induced liver injury fda drug safety 2026-06-03 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/drugs/drug-alerts-and-statements/fda-accepts-first-silico-drug-development-tool-under-istand-program-help-predict-drug-induced-liver" }, { "id": "pmid-42008277", "kind": "article", "issueId": "2026-week17", "year": 2026, "week": 17, "weekLabel": "第 17 週", "dateRange": "2026/04/20 – 04/26", "href": "2026-week17.html", "title": "Using Serious Games to Increase the Implementation of Trauma Triage Guidelines: A Randomized Clinical Trial", "journal": "JAMA", "type": "RCT", "typeLabel": "RCT", "author": "Mohan", "doi": "10.1001/jama.2026.4079", "url": "https://doi.org/10.1001/jama.2026.4079", "summary": "藥師重點：研究結果說明 serious game 可改善急診醫師對高齡嚴重創傷病人的分流行為，但尚未顯示 30 天死亡或再住院複合臨床結果改善；此類工具較適合作為指引導入與教育介入的輔助證據。", "pubDate": "2026-05-19", "terms": [ "serious", "games", "increase", "implementation", "trauma", "triage", "guidelines", "jama", "mohan", "nontrauma" ], "drugTerms": [], "searchText": "using serious games to increase the implementation of trauma triage guidelines: a randomized clinical trial jama rct mohan 10.1001/jama.2026.4079 研究背景：創傷分流屬於高度時間敏感的臨床決策，但醫師遵循分流指引的比例仍偏低，特別是在處理高齡受傷病人時。 研究方法：此 隨機臨床試驗 納入美國 nontrauma centers 急診中負責 medicare fee-for-service、65 歲以上受傷病人分流的 800 名急診醫師。介入組接受 tablet 上的 theory-based serious game training，初始 2 小時後每季 20 分鐘、共 4 次，對照組為 usual education；主要終點為隨機後 1 年內 重度 injury 病人未轉送 trauma centers 的 undertriage 比例。 主要結果：800 名醫師在 1147 家醫院照護 41073 名受傷 medicare 病人，其中 1738 人（4.2%）為 重度 injuries。game-based training 組 重度 injured older adults 的 undertriage 比例低於 usual education 組（49% vs 57%；model-校正 差異 -7%，95% ci -13% to -0.8%；p=.02）；overtriage（-3%，95% ci -6% to 1%；p=.14）與 30-day 死亡率 或 readmission 複合 結果指標（-0.4%，95% ci -5% to 4%；p=.87）未見差異。 藥師重點：研究結果說明 serious game 可改善急診醫師對高齡嚴重創傷病人的分流行為，但尚未顯示 30 天死亡或再住院複合臨床結果改善；此類工具較適合作為指引導入與教育介入的輔助證據。" }, { "id": "pmid-42018318", "kind": "article", "issueId": "2026-week17", "year": 2026, "week": 17, "weekLabel": "第 17 週", "dateRange": "2026/04/20 – 04/26", "href": "2026-week17.html", "title": "Tucidinostat Plus R-CHOP vs R-CHOP in MYC/BCL2 Double-Expressor Diffuse Large B-Cell Lymphoma: A Randomized Clinical Trial", "journal": "JAMA", "type": "RCT", "typeLabel": "RCT", "author": "Xu", "doi": "10.1001/jama.2026.4199", "url": "https://doi.org/10.1001/jama.2026.4199", "summary": "藥師重點：結論顯示 tucidinostat 加 R-CHOP 可改善新診斷 MYC/BCL2 DEL 病人的 無事件存活期；若納入治療選項，藥師需留意合併 R-CHOP 與維持治療期間的毒性管理、支持性照護與劑量延遲或停藥判斷。", "pubDate": "2026-05-19", "terms": [ "tucidinostat", "plus", "r-chop", "bcl2", "double-expressor", "diffuse", "large", "b-cell", "lymphoma", "jama" ], "drugTerms": [ "rituximab" ], "searchText": "tucidinostat plus r-chop vs r-chop in myc/bcl2 double-expressor diffuse large b-cell lymphoma: a randomized clinical trial jama rct xu 10.1001/jama.2026.4199 研究背景：myc/bcl2 double-expressor 淋巴瘤 (del) 是 瀰漫性大型 b 細胞淋巴瘤 (dlbcl) 中預後較差的族群，標準 r-chop 後仍有治療需求；tucidinostat（chidamide）為口服 selective histone deacetylase 抑制劑，先前在 del 顯示潛在活性。 研究方法：此 隨機, 雙盲, 安慰劑對照 第 3 期試驗 於中國 40 個中心進行，共納入 423 名新診斷 del 病人。受試者以 1:1 隨機接受 口服 tucidinostat 20 mg on 天 1, 4, 8, and 11 of each 21-day cycle 或 匹配安慰劑，皆合併 6 cycles r-chop；完全反應 後可續用 tucidinostat 或 安慰劑 maintenance up to 24 週，主要終點為 無事件存活期。 主要結果：423 名隨機分組病人 中位數 age 63 歲，中位數 追蹤 41.3 個月。tucidinostat 組相較 安慰劑 組，疾病 progression、完全反應 後復發、死亡或因殘餘疾病啟動新治療的風險降低 28%（stratified 風險比 0.72；95% ci 0.54-0.96；p=.02），2-year 無事件存活期 為 60.3% vs 50.5%；complete 反應率 為 73.0% vs 61.8%（差異 11.1%；95% ci 2.3%-20.0%）。tucidinostat 組治療相關毒性較高，但摘要描述多可經支持性照護處理。 藥師重點：結論顯示 tucidinostat 加 r-chop 可改善新診斷 myc/bcl2 del 病人的 無事件存活期；若納入治療選項，藥師需留意合併 r-chop 與維持治療期間的毒性管理、支持性照護與劑量延遲或停藥判斷。" }, { "id": "pmid-42019018", "kind": "article", "issueId": "2026-week17", "year": 2026, "week": 17, "weekLabel": "第 17 週", "dateRange": "2026/04/20 – 04/26", "href": "2026-week17.html", "title": "Three Low-Dose Antihypertensive Agents in a Single Pill after Intracerebral Hemorrhage", "journal": "NEJM", "type": "RCT", "typeLabel": "RCT", "author": "Anderson", "doi": "10.1056/NEJMoa2515043", "url": "https://doi.org/10.1056/NEJMoa2515043", "summary": "藥師重點：結論顯示腦內出血後病人使用 telmisartan、amlodipine、indapamide 低劑量單錠複方可降低復發中風與 主要心血管事件；藥師需同步監測血壓、腎功能與停藥原因，特別是 creatinine 上升造成的耐受性問題。", "pubDate": "2026-04-23", "terms": [ "three", "low-dose", "antihypertensive", "agents", "single", "pill", "intracerebral", "hemorrhage", "nejm", "anderson" ], "drugTerms": [ "telmisartan", "amlodipine" ], "searchText": "three low-dose antihypertensive agents in a single pill after intracerebral hemorrhage nejm rct anderson 10.1056/nejmoa2515043 研究背景：降低血壓是預防中風的重要治療策略，但腦內出血後以單錠複方低劑量降壓藥加上標準照護，是否可進一步降低血壓與復發中風風險仍不確定。 研究方法：此 多國, 雙盲, 隨機, 安慰劑對照 試驗 納入曾發生腦內出血、基準 收縮壓 130-160 mm hg 且臨床穩定的病人。所有病人先接受 2 週 活性藥物導入期 的 triple pill（telmisartan 20 mg、amlodipine 2.5 mg、indapamide 1.25 mg 每日一次），再隨機續用 triple pill 或 匹配安慰劑，主要終點為首次復發中風。 主要結果：共 1670 人隨機分組，triple-pill 組 833 人、安慰劑 組 837 人，中位數 追蹤 2.5 年。復發中風發生率為 4.6% vs 7.4%（風險比 0.61；95% ci 0.41-0.92；p=0.02），追蹤期間平均收縮壓為 127 mm hg vs 138 mm hg；主要心血管事件 為 6.6% vs 9.8%（p=0.04），因不良事件提前停藥為 13.6% vs 6.0%，最常見原因為 serum creatinine level 增加 20% 或以上。 藥師重點：結論顯示腦內出血後病人使用 telmisartan、amlodipine、indapamide 低劑量單錠複方可降低復發中風與 主要心血管事件；藥師需同步監測血壓、腎功能與停藥原因，特別是 creatinine 上升造成的耐受性問題。" }, { "id": "pmid-42033722", "kind": "article", "issueId": "2026-week17", "year": 2026, "week": 17, "weekLabel": "第 17 週", "dateRange": "2026/04/20 – 04/26", "href": "2026-week17.html", "title": "Symptom-Based Dosing for Neonatal Opioid Withdrawal: The OPTimize NOW Randomized Clinical Trial", "journal": "JAMA", "type": "RCT", "typeLabel": "RCT", "author": "Devlin", "doi": "10.1001/jama.2026.5782", "url": "https://doi.org/10.1001/jama.2026.5782", "summary": "藥師重點：結論顯示在 ESC 照護架構下，NOWS 嬰兒採 symptom-based dosing 可縮短達到出院準備的時間，但仍有三分之一以上需轉為 固定 opioid 給藥；院內導入時需搭配一致的評估工具、opioid 給藥演算法與安全監測。", "pubDate": "2026-06-23", "terms": [ "symptom-based", "dosing", "neonatal", "opioid", "withdrawal", "optimize", "jama", "devlin", "nows", "scheduled" ], "drugTerms": [], "searchText": "symptom-based dosing for neonatal opioid withdrawal: the optimize now randomized clinical trial jama rct devlin 10.1001/jama.2026.5782 研究背景：neonatal opioid withdrawal 症候群 (nows) 需藥物治療時，傳統多採 scheduled opioid taper；symptom-based dosing 可能更貼近實際戒斷嚴重度。 研究方法：optimize now 為 cluster, crossover 隨機臨床試驗 with run-in period，23 家美國醫院依 eat, sleep, console approach (esc) 或 finnegan-based care 照護嬰兒，並使用各院偏好的 主要 opioid。納入出生週數至少 36 週且有 nows、具藥物治療風險的嬰兒，院所隨機依序採 symptom-based dosing 或 scheduled opioid taper；主要終點為出生至 醫療上可出院 的時間。 主要結果：共 626 名嬰兒納入，383 名屬 esc 主要 結果指標 世代。esc 世代 中，symptom-based dosing 組至 醫療上可出院 的平均時間短於 scheduled opioid taper 組（9.18 vs 11.61 天；校正 平均值 比值 0.79，95% ci 0.65-0.96），但開始藥物治療風險（校正 風險比 0.99，95% ci 0.77-1.27）與 length of stay（amr 0.9，95% ci 0.72-1.13）未見差異；症狀導向組 中 35% 仍因戒斷嚴重度需 固定 opioid 給藥。finnegan 世代 未見 醫療上可出院 或 length of stay 顯著差異，住院 複合 safety 結果指標 少見。 藥師重點：結論顯示在 esc 照護架構下，nows 嬰兒採 symptom-based dosing 可縮短達到出院準備的時間，但仍有三分之一以上需轉為 固定 opioid 給藥；院內導入時需搭配一致的評估工具、opioid 給藥演算法與安全監測。" }, { "id": "pmid-42019019", "kind": "article", "issueId": "2026-week17", "year": 2026, "week": 17, "weekLabel": "第 17 週", "dateRange": "2026/04/20 – 04/26", "href": "2026-week17.html", "title": "Oral Nirmatrelvir-Ritonavir for Covid-19 in Higher-Risk Outpatients", "journal": "NEJM", "type": "RCT", "typeLabel": "RCT", "author": "Butler", "doi": "10.1056/NEJMoa2502457", "url": "https://doi.org/10.1056/NEJMoa2502457", "summary": "藥師重點：結論顯示在已接種疫苗的高風險 SARS-CoV-2 感染者中，nirmatrelvir-ritonavir 未降低 28 天住院或死亡發生率；用藥評估仍應回到發病天數、腎功能與 ritonavir 相關交互作用，避免把病毒量下降直接解讀為臨床事件下降。", "pubDate": "2026-04-23", "terms": [ "oral", "nirmatrelvir-ritonavir", "covid-19", "higher-risk", "outpatients", "nejm", "butler", "nejmoa2502457", "platform", "panoramic" ], "drugTerms": [ "nirmatrelvir-ritonavir", "nirmatrelvir", "ritonavir", "mg-ritonavir" ], "searchText": "oral nirmatrelvir-ritonavir for covid-19 in higher-risk outpatients nejm rct butler 10.1056/nejmoa2502457 研究背景：nirmatrelvir-ritonavir 已知可降低未接種疫苗高風險門診 covid-19 病人進展為重症的風險，但對已接種疫苗、曾自然感染或兩者皆有者的效益仍不明確。 研究方法：研究整合兩項 開放標籤 platform 試驗：英國 panoramic 與加拿大 cantreatcovid，收錄社區中 sars-cov-2 陽性且症狀不超過 5 天的高風險成人。受試者隨機接受 常規照護 加 nirmatrelvir 300 mg-ritonavir 100 mg 每日兩次 for 5 天，或 常規照護 單用，主要終點為隨機後 28 天內全因住院或死亡。 主要結果：panoramic 納入 3516 人，nirmatrelvir-ritonavir 組與 usual-care 組住院或死亡為 0.8% vs 0.7%（校正 勝算比 1.18；95% bayesian 可信區間 0.55-2.62；probability of superiority 0.334）。cantreatcovid 納入 716 人，對應結果為 0.6% vs 1.2%（校正 勝算比 0.48；95% bayesian 可信區間 0.08-2.23；probability of superiority 0.830）；634 人 substudy 顯示治療結束時病毒量下降，嚴重不良事件 分別通報 9 人與 4 人。 藥師重點：結論顯示在已接種疫苗的高風險 sars-cov-2 感染者中，nirmatrelvir-ritonavir 未降低 28 天住院或死亡發生率；用藥評估仍應回到發病天數、腎功能與 ritonavir 相關交互作用，避免把病毒量下降直接解讀為臨床事件下降。" }, { "id": "pmid-42019989", "kind": "article", "issueId": "2026-week17", "year": 2026, "week": 17, "weekLabel": "第 17 週", "dateRange": "2026/04/20 – 04/26", "href": "2026-week17.html", "title": "Home environment conditions during childhood and psychosocial outcomes across three generations in Sweden: population based adoption-discordant sibling comparison study", "journal": "BMJ", "type": "OA", "typeLabel": "Original Article", "author": "Liao", "doi": "10.1136/bmj-2025-087844", "url": "https://doi.org/10.1136/bmj-2025-087844", "summary": "藥師重點：研究結果說明童年家庭環境改善與精神、社會及認知結果的長期較佳表現有關，且可能延伸至下一代；此為登錄資料與手足比較研究，解讀時仍需注意收養選擇、家庭環境差異與非藥物介入的因果限制。", "pubDate": "2026-04-22", "terms": [ "home", "environment", "conditions", "childhood", "psychosocial", "across", "three", "generations", "sweden", "population" ], "drugTerms": [], "searchText": "home environment conditions during childhood and psychosocial outcomes across three generations in sweden: population based adoption-discordant sibling comparison study bmj original article liao 10.1136/bmj-2025-087844 研究背景：早期進入較有利的家庭環境，是否能降低來自精神或行為問題家庭兒童的長期 psychosocial risks，並延伸至下一代，仍需要長期族群資料釐清。 研究方法：此研究為瑞典登錄資料的 族群 based adoption-discordant sibling comparison 研究，追蹤 1950 至 1980 年出生者至 2020 年 12 月 31 日。研究比較風險家庭中 4254 對 full siblings 與 7796 對 maternal half siblings，依 10 歲前是否被收養進入非生物家庭分組，並追蹤其子代以評估 intergenerational spillover effects。 主要結果：被收養者（n=1535）相較未被收養手足，psychiatric 疾患 較低（29.8% v 36.1%）、criminal convictions 較低（26.1% v 34.0%）、receiving social welfare 較低（37.8% v 48.5%），且 平均值 intelligence scores（4.5 v 3.8）、non-cognitive skills scores（4.8 v 3.9）與大學就讀比例（26.0% v 15.2%）較高。被收養者子代（n=2750）相較 cousins 也呈現較佳 psychosocial functioning，但關聯較弱且估計較不精確。 藥師重點：研究結果說明童年家庭環境改善與精神、社會及認知結果的長期較佳表現有關，且可能延伸至下一代；此為登錄資料與手足比較研究，解讀時仍需注意收養選擇、家庭環境差異與非藥物介入的因果限制。" }, { "id": "pmid-42030965", "kind": "article", "issueId": "2026-week17", "year": 2026, "week": 17, "weekLabel": "第 17 週", "dateRange": "2026/04/20 – 04/26", "href": "2026-week17.html", "title": "Efficacy and safety of cemdisiran siRNA in myasthenia gravis (NIMBLE): a double-blind, randomised, placebo-controlled, phase 3 trial", "journal": "Lancet", "type": "RCT", "typeLabel": "RCT", "author": "Vu", "doi": "10.1016/S0140-6736(26)00690-2", "url": "https://doi.org/10.1016/S0140-6736(26)00690-2", "summary": "藥師重點：結論顯示 cemdisiran 單用與 cemdisiran 加 pozelimab 可改善 generalised myasthenia gravis 的 MG-ADL score，cemdisiran 每 12 週皮下注射也提供較低給藥頻率的可能性；臨床評估時仍需確認抗體陽性族群、感染風險監測與 C5 抑制相關風險管理。", "pubDate": "2026-05-02", "terms": [ "efficacy", "cemdisiran", "sirna", "myasthenia", "gravis", "nimble", "double-blind", "randomised", "placebo-controlled", "phase" ], "drugTerms": [ "pozelimab", "anti-achr", "anti-lrp4" ], "searchText": "efficacy and safety of cemdisiran sirna in myasthenia gravis (nimble): a double-blind, randomised, placebo-controlled, phase 3 trial lancet rct vu 10.1016/s0140-6736(26)00690-2 研究背景：achr 抗體-陽性 generalised myasthenia gravis 的病理與 autoantibody-mediated complement activation 有關，本研究評估 targeting complement component 5 (c5) 的 sirna cemdisiran，作為單一治療或與 c5 抗體 pozelimab 合併治療的效果。 研究方法：nimble 為 隨機, 雙盲, 安慰劑對照, 第 3 期試驗，在 13 國 86 個中心進行，納入 18 歲以上 generalised myasthenia gravis、anti-achr 或 anti-lrp4 抗體 陽性，且 mg-adl score 6 分以上的病人。受試者接受 cemdisiran 600 mg 每 12 週、pozelimab 200 mg 每 4 週、cemdisiran 200 mg 加上 pozelimab 200 mg 每 4 週，或 安慰劑，皆為皮下注射，主要終點為第 24 週 mg-adl score 相對基準值變化。 主要結果：截至資料截止日，284 人隨機分組，277 人接受至少一劑研究治療，263 人完成 雙盲 治療 period。mitt 主要 分析 set 中，第 24 週 mg-adl 最小平方平均變化 為 cemdisiran -4.5、combination -4.0、安慰劑 -2.2；相較 安慰劑 的差異為 cemdisiran -2.3（95% ci -3.6 to -1.0；p=0.0005）與 combination -1.7（95% ci -3.0 to -0.4；p=0.0086）。至少一項 不良事件 發生於 cemdisiran 69%、combination 81%、pozelimab 82%、安慰劑 77%；cemdisiran 組未發生 serious 或 meningococcal infections，雙盲 期間無死亡。 藥師重點：結論顯示 cemdisiran 單用與 cemdisiran 加 pozelimab 可改善 generalised myasthenia gravis 的 mg-adl score，cemdisiran 每 12 週皮下注射也提供較低給藥頻率的可能性；臨床評估時仍需確認抗體陽性族群、感染風險監測與 c5 抑制相關風險管理。" }, { "id": "pmid-42026010", "kind": "article", "issueId": "2026-week17", "year": 2026, "week": 17, "weekLabel": "第 17 週", "dateRange": "2026/04/20 – 04/26", "href": "2026-week17.html", "title": "Clinical and bacteriological effectiveness of three different short-course antibiotic regimens and single-dose fosfomycin for uncomplicated lower urinary tract infections in women (SCOUT): a pragmatic, multicentre, open-label, randomised clinical trial", "journal": "Lancet", "type": "RCT", "typeLabel": "RCT", "author": "Llor", "doi": "10.1016/S0140-6736(25)02171-3", "url": "https://doi.org/10.1016/S0140-6736(25)02171-3", "summary": "藥師重點：研究結果說明 uncomplicated lower UTI 女性中，nitrofurantoin 的第 7 天症狀解除比例最高，single-dose fosfomycin 最低；處方建議仍需結合在地抗藥性、腎功能、用藥禁忌與病人能否完成療程。", "pubDate": "2026-04-25", "terms": [ "bacteriological", "effectiveness", "three", "different", "short-course", "antibiotic", "regimens", "single-dose", "fosfomycin", "uncomplicated" ], "drugTerms": [ "fosfomycin" ], "searchText": "clinical and bacteriological effectiveness of three different short-course antibiotic regimens and single-dose fosfomycin for uncomplicated lower urinary tract infections in women (scout): a pragmatic, multicentre, open-label, randomised clinical trial lancet rct llor 10.1016/s0140-6736(25)02171-3 研究背景：nitrofurantoin、fosfomycin 與 pivmecillinam 常被建議用於女性 uncomplicated lower uti，但這些短療程抗生素之間仍需要直接比較療效與安全性。 研究方法：scout 為 phase 4 實務型, 多中心, parallel-group, 開放標籤, 隨機臨床試驗，於 2022 至 2024 年在西班牙基層醫療中心進行。研究納入 18 歲以上、有 dysuria、urinary urgency、urinary frequency 或 suprapubic tenderness 至少一項且尿液 dipstick nitrites 或 leukocyte esterase 陽性的女性，隨機分配至 single-dose fosfomycin 3 g、two-dose fosfomycin 3 g、nitrofurantoin 100 mg three times per day for 5 天，或 pivmecillinam 400 mg three times per day for 3 天；主要終點為第 7 天所有感染症狀消失。 主要結果：768 人完成隨機分組，720 人納入主要分析。第 7 天 臨床 resolution 以 single-dose fosfomycin 最低（109/185，59%），nitrofurantoin 最高（128/172，74%；差異 15.5 百分點，95% ci 5.9-25.1；p=0.0168），其次為 pivmecillinam（127/182，70%；差異 10.9 百分點，95% ci 1.1-20.6；p=0.2352）與 two-dose fosfomycin（122/181，67%；差異 8.5 百分點，95% ci -1.4-18.3；p=0.6935）。不良事件多為輕微且自行緩解的腸胃道事件；4 件 嚴重不良事件 中 1 件 pyelonephritis 被判定與 pivmecillinam 相關。 藥師重點：研究結果說明 uncomplicated lower uti 女性中，nitrofurantoin 的第 7 天症狀解除比例最高，single-dose fosfomycin 最低；處方建議仍需結合在地抗藥性、腎功能、用藥禁忌與病人能否完成療程。" }, { "id": "pmid-42028918", "kind": "article", "issueId": "2026-week17", "year": 2026, "week": 17, "weekLabel": "第 17 週", "dateRange": "2026/04/20 – 04/26", "href": "2026-week17.html", "title": "Balanced Fluid or 0.9% Saline in Children Treated for Septic Shock", "journal": "NEJM", "type": "OA", "typeLabel": "Original Article", "author": "Balamuth", "doi": "10.1056/NEJMoa2601969", "url": "https://doi.org/10.1056/NEJMoa2601969", "summary": "藥師重點：結論顯示兒童 septic shock 使用 balanced fluid 與 0.9% saline 復甦，在死亡、新 renal-replacement 治療 或 persistent kidney 功能障礙 的複合終點未見顯著差異；液體選擇仍需依院內流程與病人電解質、chloride、sodium、lactate 變化監測調整。", "pubDate": "2026-04-24", "terms": [ "balanced", "fluid", "saline", "children", "treated", "septic", "shock", "nejm", "balamuth", "nejmoa2601969" ], "drugTerms": [], "searchText": "balanced fluid or 0.9% saline in children treated for septic shock nejm original article balamuth 10.1056/nejmoa2601969 研究背景：兒童 septic shock 復甦時使用 balanced crystalloid fluid 是否優於 0.9% saline，特別是腎臟相關結果，臨床仍有爭議。 研究方法：此 實務型 臨床 試驗 於 5 國 47 個急診部門進行，納入 2 個月至未滿 18 歲、疑似 septic shock 且灌流異常的病人。受試者隨機接受 balanced fluid 或 0.9% saline 進行最長 48 小時 fluid resuscitation，主要終點為 30 天或出院前 重大腎臟不良事件，包括死亡、新 renal-replacement 治療 或 persistent kidney 功能障礙。 主要結果：9041 名納入者中，balanced-fluid 組 4235 人、0.9%-saline 組 4247 人進入分析。主要終點發生率為 3.4% vs 3.0%（差異 0.4 百分點；95% ci -0.5 to 1.3；風險比 1.10；95% ci 0.88-1.40；p=0.85），28 天 hospital-free 天 中位數皆為 23 天。hyperchloremia 為 31.4% vs 49.0%，hypernatremia 為 1.8% vs 3.1%，hyperlactatemia 為 19.8% vs 16.7%；其他 safety 結果指標 或 不良事件 未見差異。 藥師重點：結論顯示兒童 septic shock 使用 balanced fluid 與 0.9% saline 復甦，在死亡、新 renal-replacement 治療 或 persistent kidney 功能障礙 的複合終點未見顯著差異；液體選擇仍需依院內流程與病人電解質、chloride、sodium、lactate 變化監測調整。" }, { "id": "fda-2026-week17-1", "kind": "fda", "issueId": "2026-week17", "year": 2026, "week": 17, "weekLabel": "第 17 週", "dateRange": "2026/04/20 – 04/26", "href": "2026-week17.html", "title": "FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "concerns", "unapproved", "glp-1", "drugs", "used", "weight", "loss", "https", "drug-alerts-and-statements", "fdas-concerns-unapproved-glp-1-drugs-used-weight-loss" ], "drugTerms": [ "glp-1" ], "searchText": "fda’s concerns with unapproved glp-1 drugs used for weight loss fda drug safety 2026-06-15 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss" }, { "id": "fda-2026-week17-3", "kind": "fda", "issueId": "2026-week17", "year": 2026, "week": 17, "weekLabel": "第 17 週", "dateRange": "2026/04/20 – 04/26", "href": "2026-week17.html", "title": "FDA issues final decision to withdraw approval of Pepaxto (melphalan flufenamide)", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/node/398713", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "issues", "final", "decision", "withdraw", "approval", "pepaxto", "melphalan", "flufenamide", "https", "node" ], "drugTerms": [], "searchText": "fda issues final decision to withdraw approval of pepaxto (melphalan flufenamide) fda drug safety 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/node/398713" }, { "id": "fda-2026-week17-2", "kind": "fda", "issueId": "2026-week17", "year": 2026, "week": 17, "weekLabel": "第 17 週", "dateRange": "2026/04/20 – 04/26", "href": "2026-week17.html", "title": "FDA alerts patients, caregivers, and health care providers of cross-compatibility issues with autoinjector devices that are optional for use with glatiramer acetate injection", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/node/403159", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "alerts", "caregivers", "providers", "cross-compatibility", "issues", "autoinjector", "devices", "that", "optional", "glatiramer" ], "drugTerms": [], "searchText": "fda alerts patients, caregivers, and health care providers of cross-compatibility issues with autoinjector devices that are optional for use with glatiramer acetate injection fda drug safety 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/node/403159" }, { "id": "fda-2026-week17-4", "kind": "fda", "issueId": "2026-week17", "year": 2026, "week": 17, "weekLabel": "第 17 週", "dateRange": "2026/04/20 – 04/26", "href": "2026-week17.html", "title": "FDA Accepts First In Silico Drug Development Tool Under ISTAND Program to Help Predict Drug-Induced Liver Injury", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fda-accepts-first-silico-drug-development-tool-under-istand-program-help-predict-drug-induced-liver", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "accepts", "first", "silico", "development", "tool", "under", "istand", "program", "help", "predict" ], "drugTerms": [], "searchText": "fda accepts first in silico drug development tool under istand program to help predict drug-induced liver injury fda drug safety 2026-06-03 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/drugs/drug-alerts-and-statements/fda-accepts-first-silico-drug-development-tool-under-istand-program-help-predict-drug-induced-liver" }, { "id": "pmid-41985133", "kind": "article", "issueId": "2026-week16", "year": 2026, "week": 16, "weekLabel": "第 16 週", "dateRange": "2026/04/13 – 04/19", "href": "2026-week16.html", "title": "Randomized Trial of Adjunctive Prednisolone for Kawasaki Disease", "journal": "NEJM", "type": "RCT", "typeLabel": "RCT", "author": "Lin", "doi": "10.1056/NEJMoa2511478", "url": "https://doi.org/10.1056/NEJMoa2511478", "summary": "藥師重點：結果顯示在未篩選的新診斷 Kawasaki 疾病 族群中，prednisolone 加入初始標準治療未降低 1 個月冠狀動脈病變；藥師可留意其雖減少 rescue 治療 與縮短發燒時間，但不應據此推論可改善主要血管終點。", "pubDate": "2026-04-16", "terms": [ "adjunctive", "prednisolone", "kawasaki", "nejm", "nejmoa2511478", "glucocorticoids", "rescue" ], "drugTerms": [], "searchText": "randomized trial of adjunctive prednisolone for kawasaki disease nejm rct lin 10.1056/nejmoa2511478 研究背景：kawasaki 疾病 初始治療是否應於未篩選族群中加用 glucocorticoids，過去仍缺乏明確證據。 研究方法：此中國多中心、開放標籤、隨機對照試驗納入新診斷 kawasaki 疾病 兒童，1:1 分配接受 prednisolone 加標準治療或單用標準治療；主要終點為發病後 1 個月冠狀動脈病變。 主要結果：共 3208 人隨機分組，基線已有冠狀動脈病變者占 27.3%。1 個月時 prednisolone 加標準治療組與標準治療組冠狀動脈病變發生率為 16.0% vs 13.8%（校正 風險差 1.1 百分點，95% ci -1.0 to 3.4；p = 0.31），整體不良事件發生率未見顯著差異。 藥師重點：結果顯示在未篩選的新診斷 kawasaki 疾病 族群中，prednisolone 加入初始標準治療未降低 1 個月冠狀動脈病變；藥師可留意其雖減少 rescue 治療 與縮短發燒時間，但不應據此推論可改善主要血管終點。" }, { "id": "pmid-41969010", "kind": "article", "issueId": "2026-week16", "year": 2026, "week": 16, "weekLabel": "第 16 週", "dateRange": "2026/04/13 – 04/19", "href": "2026-week16.html", "title": "Prevalence of liver fibrosis in the general population (the LiverScreen project): a multinational European cohort study", "journal": "Lancet", "type": "OA", "typeLabel": "Original Article", "author": "Graupera", "doi": "10.1016/S0140-6736(26)00354-5", "url": "https://doi.org/10.1016/S0140-6736(26)00354-5", "summary": "藥師重點：此研究提示歐洲一般族群未診斷 liver fibrosis 與肥胖、type 2 diabetes、harmful alcohol 使用 密切相關；藥師在慢性病與代謝症候群照護中，可將肝纖維化風險納入用藥與生活型態衛教，但外推至非歐洲族群需保守。", "pubDate": "2026-04-11", "terms": [ "prevalence", "liver", "fibrosis", "general", "population", "liverscreen", "project", "multinational", "european", "lancet" ], "drugTerms": [], "searchText": "prevalence of liver fibrosis in the general population (the liverscreen project): a multinational european cohort study lancet original article graupera 10.1016/s0140-6736(26)00354-5 研究背景：小型單國研究顯示一般族群中可能存在未診斷 liver fibrosis，但真實盛行率及 metabolic factors、alcohol consumption 的關聯仍不明確。 研究方法：liverscreen 為歐洲九國前瞻性 族群-based 世代研究，納入 40 歲以上一般族群 30,199 人，使用 vibration-controlled transient elastography（vcte）測量 liver stiffness measurement（lsm）。lsm ≥8 kpa、alanine aminotransferase 至少 1.5 倍正常上限，或兩者並存者轉介肝臟科評估；主要結果為 lsm ≥8 kpa 盛行率。 主要結果：受試者平均 58 歲，57% 為女性；70% 有 metabolic factors，6.1% 報告 harmful alcohol consumption。陽性篩檢率為 6.9%，lsm ≥8 kpa 盛行率為 4.6%；完成肝臟科評估者中 32% 確認 chronic liver 疾病 with fibrosis，整體估計盛行率為 1.6%，其中 steatotic liver 疾病 占 93%。 藥師重點：此研究提示歐洲一般族群未診斷 liver fibrosis 與肥胖、type 2 diabetes、harmful alcohol 使用 密切相關；藥師在慢性病與代謝症候群照護中，可將肝纖維化風險納入用藥與生活型態衛教，但外推至非歐洲族群需保守。" }, { "id": "pmid-41985931", "kind": "article", "issueId": "2026-week16", "year": 2026, "week": 16, "weekLabel": "第 16 週", "dateRange": "2026/04/13 – 04/19", "href": "2026-week16.html", "title": "Prenatal exposure to buprenorphine or methadone and adverse neurodevelopmental outcomes: population based cohort study", "journal": "BMJ", "type": "OA", "typeLabel": "Original Article", "author": "Friedrich", "doi": "10.1136/bmj-2025-087321", "url": "https://doi.org/10.1136/bmj-2025-087321", "summary": "藥師重點：結果未顯示孕期 buprenorphine 相較 methadone 會增加子代長期神經發展不良風險；藥師協助孕婦 opioid 使用 疾患 治療時，仍需把母體穩定治療、暴露時點、共病與其他物質使用納入共同評估。", "pubDate": "2026-04-15", "terms": [ "prenatal", "exposure", "buprenorphine", "methadone", "adverse", "neurodevelopmental", "population", "friedrich", "bmj-2025-087321", "opioid" ], "drugTerms": [], "searchText": "prenatal exposure to buprenorphine or methadone and adverse neurodevelopmental outcomes: population based cohort study bmj original article friedrich 10.1136/bmj-2025-087321 研究背景：孕期 opioid 使用 疾患 治療常使用 buprenorphine 或 methadone，但兩者對子代長期 neurodevelopmental 疾患 的相對風險仍是臨床關注問題。 研究方法：此 族群 based 世代研究 使用美國 nationwide medicaid 2000-2018 年超過 250 萬活產資料，分析孕期暴露 buprenorphine 或 methadone 的兒童。主要結果為 autism spectrum 疾患、attention deficit/hyperactivity 疾患、語言或動作發展障礙、行為障礙、學習困難或 intellectual disability 的複合 neurodevelopmental 疾患，並以 propensity score overlap weighting 校正混雜因子。 主要結果：12,635 名兒童孕期暴露 buprenorphine，5,390 名暴露 methadone。8 歲時任何 neurodevelopmental 疾患 粗累積發生率為 34%（95% ci 30% to 38%）vs 33%（29% to 37%）；校正後 buprenorphine 相較 methadone 的風險略低（校正 hr 0.81，95% ci 0.70 to 0.94），prevalent 使用 分析亦較低（校正 hr 0.62，0.51 to 0.76），但 pregnancy 期間開始治療者未見此關聯（校正 hr 1.13，0.90 to 1.42）。 藥師重點：結果未顯示孕期 buprenorphine 相較 methadone 會增加子代長期神經發展不良風險；藥師協助孕婦 opioid 使用 疾患 治療時，仍需把母體穩定治療、暴露時點、共病與其他物質使用納入共同評估。" }, { "id": "pmid-41974150", "kind": "article", "issueId": "2026-week16", "year": 2026, "week": 16, "weekLabel": "第 16 週", "dateRange": "2026/04/13 – 04/19", "href": "2026-week16.html", "title": "Pembrolizumab plus weekly paclitaxel in platinum-resistant recurrent ovarian cancer (ENGOT-ov65/KEYNOTE-B96): a multicentre, randomised, double-blind, phase 3 study", "journal": "Lancet", "type": "RCT", "typeLabel": "RCT", "author": "Colombo", "doi": "10.1016/S0140-6736(26)00602-1", "url": "https://doi.org/10.1016/S0140-6736(26)00602-1", "summary": "藥師重點：研究支持 pembrolizumab 加 每週 paclitaxel（可併用 bevacizumab）作為 platinum-resistant recurrent ovarian 癌症 的治療選項之一，但 等級 3 以上治療相關不良事件較高，藥師需特別追蹤免疫相關毒性、周邊神經病變、血液學毒性與 bevacizumab 併用風險。", "pubDate": "2026-04-18", "terms": [ "pembrolizumab", "plus", "weekly", "paclitaxel", "platinum-resistant", "recurrent", "ovarian", "cancer", "engot-ov65", "keynote-b96" ], "drugTerms": [ "pembrolizumab", "paclitaxel", "bevacizumab" ], "searchText": "pembrolizumab plus weekly paclitaxel in platinum-resistant recurrent ovarian cancer (engot-ov65/keynote-b96): a multicentre, randomised, double-blind, phase 3 study lancet rct colombo 10.1016/s0140-6736(26)00602-1 研究背景：上皮性卵巢癌常復發並轉為 platinum-resistant，pembrolizumab 加 每週 paclitaxel 是否能改善 無惡化存活期 與 整體存活期 是本研究重點。 研究方法：engot-ov65/keynote-b96 為多國、隨機、雙盲、第 3 期 研究，納入曾接受 1-2 線全身治療且最後 platinum 處方 後 6 個月內惡化的 epithelial ovarian、fallopian tube 或 主要 peritoneal carcinoma 成人。受試者分配接受 pembrolizumab 400 mg 每 6 週 加 paclitaxel 80 mg/m2 天 1, 8, 15 每 21 天，或 安慰劑 加相同 paclitaxel；可依研究者判斷加用 bevacizumab。 主要結果：共 643 名女性受試者隨機分組。第一次期中分析顯示 pembrolizumab 加 paclitaxel 在 pd-l1 cps 1 or higher 族群改善 無惡化存活期（中位數 8.3 vs 7.2 個月；hr 0.72，95% ci 0.58-0.89；p=0.0014），整體族群亦改善 無惡化存活期（中位數 8.3 vs 6.4 個月；hr 0.70，95% ci 0.58-0.84；p<0.0001）；最終分析整體族群 整體存活期 為 17.7 vs 14.0 個月（hr 0.82，95% ci 0.69-0.97；p=0.011）。等級 3 or worse 治療相關不良事件 為 68% vs 55%。 藥師重點：研究支持 pembrolizumab 加 每週 paclitaxel（可併用 bevacizumab）作為 platinum-resistant recurrent ovarian 癌症 的治療選項之一，但 等級 3 以上治療相關不良事件較高，藥師需特別追蹤免疫相關毒性、周邊神經病變、血液學毒性與 bevacizumab 併用風險。" }, { "id": "pmid-41974149", "kind": "article", "issueId": "2026-week16", "year": 2026, "week": 16, "weekLabel": "第 16 週", "dateRange": "2026/04/13 – 04/19", "href": "2026-week16.html", "title": "Overall survival with relacorilant and nab-paclitaxel in patients with platinum-resistant ovarian cancer (ROSELLA): a phase 3 randomised controlled trial", "journal": "Lancet", "type": "RCT", "typeLabel": "RCT", "author": "Lorusso", "doi": "10.1016/S0140-6736(26)00462-9", "url": "https://doi.org/10.1016/S0140-6736(26)00462-9", "summary": "藥師重點：結果顯示 relacorilant 加 nab-paclitaxel 在不需 biomarker selection 的 platinum-resistant ovarian 癌症 族群可延長 整體存活期；藥師需留意 nab-paclitaxel 相關 neutropenia、anaemia、fatigue、nausea，以及三日口服 relacorilant 與輸注時程的用藥銜接。", "pubDate": "2026-04-18", "terms": [ "overall", "survival", "relacorilant", "nab-paclitaxel", "platinum-resistant", "ovarian", "cancer", "rosella", "phase", "randomised" ], "drugTerms": [ "nab-paclitaxel", "bevacizumab" ], "searchText": "overall survival with relacorilant and nab-paclitaxel in patients with platinum-resistant ovarian cancer (rosella): a phase 3 randomised controlled trial lancet rct lorusso 10.1016/s0140-6736(26)00462-9 研究背景：relacorilant 為 selective glucocorticoid 受體 拮抗劑，可能增加腫瘤細胞對化療敏感性；rosella 研究評估其與 nab-paclitaxel 用於 platinum-resistant ovarian 癌症 的療效與安全性。 研究方法：此 開放標籤 第 3 期試驗 將 18 歲以上、曾接受 1-3 線抗癌治療且 platinum-resistant 的患者，1:1 分配至 relacorilant 150 mg（nab-paclitaxel 前一天、當天與後一天口服）加 nab-paclitaxel 80 mg/m2 天 1, 8, 15 每 28 天，或 nab-paclitaxel monotherapy 100 mg/m2 同療程；無惡化存活期 與 整體存活期 為雙主要終點。 主要結果：381 名患者隨機分組，所有患者曾接受 bevacizumab，61% 曾接受 poly(adp-ribose) polymerase 抑制劑。中位追蹤 24.8 個月 時，relacorilant 加 nab-paclitaxel 較單用 nab-paclitaxel 改善 整體存活期（hr for 死亡 0.65，95% ci 0.51-0.83；p=0.0004），18-month 整體存活期 為 46% vs 27%，中位數 整體存活期 為 16.0 vs 11.9 個月；未觀察到新的安全性訊號。 藥師重點：結果顯示 relacorilant 加 nab-paclitaxel 在不需 biomarker selection 的 platinum-resistant ovarian 癌症 族群可延長 整體存活期；藥師需留意 nab-paclitaxel 相關 neutropenia、anaemia、fatigue、nausea，以及三日口服 relacorilant 與輸注時程的用藥銜接。" }, { "id": "pmid-41999286", "kind": "article", "issueId": "2026-week16", "year": 2026, "week": 16, "weekLabel": "第 16 週", "dateRange": "2026/04/13 – 04/19", "href": "2026-week16.html", "title": "Long-Term Cognitive Ability and Academic Achievement After Childhood Severe Malaria", "journal": "JAMA", "type": "OA", "typeLabel": "Original Article", "author": "Bangirana", "doi": "10.1001/jama.2026.0704", "url": "https://doi.org/10.1001/jama.2026.0704", "summary": "藥師重點：研究顯示兒童期 cerebral malaria 或 重度 malarial anemia 存活者，數年後仍可能有部分認知與數學表現下降；此結果提醒臨床照護除急性抗瘧治療外，也應重視急性腎損傷、高尿酸與 angiopoietin-2 等風險訊號及長期追蹤需求。", "pubDate": "2026-05-12", "terms": [ "long-term", "cognitive", "ability", "academic", "achievement", "childhood", "severe", "malaria", "jama", "bangirana" ], "drugTerms": [], "searchText": "long-term cognitive ability and academic achievement after childhood severe malaria jama original article bangirana 10.1001/jama.2026.0704 研究背景：cerebral malaria 與 重度 malarial anemia 後 1-2 年可能出現認知與學業表現下降，但此影響是否延續至較晚兒童期或青春期仍不清楚。 研究方法：研究追蹤烏干達兩項 重度 malaria 世代 中完成前期研究的兒童，於 2020-2023 年重新納入 939 人，分析 889 名未滿 18 歲者。暴露組包括 cerebral malaria、重度 malarial anemia、其他 重度 malaria 型態與未受影響社區兒童，評估整體認知、注意力與數學、閱讀等 academic achievement 的 age-校正 z scores。 主要結果：受試者平均 11.1 歲，距 重度 malaria 事件平均 8.4 年。相較社區兒童，cerebral malaria 與 重度 malarial anemia 病史者整體認知分數較低（校正 平均差 -0.41，bonferroni-corrected 95% ci -0.74 to -0.09；以及 -0.31，95% ci -0.61 to -0.01）且數學分數較低（-0.46，95% ci -0.78 to -0.14；以及 -0.32，95% ci -0.61 to -0.03）；注意力與閱讀未見顯著差異。 藥師重點：研究顯示兒童期 cerebral malaria 或 重度 malarial anemia 存活者，數年後仍可能有部分認知與數學表現下降；此結果提醒臨床照護除急性抗瘧治療外，也應重視急性腎損傷、高尿酸與 angiopoietin-2 等風險訊號及長期追蹤需求。" }, { "id": "pmid-41984450", "kind": "article", "issueId": "2026-week16", "year": 2026, "week": 16, "weekLabel": "第 16 週", "dateRange": "2026/04/13 – 04/19", "href": "2026-week16.html", "title": "Intrawound Tobramycin Plus Vancomycin to Prevent Surgical Site Infection in Tibial Fractures: The TOBRA Randomized Clinical Trial", "journal": "JAMA", "type": "RCT", "typeLabel": "RCT", "author": "O'Toole", "doi": "10.1001/jama.2026.4023", "url": "https://doi.org/10.1001/jama.2026.4023", "summary": "藥師重點：此研究未支持在 intrawound vancomycin powder 外常規加用 tobramycin powder 以預防高風險脛骨關節周邊骨折深部感染；骨科抗生素局部使用仍應回到感染風險、菌種涵蓋需求與院內 antimicrobial stewardship 原則。", "pubDate": "2026-05-12", "terms": [ "intrawound", "tobramycin", "plus", "vancomycin", "prevent", "surgical", "site", "infection", "tibial", "fractures" ], "drugTerms": [ "tobramycin", "vancomycin" ], "searchText": "intrawound tobramycin plus vancomycin to prevent surgical site infection in tibial fractures: the tobra randomized clinical trial jama rct o'toole 10.1001/jama.2026.4023 研究背景：既有研究指出 intrawound vancomycin powder 可能降低高感染風險脛骨關節周邊骨折的深部手術部位感染，但加用 tobramycin powder 是否能進一步降低感染仍不清楚。 研究方法：tobra 為美國 39 個 trauma centers 進行的 開放標籤、assessor-masked 隨機臨床試驗，納入需手術治療且感染風險較高的 tibial plateau 或 pilon fracture 成人。受試者於 definitive fixation 時接受 intrawound tobramycin 1.2 g 加 vancomycin 1.0 g powder，或單用 intrawound vancomycin 1.0 g powder；主要終點為 182 天內需手術處置的 deep surgical site infection。 主要結果：1660 人隨機分組，1528 人納入主要分析。deep surgical site infection 在 tobramycin 加 vancomycin 組為 51/753（182-day probability 7.4%），單用 vancomycin 組為 47/775（182-day probability 6.6%）；hr 1.11，95% bayesian 可信區間 0.75-1.66，posterior probability of superiority 29.7%。次要終點亦未達 superiority 門檻。 藥師重點：此研究未支持在 intrawound vancomycin powder 外常規加用 tobramycin powder 以預防高風險脛骨關節周邊骨折深部感染；骨科抗生素局部使用仍應回到感染風險、菌種涵蓋需求與院內 antimicrobial stewardship 原則。" }, { "id": "pmid-41985129", "kind": "article", "issueId": "2026-week16", "year": 2026, "week": 16, "weekLabel": "第 16 週", "dateRange": "2026/04/13 – 04/19", "href": "2026-week16.html", "title": "First-Line Zongertinib in Advanced HER2-Mutant Non-Small-Cell Lung Cancer", "journal": "NEJM", "type": "OA", "typeLabel": "Original Article", "author": "Heymach", "doi": "10.1056/NEJMoa2516969", "url": "https://doi.org/10.1056/NEJMoa2516969", "summary": "藥師重點：zongertinib 在未治療 advanced or 轉移性 HER2-mutant NSCLC 顯示較高反應率與一定顱內活性；由於資料來自早期 multicohort 試驗，藥師應留意 HER2 mutation 檢測、120 mg 每日一次 給藥、治療相關不良事件與後續較大規模比較資料。", "pubDate": "2026-04-30", "terms": [ "first-line", "zongertinib", "advanced", "her2-mutant", "non-small-cell", "lung", "cancer", "nejm", "heymach", "nejmoa2516969" ], "drugTerms": [ "zongertinib" ], "searchText": "first-line zongertinib in advanced her2-mutant non-small-cell lung cancer nejm original article heymach 10.1056/nejmoa2516969 研究背景：her2-mutant nsclc 過去缺乏明確 first-line targeted 治療；zongertinib 為口服 irreversible tyrosine kinase 抑制劑，可選擇性抑制 her2 並減少 wild-type egfr 相關毒性。 研究方法：beamion lung-1 為 第 1 期a-1b multicohort 試驗，評估 zongertinib 用於 advanced or 轉移性 nonsquamous her2-mutant nsclc。本摘要聚焦未曾接受治療的 世代 2，給予 zongertinib 120 mg 每日一次；主要終點為 盲性獨立中央審查 評估的 objective 反應，次要終點包括 duration of 反應 與 無惡化存活期，另有 active brain metastases exploratory 世代 4。 主要結果：世代 2 共 74 名未治療患者接受 zongertinib 120 mg，confirmed objective 反應 為 76%（95% ci 65 to 84），中位數 duration of 反應 15.2 個月（95% ci 9.8 to not evaluable），中位數 無惡化存活期 14.4 個月（95% ci 11.1 to not evaluable）。any 等級 不良事件 發生於 99%，等級 3 or higher 治療相關不良事件 為 19%；active brain metastases 世代 的 confirmed intracranial objective 反應 為 47%（95% ci 30 to 64）。 藥師重點：zongertinib 在未治療 advanced or 轉移性 her2-mutant nsclc 顯示較高反應率與一定顱內活性；由於資料來自早期 multicohort 試驗，藥師應留意 her2 mutation 檢測、120 mg 每日一次 給藥、治療相關不良事件與後續較大規模比較資料。" }, { "id": "pmid-41999287", "kind": "article", "issueId": "2026-week16", "year": 2026, "week": 16, "weekLabel": "第 16 週", "dateRange": "2026/04/13 – 04/19", "href": "2026-week16.html", "title": "Fast Antimicrobial Susceptibility Testing for Gram-Negative Bacteremia: The FAST Randomized Clinical Trial", "journal": "JAMA", "type": "RCT", "typeLabel": "RCT", "author": "Banerjee", "doi": "10.1001/jama.2026.5487", "url": "https://doi.org/10.1001/jama.2026.5487", "summary": "藥師重點：快速 AST 未能在整體 gram-negative bacilli BSI 族群改善 DOOR，但可加速抗生素升階或降階；藥師解讀時應把檢驗週轉時間與 antimicrobial stewardship 介入流程一起評估，而非單看檢測技術本身。", "pubDate": "2026-05-26", "terms": [ "fast", "antimicrobial", "susceptibility", "testing", "gram-negative", "bacteremia", "jama", "banerjee", "bloodstream", "infections" ], "drugTerms": [], "searchText": "fast antimicrobial susceptibility testing for gram-negative bacteremia: the fast randomized clinical trial jama rct banerjee 10.1001/jama.2026.5487 研究背景：新型血液培養診斷可快速提供 bloodstream infections 的 antimicrobial susceptibility testing（ast），但在 gram-negative bacilli bacteremia 中能否改善臨床結局仍不明確。 研究方法：fast 為 開放標籤 隨機臨床試驗，於希臘、印度、以色列與西班牙 7 個醫學中心納入住院成人與兒童 gram-negative bacilli bloodstream infections 患者。患者接受 陽性 blood cultures 直接快速 phenotypic ast 加標準 susceptibility testing（n=413），或單用標準 susceptibility testing（n=437）；主要終點為 第 30 天 desirability of 結果指標 ranking（door）。 主要結果：899 人隨機分組，850 人納入主要終點分析；快速檢測組 door 結果較佳的機率為 48.8%（95% ci 45.3%-52.4%），未達 superiority。as-隨機 族群 中有效抗生素治療時間無差異，但 antibiotic escalation or deescalation 中位時間快 14 hours（95% ci 6-22）；carbapenem-resistant infections 預設次族群中有效治療時間為 9.5 vs 28 hours（差異 -18 hours，95% ci -42 to 6）。 藥師重點：快速 ast 未能在整體 gram-negative bacilli bsi 族群改善 door，但可加速抗生素升階或降階；藥師解讀時應把檢驗週轉時間與 antimicrobial stewardship 介入流程一起評估，而非單看檢測技術本身。" }, { "id": "pmid-41972998", "kind": "article", "issueId": "2026-week16", "year": 2026, "week": 16, "weekLabel": "第 16 週", "dateRange": "2026/04/13 – 04/19", "href": "2026-week16.html", "title": "Endovascular Therapy for Post-Thrombotic Syndrome - A Randomized Trial", "journal": "NEJM", "type": "RCT", "typeLabel": "RCT", "author": "Vedantham", "doi": "10.1056/NEJMoa2519001", "url": "https://doi.org/10.1056/NEJMoa2519001", "summary": "藥師重點：endovascular 治療 可改善中重度 post-thrombotic 症候群 及 iliac-vein obstruction 患者 6 個月症狀與生活品質，但出血風險增加；藥師需協助評估 enhanced antithrombotic 治療 的出血風險、併用藥物與術後追蹤。", "pubDate": "2026-06-18", "terms": [ "endovascular", "post-thrombotic", "syndrome", "nejm", "vedantham", "nejmoa2519001", "deep-vein", "thrombosis", "iliac-vein", "obstruction" ], "drugTerms": [], "searchText": "endovascular therapy for post-thrombotic syndrome - a randomized trial nejm rct vedantham 10.1056/nejmoa2519001 研究背景：post-thrombotic 症候群 是 deep-vein thrombosis 後常見併發症，可造成肢體症狀並影響活動與生活品質；endovascular 治療 是否能減輕 iliac-vein obstruction 相關症狀需以隨機試驗確認。 研究方法：研究將 225 名 moderate or 重度 post-thrombotic 症候群 且影像確認 iliac-vein obstruction 患者，隨機分配至 endovascular 治療（iliac-vein stent placement 加 enhanced antithrombotic 治療）合併標準照護，或單用標準 post-thrombotic 症候群 care。主要終點為 6 個月 venous 臨床 severity score（vcss），分數越高代表症狀越嚴重。 主要結果：6 個月時 endovascular 治療 組 vcss 較低（8.1±5.1 vs 10.0±4.9；校正 差異 -2.0；p = 0.001），venous 疾病-specific quality of life 與 sf-36 physical component summary score 亦較佳。6 個月內出血在 endovascular 治療 組較多（11.6% vs 3.6%；p = 0.03）。 藥師重點：endovascular 治療 可改善中重度 post-thrombotic 症候群 及 iliac-vein obstruction 患者 6 個月症狀與生活品質，但出血風險增加；藥師需協助評估 enhanced antithrombotic 治療 的出血風險、併用藥物與術後追蹤。" }, { "id": "pmid-41985976", "kind": "article", "issueId": "2026-week16", "year": 2026, "week": 16, "weekLabel": "第 16 週", "dateRange": "2026/04/13 – 04/19", "href": "2026-week16.html", "title": "Effectiveness of interventions to increase vaccine uptake: component network meta-analysis", "journal": "BMJ", "type": "MA", "typeLabel": "Meta-analysis", "author": "Davies", "doi": "10.1136/bmj-2025-087578", "url": "https://doi.org/10.1136/bmj-2025-087578", "summary": "藥師重點：研究結果說明提升疫苗接種率不宜只靠單一衛教訊息，介入成分需依年齡與族群調整；藥師參與接種推廣時，可優先考慮人工互動、預約協助、延伸接種機會與動機式晤談，但仍需留意納入研究異質性與資源成本。", "pubDate": "2026-04-15", "terms": [ "effectiveness", "interventions", "increase", "vaccine", "uptake", "component", "network", "meta-analysis", "davies", "bmj-2025-087578" ], "drugTerms": [], "searchText": "effectiveness of interventions to increase vaccine uptake: component network meta-analysis bmj meta-analysis davies 10.1136/bmj-2025-087578 研究背景：提升疫苗接種率的介入方式很多，但哪些內容與執行成分最有效，且是否因年齡、弱勢族群或 covid-19 pandemic 前後而不同，仍需整合證據。 研究方法：此 component network 統合分析 納入 high and upper middle income countries 的隨機對照試驗，共 237 項研究、570 個介入組與 4,361,717 名參與者；主要結果為 疫苗 uptake，並以 bayesian component level meta-regression 估計各介入成分的 比值 of 勝算比s 與 95% 可信區間s（cris）。 主要結果：兒童族群中，支付相關成本（比值 of 勝算比s 3.01，95% cri 1.49 to 6.06）與 decision aids（2.73，1.14 to 7.06）有助於提升接種；青少年與年輕成人以 personal delivery formats（2.13，1.09 to 4.40）、社區成員與醫療專業人員共同執行（6.42，1.94 to 25.62）及 social factors（2.62，1.45 to 5.04）較有效；成人則以 human interaction（1.86，1.42 to 2.45）、extended opportunities（1.63，1.35 to 2.00）、appointment scheduling help（1.38，1.06 to 1.78）與 motivational interviewing（1.79，1.21 to 2.64）較有利。 藥師重點：研究結果說明提升疫苗接種率不宜只靠單一衛教訊息，介入成分需依年齡與族群調整；藥師參與接種推廣時，可優先考慮人工互動、預約協助、延伸接種機會與動機式晤談，但仍需留意納入研究異質性與資源成本。" }, { "id": "pmid-41985132", "kind": "article", "issueId": "2026-week16", "year": 2026, "week": 16, "weekLabel": "第 16 週", "dateRange": "2026/04/13 – 04/19", "href": "2026-week16.html", "title": "Asundexian for Secondary Stroke Prevention", "journal": "NEJM", "type": "RCT", "typeLabel": "RCT", "author": "Sharma", "doi": "10.1056/NEJMoa2513880", "url": "https://doi.org/10.1056/NEJMoa2513880", "summary": "藥師重點：結論顯示 asundexian 50 mg 每日 併用抗血小板治療可降低缺血性中風與主要心血管事件風險，且未增加 重大出血；實務上仍需依病人出血風險、抗血小板策略與動脈粥樣硬化證據評估適用性。", "pubDate": "2026-04-16", "terms": [ "asundexian", "stroke", "prevention", "nejm", "sharma", "nejmoa2513880", "high-risk", "activated", "factor", "ischemic" ], "drugTerms": [], "searchText": "asundexian for secondary stroke prevention nejm rct sharma 10.1056/nejmoa2513880 研究背景：非心因性缺血性中風或 high-risk tia 患者仍有復發風險，asundexian 作為 activated factor xi 抑制劑，是否能在抗血小板治療外提供額外保護仍需驗證。 研究方法：此 第 3 期、雙盲 試驗 將發病 72 小時內的非心因性缺血性中風或 high-risk tia 患者隨機分配至 asundexian 50 mg 每日一次 或 安慰劑，並併用計畫中的單一或雙重抗血小板治療；主要療效終點為 ischemic stroke，主要安全性終點為 重大出血。 主要結果：共 12,327 人隨機分組，asundexian 組 ischemic stroke 低於 安慰劑（6.2% vs 8.4%；cause-specific hr 0.74，95% ci 0.65 to 0.84；p<0.001）。重大出血 發生率相近（1.9% vs 1.7%；cause-specific hr 1.10，95% ci 0.85 to 1.44），嚴重不良事件為 19.2% vs 19.5%。 藥師重點：結論顯示 asundexian 50 mg 每日 併用抗血小板治療可降低缺血性中風與主要心血管事件風險，且未增加 重大出血；實務上仍需依病人出血風險、抗血小板策略與動脈粥樣硬化證據評估適用性。" }, { "id": "pmid-41999289", "kind": "article", "issueId": "2026-week16", "year": 2026, "week": 16, "weekLabel": "第 16 週", "dateRange": "2026/04/13 – 04/19", "href": "2026-week16.html", "title": "Amoxicillin-Clavulanate vs Amoxicillin for Acute Sinusitis in Adults", "journal": "JAMA", "type": "OA", "typeLabel": "Original Article", "author": "Savage", "doi": "10.1001/jama.2025.26902", "url": "https://doi.org/10.1001/jama.2025.26902", "summary": "藥師重點：在 18-64 歲門診 uncomplicated 急性 sinusitis 觀察性資料中，standard-dose amoxicillin 與 amoxicillin-clavulanate 治療失敗率相近，且後者次發感染風險較高；藥師可據此支持窄效抗生素優先與避免不必要 clavulanate 暴露。", "pubDate": "2026-05-19", "terms": [ "amoxicillin-clavulanate", "amoxicillin", "acute", "sinusitis", "adults", "jama", "savage", "uncomplicated", "new-user", "active" ], "drugTerms": [ "amoxicillin" ], "searchText": "amoxicillin-clavulanate vs amoxicillin for acute sinusitis in adults jama original article savage 10.1001/jama.2025.26902 研究背景：成人急性鼻竇炎是抗生素處方常見原因，但 uncomplicated 急性 sinusitis 第一線使用 amoxicillin-clavulanate 或 amoxicillin 仍缺乏一致共識。 研究方法：此 new-user、active comparator 回溯性世代研究 使用全國性醫療利用資料庫，納入 2018 年 1 月 1 日至 2023 年 12 月 1 日新診斷門診 急性 sinusitis、年齡 18-64 歲成人，並以 propensity score matching 比較 standard-dose amoxicillin-clavulanate 875 mg-125 mg 每日兩次 與 amoxicillin 875 mg 每日兩次 或 500 mg 3 times 每日。 主要結果：配對後共有 234,608 人，每組 117,304 人；整體 治療 failure 為 3.1%，需急診或住院者為 0.03%。amoxicillin-clavulanate 與 amoxicillin 的 治療 failure 無差異（3.0% vs 3.1%；rr 0.96，95% ci 0.92-1.01），抗生素相關不良事件亦相近（1.3% vs 1.2%；rr 1.04，95% ci 0.97-1.12）；但 amoxicillin-clavulanate 的 yeast infections（1.1% vs 0.8%；rr 1.40，95% ci 1.29-1.53）與 clostridioides difficile infections（0.04% vs 0.02%；rr 2.14，95% ci 1.29-3.54）較高。 藥師重點：在 18-64 歲門診 uncomplicated 急性 sinusitis 觀察性資料中，standard-dose amoxicillin 與 amoxicillin-clavulanate 治療失敗率相近，且後者次發感染風險較高；藥師可據此支持窄效抗生素優先與避免不必要 clavulanate 暴露。" }, { "id": "fda-2026-week16-1", "kind": "fda", "issueId": "2026-week16", "year": 2026, "week": 16, "weekLabel": "第 16 週", "dateRange": "2026/04/13 – 04/19", "href": "2026-week16.html", "title": "FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "concerns", "unapproved", "glp-1", "drugs", "used", "weight", "loss", "https", "drug-alerts-and-statements", "fdas-concerns-unapproved-glp-1-drugs-used-weight-loss" ], "drugTerms": [ "glp-1" ], "searchText": "fda’s concerns with unapproved glp-1 drugs used for weight loss fda drug safety 2026-06-15 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss" }, { "id": "fda-2026-week16-3", "kind": "fda", "issueId": "2026-week16", "year": 2026, "week": 16, "weekLabel": "第 16 週", "dateRange": "2026/04/13 – 04/19", "href": "2026-week16.html", "title": "FDA issues final decision to withdraw approval of Pepaxto (melphalan flufenamide)", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/node/398713", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "issues", "final", "decision", "withdraw", "approval", "pepaxto", "melphalan", "flufenamide", "https", "node" ], "drugTerms": [], "searchText": "fda issues final decision to withdraw approval of pepaxto (melphalan flufenamide) fda drug safety 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/node/398713" }, { "id": "fda-2026-week16-2", "kind": "fda", "issueId": "2026-week16", "year": 2026, "week": 16, "weekLabel": "第 16 週", "dateRange": "2026/04/13 – 04/19", "href": "2026-week16.html", "title": "FDA alerts patients, caregivers, and health care providers of cross-compatibility issues with autoinjector devices that are optional for use with glatiramer acetate injection", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/node/403159", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "alerts", "caregivers", "providers", "cross-compatibility", "issues", "autoinjector", "devices", "that", "optional", "glatiramer" ], "drugTerms": [], "searchText": "fda alerts patients, caregivers, and health care providers of cross-compatibility issues with autoinjector devices that are optional for use with glatiramer acetate injection fda drug safety 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/node/403159" }, { "id": "fda-2026-week16-4", "kind": "fda", "issueId": "2026-week16", "year": 2026, "week": 16, "weekLabel": "第 16 週", "dateRange": "2026/04/13 – 04/19", "href": "2026-week16.html", "title": "FDA Accepts First In Silico Drug Development Tool Under ISTAND Program to Help Predict Drug-Induced Liver Injury", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fda-accepts-first-silico-drug-development-tool-under-istand-program-help-predict-drug-induced-liver", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "accepts", "first", "silico", "development", "tool", "under", "istand", "program", "help", "predict" ], "drugTerms": [], "searchText": "fda accepts first in silico drug development tool under istand program to help predict drug-induced liver injury fda drug safety 2026-06-03 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/drugs/drug-alerts-and-statements/fda-accepts-first-silico-drug-development-tool-under-istand-program-help-predict-drug-induced-liver" }, { "id": "pmid-41936368", "kind": "article", "issueId": "2026-week15", "year": 2026, "week": 15, "weekLabel": "第 15 週", "dateRange": "2026/04/06 – 04/12", "href": "2026-week15.html", "title": "Percutaneous coronary intervention versus coronary artery bypass grafting for unprotected left main stenosis: 10-year final results from the randomised, open-label, non-inferiority NOBLE trial", "journal": "Lancet", "type": "RCT", "typeLabel": "RCT", "author": "Holck", "doi": "10.1016/S0140-6736(26)00205-9", "url": "https://doi.org/10.1016/S0140-6736(26)00205-9", "summary": "藥師重點：結論顯示，在同時適合 PCI 與 CABG 且無額外複雜病灶的 left main 冠狀動脈 動脈 疾病 患者，兩種策略 10 年死亡率相近；臨床討論仍需回到 heart team 對冠狀動脈解剖、共病與病人偏好的整體判斷。", "pubDate": "2026-04-04", "terms": [ "percutaneous", "coronary", "intervention", "artery", "bypass", "grafting", "unprotected", "left", "main", "stenosis" ], "drugTerms": [], "searchText": "percutaneous coronary intervention versus coronary artery bypass grafting for unprotected left main stenosis: 10-year final results from the randomised, open-label, non-inferiority noble trial lancet rct holck 10.1016/s0140-6736(26)00205-9 研究背景：對於 significant unprotected left main 冠狀動脈 動脈 疾病，臨床多建議 cabg 優先於 pci；然而 newer generation drug-eluting stents 與 cabg 的長期比較資料仍有限。 研究方法：noble 試驗 為前瞻性、隨機、開放標籤、不劣性 試驗，納入歐洲 36 家醫院中經 heart team 評估可接受 pci 或 cabg 的 unprotected left main 冠狀動脈 動脈 stenosis 患者。受試者以 1:1 分配至 pci 或 cabg，主要終點為 itt 族群 的 10-year 全因死亡率。 主要結果：2008 年 12 月至 2015 年 1 月共 1201 人隨機分組，itt 族群 兩組各 592 人。10 年 全因死亡率 無顯著差異，pci 組 136/592（23%），cabg 組 145/592（25%）；hr 0.93，95% ci 0.74-1.18，p=0.56。 藥師重點：結論顯示，在同時適合 pci 與 cabg 且無額外複雜病灶的 left main 冠狀動脈 動脈 疾病 患者，兩種策略 10 年死亡率相近；臨床討論仍需回到 heart team 對冠狀動脈解剖、共病與病人偏好的整體判斷。" }, { "id": "pmid-41965242", "kind": "article", "issueId": "2026-week15", "year": 2026, "week": 15, "weekLabel": "第 15 週", "dateRange": "2026/04/06 – 04/12", "href": "2026-week15.html", "title": "Non-surgical casting versus surgical reduction for children with severely displaced distal radial fractures (the CRAFFT Study): a multicentre, randomised, controlled non-inferiority trial and economic evaluation", "journal": "Lancet", "type": "RCT", "typeLabel": "RCT", "author": "Perry", "doi": "10.1016/S0140-6736(26)00409-5", "url": "https://doi.org/10.1016/S0140-6736(26)00409-5", "summary": "藥師重點：研究未在保守界值下證明 non-surgical casting 於 3 個月功能 non-inferior，但差異小且未延續至早期恢復後；兒童骨折照護可討論 cast-first strategy，同時向家屬說明短期功能、外觀、麻醉與手術併發症取捨。", "pubDate": "2026-04-18", "terms": [ "non-surgical", "casting", "surgical", "reduction", "children", "severely", "displaced", "distal", "radial", "fractures" ], "drugTerms": [], "searchText": "non-surgical casting versus surgical reduction for children with severely displaced distal radial fractures (the crafft study): a multicentre, randomised, controlled non-inferiority trial and economic evaluation lancet rct perry 10.1016/s0140-6736(26)00409-5 研究背景：兒童 severely displaced distal radial fractures 常因影像外觀明顯位移而接受手術復位固定，但較年幼兒童具骨骼重塑能力，是否可優先採 non-surgical casting 仍有爭議。 研究方法：crafft 研究 為英國 49 家醫院進行的 實務型、多中心、隨機、controlled 不劣性 試驗，納入 4-10 歲 severely displaced distal radial fracture 兒童。受試者分配至 non-surgical casting 或 surgical reduction，主要終點為 3 個月 promis upper extremity score for children，並進行 12 個月 nhs 觀點經濟評估。 主要結果：共 750 名兒童隨機分組，兩組各 375 人；3 個月 promis upper extremity score 為 casting 組 44.9（sd 8.7）、surgical reduction 組 46.6（8.8），校正 平均差 -1.64，95% ci -2.84 to -0.44，信賴區間超過預設 不劣性 margin -2.5。手術組 8 週內併發症較多，non-surgical casting 平均每人節省 £1665（95% ci 1487 to 1843）。 藥師重點：研究未在保守界值下證明 non-surgical casting 於 3 個月功能 non-inferior，但差異小且未延續至早期恢復後；兒童骨折照護可討論 cast-first strategy，同時向家屬說明短期功能、外觀、麻醉與手術併發症取捨。" }, { "id": "pmid-41956522", "kind": "article", "issueId": "2026-week15", "year": 2026, "week": 15, "weekLabel": "第 15 週", "dateRange": "2026/04/06 – 04/12", "href": "2026-week15.html", "title": "Non-drug perioperative interventions to reduce postoperative pulmonary complications after abdominal surgery: systematic review and meta-analysis", "journal": "BMJ", "type": "MA", "typeLabel": "Meta-analysis", "author": "Huang", "doi": "10.1136/bmj-2025-089001", "url": "https://doi.org/10.1136/bmj-2025-089001", "summary": "藥師重點：此分析建立腹部手術 PPC 預防介入的證據排序，low FiO2 證據最穩定；藥師參與 perioperative care 時，可將鎮痛策略、營養支持與跨團隊肺部保護措施納入討論，但仍需留意各介入異質性與病人手術風險。", "pubDate": "2026-04-09", "terms": [ "non-drug", "perioperative", "interventions", "reduce", "postoperative", "pulmonary", "complications", "abdominal", "surgery", "meta-analysis" ], "drugTerms": [], "searchText": "non-drug perioperative interventions to reduce postoperative pulmonary complications after abdominal surgery: systematic review and meta-analysis bmj meta-analysis huang 10.1136/bmj-2025-089001 研究背景：腹部手術後 postoperative pulmonary complications（ppcs）會增加住院與照護負擔，圍手術期非藥物介入的相對效益需要系統性整理。 研究方法：此 系統性回顧與統合分析 納入自資料庫建置至 2025 年 1 月、並於 2026 年 1 月更新的 隨機對照試驗s，評估成人 elective abdominal surgery under general anaesthesia 的非藥物 ppc 預防介入。主要終點為發生 ppcs 的比例，證據確定性以 等級 評估。 主要結果：共納入 255 試驗、55,260 名受試者，評估 10 類介入與 39 個 subtype；ppcs 發生於 6467 人（11.7%）。high certainty evidence 顯示 low fio2 可降低 ppcs（rr 0.81，95% ci 0.71 to 0.92）；moderate certainty evidence 支持 lung protective ventilation（rr 0.66，0.57 to 0.76）、physiotherapy（0.55，0.46 to 0.65）、analgesia（0.73，0.64 to 0.84）與 nutrition（0.74，0.63 to 0.87）。 藥師重點：此分析建立腹部手術 ppc 預防介入的證據排序，low fio2 證據最穩定；藥師參與 perioperative care 時，可將鎮痛策略、營養支持與跨團隊肺部保護措施納入討論，但仍需留意各介入異質性與病人手術風險。" }, { "id": "pmid-41950472", "kind": "article", "issueId": "2026-week15", "year": 2026, "week": 15, "weekLabel": "第 15 週", "dateRange": "2026/04/06 – 04/12", "href": "2026-week15.html", "title": "Multifaceted Strategies for Hypertension Control in Low-Income Patients", "journal": "NEJM", "type": "RCT", "typeLabel": "RCT", "author": "Mills", "doi": "10.1056/NEJMoa2504068", "url": "https://doi.org/10.1056/NEJMoa2504068", "summary": "藥師重點：研究結果支持低收入高血壓患者採用團隊照護與居家血壓監測等整合策略，可比單純加強 guideline 教育帶來更大收縮壓下降；藥師角色可聚焦於用藥調整流程、服藥遵從性與居家量測回饋。", "pubDate": "2026-04-09", "terms": [ "multifaceted", "strategies", "hypertension", "control", "low-income", "nejm", "mills", "nejmoa2504068", "uncontrolled", "team-based" ], "drugTerms": [], "searchText": "multifaceted strategies for hypertension control in low-income patients nejm rct mills 10.1056/nejmoa2504068 研究背景：uncontrolled hypertension 在健康不平等族群中負擔較高，但低收入患者使用多面向、team-based strategies 控制血壓的成效與執行資料仍不足。 研究方法：研究將 louisiana 與 mississippi 的 federally qualified 健康 center clinics 隨機分配至 multifaceted implementation strategy 或 enhanced 常規照護。介入包含 team-based care、protocol-based intensive blood-pressure management、audit and feedback、生活型態與服藥遵從性 coaching，以及 home blood-pressure monitoring；主要成效終點為 18 個月 收縮壓 變化。 主要結果：共 36 間診所、1272 名 40 歲以上 uncontrolled hypertension 患者納入分析。18 個月 收縮壓 平均變化為介入組 -15.5 mm hg（95% ci -17.4 to -13.6），對照組 -9.1 mm hg（95% ci -11.0 to -7.2），組間差 -6.4 mm hg，95% ci -9.0 to -3.8，p<0.001；嚴重不良事件 為 20.9% vs 21.7%。 藥師重點：研究結果支持低收入高血壓患者採用團隊照護與居家血壓監測等整合策略，可比單純加強 guideline 教育帶來更大收縮壓下降；藥師角色可聚焦於用藥調整流程、服藥遵從性與居家量測回饋。" }, { "id": "pmid-41950474", "kind": "article", "issueId": "2026-week15", "year": 2026, "week": 15, "weekLabel": "第 15 週", "dateRange": "2026/04/06 – 04/12", "href": "2026-week15.html", "title": "Immunogenicity and Safety of vYF, a Yellow Fever Vaccine - A Phase 2 Trial", "journal": "NEJM", "type": "RCT", "typeLabel": "RCT", "author": "Feroldi", "doi": "10.1056/NEJMoa2505665", "url": "https://doi.org/10.1056/NEJMoa2505665", "summary": "藥師重點：研究結果說明 vYF 的早期免疫生成性與安全性大致與 YF-VAX 相近，可作為後續疫苗供應與替代品評估的依據；實際採用仍需等待完整追蹤與核准資訊。", "pubDate": "2026-04-09", "terms": [ "immunogenicity", "yellow", "fever", "vaccine", "phase", "nejm", "feroldi", "nejmoa2505665", "vero", "cells" ], "drugTerms": [], "searchText": "immunogenicity and safety of vyf, a yellow fever vaccine - a phase 2 trial nejm rct feroldi 10.1056/nejmoa2505665 研究背景：vyf 是以 vero cells 製備的新一代 live-attenuated yellow fever 疫苗，目的在改善黃熱病疫苗供應；其相較於已核准 yf-vax 的免疫反應與安全性仍需確認。 研究方法：此 第 2 期、observer-blinded、隨機、活性對照 試驗 的第 1 年期中分析，將 18-60 歲健康成人以 2:1 分配接受單劑 vyf 或 yf-vax。研究於 第 29 天、month 6 與 year 1 測量 neutralizing 抗體 titers，主要分析評估 第 29 天 seroconversion 的 不劣性。 主要結果：共納入 568 人，vyf 組 382 人、yf-vax 組 186 人；per-protocol 不劣性 分析分別為 329 人與 156 人。第 29 天 seroconversion 為 99.7% vs 99.4%，差異 0.3 百分點，95% ci -1.2 to 3.2，達 不劣性；solicited 不良事件 為 56.7% vs 61.1%，未發現 重大 safety concerns。 藥師重點：研究結果說明 vyf 的早期免疫生成性與安全性大致與 yf-vax 相近，可作為後續疫苗供應與替代品評估的依據；實際採用仍需等待完整追蹤與核准資訊。" }, { "id": "pmid-41936367", "kind": "article", "issueId": "2026-week15", "year": 2026, "week": 15, "weekLabel": "第 15 週", "dateRange": "2026/04/06 – 04/12", "href": "2026-week15.html", "title": "Global burden of cancer in children and adolescents aged 0-19 years, 1990-2023: a systematic analysis for the Global Burden of Disease Study 2023", "journal": "Lancet", "type": "OA", "typeLabel": "Original Article", "author": "N/A", "doi": "10.1016/S0140-6736(26)00200-X", "url": "https://doi.org/10.1016/S0140-6736(26)00200-X", "summary": "藥師重點：研究結果說明全球兒癌負擔仍明顯集中於資源有限地區，改善診斷、可近性與完整照護流程仍是核心；藥師可將此作為支持兒癌藥品可近性、支持療法與跨國資源配置討論的背景資料。", "pubDate": "2026-04-04", "terms": [ "global", "burden", "cancer", "children", "adolescents", "aged", "years", "lancet", "s0140-6736", "childhood" ], "drugTerms": [], "searchText": "global burden of cancer in children and adolescents aged 0-19 years, 1990-2023: a systematic analysis for the global burden of disease study 2023 lancet original article 10.1016/s0140-6736(26)00200-x 研究背景：兒童與青少年癌症負擔資料對癌症政策與資源配置重要，但許多國家缺乏完整兒癌觀察資料，過去全球估計也未能細分多種常見兒童癌症。 研究方法：本研究分析 gbd 2023 中 0-19 歲 childhood cancers 的全球疾病負擔，資料來源包含 族群-based 癌症 registries、vital registration systems 與 verbal autopsies。研究估計 incidence、死亡率、ylls、ylds 與 dalys，並以地區與資源分組呈現 95% uncertainty intervals（uis）。 主要結果：2023 年全球估計有 377,000 件 childhood 癌症 新發病例（95% ui 288,000-489,000）、144,000 例死亡（131,000-162,000），以及 11.7 百萬 dalys（10.7-13.2）。1990 至 2023 年全球兒癌死亡下降 27.0%（15.5-36.1），但 who african region 增加 55.6%（25.5-92.4）；who gicc target cancers 佔 2023 年全球兒癌死亡 47.3%（42.2-52.0）。 藥師重點：研究結果說明全球兒癌負擔仍明顯集中於資源有限地區，改善診斷、可近性與完整照護流程仍是核心；藥師可將此作為支持兒癌藥品可近性、支持療法與跨國資源配置討論的背景資料。" }, { "id": "pmid-41962942", "kind": "article", "issueId": "2026-week15", "year": 2026, "week": 15, "weekLabel": "第 15 週", "dateRange": "2026/04/06 – 04/12", "href": "2026-week15.html", "title": "Efficacy and safety of VPM1002 and Immuvac in preventing tuberculosis: phase 3 randomised clinical trial (PreVenTB trial)", "journal": "BMJ", "type": "RCT", "typeLabel": "RCT", "author": "Singh", "doi": "10.1136/bmj-2025-085716", "url": "https://doi.org/10.1136/bmj-2025-085716", "summary": "藥師重點：結論顯示 VPM1002 與 Immuvac 整體安全性可接受，但未證實可預防 all forms of microbiologically confirmed TB 或 pulmonary TB；VPM1002 對 extrapulmonary TB 的訊號需結合族群、tuberculin skin test 狀態與後續證據審慎解讀。", "pubDate": "2026-04-09", "terms": [ "efficacy", "vpm1002", "immuvac", "preventing", "tuberculosis", "phase", "randomised", "preventb", "singh", "bmj-2025-085716" ], "drugTerms": [], "searchText": "efficacy and safety of vpm1002 and immuvac in preventing tuberculosis: phase 3 randomised clinical trial (preventb trial) bmj rct singh 10.1136/bmj-2025-085716 研究背景：結核病家庭接觸者為高風險族群，vpm1002 與 immuvac 是否能降低 microbiologically confirmed tb、latent tb infection 並維持安全性仍需大型試驗評估。 研究方法：preventb 試驗 為印度 18 個試驗地點進行的 第 3 期 隨機臨床試驗，納入 12,717 名 6 歲以上、smear 陽性 tb 患者的健康家庭接觸者。受試者以 1:1:1 分配接受 vpm1002、immuvac 或 安慰劑 皮內注射，並追蹤 38 個月；主要終點為 confirmed tb。 主要結果：per protocol 分析中，vpm1002、immuvac 與 安慰劑 組 confirmed tb 分別為 65（1.68%）、80（2.09%）與 82（2.13%）。vpm1002 對 all tb、pulmonary tb 與 extrapulmonary tb 的 疫苗 efficacy 分別為 21.4%（95% ci -8.9% to 43.2%）、19.5%（-14.6% to 43.4%）與 50.4%（0.8% to 75.2%）；兩種疫苗約三分之一受試者出現 mild local reactions。 藥師重點：結論顯示 vpm1002 與 immuvac 整體安全性可接受，但未證實可預防 all forms of microbiologically confirmed tb 或 pulmonary tb；vpm1002 對 extrapulmonary tb 的訊號需結合族群、tuberculin skin test 狀態與後續證據審慎解讀。" }, { "id": "pmid-41949879", "kind": "article", "issueId": "2026-week15", "year": 2026, "week": 15, "weekLabel": "第 15 週", "dateRange": "2026/04/06 – 04/12", "href": "2026-week15.html", "title": "Cost-Effectiveness of ApoB, Non-HDL-C, and LDL-C Goals for Primary Prevention Lipid-Lowering Therapy", "journal": "JAMA", "type": "OA", "typeLabel": "Original Article", "author": "Luebbe", "doi": "10.1001/jama.2026.2986", "url": "https://doi.org/10.1001/jama.2026.2986", "summary": "藥師重點：研究結果支持 apoB 可作為 主要 prevention LLT 強化決策的成本效益指標之一；實務採用仍需考量檢驗可近性、不同醫療支付情境，以及模型假設與真實族群差異。", "pubDate": "2026-05-05", "terms": [ "cost-effectiveness", "apob", "non-hdl-c", "ldl-c", "goals", "prevention", "lipid-lowering", "jama", "luebbe", "residual" ], "drugTerms": [ "statin" ], "searchText": "cost-effectiveness of apob, non-hdl-c, and ldl-c goals for primary prevention lipid-lowering therapy jama original article luebbe 10.1001/jama.2026.2986 研究背景：在接受 lipid-lowering 治療（llt）的患者中，apob 可能比 ldl-c 與 non-hdl-c 更能反映 residual atherosclerotic 心血管 疾病 risk；但以 apob 目標強化 主要 prevention llt 的成本效益尚未確立。 研究方法：此 economic evaluation 使用 computer simulation model，比較依 ldl-c、non-hdl-c 或 apob 目標強化 llt 的成本效益。模型建立 250,000 名符合 statin 條件且無 atherosclerotic 心血管 疾病 的美國成人 世代，依 2018 american heart association/american college of cardiology guidelines 起始 statin 治療，並在未達 ldl-c <100 mg/dl、non-hdl-c <118 mg/dl 或 apob <78.7 mg/dl 時強化治療。 主要結果：相較 ldl-c 目標，non-hdl-c 目標增加 965 qalys（95% ui -3551 to 5341 qalys），並減少 $2.1 百萬 成本（95% ui -$94.2 百萬 to $92.0 百萬）。相較 non-hdl-c 目標，apob 目標增加 1324 qalys（95% ui -2602 to 5669 qalys），成本增加 $40.2 百萬（95% ui -$43.6 百萬 to $134 百萬），incremental cost-effectiveness 比值 為 $30,300 per qaly gained。 藥師重點：研究結果支持 apob 可作為 主要 prevention llt 強化決策的成本效益指標之一；實務採用仍需考量檢驗可近性、不同醫療支付情境，以及模型假設與真實族群差異。" }, { "id": "pmid-41954928", "kind": "article", "issueId": "2026-week15", "year": 2026, "week": 15, "weekLabel": "第 15 週", "dateRange": "2026/04/06 – 04/12", "href": "2026-week15.html", "title": "Colorectal Cancer and Mortality Risk Among Older Adults With vs Without Adenoma on Prior Colonoscopy", "journal": "JAMA", "type": "OA", "typeLabel": "Original Article", "author": "Gupta", "doi": "10.1001/jama.2026.3414", "url": "https://doi.org/10.1001/jama.2026.3414", "summary": "藥師重點：結論顯示曾有 adenoma 的高齡者 CRC 與 CRC 死亡 風險雖較高，但絕對風險低且常被 non-CRC 死亡 競爭風險超過；藥師在高齡照護討論中可協助評估 frailty、預期壽命、用藥負擔與監測程序風險。", "pubDate": "2026-05-05", "terms": [ "colorectal", "cancer", "mortality", "older", "adults", "adenoma", "prior", "colonoscopy", "jama", "gupta" ], "drugTerms": [], "searchText": "colorectal cancer and mortality risk among older adults with vs without adenoma on prior colonoscopy jama original article gupta 10.1001/jama.2026.3414 研究背景：75 歲以上成人若過去 colonoscopy 曾發現 adenoma，其後續 colorectal 癌症（crc）與死亡風險仍不明確，是否持續監測需與其他健康風險一起評估。 研究方法：此 回溯性世代研究 使用 us department of veterans affairs 資料，納入 2006 年 1 月 1 日至 2019 年 12 月 31 日間、75 歲前曾接受 colonoscopy 的高齡成人。研究比較 75 歲前有無 adenoma 者在 10 年追蹤的 crc、crc 死亡、non-crc 死亡 與 全因死亡率 累積發生率，並依 veterans affairs frailty index 分層。 主要結果：共 91,952 人納入分析，最後一次 colonoscopy 時 中位數 age 71 歲（iqr 69-73），98% 為男性；25,538 人（27.8%）曾有 adenoma。10 年 crc 累積發生率為 adenoma 組 1.1%（95% ci 0.8%-1.3%）、無 adenoma 組 0.7%（0.5%-0.8%），gray test p<.001；crc 死亡 為 0.5%（0.3%-0.7%）vs 0.4%（0.3%-0.5%），p=.005；non-crc 死亡 風險遠高於 crc。 藥師重點：結論顯示曾有 adenoma 的高齡者 crc 與 crc 死亡 風險雖較高，但絕對風險低且常被 non-crc 死亡 競爭風險超過；藥師在高齡照護討論中可協助評估 frailty、預期壽命、用藥負擔與監測程序風險。" }, { "id": "pmid-41950473", "kind": "article", "issueId": "2026-week15", "year": 2026, "week": 15, "weekLabel": "第 15 週", "dateRange": "2026/04/06 – 04/12", "href": "2026-week15.html", "title": "A Phase 2 Randomized Trial of Mezagitamab in Primary Immune Thrombocytopenia", "journal": "NEJM", "type": "RCT", "typeLabel": "RCT", "author": "Kuter", "doi": "10.1056/NEJMoa2513120", "url": "https://doi.org/10.1056/NEJMoa2513120", "summary": "藥師重點：結論顯示 mezagitamab 可能提高 persistent or chronic ITP 患者血小板數，且本研究安全性與 安慰劑 大致相近；但樣本數很小，藥師解讀時需留意劑量別資料、感染或免疫相關風險與後續較大型試驗結果。", "pubDate": "2026-04-09", "terms": [ "phase", "mezagitamab", "immune", "thrombocytopenia", "nejm", "kuter", "nejmoa2513120", "anti-cd38", "plasma", "cells" ], "drugTerms": [ "mezagitamab", "anti-cd38" ], "searchText": "a phase 2 randomized trial of mezagitamab in primary immune thrombocytopenia nejm rct kuter 10.1056/nejmoa2513120 研究背景：immune thrombocytopenia（itp）會造成血小板破壞增加與生成下降，並提高出血風險；現有治療仍有至少 20% 病例療效不足。mezagitamab 為 anti-cd38 抗體，可作用於 plasma cells、plasmablasts 與 natural killer cells。 研究方法：此 多中心、雙盲、隨機、安慰劑對照 試驗 評估 mezagitamab 100 mg、300 mg 或 600 mg 相較於 安慰劑 的安全性與療效。成人 persistent or chronic itp 患者接受每週一次皮下注射、共 8 週；主要終點為 不良事件，關鍵次要終點為 week 16 前至少兩次達 platelet 反應。 主要結果：合併 mezagitamab 組 28 人、安慰劑 組 13 人，基準值 平均值 platelet count 分別為 19,100 與 17,300 per microliter。不良事件 為 68% vs 69%，等級 3 or higher 不良事件 為 18% vs 23%，嚴重不良事件 為 14% vs 8%；week 16 前 platelet 反應 在 mezagitamab 600-mg 組為 10/11（91%），合併 安慰劑 組為 3/13（23%）。 藥師重點：結論顯示 mezagitamab 可能提高 persistent or chronic itp 患者血小板數，且本研究安全性與 安慰劑 大致相近；但樣本數很小，藥師解讀時需留意劑量別資料、感染或免疫相關風險與後續較大型試驗結果。" }, { "id": "fda-2026-week15-1", "kind": "fda", "issueId": "2026-week15", "year": 2026, "week": 15, "weekLabel": "第 15 週", "dateRange": "2026/04/06 – 04/12", "href": "2026-week15.html", "title": "FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "concerns", "unapproved", "glp-1", "drugs", "used", "weight", "loss", "https", "drug-alerts-and-statements", "fdas-concerns-unapproved-glp-1-drugs-used-weight-loss" ], "drugTerms": [ "glp-1" ], "searchText": "fda’s concerns with unapproved glp-1 drugs used for weight loss fda drug safety 2026-06-15 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss" }, { "id": "fda-2026-week15-3", "kind": "fda", "issueId": "2026-week15", "year": 2026, "week": 15, "weekLabel": "第 15 週", "dateRange": "2026/04/06 – 04/12", "href": "2026-week15.html", "title": "FDA issues final decision to withdraw approval of Pepaxto (melphalan flufenamide)", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/node/398713", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "issues", "final", "decision", "withdraw", "approval", "pepaxto", "melphalan", "flufenamide", "https", "node" ], "drugTerms": [], "searchText": "fda issues final decision to withdraw approval of pepaxto (melphalan flufenamide) fda drug safety 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/node/398713" }, { "id": "fda-2026-week15-2", "kind": "fda", "issueId": "2026-week15", "year": 2026, "week": 15, "weekLabel": "第 15 週", "dateRange": "2026/04/06 – 04/12", "href": "2026-week15.html", "title": "FDA alerts patients, caregivers, and health care providers of cross-compatibility issues with autoinjector devices that are optional for use with glatiramer acetate injection", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/node/403159", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "alerts", "caregivers", "providers", "cross-compatibility", "issues", "autoinjector", "devices", "that", "optional", "glatiramer" ], "drugTerms": [], "searchText": "fda alerts patients, caregivers, and health care providers of cross-compatibility issues with autoinjector devices that are optional for use with glatiramer acetate injection fda drug safety 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/node/403159" }, { "id": "fda-2026-week15-4", "kind": "fda", "issueId": "2026-week15", "year": 2026, "week": 15, "weekLabel": "第 15 週", "dateRange": "2026/04/06 – 04/12", "href": "2026-week15.html", "title": "FDA Accepts First In Silico Drug Development Tool Under ISTAND Program to Help Predict Drug-Induced Liver Injury", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fda-accepts-first-silico-drug-development-tool-under-istand-program-help-predict-drug-induced-liver", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "accepts", "first", "silico", "development", "tool", "under", "istand", "program", "help", "predict" ], "drugTerms": [], "searchText": "fda accepts first in silico drug development tool under istand program to help predict drug-induced liver injury fda drug safety 2026-06-03 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/drugs/drug-alerts-and-statements/fda-accepts-first-silico-drug-development-tool-under-istand-program-help-predict-drug-induced-liver" }, { "id": "pmid-41910345", "kind": "article", "issueId": "2026-week14", "year": 2026, "week": 14, "weekLabel": "第 14 週", "dateRange": "2026/03/30 – 04/05", "href": "2026-week14.html", "title": "Ultrasound-Facilitated, Catheter-Directed Fibrinolysis for Acute Pulmonary Embolism", "journal": "NEJM", "type": "RCT", "typeLabel": "RCT", "author": "Rosenfield", "doi": "10.1056/NEJMoa2516567", "url": "https://doi.org/10.1056/NEJMoa2516567", "summary": "藥師重點：結論顯示在特定 intermediate-risk PE 病人中，導管超音波輔助纖溶加抗凝可降低短期惡化複合事件；藥師需協助評估 alteplase 出血風險、抗凝銜接與術後監測。", "pubDate": "2026-05-28", "terms": [ "ultrasound-facilitated", "catheter-directed", "fibrinolysis", "acute", "pulmonary", "embolism", "nejm", "rosenfield", "nejmoa2516567", "intermediate-risk" ], "drugTerms": [], "searchText": "ultrasound-facilitated, catheter-directed fibrinolysis for acute pulmonary embolism nejm rct rosenfield 10.1056/nejmoa2516567 研究背景：急性 intermediate-risk pulmonary embolism 是否僅以抗凝治療即足夠仍有爭議，特別是合併右心負荷與心肺窘迫指標者。 研究方法：此 多國 adaptive-design 試驗 納入 intermediate-risk pulmonary embolism 且具右心室擴大、troponin 升高與至少兩項心肺窘迫指標的病人 544 人，隨機接受 ultrasound-facilitated catheter-directed fibrinolysis with alteplase 加抗凝或單用抗凝；主要終點為 7 天內 pe 相關死亡、心肺代償失調或 collapse、或症狀性 pe 復發。 主要結果：主要終點發生率為介入組 4.0% vs control 組 10.3%（rr 0.39，95% ci 0.20 to 0.77；p=0.005），主要由心肺代償失調或 collapse 減少所驅動。7 天 重大出血 為 4.1% vs 2.2%，30 天為 4.1% vs 3.0%，未發生 intracranial hemorrhage。 藥師重點：結論顯示在特定 intermediate-risk pe 病人中，導管超音波輔助纖溶加抗凝可降低短期惡化複合事件；藥師需協助評估 alteplase 出血風險、抗凝銜接與術後監測。" }, { "id": "pmid-41911022", "kind": "article", "issueId": "2026-week14", "year": 2026, "week": 14, "weekLabel": "第 14 週", "dateRange": "2026/03/30 – 04/05", "href": "2026-week14.html", "title": "Sirolimus-Coated Balloon Angioplasty for Infrainguinal Artery Disease", "journal": "NEJM", "type": "OA", "typeLabel": "Original Article", "author": "Barco", "doi": "10.1056/NEJMoa2600360", "url": "https://doi.org/10.1056/NEJMoa2600360", "summary": "藥師重點：結論顯示 sirolimus-coated balloon angioplasty 可降低 infrainguinal 動脈 疾病 血管內治療後 1 年 重大 adverse limb 事件；藥師仍需協助周邊動脈疾病病人的抗栓、降脂與傷口照護用藥整合。", "pubDate": "2026-03-30", "terms": [ "sirolimus-coated", "balloon", "angioplasty", "infrainguinal", "artery", "nejm", "barco", "nejmoa2600360", "adverse", "limb" ], "drugTerms": [], "searchText": "sirolimus-coated balloon angioplasty for infrainguinal artery disease nejm original article barco 10.1056/nejmoa2600360 研究背景：infrainguinal 動脈 疾病 接受血管內治療後仍可能發生 重大 adverse limb 事件，sirolimus-coated balloon 是否優於 uncoated balloon 仍需臨床試驗證實。 研究方法：此 prospective 開放標籤 不劣性 試驗 納入 1252 名 infrainguinal 動脈 疾病 病人，1:1 分配 sirolimus-coated balloon 或 uncoated balloon angioplasty；主要終點為 1 年內目標肢體非計畫 重大 amputation 或因 critical limb ischemia 進行目標病灶再血運重建。 主要結果：主要終點為 sirolimus-coated balloon 組 8.8% vs uncoated balloon 組 15.0%（風險差 -4.9 百分點，95% ci -8.5 to -1.3；p<0.001 for 不劣性；p=0.009 for superiority）。1 年死亡為 11.8% vs 12.8%，不良事件發生率大致相近。 藥師重點：結論顯示 sirolimus-coated balloon angioplasty 可降低 infrainguinal 動脈 疾病 血管內治療後 1 年 重大 adverse limb 事件；藥師仍需協助周邊動脈疾病病人的抗栓、降脂與傷口照護用藥整合。" }, { "id": "pmid-41905383", "kind": "article", "issueId": "2026-week14", "year": 2026, "week": 14, "weekLabel": "第 14 週", "dateRange": "2026/03/30 – 04/05", "href": "2026-week14.html", "title": "Progress towards the WHO Global Initiative for Childhood Cancer target of 60% 5-year survival for all childhood cancers combined, 1990-2019 (CONCORD-4): a Cancer Survival Index derived for 68 countries by analysis of individual records for 613 021 children from 307 population-based cancer registries", "journal": "Lancet", "type": "OA", "typeLabel": "Original Article", "author": "Allemani", "doi": "10.1016/S0140-6736(26)00189-3", "url": "https://doi.org/10.1016/S0140-6736(26)00189-3", "summary": "藥師重點：研究結果說明 CSI 可用於跨國監測兒童癌症存活進展，許多參與國已接近或超過 60% 目標；臨床解讀仍需注意 registry 覆蓋率、國家收入層級與癌別組成差異。", "pubDate": "2026-04-04", "terms": [ "progress", "towards", "global", "initiative", "childhood", "cancer", "target", "year", "survival", "cancers" ], "drugTerms": [], "searchText": "progress towards the who global initiative for childhood cancer target of 60% 5-year survival for all childhood cancers combined, 1990-2019 (concord-4): a cancer survival index derived for 68 countries by analysis of individual records for 613 021 children from 307 population-based cancer registries lancet original article allemani 10.1016/s0140-6736(26)00189-3 研究背景：who global initiative for childhood 癌症 設定 2030 年全球兒童癌症 5 年存活率達 60% 的目標，concord-4 評估多國長期趨勢與是否接近此目標。 研究方法：研究邀請 101 國 513 個 族群-based 癌症 registries，收集 1990-2019 年或更新年度 0-14 歲兒童癌症個案資料；以 2010-2019 年資料建立依年齡、性別與癌症 subtype 加權的 癌症 存活期 index（csi），估計 5-year net 存活期。 主要結果：研究收到 68 個國家與地區、307 個 registry 的 679,776 筆兒童癌症資料，存活分析限制於 613,021 名 1990-2019 年診斷兒童。2015-2019 年 all childhood cancers csi 在多數高收入國家 >80%，多數 upper-middle-income countries 為 60-80%，5 個 lower-middle-income countries 為 50-60%。 藥師重點：研究結果說明 csi 可用於跨國監測兒童癌症存活進展，許多參與國已接近或超過 60% 目標；臨床解讀仍需注意 registry 覆蓋率、國家收入層級與癌別組成差異。" }, { "id": "pmid-41916664", "kind": "article", "issueId": "2026-week14", "year": 2026, "week": 14, "weekLabel": "第 14 週", "dateRange": "2026/03/30 – 04/05", "href": "2026-week14.html", "title": "Peer support intervention (ABA-feed) to improve breastfeeding: UK based, multicentre, parallel group, randomised controlled trial", "journal": "BMJ", "type": "RCT", "typeLabel": "RCT", "author": "Jolly", "doi": "10.1136/bmj-2025-086558", "url": "https://doi.org/10.1136/bmj-2025-086558", "summary": "藥師重點：研究結果說明 ABA-feed 在英國情境下未提升哺乳率；臨床衛教可參考其增加短期社會支持的可能性，但不宜期待單一同儕支持方案即可改善主要哺乳結果。", "pubDate": "2026-03-31", "terms": [ "peer", "support", "intervention", "aba-feed", "improve", "breastfeeding", "multicentre", "parallel", "randomised", "jolly" ], "drugTerms": [], "searchText": "peer support intervention (aba-feed) to improve breastfeeding: uk based, multicentre, parallel group, randomised controlled trial bmj rct jolly 10.1136/bmj-2025-086558 研究背景：產後哺乳支持常仰賴常規照護與被動求助，aba-feed peer support 是否能進一步提高哺乳率仍需大型試驗確認。 研究方法：此英國多中心、parallel-group、unblinded 隨機對照試驗 納入 2475 名妊娠 20-35 週初產婦，比較 aba-feed 主動式同儕支持加 常規照護 與 常規照護 單用；主要終點為產後 8 週仍有任何哺乳。 主要結果：產後 8 週任何哺乳率在介入組與 常規照護 組相近（1013/1452，69.8% vs 698/1015，68.8%；校正 風險差 0.01，95% ci -0.03 to 0.04），其他多數次要終點亦未見差異。 藥師重點：研究結果說明 aba-feed 在英國情境下未提升哺乳率；臨床衛教可參考其增加短期社會支持的可能性，但不宜期待單一同儕支持方案即可改善主要哺乳結果。" }, { "id": "pmid-41916649", "kind": "article", "issueId": "2026-week14", "year": 2026, "week": 14, "weekLabel": "第 14 週", "dateRange": "2026/03/30 – 04/05", "href": "2026-week14.html", "title": "Medial retropharyngeal nodal region sparing radiotherapy in nasopharyngeal carcinoma: five year analysis of open label, non-inferiority, multicentre, randomised phase 3 trial", "journal": "BMJ", "type": "RCT", "typeLabel": "RCT", "author": "Wang", "doi": "10.1136/bmj-2025-086050", "url": "https://doi.org/10.1136/bmj-2025-086050", "summary": "藥師重點：結論顯示在無 MRLN 侵犯的非轉移性鼻咽癌，MRLN sparing radiotherapy 可維持局部控制並改善長期吞嚥相關結果；臨床採用仍需由放射腫瘤團隊依影像侵犯範圍評估。", "pubDate": "2026-03-31", "terms": [ "medial", "retropharyngeal", "nodal", "region", "sparing", "radiotherapy", "nasopharyngeal", "carcinoma", "five", "year" ], "drugTerms": [], "searchText": "medial retropharyngeal nodal region sparing radiotherapy in nasopharyngeal carcinoma: five year analysis of open label, non-inferiority, multicentre, randomised phase 3 trial bmj rct wang 10.1136/bmj-2025-086050 研究背景：鼻咽癌放射治療可能造成吞嚥功能受損，保留 medial retropharyngeal lymph node（mrln）區域是否能維持療效並降低長期毒性仍需追蹤。 研究方法：此 開放標籤、不劣性、多中心 隨機 第 3 期試驗 的 5 年預設分析，納入未治療、非角化、非轉移性且無 mrln 侵犯的鼻咽癌成人，1:1 分配 mrln sparing radiotherapy 或 standard radiotherapy。 主要結果：568 人納入分析，中位數 追蹤 70 個月；5 年 local relapse-free 存活期 為 89.2% vs 90.6%（stratified hr 1.03，95% ci 0.61 to 1.74；p=0.90），整體存活期 為 89.2% vs 90.3%。mrln sparing 組 等級 ≥1 dysphagia 與 等級 ≥2 dry mouth 較低。 藥師重點：結論顯示在無 mrln 侵犯的非轉移性鼻咽癌，mrln sparing radiotherapy 可維持局部控制並改善長期吞嚥相關結果；臨床採用仍需由放射腫瘤團隊依影像侵犯範圍評估。" }, { "id": "pmid-41910394", "kind": "article", "issueId": "2026-week14", "year": 2026, "week": 14, "weekLabel": "第 14 週", "dateRange": "2026/03/30 – 04/05", "href": "2026-week14.html", "title": "Mavacamten in Adolescents with Obstructive Hypertrophic Cardiomyopathy", "journal": "NEJM", "type": "OA", "typeLabel": "Original Article", "author": "Rossano", "doi": "10.1056/NEJMoa2601103", "url": "https://doi.org/10.1056/NEJMoa2601103", "summary": "藥師重點：結論顯示 mavacamten 可明顯降低青少年 obstructive hypertrophic cardiomyopathy 的 LVOT obstruction；實務仍需依藥品可近性與適應症，嚴密追蹤 LVEF、症狀與潛在交互作用。", "pubDate": "2026-03-29", "terms": [ "mavacamten", "adolescents", "obstructive", "hypertrophic", "cardiomyopathy", "nejm", "rossano", "nejmoa2601103", "cardiac", "myosin" ], "drugTerms": [], "searchText": "mavacamten in adolescents with obstructive hypertrophic cardiomyopathy nejm original article rossano 10.1056/nejmoa2601103 研究背景：兒童與青少年 obstructive hypertrophic cardiomyopathy 缺乏核准藥物選項，成人可用的 cardiac myosin 抑制劑 mavacamten 需評估於青少年族群的療效與安全性。 研究方法：此 第 3 期、雙盲、隨機 安慰劑對照 試驗 納入 12 至 <18 歲、nyha class ii 或 iii 有症狀 obstructive hypertrophic cardiomyopathy 青少年 44 人，1:1 分配 mavacamten 或 安慰劑；主要終點為 week 28 valsalva provoked lvot pressure gradient 自基準變化。 主要結果：week 28 valsalva lvot gradient 最小平方平均變化 為 mavacamten -48.5 mm hg vs 安慰劑 -0.5 mm hg（差異 -48.0 mm hg，95% ci -67.7 to -28.3；p<0.001）。不良事件發生率相近，無 lvef 降至 <50%，試驗期間無死亡。 藥師重點：結論顯示 mavacamten 可明顯降低青少年 obstructive hypertrophic cardiomyopathy 的 lvot obstruction；實務仍需依藥品可近性與適應症，嚴密追蹤 lvef、症狀與潛在交互作用。" }, { "id": "pmid-41910380", "kind": "article", "issueId": "2026-week14", "year": 2026, "week": 14, "weekLabel": "第 14 週", "dateRange": "2026/03/30 – 04/05", "href": "2026-week14.html", "title": "Left Ventricular Unloading in High-Risk Percutaneous Coronary Intervention", "journal": "NEJM", "type": "RCT", "typeLabel": "RCT", "author": "Perera", "doi": "10.1056/NEJMoa2515704", "url": "https://doi.org/10.1056/NEJMoa2515704", "summary": "藥師重點：研究結果未支持在高風險複雜 PCI 常規使用 elective microaxial flow pump unloading 以降低重大臨床事件；藥師可留意此類病人仍需嚴密監測血流動力、抗栓治療與併發症。", "pubDate": "2026-05-07", "terms": [ "left", "ventricular", "unloading", "high-risk", "percutaneous", "coronary", "intervention", "nejm", "perera", "nejmoa2515704" ], "drugTerms": [], "searchText": "left ventricular unloading in high-risk percutaneous coronary intervention nejm rct perera 10.1056/nejmoa2515704 研究背景：嚴重左心室功能不全且需複雜 pci 的病人併發症風險高，elective left ventricular unloading 是否能改善臨床結果仍不確定。 研究方法：研究將 300 名 重度 left ventricular 功能障礙 且 extensive 冠狀動脈 動脈 疾病 病人 1:1 分配至計畫性複雜 pci 期間使用 microaxial flow pump unloading 或 標準照護；主要終點為以 win 比值 分析的階層式複合事件，包含全因死亡、失能性中風、自發性心肌梗塞、心血管住院或程序相關心肌損傷。 主要結果：中位數 追蹤 22 個月，36.6% pairwise comparisons 有利於 microaxial flow pump，43.0% 有利於 標準照護（win 比值 0.85，95% ci 0.63 to 1.15；p=0.30）。全因死亡為 47 人 vs 33 人（hr 1.54，95% ci 0.99 to 2.41），出血或血管併發症未見實質差異。 藥師重點：研究結果未支持在高風險複雜 pci 常規使用 elective microaxial flow pump unloading 以降低重大臨床事件；藥師可留意此類病人仍需嚴密監測血流動力、抗栓治療與併發症。" }, { "id": "pmid-41910347", "kind": "article", "issueId": "2026-week14", "year": 2026, "week": 14, "weekLabel": "第 14 週", "dateRange": "2026/03/30 – 04/05", "href": "2026-week14.html", "title": "Left Atrial Appendage Closure or Anticoagulation for Atrial Fibrillation", "journal": "NEJM", "type": "RCT", "typeLabel": "RCT", "author": "Doshi", "doi": "10.1056/NEJMoa2517213", "url": "https://doi.org/10.1056/NEJMoa2517213", "summary": "藥師重點：結論顯示在適合抗凝的心房顫動病人，左心耳封堵 對主要栓塞相關複合終點不劣於 NOAC，且非程序相關出血較少；選擇時仍需納入程序風險與短期術後抗栓策略。", "pubDate": "2026-06-04", "terms": [ "left", "atrial", "appendage", "closure", "anticoagulation", "fibrillation", "nejm", "doshi", "nejmoa2517213", "anticoagulant" ], "drugTerms": [], "searchText": "left atrial appendage closure or anticoagulation for atrial fibrillation nejm rct doshi 10.1056/nejmoa2517213 研究背景：心房顫動病人使用 口服 anticoagulant 預防中風會受出血風險限制，左心耳封堵 在可使用抗凝者中的定位尚未確立。 研究方法：此 進行中、prospective、international 隨機試驗 納入適合抗凝治療的心房顫動病人 3000 人，1:1 分配 device-based 左心耳封堵 或 noac 治療；主要療效終點為 3 年心血管死亡、中風或全身性栓塞，主要安全終點為非程序相關出血。 主要結果：3 年主要療效終點為 device 組 5.7% vs noac 組 4.8%（差異 0.9 百分點，95% ci -0.8 to 2.6；p<0.001 for 不劣性）。non-procedure-related 出血 為 10.9% vs 19.0%（hr 0.55，95% ci 0.45 to 0.67；p<0.001）。 藥師重點：結論顯示在適合抗凝的心房顫動病人，左心耳封堵 對主要栓塞相關複合終點不劣於 noac，且非程序相關出血較少；選擇時仍需納入程序風險與短期術後抗栓策略。" }, { "id": "pmid-41910985", "kind": "article", "issueId": "2026-week14", "year": 2026, "week": 14, "weekLabel": "第 14 週", "dateRange": "2026/03/30 – 04/05", "href": "2026-week14.html", "title": "Lead-Attributable Cardiovascular Disease Burden: Global Burden of Disease Study 2023", "journal": "JAMA", "type": "MA", "typeLabel": "Meta-analysis", "author": "Stanaway", "doi": "10.1001/jama.2026.2197", "url": "https://doi.org/10.1001/jama.2026.2197", "summary": "藥師重點：研究結果說明累積鉛暴露仍是全球心血管疾病可預防負擔之一；臨床與公衛端可強化高風險族群暴露史詢問、監測與環境減量政策連結。", "pubDate": "2026-04-28", "terms": [ "lead-attributable", "cardiovascular", "burden", "global", "jama", "meta-analysis", "stanaway", "nhanes", "meta-regression", "dalys" ], "drugTerms": [], "searchText": "lead-attributable cardiovascular disease burden: global burden of disease study 2023 jama meta-analysis stanaway 10.1001/jama.2026.2197 研究背景：鉛暴露雖已下降，仍可能是心血管死亡的重要可預防風險因子；以累積骨鉛估計全球疾病負擔可協助公共衛生決策。 研究方法：研究結合 nhanes 1988-2013 年 42,028 名成人資料、死亡追蹤至 2015 年，以及 systematic review 與 meta-regression；以血鉛、年齡與世代暴露史估計骨鉛，並推估 1990-2023 年全球、區域與國家的鉛暴露歸因心血管疾病負擔。 主要結果：較高骨鉛與較高心血管死亡風險相關；以 2023 年估計，全球有 350 萬例死亡（95% ui 260-440 萬）與 7160 萬 dalys（95% ui 5240-9030 萬）歸因於鉛暴露，分別占所有死亡 5.8% 與所有 dalys 2.6%。 藥師重點：研究結果說明累積鉛暴露仍是全球心血管疾病可預防負擔之一；臨床與公衛端可強化高風險族群暴露史詢問、監測與環境減量政策連結。" }, { "id": "pmid-41910396", "kind": "article", "issueId": "2026-week14", "year": 2026, "week": 14, "weekLabel": "第 14 週", "dateRange": "2026/03/30 – 04/05", "href": "2026-week14.html", "title": "Iptacopan in IgA Nephropathy - Final 24-Month Data", "journal": "NEJM", "type": "OA", "typeLabel": "Original Article", "author": "Barratt", "doi": "10.1056/NEJMoa2600743", "url": "https://doi.org/10.1056/NEJMoa2600743", "summary": "藥師重點：結論顯示 iptacopan 可減緩 IgA nephropathy 腎功能下降並降低腎衰竭複合事件；藥師需留意補體抑制相關感染風險、疫苗與腎功能及蛋白尿追蹤。", "pubDate": "2026-03-29", "terms": [ "iptacopan", "nephropathy", "final", "month", "nejm", "barratt", "nejmoa2600743", "alternative", "complement", "pathway" ], "drugTerms": [], "searchText": "iptacopan in iga nephropathy - final 24-month data nejm original article barratt 10.1056/nejmoa2600743 研究背景：alternative complement pathway 過度活化會促進 iga nephropathy 腎絲球發炎，iptacopan 為 complement factor b 抑制劑，先前 9 個月分析已顯示可降低蛋白尿。 研究方法：此 第 3 期試驗 納入接受支持性治療後仍有 iga nephropathy、egfr ≥30 ml/min/1.73 m2 且 24 小時 urinary protein-to-creatinine 比值 ≥1 的成人 477 人，1:1 分配 iptacopan 200 mg 每日兩次 或 安慰劑；最終分析主要終點為 24 個月 annualized total egfr slope。 主要結果：iptacopan 組 annualized total egfr slope 為 -3.10 vs 安慰劑 -6.12 ml/min/1.73 m2/year（差異 3.02，95% ci 2.02 to 4.01；校正 p<0.001）。複合 kidney-failure 終點 為 21.4% vs 33.5%（hr 0.57，95% ci 0.40 to 0.81；校正 p=0.003），嚴重感染為 6.7% vs 2.1%。 藥師重點：結論顯示 iptacopan 可減緩 iga nephropathy 腎功能下降並降低腎衰竭複合事件；藥師需留意補體抑制相關感染風險、疫苗與腎功能及蛋白尿追蹤。" }, { "id": "pmid-41911016", "kind": "article", "issueId": "2026-week14", "year": 2026, "week": 14, "weekLabel": "第 14 週", "dateRange": "2026/03/30 – 04/05", "href": "2026-week14.html", "title": "Intravascular Ultrasound-Guided or Angiography-Guided Complex High-Risk PCI", "journal": "NEJM", "type": "RCT", "typeLabel": "RCT", "author": "Diletti", "doi": "10.1056/NEJMoa2601521", "url": "https://doi.org/10.1056/NEJMoa2601521", "summary": "藥師重點：結論顯示 routine IVUS-guided complex high-risk PCI 未降低 目標血管失敗；藥師解讀介入結果時可留意此研究不支持將影像導引視為一定改善臨床事件的策略。", "pubDate": "2026-06-11", "terms": [ "intravascular", "ultrasound-guided", "angiography-guided", "complex", "high-risk", "nejm", "diletti", "nejmoa2601521", "ivus", "guidance" ], "drugTerms": [], "searchText": "intravascular ultrasound-guided or angiography-guided complex high-risk pci nejm rct diletti 10.1056/nejmoa2601521 研究背景：ivus guidance 可提升 stent optimization，但在歐洲當代 complex high-risk pci 實務中，是否能降低 目標血管失敗 仍需直接證據。 研究方法：此 investigator-initiated、international 開放標籤 隨機試驗 納入接受 complex pci 的病人 2020 人，分配至依預設 stent-optimization criteria 執行 ivus-guided pci 或 angiography-guided pci；主要終點為心因性死亡、target-vessel myocardial infarction 或 clinically indicated target-vessel revascularization。 主要結果：中位數 追蹤 19.0 個月，目標血管失敗 為 ivus-guided pci 組 13.9% vs angiography-guided pci 組 11.1%（hr 1.25，95% ci 0.97 to 1.60；p=0.08）。ivus 組 procedure duration 較長，程序併發症與不良事件頻率相近。 藥師重點：結論顯示 routine ivus-guided complex high-risk pci 未降低 目標血管失敗；藥師解讀介入結果時可留意此研究不支持將影像導引視為一定改善臨床事件的策略。" }, { "id": "pmid-41910315", "kind": "article", "issueId": "2026-week14", "year": 2026, "week": 14, "weekLabel": "第 14 週", "dateRange": "2026/03/30 – 04/05", "href": "2026-week14.html", "title": "Intensive LDL Cholesterol Targeting in Atherosclerotic Cardiovascular Disease", "journal": "NEJM", "type": "RCT", "typeLabel": "RCT", "author": "Lee", "doi": "10.1056/NEJMoa2600283", "url": "https://doi.org/10.1056/NEJMoa2600283", "summary": "藥師重點：研究結果支持 ASCVD 次級預防中較積極 LDL 膽固醇 目標可降低 3 年心血管事件；藥師需協助追蹤降脂藥物耐受性、腎功能與是否能穩定達標。", "pubDate": "2026-04-09", "terms": [ "intensive", "cholesterol", "targeting", "atherosclerotic", "cardiovascular", "nejm", "nejmoa2600283", "nonfatal", "myocardial", "infarction" ], "drugTerms": [], "searchText": "intensive ldl cholesterol targeting in atherosclerotic cardiovascular disease nejm rct lee 10.1056/nejmoa2600283 研究背景：動脈粥樣硬化心血管疾病次級預防需控制 ldl 膽固醇，但 隨機試驗 對 <55 mg/dl 與 <70 mg/dl 目標的直接比較仍有限。 研究方法：此韓國 開放標籤 優越性試驗 將 3048 名 atherosclerotic 心血管 疾病 病人 1:1 分配至 ldl 膽固醇 目標 <55 mg/dl 或 <70 mg/dl；主要終點為 3 年 心血管 死亡、nonfatal myocardial infarction、nonfatal stroke、revascularization 或 unstable angina 住院。 主要結果：3 年追蹤中，intensive-targeting 組與 conventional-targeting 組 試驗 期間 中位數 ldl 膽固醇 為 56 vs 66 mg/dl；主要終點為 6.6% vs 9.7%（hr 0.67，95% ci 0.52 to 0.86；p=0.002），多數安全性終點相近。 藥師重點：研究結果支持 ascvd 次級預防中較積極 ldl 膽固醇 目標可降低 3 年心血管事件；藥師需協助追蹤降脂藥物耐受性、腎功能與是否能穩定達標。" }, { "id": "pmid-41911017", "kind": "article", "issueId": "2026-week14", "year": 2026, "week": 14, "weekLabel": "第 14 週", "dateRange": "2026/03/30 – 04/05", "href": "2026-week14.html", "title": "IVUS-Guided versus Angiography-Guided PCI in Unprotected Left Main Coronary Disease", "journal": "NEJM", "type": "RCT", "typeLabel": "RCT", "author": "Testa", "doi": "10.1056/NEJMoa2600440", "url": "https://doi.org/10.1056/NEJMoa2600440", "summary": "藥師重點：研究結果未顯示 unprotected left main PCI 中常規 IVUS guidance 可優於 angiography guidance；臨床仍需依病灶複雜度、造影品質與介入醫師判斷使用影像導引。", "pubDate": "2026-06-11", "terms": [ "ivus-guided", "angiography-guided", "unprotected", "left", "main", "coronary", "nejm", "testa", "nejmoa2600440", "ivus" ], "drugTerms": [], "searchText": "ivus-guided versus angiography-guided pci in unprotected left main coronary disease nejm rct testa 10.1056/nejmoa2600440 研究背景：unprotected left main 冠狀動脈 動脈 疾病 越來越常以 pci 進行血運重建，ivus guidance 是否比單純 angiography guidance 改善長期結果仍不確定。 研究方法：此 international 多中心 開放標籤試驗 將 806 名 unprotected left main 冠狀動脈 動脈 疾病 病人 1:1 分配接受 ivus-guided pci 或 angiography-guided pci；主要終點為最長追蹤期間任何中風、心肌梗塞、再血運重建或全因死亡的 patient-oriented 複合。 主要結果：中位數 追蹤 2.9 年，主要終點為 ivus-guided pci 組 33.7% vs angiography-guided pci 組 30.9%（hr 1.11，95% ci 0.87 to 1.42；p=0.40），死亡、心肌梗塞、再血運重建與安全事件大致相近。 藥師重點：研究結果未顯示 unprotected left main pci 中常規 ivus guidance 可優於 angiography guidance；臨床仍需依病灶複雜度、造影品質與介入醫師判斷使用影像導引。" }, { "id": "pmid-41905364", "kind": "article", "issueId": "2026-week14", "year": 2026, "week": 14, "weekLabel": "第 14 週", "dateRange": "2026/03/30 – 04/05", "href": "2026-week14.html", "title": "Efficacy and safety of LEVI-04 in patients with osteoarthritis of the knee: a randomised, double-blind, placebo-controlled, phase 2 trial", "journal": "Lancet", "type": "RCT", "typeLabel": "RCT", "author": "Conaghan", "doi": "10.1016/S0140-6736(26)00131-5", "url": "https://doi.org/10.1016/S0140-6736(26)00131-5", "summary": "藥師重點：結論顯示 LEVI-04 對膝關節骨關節炎疼痛與功能有改善訊號且耐受性尚可；但目前為 第 2 期 資料，藥師解讀時仍需留意劑量、給藥途徑與長期關節安全性。", "pubDate": "2026-03-28", "terms": [ "efficacy", "levi-04", "osteoarthritis", "knee", "randomised", "double-blind", "placebo-controlled", "phase", "lancet", "conaghan" ], "drugTerms": [], "searchText": "efficacy and safety of levi-04 in patients with osteoarthritis of the knee: a randomised, double-blind, placebo-controlled, phase 2 trial lancet rct conaghan 10.1016/s0140-6736(26)00131-5 研究背景：膝關節骨關節炎現有治療仍有限，levi-04 為 p75 neurotrophin 受體（p75ntr）fusion protein，可抑制 neurotrophin-3，本研究評估其止痛與安全性。 研究方法：此 隨機、雙盲、安慰劑對照 第 2 期 試驗 納入具疼痛與影像學膝關節骨關節炎者 518 人，1:1:1:1 分配每月靜脈給予 安慰劑 或 levi-04 0·3、1·0、2·0 mg/kg 至 week 16；主要終點為 week 17 womac pain 變化。 主要結果：week 17 時 levi-04 0·3、1·0、2·0 mg/kg 相較 安慰劑 的 womac pain least squares 平均差 分別為 -0·51、-0·62、-0·79，且未增加嚴重不良事件、治療期間不良事件或快速惡化骨關節炎等關節病變。 藥師重點：結論顯示 levi-04 對膝關節骨關節炎疼痛與功能有改善訊號且耐受性尚可；但目前為 第 2 期 資料，藥師解讀時仍需留意劑量、給藥途徑與長期關節安全性。" }, { "id": "pmid-41910427", "kind": "article", "issueId": "2026-week14", "year": 2026, "week": 14, "weekLabel": "第 14 週", "dateRange": "2026/03/30 – 04/05", "href": "2026-week14.html", "title": "Discontinuation of Beta-Blocker Therapy after Myocardial Infarction", "journal": "NEJM", "type": "RCT", "typeLabel": "RCT", "author": "Choi", "doi": "10.1056/NEJMoa2601005", "url": "https://doi.org/10.1056/NEJMoa2601005", "summary": "藥師重點：結論顯示對已超過心肌梗塞後 1 年、LVEF 保留且無心衰竭者，停用 beta-blocker 在複合臨床終點上不劣於續用；藥師可協助評估心率、血壓、其他適應症與停藥後監測。", "pubDate": "2026-04-02", "terms": [ "discontinuation", "beta-blocker", "myocardial", "infarction", "nejm", "choi", "nejmoa2601005", "lvef" ], "drugTerms": [], "searchText": "discontinuation of beta-blocker therapy after myocardial infarction nejm rct choi 10.1056/nejmoa2601005 研究背景：在現代冠狀動脈再灌流與次級預防治療下，無左心室收縮功能不全或心衰竭的心肌梗塞病人是否需長期使用 beta-blocker 仍不明確。 研究方法：此韓國 25 中心 開放標籤、隨機 不劣性 試驗 納入心肌梗塞後狀況穩定、lvef ≥40%、無心衰竭且已使用 beta-blocker 至少 1 年的病人 2540 人，1:1 分配停用或續用 beta-blocker；主要終點為全因死亡、復發心肌梗塞或心衰竭住院。 主要結果：中位數 追蹤 3.1 年，主要終點在停用組與續用組分別為 7.2% vs 9.0%（hr 0.80，95% ci 0.57 to 1.13；p=0.001 for 不劣性），嚴重不良事件 發生率相近。 藥師重點：結論顯示對已超過心肌梗塞後 1 年、lvef 保留且無心衰竭者，停用 beta-blocker 在複合臨床終點上不劣於續用；藥師可協助評估心率、血壓、其他適應症與停藥後監測。" }, { "id": "pmid-41921523", "kind": "article", "issueId": "2026-week14", "year": 2026, "week": 14, "weekLabel": "第 14 週", "dateRange": "2026/03/30 – 04/05", "href": "2026-week14.html", "title": "Deferral of percutaneous coronary intervention in patients undergoing transcatheter aortic valve implantation (PRO-TAVI): an investigator-initiated, multicentre, open-label, non-inferiority, randomised controlled trial", "journal": "Lancet", "type": "RCT", "typeLabel": "RCT", "author": "Delewi", "doi": "10.1016/S0140-6736(26)00308-9", "url": "https://doi.org/10.1016/S0140-6736(26)00308-9", "summary": "藥師重點：結論顯示在選定 TAVI 合併冠狀動脈疾病病人中，延後 PCI 對 1 年複合事件不劣於 TAVI 前 PCI；團隊決策仍需依冠狀動脈解剖、症狀、抗血小板與出血風險個別化。", "pubDate": "2026-04-11", "terms": [ "deferral", "percutaneous", "coronary", "intervention", "undergoing", "transcatheter", "aortic", "valve", "implantation", "pro-tavi" ], "drugTerms": [], "searchText": "deferral of percutaneous coronary intervention in patients undergoing transcatheter aortic valve implantation (pro-tavi): an investigator-initiated, multicentre, open-label, non-inferiority, randomised controlled trial lancet rct delewi 10.1016/s0140-6736(26)00308-9 研究背景：接受 tavi 的病人常合併冠狀動脈疾病，是否需在 tavi 前常規執行 pci，或可先延後 pci，仍是臨床決策問題。 研究方法：pro-tavi 為荷蘭 12 家醫院 investigator-initiated、開放標籤、不劣性 隨機試驗，將合併冠狀動脈疾病的 tavi 病人 466 人分配至 deferral of pci 或 tavi 前 pci；主要終點為 1 年全因死亡、心肌梗塞、中風與 重大出血 複合事件。 主要結果：主要終點發生率為 deferral 組 24% vs pci 組 26%（比率 差異 -1·7%，95% ci -9·5 to 6·2；hr 0·89，95% ci 0·62-1·28；p=0·0008 for 不劣性），superiority 未達顯著。 藥師重點：結論顯示在選定 tavi 合併冠狀動脈疾病病人中，延後 pci 對 1 年複合事件不劣於 tavi 前 pci；團隊決策仍需依冠狀動脈解剖、症狀、抗血小板與出血風險個別化。" }, { "id": "pmid-41931048", "kind": "article", "issueId": "2026-week14", "year": 2026, "week": 14, "weekLabel": "第 14 週", "dateRange": "2026/03/30 – 04/05", "href": "2026-week14.html", "title": "CRISPR-Cas12a Gene Editing of HBG1 and HBG2 Promoters to Treat β-Thalassemia", "journal": "NEJM", "type": "OA", "typeLabel": "Original Article", "author": "Frangoul", "doi": "10.1056/NEJMoa2501277", "url": "https://doi.org/10.1056/NEJMoa2501277", "summary": "藥師重點：研究結果顯示 reni-cel 在小型早期研究中可提高 HbF 並達成輸血獨立，但研究提前終止且分析非預設；藥師解讀時需特別留意 conditioning 毒性、感染與長期追蹤不足。", "pubDate": "2026-04-02", "terms": [ "crispr-cas12a", "gene", "editing", "hbg1", "hbg2", "promoters", "treat", "thalassemia", "nejm", "frangoul" ], "drugTerms": [], "searchText": "crispr-cas12a gene editing of hbg1 and hbg2 promoters to treat β-thalassemia nejm original article frangoul 10.1056/nejmoa2501277 研究背景：reni-cel 為 investigational crispr-cas12a gene-edited autologous hematopoietic stem-cell 治療，透過破壞 hbg1/hbg2 promoters 的 bcl11a binding sites 以重新活化 fetal hemoglobin，用於 transfusion-dependent β-thalassemia。 研究方法：此 第 1 期-2 多中心 開放標籤 single-group 研究 納入 18-35 歲 transfusion-dependent β-thalassemia 參與者 9 人，busulfan myeloablative conditioning 後輸注 reni-cel；主要終點為 42 天內 neutrophil engraftment 與不良事件。 主要結果：中位數 postinfusion 追蹤 17.5 個月，所有參與者於 42 天內完成 neutrophil 與 platelet engraftment；9 人最後追蹤時皆不需輸血，6 名可評估 12 個月以上者達 transfusion independence。共通報 69 件 等級 3 或 4 不良事件，6 件 嚴重不良事件 發生於 4 人，多數與 myeloablative conditioning 一致。 藥師重點：研究結果顯示 reni-cel 在小型早期研究中可提高 hbf 並達成輸血獨立，但研究提前終止且分析非預設；藥師解讀時需特別留意 conditioning 毒性、感染與長期追蹤不足。" }, { "id": "pmid-41931047", "kind": "article", "issueId": "2026-week14", "year": 2026, "week": 14, "weekLabel": "第 14 週", "dateRange": "2026/03/30 – 04/05", "href": "2026-week14.html", "title": "CRISPR-Cas12a Gene Editing of HBG1 and HBG2 Promoters to Treat Sickle Cell Disease", "journal": "NEJM", "type": "OA", "typeLabel": "Original Article", "author": "Hanna", "doi": "10.1056/NEJMoa2415550", "url": "https://doi.org/10.1056/NEJMoa2415550", "summary": "藥師重點：結論顯示 reni-cel 對 重度 sickle cell 疾病 有提高 total hemoglobin 與 HbF、減少 vaso-occlusive 事件 的早期訊號；但研究為單組且提前終止，需審慎評估 busulfan conditioning 與長期基因編輯安全性。", "pubDate": "2026-04-02", "terms": [ "crispr-cas12a", "gene", "editing", "hbg1", "hbg2", "promoters", "treat", "sickle", "cell", "nejm" ], "drugTerms": [], "searchText": "crispr-cas12a gene editing of hbg1 and hbg2 promoters to treat sickle cell disease nejm original article hanna 10.1056/nejmoa2415550 研究背景：reni-cel 透過 crispr-cas12a gene editing 破壞 hbg1/hbg2 promoters 的 bcl11a binding sites，以重新活化 fetal hemoglobin，可能用於 重度 sickle cell 疾病。 研究方法：此 第 1 期-2 多中心 開放標籤 single-group 研究 納入 12-50 歲、過去 2 年每年至少 2 次 重度 vaso-occlusive 事件 的 重度 sickle cell 疾病 病人；busulfan myeloablative conditioning 後單次輸注 reni-cel，追蹤 engraftment、hemoglobin measures、allelic editing、vaso-occlusive 事件 與 不良事件。 主要結果：截至 2024 年 10 月 29 日，共 28 人接受 reni-cel，中位數 追蹤 9.5 個月；27 人完成 neutrophil 與 platelet engraftment。month 6 時，18 名有資料者 平均值 total hemoglobin 由 9.8±1.7 增至 13.8±1.9 g/dl，平均值 fetal hemoglobin 由 2.5±2.5% 增至 48.1±3.2%；輸注後 27/28 人未再發生 vaso-occlusive 事件。 藥師重點：結論顯示 reni-cel 對 重度 sickle cell 疾病 有提高 total hemoglobin 與 hbf、減少 vaso-occlusive 事件 的早期訊號；但研究為單組且提前終止，需審慎評估 busulfan conditioning 與長期基因編輯安全性。" }, { "id": "pmid-41931046", "kind": "article", "issueId": "2026-week14", "year": 2026, "week": 14, "weekLabel": "第 14 週", "dateRange": "2026/03/30 – 04/05", "href": "2026-week14.html", "title": "Base Editing of HBG1 and HBG2 Promoters for Sickle Cell Disease", "journal": "NEJM", "type": "OA", "typeLabel": "Original Article", "author": "Gupta", "doi": "10.1056/NEJMoa2504835", "url": "https://doi.org/10.1056/NEJMoa2504835", "summary": "藥師重點：研究結果顯示 risto-cel 具有快速 engraftment、持續 HbF 表現與降低 HbS 的早期訊號；但安全性事件與死亡案例需審慎解讀，仍需更長追蹤確認基因編輯與 conditioning 相關風險。", "pubDate": "2026-05-07", "terms": [ "base", "editing", "hbg1", "hbg2", "promoters", "sickle", "cell", "nejm", "gupta", "nejmoa2504835" ], "drugTerms": [], "searchText": "base editing of hbg1 and hbg2 promoters for sickle cell disease nejm original article gupta 10.1056/nejmoa2504835 研究背景：鐮刀型細胞疾病以慢性溶血性貧血與反覆 重度 vaso-occlusive crises 為特徵，risto-cel 為 base-edited autologous cd34+ hematopoietic stem and progenitor cells，目標為 hbg1/hbg2 promoters 以提高 hbf 並降低 hbs。 研究方法：此 第 1 期-2 研究 納入 12-35 歲、收案前 2 年至少 4 次 重度 vaso-occlusive crises 的 sickle cell 疾病 病人；busulfan myeloablative conditioning 後單次輸注 risto-cel ≥3.0×106 viable cd34+ cells/kg。此為未計畫 interim 分析，描述安全性、editing、engraftment、hemoglobin production 與 crisis 發生。 主要結果：31 人接受 risto-cel，平均值 追蹤 6.6 個月；neutrophil engraftment 中位數 17.5 天，platelet engraftment 中位數 19 天。1 人死於 idiopathic pneumonia 症候群，27 人（87%）發生 等級 ≥3 不良事件，12 人（39%）有 嚴重不良事件；6 個月時 周邊血液 目標位點編輯等位基因 平均值 67.4%，hbf >60%，hbs <40%，且最後一次輸血後 60 天起未通報 重度 vaso-occlusive crises。 藥師重點：研究結果顯示 risto-cel 具有快速 engraftment、持續 hbf 表現與降低 hbs 的早期訊號；但安全性事件與死亡案例需審慎解讀，仍需更長追蹤確認基因編輯與 conditioning 相關風險。" }, { "id": "pmid-41921522", "kind": "article", "issueId": "2026-week14", "year": 2026, "week": 14, "weekLabel": "第 14 週", "dateRange": "2026/03/30 – 04/05", "href": "2026-week14.html", "title": "Aspirin versus clopidogrel for chronic maintenance monotherapy after percutaneous coronary intervention: 10-year follow-up of the HOST-EXAM trial", "journal": "Lancet", "type": "RCT", "typeLabel": "RCT", "author": "Kang", "doi": "10.1016/S0140-6736(26)00422-8", "url": "https://doi.org/10.1016/S0140-6736(26)00422-8", "summary": "藥師重點：結論顯示 PCI 後慢性維持期可將 clopidogrel 視為 aspirin 以外的長期單一抗血小板選項；實務仍需考量出血風險、缺血風險、CYP2C19 相關疑慮與病人用藥可近性。", "pubDate": "2026-04-11", "terms": [ "aspirin", "clopidogrel", "chronic", "maintenance", "monotherapy", "percutaneous", "coronary", "intervention", "year", "follow-up" ], "drugTerms": [ "clopidogrel" ], "searchText": "aspirin versus clopidogrel for chronic maintenance monotherapy after percutaneous coronary intervention: 10-year follow-up of the host-exam trial lancet rct kang 10.1016/s0140-6736(26)00422-8 研究背景：pci 後完成 雙重抗血小板治療 且進入慢性維持期後，clopidogrel 單藥與 aspirin 單藥的長期臨床結果仍有不確定性。 研究方法：host-exam 10 年延伸追蹤納入 pci 後 6-18 個月無臨床事件並完成 雙重抗血小板治療 的病人，隨機接受 clopidogrel 75 mg 每日一次 或 aspirin 100 mg 每日一次；主要終點為全因死亡、非致死性心肌梗塞、中風、急性 冠狀動脈 症候群 再住院或 barc type ≥3 出血。 主要結果：5438 人隨機分組，中位數 追蹤 10·5 年；clopidogrel 組主要複合終點低於 aspirin 組（25·4% vs 28·5%；hr 0·86，95% ci 0·77-0·96；log-rank p=0·0050），thrombotic 終點 與 出血 終點 亦較低，全因死亡相近。 藥師重點：結論顯示 pci 後慢性維持期可將 clopidogrel 視為 aspirin 以外的長期單一抗血小板選項；實務仍需考量出血風險、缺血風險、cyp2c19 相關疑慮與病人用藥可近性。" }, { "id": "pmid-41910384", "kind": "article", "issueId": "2026-week14", "year": 2026, "week": 14, "weekLabel": "第 14 週", "dateRange": "2026/03/30 – 04/05", "href": "2026-week14.html", "title": "Angiography-Derived Fractional Flow Reserve to Guide PCI", "journal": "NEJM", "type": "OA", "typeLabel": "Original Article", "author": "Fearon", "doi": "10.1056/NEJMoa2600949", "url": "https://doi.org/10.1056/NEJMoa2600949", "summary": "藥師重點：結論顯示 FFRangio 用於中度冠狀動脈病灶生理評估，在 1 年複合臨床終點上不劣於 pressure-wire 策略；此結果主要影響介入決策流程，藥師可關注後續抗血小板與次級預防照護。", "pubDate": "2026-03-29", "terms": [ "angiography-derived", "fractional", "flow", "reserve", "guide", "nejm", "fearon", "nejmoa2600949", "pressure-wire-based", "ffrangio" ], "drugTerms": [], "searchText": "angiography-derived fractional flow reserve to guide pci nejm original article fearon 10.1056/nejmoa2600949 研究背景：中度冠狀動脈狹窄以 pressure-wire-based ffr 評估可改善 pci 決策，但臨床使用率低；ffrangio 由冠狀動脈造影影像推估，可能簡化流程。 研究方法：此 international 不劣性 試驗 將接受 冠狀動脈 angiography 並發現至少一處 intermediate 冠狀動脈 stenosis 的病人 1930 人，隨機分配至 ffrangio 或 pressure-wire-based measurements；主要終點為 1 年死亡、心肌梗塞或非計畫且具臨床適應症的冠狀動脈再血運重建。 主要結果：1 年主要終點為 ffrangio 組 6.9% vs pressure-wire 組 7.1%（hr 0.98，95% ci 0.70 to 1.39；差異 -0.2 百分點；p<0.001 for 不劣性），出血、急性腎損傷與程序相關不良事件未見明顯差異。 藥師重點：結論顯示 ffrangio 用於中度冠狀動脈病灶生理評估，在 1 年複合臨床終點上不劣於 pressure-wire 策略；此結果主要影響介入決策流程，藥師可關注後續抗血小板與次級預防照護。" }, { "id": "pmid-41910382", "kind": "article", "issueId": "2026-week14", "year": 2026, "week": 14, "weekLabel": "第 14 週", "dateRange": "2026/03/30 – 04/05", "href": "2026-week14.html", "title": "Angiography-Based Physiology to Guide Coronary Revascularization", "journal": "NEJM", "type": "OA", "typeLabel": "Original Article", "author": "Daemen", "doi": "10.1056/NEJMoa2601841", "url": "https://doi.org/10.1056/NEJMoa2601841", "summary": "藥師重點：研究結果說明 vFFR-guided revascularization 在 1 年複合事件上不劣於傳統 FFR-guided strategy；藥師仍應把重點放在 PCI 後抗栓、降脂與危險因子控制。", "pubDate": "2026-03-29", "terms": [ "angiography-based", "physiology", "guide", "coronary", "revascularization", "nejm", "daemen", "nejmoa2601841", "guidelines", "vffr" ], "drugTerms": [], "searchText": "angiography-based physiology to guide coronary revascularization nejm original article daemen 10.1056/nejmoa2601841 研究背景：治療中度冠狀動脈病灶時，guidelines 建議以生理評估引導血運重建；vffr 可由三維定量冠狀動脈造影推估，無需 pressure wire 或 hyperemic agent。 研究方法：此歐洲 37 站 international 開放標籤 隨機 不劣性 試驗 納入 chronic 或 急性 冠狀動脈 syndromes 且有 30-80% intermediate 冠狀動脈-動脈 lesions 的病人，隨機接受 vffr-guided 或 ffr-guided revascularization；主要終點為 1 年死亡、心肌梗塞或再血運重建。 主要結果：主要終點納入 vffr 組 1116 人與 ffr 組 1095 人，1 年事件率皆為 7.5%（風險差 -0.02 百分點，95% ci -2.25 to 2.21；p=0.004 for 不劣性），嚴重不良事件 大致相近。 藥師重點：研究結果說明 vffr-guided revascularization 在 1 年複合事件上不劣於傳統 ffr-guided strategy；藥師仍應把重點放在 pci 後抗栓、降脂與危險因子控制。" }, { "id": "pmid-41910335", "kind": "article", "issueId": "2026-week14", "year": 2026, "week": 14, "weekLabel": "第 14 週", "dateRange": "2026/03/30 – 04/05", "href": "2026-week14.html", "title": "A Phase 3 Trial of Brepocitinib in Dermatomyositis", "journal": "NEJM", "type": "RCT", "typeLabel": "RCT", "author": "Vleugels", "doi": "10.1056/NEJMoa2503531", "url": "https://doi.org/10.1056/NEJMoa2503531", "summary": "藥師重點：結論顯示 brepocitinib 30 mg 對先前治療反應不佳的成人皮肌炎有臨床改善，但感染風險需納入評估；藥師應留意免疫抑制背景、疫苗與感染監測。", "pubDate": "2026-05-14", "terms": [ "phase", "brepocitinib", "dermatomyositis", "nejm", "vleugels", "nejmoa2503531", "cytokine", "signaling", "tyk2-jak1", "week" ], "drugTerms": [ "brepocitinib" ], "searchText": "a phase 3 trial of brepocitinib in dermatomyositis nejm rct vleugels 10.1056/nejmoa2503531 研究背景：皮肌炎與多種 cytokine signaling 有關，brepocitinib 為口服選擇性 tyk2-jak1 抑制劑，可能改善對既有治療反應不佳的疾病活動。 研究方法：此 第 3 期、雙盲、隨機、安慰劑對照 試驗 納入成人皮肌炎患者 241 人，1:1:1 分配 brepocitinib 30 mg、brepocitinib 15 mg 或 安慰劑 每日一次 52 週；主要終點為 week 52 total improvement score。 主要結果：week 52 平均值 total improvement score 為 46.5、37.5、31.2；brepocitinib 30 mg 相較 安慰劑 差異 15.3（95% ci 6.7 to 24.0；p<0.001），15 mg 未達顯著。30 mg 組在皮膚病灶、glucocorticoid tapering 與功能失能等次要終點較佳，但嚴重感染較 安慰劑 多（10% vs 1%）。 藥師重點：結論顯示 brepocitinib 30 mg 對先前治療反應不佳的成人皮肌炎有臨床改善，但感染風險需納入評估；藥師應留意免疫抑制背景、疫苗與感染監測。" }, { "id": "fda-2026-week14-1", "kind": "fda", "issueId": "2026-week14", "year": 2026, "week": 14, "weekLabel": "第 14 週", "dateRange": "2026/03/30 – 04/05", "href": "2026-week14.html", "title": "FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "concerns", "unapproved", "glp-1", "drugs", "used", "weight", "loss", "https", "drug-alerts-and-statements", "fdas-concerns-unapproved-glp-1-drugs-used-weight-loss" ], "drugTerms": [ "glp-1" ], "searchText": "fda’s concerns with unapproved glp-1 drugs used for weight loss fda drug safety 2026-06-15 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss" }, { "id": "fda-2026-week14-3", "kind": "fda", "issueId": "2026-week14", "year": 2026, "week": 14, "weekLabel": "第 14 週", "dateRange": "2026/03/30 – 04/05", "href": "2026-week14.html", "title": "FDA issues final decision to withdraw approval of Pepaxto (melphalan flufenamide)", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/node/398713", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "issues", "final", "decision", "withdraw", "approval", "pepaxto", "melphalan", "flufenamide", "https", "node" ], "drugTerms": [], "searchText": "fda issues final decision to withdraw approval of pepaxto (melphalan flufenamide) fda drug safety 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/node/398713" }, { "id": "fda-2026-week14-2", "kind": "fda", "issueId": "2026-week14", "year": 2026, "week": 14, "weekLabel": "第 14 週", "dateRange": "2026/03/30 – 04/05", "href": "2026-week14.html", "title": "FDA alerts patients, caregivers, and health care providers of cross-compatibility issues with autoinjector devices that are optional for use with glatiramer acetate injection", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/node/403159", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "alerts", "caregivers", "providers", "cross-compatibility", "issues", "autoinjector", "devices", "that", "optional", "glatiramer" ], "drugTerms": [], "searchText": "fda alerts patients, caregivers, and health care providers of cross-compatibility issues with autoinjector devices that are optional for use with glatiramer acetate injection fda drug safety 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/node/403159" }, { "id": "fda-2026-week14-4", "kind": "fda", "issueId": "2026-week14", "year": 2026, "week": 14, "weekLabel": "第 14 週", "dateRange": "2026/03/30 – 04/05", "href": "2026-week14.html", "title": "FDA Accepts First In Silico Drug Development Tool Under ISTAND Program to Help Predict Drug-Induced Liver Injury", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fda-accepts-first-silico-drug-development-tool-under-istand-program-help-predict-drug-induced-liver", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "accepts", "first", "silico", "development", "tool", "under", "istand", "program", "help", "predict" ], "drugTerms": [], "searchText": "fda accepts first in silico drug development tool under istand program to help predict drug-induced liver injury fda drug safety 2026-06-03 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/drugs/drug-alerts-and-statements/fda-accepts-first-silico-drug-development-tool-under-istand-program-help-predict-drug-induced-liver" }, { "id": "pmid-41880608", "kind": "article", "issueId": "2026-week13", "year": 2026, "week": 13, "weekLabel": "第 13 週", "dateRange": "2026/03/23 – 03/29", "href": "2026-week13.html", "title": "Transdermal Estradiol Patches in Locally Advanced Prostate Cancer", "journal": "NEJM", "type": "RCT", "typeLabel": "RCT", "author": "Langley", "doi": "10.1056/NEJMoa2511781", "url": "https://doi.org/10.1056/NEJMoa2511781", "summary": "藥師重點：結論顯示 tE2 在局部晚期前列腺癌的 3-year 無轉移存活期 不劣於 LHRH agonists，且熱潮紅較少但男性女乳症較多；藥師需留意貼片使用、皮膚反應、荷爾蒙相關不良反應與病人對副作用取捨的偏好。", "pubDate": "2026-04-23", "terms": [ "transdermal", "estradiol", "patches", "locally", "advanced", "prostate", "cancer", "nejm", "langley", "nejmoa2511781" ], "drugTerms": [], "searchText": "transdermal estradiol patches in locally advanced prostate cancer nejm rct langley 10.1056/nejmoa2511781 研究背景：te2 patches 可作為前列腺癌 androgen-deprivation 治療 的替代選項，可能減少 lhrh agonists 造成的 estrogen depletion 相關副作用與口服 estrogen 的血栓風險。 研究方法：此 第 3 期 不劣性 隨機試驗 將局部晚期（m0 且 n0 或 n+）前列腺癌男性分配至 te2 patches（100 μg estradiol every 24 hours）或 lhrh agonists。主要結果為 3-year 無轉移存活期，不劣性 margin 為 4 百分點，次要結果包括 castrate testosterone level、整體存活期 與安全性。 主要結果：2007 至 2022 年於英國 75 個中心收錄 1360 人；3-year 無轉移存活期 為 te2 87.1% 與 lhrh agonists 85.9%，confirmed metastasis or 死亡 的 hr 0.96，one-sided 95% ci upper limit 1.11，符合 不劣性。5-year 整體存活期 為 81.1% vs 79.2%（hr 0.90，95% ci 0.75 to 1.07）；hot flashes 為 44% vs 89%，gynecomastia 為 85% vs 42%。 藥師重點：結論顯示 te2 在局部晚期前列腺癌的 3-year 無轉移存活期 不劣於 lhrh agonists，且熱潮紅較少但男性女乳症較多；藥師需留意貼片使用、皮膚反應、荷爾蒙相關不良反應與病人對副作用取捨的偏好。" }, { "id": "pmid-41879829", "kind": "article", "issueId": "2026-week13", "year": 2026, "week": 13, "weekLabel": "第 13 週", "dateRange": "2026/03/23 – 03/29", "href": "2026-week13.html", "title": "Setidegrasib in Advanced Non-Small-Cell Lung Cancer and Pancreatic Cancer", "journal": "NEJM", "type": "OA", "typeLabel": "Original Article", "author": "Park", "doi": "10.1056/NEJMoa2600752", "url": "https://doi.org/10.1056/NEJMoa2600752", "summary": "藥師重點：研究結果顯示 setidegrasib 在先前治療過的 KRAS p.G12D-mutated NSCLC 或 pancreatic ductal adenocarcinoma 具有早期抗腫瘤活性，且因不良事件停藥比例低；但資料仍屬 第 1 期，藥師需留意輸注反應、噁心、600 mg 每週 靜脈給藥與後續 第 2 期/3 確認資料。", "pubDate": "2026-04-09", "terms": [ "setidegrasib", "advanced", "non-small-cell", "lung", "cancer", "pancreatic", "nejm", "park", "nejmoa2600752", "kras" ], "drugTerms": [], "searchText": "setidegrasib in advanced non-small-cell lung cancer and pancreatic cancer nejm original article park 10.1056/nejmoa2600752 研究背景：kras p.g12d variant 見於約 5% nsclc 與約 40% pancreatic ductal adenocarcinoma，但目前尚無針對此變異核准的標靶治療；setidegrasib（asp3082）為 kras g12d-targeted protein degrader。 研究方法：此 第 1 期 研究 評估 setidegrasib 用於先前接受治療、帶有 kras p.g12d variants 的晚期 solid tumors 病人之安全性、pharmacokinetics、pharmacodynamics 與抗腫瘤活性。主要目標為 dose-limiting toxic effects、不良事件 與 第 2 期 dose；setidegrasib 以每週一次靜脈給藥 10-800 mg。 主要結果：共 203 人納入；最終選定 第 2 期 dose 為 600 mg。600 mg 組 76 人中，所有病人皆發生 治療期間出現的不良事件，等級 ≥3 為 42%；治療相關不良事件 為 93%，最常見為 transient 輸注相關反應（80%）與 nausea（30%），2 人因 不良事件 停藥。600 mg 劑量下，nsclc 病人 partial 反應 為 36%（95% ci 22 to 51），中位數 無惡化存活期 8.3 個月；第二或三線 轉移性 pancreatic ductal adenocarcinoma 病人 反應 為 24%（95% ci 8 to 47），中位數 無惡化存活期 3.0 個月，中位數 整體存活期 10.3 個月。 藥師重點：研究結果顯示 setidegrasib 在先前治療過的 kras p.g12d-mutated nsclc 或 pancreatic ductal adenocarcinoma 具有早期抗腫瘤活性，且因不良事件停藥比例低；但資料仍屬 第 1 期，藥師需留意輸注反應、噁心、600 mg 每週 靜脈給藥與後續 第 2 期/3 確認資料。" }, { "id": "pmid-41875914", "kind": "article", "issueId": "2026-week13", "year": 2026, "week": 13, "weekLabel": "第 13 週", "dateRange": "2026/03/23 – 03/29", "href": "2026-week13.html", "title": "Proton beam therapy for oropharyngeal cancer (TORPEdO): a phase 3, randomised controlled trial", "journal": "Lancet", "type": "RCT", "typeLabel": "RCT", "author": "Thomson", "doi": "10.1016/S0140-6736(26)00314-4", "url": "https://doi.org/10.1016/S0140-6736(26)00314-4", "summary": "藥師重點：研究結果說明 IMPT 未在本試驗中顯示較 IMRT 改善晚期身體生活品質、餵食管依賴、局部控制或存活；藥師在 cisplatin 合併放療照護時仍應聚焦腎功能、噁心嘔吐、聽力、神經毒性與營養支持監測。", "pubDate": "2026-03-28", "terms": [ "proton", "beam", "oropharyngeal", "cancer", "torpedo", "phase", "randomised", "lancet", "thomson", "s0140-6736" ], "drugTerms": [ "cisplatin" ], "searchText": "proton beam therapy for oropharyngeal cancer (torpedo): a phase 3, randomised controlled trial lancet rct thomson 10.1016/s0140-6736(26)00314-4 研究背景：口咽鱗狀細胞癌接受放射治療後可能影響吞嚥、唾液、味覺與生活品質；impt 相較 imrt 是否能改善晚期功能與病人回報結果仍不確定。 研究方法：torpedo 為英國 20 家 nhs 醫院進行的 第 3 期 隨機對照試驗，將局部晚期 口咽鱗狀細胞癌 病人以 2:1 分配至 impt 或 imrt（70 gy in 33 fractions, 持續 6.5 週），並合併兩個療程 高劑量 cisplatin 100 mg/m2 每 3 週。共同主要終點為 12 個月 胃造口管依賴 或 重度 體重減輕，以及 uw-qol physical 複合 score。 主要結果：共 205 人隨機分組，impt 136 人、imrt 69 人。12 個月時 胃造口管依賴 皆約 2%，重度 體重減輕 為 18% vs 6%，combined 勝算比 2.80（97.5% ci 0.75 to 10.4；p=0.079）；uw-qol physical 複合 score 為 78.3 vs 77.1（差異 1.3，97.5% ci -3.7 to 6.2；p=0.56）。24-month freedom from loco-regional recurrence 與 整體存活期 亦相近，無 治療-related deaths。 藥師重點：研究結果說明 impt 未在本試驗中顯示較 imrt 改善晚期身體生活品質、餵食管依賴、局部控制或存活；藥師在 cisplatin 合併放療照護時仍應聚焦腎功能、噁心嘔吐、聽力、神經毒性與營養支持監測。" }, { "id": "pmid-41876122", "kind": "article", "issueId": "2026-week13", "year": 2026, "week": 13, "weekLabel": "第 13 週", "dateRange": "2026/03/23 – 03/29", "href": "2026-week13.html", "title": "Home based, tailored intervention to reduce rate of falls after stroke (FAST): randomised trial", "journal": "BMJ", "type": "RCT", "typeLabel": "RCT", "author": "Clemson", "doi": "10.1136/bmj-2025-085519", "url": "https://doi.org/10.1136/bmj-2025-085519", "summary": "藥師重點：研究結果說明中風後跌倒預防不只依賴藥物調整，也需要復健、職能治療與居家環境介入；藥師可在用藥評估時同步檢視鎮靜、降壓、低血糖或姿勢性低血壓相關藥物，並協助轉介跌倒風險管理。", "pubDate": "2026-03-24", "terms": [ "home", "tailored", "intervention", "reduce", "rate", "falls", "stroke", "fast", "randomised", "clemson" ], "drugTerms": [], "searchText": "home based, tailored intervention to reduce rate of falls after stroke (fast): randomised trial bmj rct clemson 10.1136/bmj-2025-085519 研究背景：中風後社區居住且可行走者仍有跌倒風險，居家多專業、個別化介入是否能降低跌倒率是本研究重點。 研究方法：此 two-arm 隨機試驗 於澳洲三州進行，納入中風 5 年內、50 歲以上、已由正式復健出院至社區且可行走 10 m 的病人。介入組接受 6 個月習慣養成功能性運動、居家跌倒危害改善與社區移動目標導向 coaching；對照組接受 常規照護，主要終點為 12 個月跌倒率。 主要結果：共 370 名中風病人納入；12 個月時介入組跌倒率較低，代表跌倒減少 33%（發生率比 0.67，95% ci 0.48 to 0.94；p=0.02）。曾發生跌倒的病人比例未見顯著差異（absolute risk reduction 0.03，95% ci -0.07 to 0.13；p=0.52），但社區參與、自我效能、步行速度與平衡表現較有利。 藥師重點：研究結果說明中風後跌倒預防不只依賴藥物調整，也需要復健、職能治療與居家環境介入；藥師可在用藥評估時同步檢視鎮靜、降壓、低血糖或姿勢性低血壓相關藥物，並協助轉介跌倒風險管理。" }, { "id": "pmid-41903215", "kind": "article", "issueId": "2026-week13", "year": 2026, "week": 13, "weekLabel": "第 13 週", "dateRange": "2026/03/23 – 03/29", "href": "2026-week13.html", "title": "Evolocumab to Reduce First Major Cardiovascular Events in Patients Without Known Significant Atherosclerosis and With Diabetes: Results From the VESALIUS-CV Trial", "journal": "JAMA", "type": "RCT", "typeLabel": "RCT", "author": "Marston", "doi": "10.1001/jama.2026.3277", "url": "https://doi.org/10.1001/jama.2026.3277", "summary": "藥師重點：研究結果說明 evolocumab 加於可耐受 statin 治療，可降低無已知重大動脈粥樣硬化且合併糖尿病高風險病人的首次 MACE；藥師應協助確認 LDL-C 基準、既有 statin 最適化程度、給藥頻率與成本可近性。", "pubDate": "2026-04-28", "terms": [ "evolocumab", "reduce", "first", "major", "cardiovascular", "events", "known", "significant", "atherosclerosis", "diabetes" ], "drugTerms": [ "evolocumab", "statin" ], "searchText": "evolocumab to reduce first major cardiovascular events in patients without known significant atherosclerosis and with diabetes: results from the vesalius-cv trial jama rct marston 10.1001/jama.2026.3277 研究背景：pcsk9 抑制劑 過去多用於已有明顯動脈粥樣硬化的高風險病人；對沒有已知重大動脈粥樣硬化但合併糖尿病者，evolocumab 是否能預防首次主要心血管事件仍需資料支持。 研究方法：vesalius-cv 為 隨機、雙盲、安慰劑對照 試驗，本次為預先指定 次族群 分析，分析無 prior myocardial infarction 或 stroke、ldl-c ≥90 mg/dl、無已知重大動脈粥樣硬化且皆有 diabetes 的 3655 名病人。受試者以 1:1 接受 evolocumab 140 mg 每 2 週 或 安慰劑，皆加於 optimally tolerated statin 治療；雙主要終點為 3-p mace 與 4-p mace。 主要結果：次族群 中 evolocumab 組 1849 人、安慰劑 組 1806 人，中位數 追蹤 4.8 years。48 週 ldl-c 中位數為 52 mg/dl vs 111 mg/dl（p<.001）；3-p mace 為 5.0% vs 7.1%（hr 0.69，95% ci 0.52-0.91；p=.009），4-p mace 為 7.6% vs 10.5%（hr 0.69，95% ci 0.55-0.86；p=.001），全因死亡為 7.8% vs 10.1%（hr 0.76，95% ci 0.61-0.95）。 藥師重點：研究結果說明 evolocumab 加於可耐受 statin 治療，可降低無已知重大動脈粥樣硬化且合併糖尿病高風險病人的首次 mace；藥師應協助確認 ldl-c 基準、既有 statin 最適化程度、給藥頻率與成本可近性。" }, { "id": "pmid-41865758", "kind": "article", "issueId": "2026-week13", "year": 2026, "week": 13, "weekLabel": "第 13 週", "dateRange": "2026/03/23 – 03/29", "href": "2026-week13.html", "title": "Efficacy and safety of oral semaglutide 14 mg (flexible dose) in early-stage symptomatic Alzheimer's disease (evoke and evoke+): two phase 3, randomised, placebo-controlled trials", "journal": "Lancet", "type": "RCT", "typeLabel": "RCT", "author": "Cummings", "doi": "10.1016/S0140-6736(26)00459-9", "url": "https://doi.org/10.1016/S0140-6736(26)00459-9", "summary": "藥師重點：結論顯示 口服 semaglutide 未能延緩早期 Alzheimer 疾病 的臨床進展，安全性與耐受性大致符合其他適應症經驗；藥師不應將代謝疾病或觀察性失智風險訊號直接外推為 Alzheimer 疾病 治療效果。", "pubDate": "2026-05-30", "terms": [ "efficacy", "oral", "semaglutide", "flexible", "dose", "early-stage", "symptomatic", "alzheimer", "evoke", "phase" ], "drugTerms": [ "semaglutide", "glp-1" ], "searchText": "efficacy and safety of oral semaglutide 14 mg (flexible dose) in early-stage symptomatic alzheimer's disease (evoke and evoke+): two phase 3, randomised, placebo-controlled trials lancet rct cummings 10.1016/s0140-6736(26)00459-9 研究背景：glp-1 受體 致效劑 暴露曾在動物、臨床與真實世界資料中與較低失智或 alzheimer 疾病 風險相關，但 口服 semaglutide 對早期 alzheimer 疾病 臨床進展是否有效仍需大型試驗驗證。 研究方法：evoke 與 evoke+ 為 40 國 566 個中心進行的 多中心、隨機、雙盲、安慰劑對照 第 3 期試驗s，納入 55-85 歲、amyloid-confirmed alzheimer 疾病，且為 mild cognitive impairment 或 mild dementia 的病人。受試者以 1:1 接受 口服 semaglutide up to 14 mg 每日一次（flexible dose）或 安慰劑，最長 156 週；主要終點為第 104 週 cdr-sb 相對基準值變化。 主要結果：共 3808 人隨機分組；evoke 與 evoke+ 中，第 104 週 cdr-sb 平均變化為 semaglutide 2.3 與 2.2，安慰劑 2.3 與 2.1，estimated 差異 分別為 -0.08（95% ci -0.35 to 0.20；p=0.57）與 0.10（95% ci -0.17 to 0.38；p=0.46）。治療期間出現的不良事件 為 91.2% vs 84.8%，研究因 negative 臨床 結果指標 已停止。 藥師重點：結論顯示 口服 semaglutide 未能延緩早期 alzheimer 疾病 的臨床進展，安全性與耐受性大致符合其他適應症經驗；藥師不應將代謝疾病或觀察性失智風險訊號直接外推為 alzheimer 疾病 治療效果。" }, { "id": "pmid-41880613", "kind": "article", "issueId": "2026-week13", "year": 2026, "week": 13, "weekLabel": "第 13 週", "dateRange": "2026/03/23 – 03/29", "href": "2026-week13.html", "title": "Early Surgery or Conservative Care for Asymptomatic Aortic Stenosis at 10 Years", "journal": "NEJM", "type": "RCT", "typeLabel": "RCT", "author": "Kang", "doi": "10.1056/NEJMoa2511920", "url": "https://doi.org/10.1056/NEJMoa2511920", "summary": "藥師重點：結論顯示無症狀 極重度主動脈瓣狹窄 病人早期手術可降低 10 年心血管死亡相關複合風險；藥師在圍手術期照護可協助釐清抗凝、抗血小板、心衰竭與血壓用藥調整，但治療決策仍需由心臟團隊依手術風險與病人偏好評估。", "pubDate": "2026-03-26", "terms": [ "early", "surgery", "conservative", "asymptomatic", "aortic", "stenosis", "years", "nejm", "kang", "nejmoa2511920" ], "drugTerms": [], "searchText": "early surgery or conservative care for asymptomatic aortic stenosis at 10 years nejm rct kang 10.1056/nejmoa2511920 研究背景：無症狀重度主動脈瓣狹窄是否應早期手術仍有爭議，先前分析顯示早期手術可能降低手術死亡或心血管死亡風險，但長期存活效益仍需追蹤。 研究方法：研究將無症狀 極重度主動脈瓣狹窄 病人以 1:1 隨機分配至 early surgery 或 conservative care。納入條件包含 aortic-valve area ≤0.75 cm2 且 peak aortic jet velocity ≥4.5 m/s；主要終點為 10 年追蹤期間 operative 死亡率 或 心血管 死亡 的複合終點。 主要結果：共 145 人隨機分組；意向治療分析 中，主要終點事件在 early-surgery 組為 2/73 人（3%），conservative-care 組為 17/72 人（24%）（hr 0.10，95% ci 0.02 to 0.43；p=0.002）。10 年 operative 死亡率 或 心血管 死亡 累積發生率為 1% vs 19%；全因死亡為 15% vs 32%（hr 0.42，95% ci 0.21 to 0.86）。 藥師重點：結論顯示無症狀 極重度主動脈瓣狹窄 病人早期手術可降低 10 年心血管死亡相關複合風險；藥師在圍手術期照護可協助釐清抗凝、抗血小板、心衰竭與血壓用藥調整，但治療決策仍需由心臟團隊依手術風險與病人偏好評估。" }, { "id": "pmid-41880612", "kind": "article", "issueId": "2026-week13", "year": 2026, "week": 13, "weekLabel": "第 13 週", "dateRange": "2026/03/23 – 03/29", "href": "2026-week13.html", "title": "Atezolizumab plus FOLFOX for Stage III Mismatch Repair-Deficient Colon Cancer", "journal": "NEJM", "type": "RCT", "typeLabel": "RCT", "author": "Sinicrope", "doi": "10.1056/NEJMoa2507874", "url": "https://doi.org/10.1056/NEJMoa2507874", "summary": "藥師重點：結論顯示 atezolizumab 加入 mFOLFOX6 可改善已切除 stage III dMMR colon 癌症 的 無病存活期；藥師需留意免疫相關不良反應、化療毒性疊加、12 個月治療銜接與 dMMR 狀態確認。", "pubDate": "2026-03-26", "terms": [ "atezolizumab", "plus", "folfox", "stage", "mismatch", "repair-deficient", "colon", "cancer", "nejm", "sinicrope" ], "drugTerms": [ "atezolizumab", "fluoropyrimidine-plus-oxaliplatin", "anti-programmed", "oxaliplatin" ], "searchText": "atezolizumab plus folfox for stage iii mismatch repair-deficient colon cancer nejm rct sinicrope 10.1056/nejmoa2507874 研究背景：stage iii colon 癌症 的標準輔助治療為 fluoropyrimidine-加上-oxaliplatin 處方；對 dmmr 腫瘤，在 mfolfox6 加入 atezolizumab 是否能改善預後仍需驗證。 研究方法：此 第 3 期試驗 將已切除 stage iii dmmr colon 癌症 病人以 1:1 分配至 atezolizumab 加 mfolfox6 6 個月、之後 atezolizumab 單藥至總療程 12 個月，或 mfolfox6 單用 6 個月。主要終點為 無病存活期，次要終點包括 整體存活期 與 adverse-event profile。 主要結果：共有 355 人接受 atezolizumab 加 mfolfox6，357 人接受 mfolfox6；中位數 追蹤 40.9 個月 時，3-year 無病存活期 為 86.3%（95% ci 81.8 to 89.8）vs 76.2%（95% ci 70.9 to 80.6），疾病 recurrence or 死亡 的 hr 0.50（95% ci 0.35 to 0.73；p<0.001）。等級 3 or 4 不良事件 為 84.1% vs 71.9%。 藥師重點：結論顯示 atezolizumab 加入 mfolfox6 可改善已切除 stage iii dmmr colon 癌症 的 無病存活期；藥師需留意免疫相關不良反應、化療毒性疊加、12 個月治療銜接與 dmmr 狀態確認。" }, { "id": "pmid-41879224", "kind": "article", "issueId": "2026-week13", "year": 2026, "week": 13, "weekLabel": "第 13 週", "dateRange": "2026/03/23 – 03/29", "href": "2026-week13.html", "title": "A Placebo-Controlled Trial of the Oral PCSK9 Inhibitor Enlicitide", "journal": "NEJM", "type": "RCT", "typeLabel": "RCT", "author": "Navar", "doi": "10.1056/NEJMoa2511002", "url": "https://doi.org/10.1056/NEJMoa2511002", "summary": "藥師重點：結論顯示 enlicitide 可在具動脈粥樣硬化心血管事件病史或高風險族群中明顯降低 LDL 膽固醇；藥師需留意這是 lipid-lowering 終點，臨床採用前仍需確認長期心血管事件資料、服藥順從性與既有降脂治療的銜接。", "pubDate": "2026-02-05", "terms": [ "placebo-controlled", "oral", "pcsk9", "inhibitor", "enlicitide", "nejm", "navar", "nejmoa2511002", "decanoate", "intention-to-treat" ], "drugTerms": [], "searchText": "a placebo-controlled trial of the oral pcsk9 inhibitor enlicitide nejm rct navar 10.1056/nejmoa2511002 研究背景：enlicitide decanoate 為口服 pcsk9 抑制劑，第 2 期 試驗已顯示可降低 ldl 膽固醇，但較長期療效與安全性仍需確認。 研究方法：此 多國、雙盲、隨機、安慰劑對照 試驗 納入曾有重大動脈粥樣硬化心血管事件且 ldl 膽固醇 ≥55 mg/dl，或有首次事件風險且 ldl 膽固醇 ≥70 mg/dl 的成人。受試者以 2:1 分配接受 enlicitide 20 mg 每日 或 安慰劑 52 週，主要終點為第 24 週 ldl 膽固醇 平均百分比變化。 主要結果：intention-to-treat 族群 共 2909 人；第 24 週 ldl 膽固醇 變化為 enlicitide -57.1%（95% ci -61.8 to -52.5）與 安慰劑 3.0%（95% ci 0.9 to 5.1），校正 between-group 差異 為 -55.8 百分點（95% ci -60.9 to -50.7；p<0.001）。第 52 週 ldl 膽固醇，以及第 24 週 non-hdl 膽固醇、apolipoprotein b 與 lipoprotein(a) 亦均較 安慰劑 改善，不良事件發生率未見明顯差異。 藥師重點：結論顯示 enlicitide 可在具動脈粥樣硬化心血管事件病史或高風險族群中明顯降低 ldl 膽固醇；藥師需留意這是 lipid-lowering 終點，臨床採用前仍需確認長期心血管事件資料、服藥順從性與既有降脂治療的銜接。" }, { "id": "fda-2026-week13-1", "kind": "fda", "issueId": "2026-week13", "year": 2026, "week": 13, "weekLabel": "第 13 週", "dateRange": "2026/03/23 – 03/29", "href": "2026-week13.html", "title": "FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "concerns", "unapproved", "glp-1", "drugs", "used", "weight", "loss", "https", "drug-alerts-and-statements", "fdas-concerns-unapproved-glp-1-drugs-used-weight-loss" ], "drugTerms": [ "glp-1" ], "searchText": "fda’s concerns with unapproved glp-1 drugs used for weight loss fda drug safety 2026-06-15 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss" }, { "id": "fda-2026-week13-3", "kind": "fda", "issueId": "2026-week13", "year": 2026, "week": 13, "weekLabel": "第 13 週", "dateRange": "2026/03/23 – 03/29", "href": "2026-week13.html", "title": "FDA issues final decision to withdraw approval of Pepaxto (melphalan flufenamide)", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/node/398713", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "issues", "final", "decision", "withdraw", "approval", "pepaxto", "melphalan", "flufenamide", "https", "node" ], "drugTerms": [], "searchText": "fda issues final decision to withdraw approval of pepaxto (melphalan flufenamide) fda drug safety 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/node/398713" }, { "id": "fda-2026-week13-2", "kind": "fda", "issueId": "2026-week13", "year": 2026, "week": 13, "weekLabel": "第 13 週", "dateRange": "2026/03/23 – 03/29", "href": "2026-week13.html", "title": "FDA alerts patients, caregivers, and health care providers of cross-compatibility issues with autoinjector devices that are optional for use with glatiramer acetate injection", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/node/403159", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "alerts", "caregivers", "providers", "cross-compatibility", "issues", "autoinjector", "devices", "that", "optional", "glatiramer" ], "drugTerms": [], "searchText": "fda alerts patients, caregivers, and health care providers of cross-compatibility issues with autoinjector devices that are optional for use with glatiramer acetate injection fda drug safety 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/node/403159" }, { "id": "fda-2026-week13-4", "kind": "fda", "issueId": "2026-week13", "year": 2026, "week": 13, "weekLabel": "第 13 週", "dateRange": "2026/03/23 – 03/29", "href": "2026-week13.html", "title": "FDA Accepts First In Silico Drug Development Tool Under ISTAND Program to Help Predict Drug-Induced Liver Injury", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fda-accepts-first-silico-drug-development-tool-under-istand-program-help-predict-drug-induced-liver", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "accepts", "first", "silico", "development", "tool", "under", "istand", "program", "help", "predict" ], "drugTerms": [], "searchText": "fda accepts first in silico drug development tool under istand program to help predict drug-induced liver injury fda drug safety 2026-06-03 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/drugs/drug-alerts-and-statements/fda-accepts-first-silico-drug-development-tool-under-istand-program-help-predict-drug-induced-liver" }, { "id": "pmid-41837962", "kind": "article", "issueId": "2026-week12", "year": 2026, "week": 12, "weekLabel": "第 12 週", "dateRange": "2026/03/16 – 03/22", "href": "2026-week12.html", "title": "Tumor Debulking in Combination With Chemotherapy in Multiorgan Metastatic Colorectal Cancer: The ORCHESTRA Randomized Clinical Trial", "journal": "JAMA", "type": "RCT", "typeLabel": "RCT", "author": "Gootjes", "doi": "10.1001/jama.2026.1929", "url": "https://doi.org/10.1001/jama.2026.1929", "summary": "藥師重點：結論顯示在可行大幅 腫瘤減積 的 multiorgan mCRC 族群中，加上局部減積治療未改善 整體存活期，且 嚴重不良事件 較高；治療討論仍應以全身治療效益、手術風險與化療中斷影響為核心。", "pubDate": "2026-04-21", "terms": [ "tumor", "debulking", "combination", "chemotherapy", "multiorgan", "metastatic", "colorectal", "cancer", "orchestra", "jama" ], "drugTerms": [ "oxaliplatin", "bevacizumab" ], "searchText": "tumor debulking in combination with chemotherapy in multiorgan metastatic colorectal cancer: the orchestra randomized clinical trial jama rct gootjes 10.1001/jama.2026.1929 研究背景：多器官轉移性大腸直腸癌（mcrc）病人愈來愈常使用手術、放射治療或消融等局部治療，但 腫瘤減積 是否能在全身治療外帶來存活效益仍缺乏前瞻性證據。 研究方法：orchestra 為 investigator-initiated、開放標籤、多中心 隨機臨床試驗，於荷蘭 27 家醫院與英國 1 家醫院納入 multiorgan mcrc 成人。病人需在第一線緩和性化療後達到 objective 反應 或 stable 疾病，且評估可完成超過 80% 腫瘤減積，隨機接受 chemotherapy 單用 或 腫瘤減積 後續接 chemotherapy；主要終點為 整體存活期。 主要結果：382 名病人隨機分組，追蹤中位數 32.3 個月後，chemotherapy 單用 組與 化療加上 腫瘤減積 組 中位數 整體存活期 為 27.5 vs 30.0 個月（校正 hr 0.88，95% ci 0.70-1.10；p=0.26）。中位數 無惡化存活期 為 10.4 vs 10.5 個月（校正 hr 0.83，95% ci 0.67-1.02；p=0.08），嚴重不良事件 較常見於 腫瘤減積 組（53% vs 39%；p=0.006）。 藥師重點：結論顯示在可行大幅 腫瘤減積 的 multiorgan mcrc 族群中，加上局部減積治療未改善 整體存活期，且 嚴重不良事件 較高；治療討論仍應以全身治療效益、手術風險與化療中斷影響為核心。" }, { "id": "pmid-41864749", "kind": "article", "issueId": "2026-week12", "year": 2026, "week": 12, "weekLabel": "第 12 週", "dateRange": "2026/03/16 – 03/22", "href": "2026-week12.html", "title": "Survival outcome of VATS compared with open lobectomy for lung cancer: an individual patient data meta-analysis of randomised trials", "journal": "Lancet", "type": "MA", "typeLabel": "Meta-analysis", "author": "Harris", "doi": "10.1016/S0140-6736(26)00031-0", "url": "https://doi.org/10.1016/S0140-6736(26)00031-0", "summary": "藥師重點：研究結果支持技術可行時 VATS lobectomy 可能在早期 non-small-cell lung 癌症 提供存活優勢且未犧牲 無病存活期；解讀時仍需留意僅納入 3 項試驗，並回到手術可行性與圍手術期用藥管理。", "pubDate": "2026-03-21", "terms": [ "survival", "vats", "open", "lobectomy", "lung", "cancer", "individual", "meta-analysis", "randomised", "trials" ], "drugTerms": [], "searchText": "survival outcome of vats compared with open lobectomy for lung cancer: an individual patient data meta-analysis of randomised trials lancet meta-analysis harris 10.1016/s0140-6736(26)00031-0 研究背景：vats lobectomy 已廣泛用於早期肺癌，主要優勢多來自疼痛、併發症與恢復速度等非腫瘤結果；其相較 open lobectomy 的存活影響仍需整合隨機試驗資料。 研究方法：此 individual patient 資料 統合分析 系統性搜尋 2000 年 1 月 1 日至 2025 年 6 月 13 日發表、比較 vats 與 open lobectomy 的隨機試驗，納入 18 歲以上 臨床 early-stage non-small-cell lung 癌症 且有死亡與復發資料者。主要終點為 整體存活期，次要終點為 無病存活期，分析使用 random effects cox proportional hazards model。 主要結果：554 篇文獻中 3 項研究符合納入條件，共 1185 名病人（vats 586 人、open lobectomy 599 人）。整體存活期 較有利於 vats lobectomy（pooled hr 0·79，95% ci 0·65-0·96），相當於死亡風險降低 21%；無病存活期 兩組相近（pooled hr 0·91，95% ci 0·75-1·12），且未見統計異質性。 藥師重點：研究結果支持技術可行時 vats lobectomy 可能在早期 non-small-cell lung 癌症 提供存活優勢且未犧牲 無病存活期；解讀時仍需留意僅納入 3 項試驗，並回到手術可行性與圍手術期用藥管理。" }, { "id": "pmid-41841304", "kind": "article", "issueId": "2026-week12", "year": 2026, "week": 12, "weekLabel": "第 12 週", "dateRange": "2026/03/16 – 03/22", "href": "2026-week12.html", "title": "Restrictive vs Liberal Physical Restraint Strategies in Critically Ill Patients: The R2D2-ICU Randomized Clinical Trial", "journal": "JAMA", "type": "RCT", "typeLabel": "RCT", "author": "Sonneville", "doi": "10.1001/jama.2026.2897", "url": "https://doi.org/10.1001/jama.2026.2897", "summary": "藥師重點：研究結果說明低使用腕部約束策略未改善 14 天無譫妄或昏迷天數，也未明顯增加自拔管；藥師參與 ICU 照護時仍應聚焦鎮靜、止痛、譫妄風險與非藥物安全措施的整體評估。", "pubDate": "2026-04-14", "terms": [ "restrictive", "liberal", "physical", "restraint", "strategies", "critically", "r2d2-icu", "jama", "sonneville", "rass" ], "drugTerms": [], "searchText": "restrictive vs liberal physical restraint strategies in critically ill patients: the r2d2-icu randomized clinical trial jama rct sonneville 10.1001/jama.2026.2897 研究背景：icu 中接受侵入性機械通氣的病人常因安全考量使用腕部身體約束，但其對譫妄、昏迷與自拔管等結果的影響仍不明確。 研究方法：r2d2-icu 為法國 10 個 icu 的 開放標籤 隨機臨床試驗，納入 405 名開始侵入性機械通氣 6 小時內且預期需通氣至少 48 小時的成人。受試者分配至低使用約束策略，僅在 rass ≥3 嚴重躁動且必要時使用腕帶，或高使用策略，系統性使用腕帶並每日重新評估；主要終點為隨機後 14 天內存活且無昏迷或譫妄天數。 主要結果：396 名病人有主要終點資料，低使用與高使用策略組平均存活且無昏迷或譫妄天數為 6.67 vs 6.30 天（校正 平均差 0.37 天，95% ci -0.71 to 1.46；p=0.51）。自拔管為 9.2% vs 8.5%，day-90 死亡率 為 37.2% vs 41.0%。 藥師重點：研究結果說明低使用腕部約束策略未改善 14 天無譫妄或昏迷天數，也未明顯增加自拔管；藥師參與 icu 照護時仍應聚焦鎮靜、止痛、譫妄風險與非藥物安全措施的整體評估。" }, { "id": "pmid-41839514", "kind": "article", "issueId": "2026-week12", "year": 2026, "week": 12, "weekLabel": "第 12 週", "dateRange": "2026/03/16 – 03/22", "href": "2026-week12.html", "title": "Pyrotinib or placebo in combination with trastuzumab and docetaxel for HER2 positive metastatic breast cancer: long term survival results from randomised phase 3 PHILA trial", "journal": "BMJ", "type": "RCT", "typeLabel": "RCT", "author": "Ma", "doi": "10.1136/bmj-2025-087259", "url": "https://doi.org/10.1136/bmj-2025-087259", "summary": "藥師重點：結論顯示 pyrotinib 合併 trastuzumab 與 docetaxel 可延長 untreated HER2 陽性 轉移性 breast 癌症 的 無惡化存活期 並改善 整體存活期；藥師需留意口服標靶藥順從性、docetaxel 停用後治療銜接與不良事件追蹤。", "pubDate": "2026-03-16", "terms": [ "pyrotinib", "placebo", "combination", "trastuzumab", "docetaxel", "her2", "positive", "metastatic", "breast", "cancer" ], "drugTerms": [ "pyrotinib", "trastuzumab", "docetaxel", "anti-her2" ], "searchText": "pyrotinib or placebo in combination with trastuzumab and docetaxel for her2 positive metastatic breast cancer: long term survival results from randomised phase 3 phila trial bmj rct ma 10.1136/bmj-2025-087259 研究背景：her2 陽性 轉移性 breast 癌症 第一線治療仍需兼顧疾病控制與長期存活，phila 試驗 更新分析評估 pyrotinib 加 trastuzumab 與 docetaxel 的長期療效與安全性。 研究方法：此中國 40 個中心、雙盲、隨機、安慰劑對照 第 3 期試驗 納入 590 名未治療 her2 陽性 轉移性 breast 癌症 女性，隨機接受 pyrotinib 400 mg orally 每日一次 或 安慰劑，兩組皆合併 trastuzumab 與 docetaxel，每 21 天為一療程；主要終點為 investigator-assessed 無惡化存活期。 主要結果：追蹤中位數約 35 個月時，pyrotinib 組死亡比例低於 安慰劑 組（20% vs 30%），整體存活期 較佳（hr 0.64，95% ci 0.46 to 0.89；nominal one-sided p=0.004），兩組 中位數 整體存活期 皆尚未達到。無惡化存活期 效益維持（22.1 vs 10.5 個月；hr 0.44，95% ci 0.36 to 0.53；nominal one-sided p<0.001），安全性型態與期中分析一致。 藥師重點：結論顯示 pyrotinib 合併 trastuzumab 與 docetaxel 可延長 untreated her2 陽性 轉移性 breast 癌症 的 無惡化存活期 並改善 整體存活期；藥師需留意口服標靶藥順從性、docetaxel 停用後治療銜接與不良事件追蹤。" }, { "id": "pmid-41864748", "kind": "article", "issueId": "2026-week12", "year": 2026, "week": 12, "weekLabel": "第 12 週", "dateRange": "2026/03/16 – 03/22", "href": "2026-week12.html", "title": "Prevention of urinary stones with hydration: a randomised clinical trial of an adherence intervention", "journal": "Lancet", "type": "RCT", "typeLabel": "RCT", "author": "Desai", "doi": "10.1016/S0140-6736(25)02637-6", "url": "https://doi.org/10.1016/S0140-6736(25)02637-6", "summary": "藥師重點：研究結果說明促進飲水的行為介入可小幅增加尿量，但未降低 2 年內結石復發；藥師衛教時可強調飲水目標、順從性與泌尿症狀，同時避免把尿量改善直接等同於復發風險下降。", "pubDate": "2026-03-21", "terms": [ "prevention", "urinary", "stones", "hydration", "randomised", "adherence", "intervention", "lancet", "desai", "s0140-6736" ], "drugTerms": [], "searchText": "prevention of urinary stones with hydration: a randomised clinical trial of an adherence intervention lancet rct desai 10.1016/s0140-6736(25)02637-6 研究背景：增加水分攝取常被建議用於降低尿路結石復發，但長期維持足夠飲水量並不容易，行為介入是否能減少症狀性復發仍缺乏明確證據。 研究方法：此美國 6 個學術醫學中心 隨機臨床試驗 納入 12 歲以上、有尿路結石病史且 24 h urine volume 偏低者，隨機接受多元行為介入或 guideline-concordant care。介入包含 fluid prescription、財務誘因、健康 coaching 與簡訊等病人自選提醒，主要終點為 2 年內症狀性結石復發。 主要結果：共 1658 人隨機分組，追蹤中位數 738 天時，介入組與對照組症狀性結石事件為 19% vs 20%（hr 0·96，95% ci 0·77-1·20）。介入組 24 h urine volume 較高，但結石新增或增大、複合終點皆未見差異；未發生需住院的 hyponatremia，無症狀 hyponatraemia 為 1% vs <1%。 藥師重點：研究結果說明促進飲水的行為介入可小幅增加尿量，但未降低 2 年內結石復發；藥師衛教時可強調飲水目標、順從性與泌尿症狀，同時避免把尿量改善直接等同於復發風險下降。" }, { "id": "pmid-41841706", "kind": "article", "issueId": "2026-week12", "year": 2026, "week": 12, "weekLabel": "第 12 週", "dateRange": "2026/03/16 – 03/22", "href": "2026-week12.html", "title": "Prehospital Whole Blood in Traumatic Hemorrhage - A Randomized Controlled Trial", "journal": "NEJM", "type": "RCT", "typeLabel": "RCT", "author": "Smith", "doi": "10.1056/NEJMoa2516043", "url": "https://doi.org/10.1056/NEJMoa2516043", "summary": "藥師重點：結論顯示到院前輸注 2 units whole blood 未優於標準血液成分治療以降低 24 小時死亡或 massive transfusion；輸血流程規劃仍需兼顧血品可近性、凝血監測與創傷團隊後續大量輸血策略。", "pubDate": "2026-06-18", "terms": [ "prehospital", "whole", "blood", "traumatic", "hemorrhage", "nejm", "smith", "nejmoa2516043", "ambulance", "services" ], "drugTerms": [], "searchText": "prehospital whole blood in traumatic hemorrhage - a randomized controlled trial nejm rct smith 10.1056/nejmoa2516043 研究背景：嚴重創傷出血的到院前輸血策略近年重新關注 全血輸血，但其相較紅血球與血漿成分治療的臨床效益與安全性仍缺乏大型試驗資料。 研究方法：此英格蘭 10 個 air ambulance services 進行的 實務型、第 3 期、多中心、unblinded、隨機 優越性試驗，納入重大創傷出血病人。受試者在到院前隨機接受 全血輸血 up to 2 units，或 標準照護 with blood components（red cells 與 plasma 各 up to 2 units）；主要終點為隨機後 24 小時內全因死亡或 massive transfusion。 主要結果：942 人隨機分組，排除非創傷出血或創傷性心跳停止後，616 人納入分析。主要終點事件為 48.7% vs 47.7%（rr 1.02，95% ci 0.80 to 1.31；p=0.84），各時間點死亡、massive transfusion 與其他次要終點大致相近；prothrombin time 高於正常範圍為 40.7% vs 30.5%，thrombotic 事件 相近。 藥師重點：結論顯示到院前輸注 2 units whole blood 未優於標準血液成分治療以降低 24 小時死亡或 massive transfusion；輸血流程規劃仍需兼顧血品可近性、凝血監測與創傷團隊後續大量輸血策略。" }, { "id": "pmid-41865411", "kind": "article", "issueId": "2026-week12", "year": 2026, "week": 12, "weekLabel": "第 12 週", "dateRange": "2026/03/16 – 03/22", "href": "2026-week12.html", "title": "National Estimates of Pediatric Sepsis in US Hospitals Using Clinical Data", "journal": "JAMA", "type": "OA", "typeLabel": "Original Article", "author": "Rhee", "doi": "10.1001/jama.2026.3100", "url": "https://doi.org/10.1001/jama.2026.3100", "summary": "藥師重點：結論顯示 EHR-based PSE definition 可作為兒童敗血症監測工具，並凸顯兒童 sepsis 仍有約 10% 院內死亡率；藥師可將其作為抗感染 stewardship 與 sepsis protocol 規劃背景，但不應取代個別病人的臨床診斷。", "pubDate": "2026-04-21", "terms": [ "national", "estimates", "pediatric", "sepsis", "hospitals", "jama", "rhee", "morbidity", "event", "epic" ], "drugTerms": [], "searchText": "national estimates of pediatric sepsis in us hospitals using clinical data jama original article rhee 10.1001/jama.2026.3100 研究背景：兒童敗血症會造成顯著 morbidity 與 死亡率，但以行政編碼進行族群監測的準確性有限；本研究評估以 ehr 臨床資料建立的 pediatric sepsis event（pse）定義。 研究方法：此 回溯性世代研究 使用兩個 ehr 資料庫，共 3.9 百萬 筆 >30 天至 17 歲住院資料，包含 epic cosmos（245 健康 care systems，2016-2023）與 hca healthcare（146 hospitals，2018-2023）。pse 定義為疑似感染合併 phoenix-derived organ 功能障礙 threshold，septic shock 則為 pse 合併 心血管 功能障礙，並以 581 筆高風險病歷審查驗證。 主要結果：2016 至 2023 年 3,925,809 筆兒科住院中，pse 辨識出 51,542 例 sepsis（incidence 1.3%），其中 72.6% 為 community onset，61.6% 有 septic shock；院內死亡率為 10.1%，死亡住院中 17.8% 有 sepsis。pse 對 physician-adjudicated phoenix sepsis 的 sensitivity 為 69.9%（95% ci 58.1%-79.8%），specificity 為 93.1%（95% ci 89.6%-95.7%）；2022 年全美估計 18,231 例與 1877 死亡。 藥師重點：結論顯示 ehr-based pse definition 可作為兒童敗血症監測工具，並凸顯兒童 sepsis 仍有約 10% 院內死亡率；藥師可將其作為抗感染 stewardship 與 sepsis protocol 規劃背景，但不應取代個別病人的臨床診斷。" }, { "id": "pmid-41849741", "kind": "article", "issueId": "2026-week12", "year": 2026, "week": 12, "weekLabel": "第 12 週", "dateRange": "2026/03/16 – 03/22", "href": "2026-week12.html", "title": "Left Atrial Appendage Closure or Medical Therapy in Atrial Fibrillation", "journal": "NEJM", "type": "RCT", "typeLabel": "RCT", "author": "Landmesser", "doi": "10.1056/NEJMoa2513310", "url": "https://doi.org/10.1056/NEJMoa2513310", "summary": "藥師重點：結論顯示在高中風與高出血風險心房顫動患者中，左心耳封堵 未證實不劣於 physician-directed best 醫療照護；藥師評估時仍需重視 DOAC 適用性、出血風險、順從性與裝置治療後的抗血栓銜接。", "pubDate": "2026-04-02", "terms": [ "left", "atrial", "appendage", "closure", "fibrillation", "nejm", "landmesser", "nejmoa2513310", "physician-directed", "best" ], "drugTerms": [], "searchText": "left atrial appendage closure or medical therapy in atrial fibrillation nejm rct landmesser 10.1056/nejmoa2513310 研究背景：心房顫動且同時具有高中風與高出血風險的患者，左心耳封堵 常被視為口服抗凝血治療替代方案，但相較 physician-directed best 醫療照護 的效果仍不確定。 研究方法：此德國多中心 隨機試驗 納入 912 名高風險心房顫動成人，分配接受 左心耳封堵 或 physician-directed best 醫療照護，後者包含符合條件者使用 direct 口服 anticoagulants。主要終點以 不劣性 檢定，為中風、systemic embolism、重大出血、心血管或原因不明死亡的複合終點，不劣性 margin 為 hr 1.3。 主要結果：主要分析納入 device 組 446 人與 medical-治療 組 442 人，平均年齡 77.9 歲，平均 cha2ds2-vasc score 5.2、has-bled score 3.0。追蹤中位數 3 年後，主要終點事件率為 16.8 vs 13.3 per 100 patient-years，restricted 平均值 存活期 time 差異為 -0.36 years（95% ci -0.70 to -0.01；p=0.44 for 不劣性）；嚴重不良事件 為 82.5% vs 77.4%。 藥師重點：結論顯示在高中風與高出血風險心房顫動患者中，左心耳封堵 未證實不劣於 physician-directed best 醫療照護；藥師評估時仍需重視 doac 適用性、出血風險、順從性與裝置治療後的抗血栓銜接。" }, { "id": "pmid-41841715", "kind": "article", "issueId": "2026-week12", "year": 2026, "week": 12, "weekLabel": "第 12 週", "dateRange": "2026/03/16 – 03/22", "href": "2026-week12.html", "title": "High-Flow or Standard Oxygen in Acute Hypoxemic Respiratory Failure", "journal": "NEJM", "type": "RCT", "typeLabel": "RCT", "author": "Frat", "doi": "10.1056/NEJMoa2516087", "url": "https://doi.org/10.1056/NEJMoa2516087", "summary": "藥師重點：結論顯示 高流量鼻導管 未降低急性低血氧性呼吸衰竭病人的 28 天死亡率，雖有較低插管率訊號；臨床照護仍需密切評估呼吸惡化、升階治療時機與相關併發症。", "pubDate": "2026-06-04", "terms": [ "high-flow", "standard", "oxygen", "acute", "hypoxemic", "respiratory", "failure", "nejm", "frat", "nejmoa2516087" ], "drugTerms": [], "searchText": "high-flow or standard oxygen in acute hypoxemic respiratory failure nejm rct frat 10.1056/nejmoa2516087 研究背景：急性低血氧性呼吸衰竭病人常使用 高流量鼻導管，但相較標準氧氣治療，其對插管與死亡的影響仍需大型隨機試驗確認。 研究方法：此 多中心、開放標籤試驗 將急性低血氧性呼吸衰竭病人隨機分配至 high-flow-oxygen 或 standard-oxygen 治療。納入條件包括 pao2/fio2 ≤200、呼吸速率 >25 breaths per minute，且胸部影像有肺部浸潤；主要終點為 第 28 天 死亡。 主要結果：1110 名病人納入分析，第 28 天 死亡率 在 high-flow-oxygen 組與 standard-oxygen 組皆為 14.6%（差異 -0.05 百分點，95% ci -4.21 to 4.10；p=0.98）。第 28 天 插管率為 42.4% vs 48.4%（差異 -5.93 百分點，95% ci -11.78 to -0.08）；自發呼吸期間 嚴重不良事件 為 2.3% vs 1.1%。 藥師重點：結論顯示 高流量鼻導管 未降低急性低血氧性呼吸衰竭病人的 28 天死亡率，雖有較低插管率訊號；臨床照護仍需密切評估呼吸惡化、升階治療時機與相關併發症。" }, { "id": "pmid-41862204", "kind": "article", "issueId": "2026-week12", "year": 2026, "week": 12, "weekLabel": "第 12 週", "dateRange": "2026/03/16 – 03/22", "href": "2026-week12.html", "title": "Effect of a clinical decision support system on stroke care quality and outcomes in patients with acute ischaemic stroke (GOLDEN BRIDGE II): cluster randomised clinical trial", "journal": "BMJ", "type": "RCT", "typeLabel": "RCT", "author": "Zhang", "doi": "10.1136/bmj-2025-085810", "url": "https://doi.org/10.1136/bmj-2025-085810", "summary": "藥師重點：結論顯示 stroke CDSS 可改善急性缺血性中風照護品質並降低血管事件；藥師可將其視為流程輔助工具，仍需逐案確認抗血栓、降脂與出血風險等用藥決策。", "pubDate": "2026-03-20", "terms": [ "decision", "support", "system", "stroke", "quality", "acute", "ischaemic", "golden", "bridge", "cluster" ], "drugTerms": [], "searchText": "effect of a clinical decision support system on stroke care quality and outcomes in patients with acute ischaemic stroke (golden bridge ii): cluster randomised clinical trial bmj rct zhang 10.1136/bmj-2025-085810 研究背景：急性缺血性中風照護需快速完成影像判讀、病因分類與證據導向治療，臨床 decision support system（cdss）是否能改善照護品質與臨床事件仍需大型試驗驗證。 研究方法：golden bridge ii 為中國 77 家醫院的 多中心 群集隨機試驗，納入發病 7 天內住院的 21,603 名急性缺血性中風患者。介入醫院使用 stroke cdss，包括 ai 輔助影像分析、中風病因分類與 evidence-based 治療 recommendations；對照組為 常規照護，主要終點為 3 個月內新發血管事件。 主要結果：3 個月新發血管事件於 cdss 組與對照組分別為 2.9% vs 3.9%（校正 hr 0.74，95% ci 0.58 to 0.93；p=0.01）。cdss 組 evidence-based performance 複合 measure 較高（校正 or 1.21，95% ci 1.17 to 1.26；p<0.001），12 個月新發血管事件亦較低（4.0% vs 5.5%；校正 hr 0.73，95% ci 0.56 to 0.95；p=0.02），失能、全因死亡與出血未見顯著差異。 藥師重點：結論顯示 stroke cdss 可改善急性缺血性中風照護品質並降低血管事件；藥師可將其視為流程輔助工具，仍需逐案確認抗血栓、降脂與出血風險等用藥決策。" }, { "id": "pmid-41864747", "kind": "article", "issueId": "2026-week12", "year": 2026, "week": 12, "weekLabel": "第 12 週", "dateRange": "2026/03/16 – 03/22", "href": "2026-week12.html", "title": "Angiography-derived fractional flow reserve versus coronary angiography to guide coronary artery bypass grafting in patients undergoing surgical valve procedures with concomitant coronary artery disease in China (FAVOR IV-QVAS): a multicentre, triple-blind, randomised trial", "journal": "Lancet", "type": "RCT", "typeLabel": "RCT", "author": "Zhu", "doi": "10.1016/S0140-6736(25)02418-3", "url": "https://doi.org/10.1016/S0140-6736(25)02418-3", "summary": "藥師重點：結論顯示瓣膜手術合併冠狀動脈疾病患者中，以 angiography-derived FFR 指引的選擇性 CABG 可降低圍手術期複合事件；藥師在術前後照護可留意抗血栓策略、腎功能與血流動力學風險，並避免將結果外推至未接受瓣膜手術族群。", "pubDate": "2026-03-21", "terms": [ "angiography-derived", "fractional", "flow", "reserve", "coronary", "angiography", "guide", "artery", "bypass", "grafting" ], "drugTerms": [], "searchText": "angiography-derived fractional flow reserve versus coronary angiography to guide coronary artery bypass grafting in patients undergoing surgical valve procedures with concomitant coronary artery disease in china (favor iv-qvas): a multicentre, triple-blind, randomised trial lancet rct zhu 10.1016/s0140-6736(25)02418-3 研究背景：接受瓣膜手術且合併冠狀動脈疾病的患者，cabg 傳統上依冠狀動脈攝影狹窄程度決定；angiography-derived ffr 是否能協助選擇需要繞道的病灶，是 favor iv-qvas 的研究重點。 研究方法：favor iv-qvas 為中國 12 家三級醫院進行的 investigator-initiated、多中心、隨機、triple-blind 試驗，納入預計接受瓣膜手術且至少一條主要冠狀動脈有臨床重要狹窄的成人。受試者分配至 physiologically guided cabg（angiography-derived ffr ≤0·80 才繞道）或 anatomically guided cabg（冠狀動脈攝影狹窄直徑 ≥50% 才繞道），主要終點為術後 30 天複合不良事件。 主要結果：共 793 人納入，angiography-derived ffr 組與 冠狀動脈 angiography 組實際接受 concomitant cabg 比例為 56% vs 98%。30 天主要複合終點為 7·8% vs 13·4%（absolute 差異 -5·6 百分點，95% ci -9·9 to -1·3；rr 0·58，95% ci 0·38 to 0·89；p=0·011）；追蹤中位數 27 個月時，關鍵次要複合終點為 20·7% vs 26·8%（hr 0·74，95% ci 0·55-0·98；p=0·036）。 藥師重點：結論顯示瓣膜手術合併冠狀動脈疾病患者中，以 angiography-derived ffr 指引的選擇性 cabg 可降低圍手術期複合事件；藥師在術前後照護可留意抗血栓策略、腎功能與血流動力學風險，並避免將結果外推至未接受瓣膜手術族群。" }, { "id": "pmid-41856526", "kind": "article", "issueId": "2026-week12", "year": 2026, "week": 12, "weekLabel": "第 12 週", "dateRange": "2026/03/16 – 03/22", "href": "2026-week12.html", "title": "Accuracy of glomerular filtration rate estimation based on creatinine and cystatin C for monitoring moderate chronic kidney disease in adults: prospective, longitudinal cohort study", "journal": "BMJ", "type": "OA", "typeLabel": "Original Article", "author": "Scandrett", "doi": "10.1136/bmj-2025-085005", "url": "https://doi.org/10.1136/bmj-2025-085005", "summary": "藥師重點：結論顯示 creatinine 合併 cystatin C 的公式較能追蹤中度慢性腎臟病 GFR 變化，但對疾病進展的敏感度仍不足；藥師進行腎功能劑量調整時，宜結合趨勢、臨床狀態與必要時的進一步檢測。", "pubDate": "2026-03-19", "terms": [ "accuracy", "glomerular", "filtration", "rate", "estimation", "creatinine", "cystatin", "monitoring", "moderate", "chronic" ], "drugTerms": [ "cystatin", "ckd-epicreatinine-cystatin", "creatinine-cystatin", "ekfccreatinine-cystatin" ], "searchText": "accuracy of glomerular filtration rate estimation based on creatinine and cystatin c for monitoring moderate chronic kidney disease in adults: prospective, longitudinal cohort study bmj original article scandrett 10.1136/bmj-2025-085005 研究背景：中度慢性腎臟病病人的腎功能追蹤常依賴 estimated gfr，但 creatinine 與 cystatin c 合併估算是否比單一 biomarker 更能反映 gfr 變化仍需長期資料。 研究方法：此英格蘭 6 個中心 prospective longitudinal 世代研究 納入 1229 名成人，條件為 creatinine estimated gfr 30-59 ml/min/1.73 m2 且持續至少 3 個月。研究比較 ckd-epi 與 ekfc 等 gfr estimating equations 在 3 年內追蹤 measured gfr（iohexol clearance）變化與偵測腎病進展的準確性。 主要結果：875 名受試者有完整起始與 3 年資料，中位數 measured gfr 由 48.1 降至 43.6 ml/min/1.73 m2。所有公式皆低估 measured gfr 下降幅度；dual biomarker equations 與 measured gfr 變化的一致性較好（ckd-epicreatinine-cystatin 78.6%、ckd-epi(2021)creatinine-cystatin 78.1%、ekfccreatinine-cystatin 80.2%），優於 ckd-epicreatinine 73.1%（all p<0.001）。所有公式偵測腎病進展的 sensitivity 皆 <54.1%，specificity 皆 >90.4%。 藥師重點：結論顯示 creatinine 合併 cystatin c 的公式較能追蹤中度慢性腎臟病 gfr 變化，但對疾病進展的敏感度仍不足；藥師進行腎功能劑量調整時，宜結合趨勢、臨床狀態與必要時的進一步檢測。" }, { "id": "fda-2026-week12-1", "kind": "fda", "issueId": "2026-week12", "year": 2026, "week": 12, "weekLabel": "第 12 週", "dateRange": "2026/03/16 – 03/22", "href": "2026-week12.html", "title": "FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "concerns", "unapproved", "glp-1", "drugs", "used", "weight", "loss", "https", "drug-alerts-and-statements", "fdas-concerns-unapproved-glp-1-drugs-used-weight-loss" ], "drugTerms": [ "glp-1" ], "searchText": "fda’s concerns with unapproved glp-1 drugs used for weight loss fda drug safety 2026-06-15 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss" }, { "id": "fda-2026-week12-3", "kind": "fda", "issueId": "2026-week12", "year": 2026, "week": 12, "weekLabel": "第 12 週", "dateRange": "2026/03/16 – 03/22", "href": "2026-week12.html", "title": "FDA issues final decision to withdraw approval of Pepaxto (melphalan flufenamide)", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/node/398713", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "issues", "final", "decision", "withdraw", "approval", "pepaxto", "melphalan", "flufenamide", "https", "node" ], "drugTerms": [], "searchText": "fda issues final decision to withdraw approval of pepaxto (melphalan flufenamide) fda drug safety 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/node/398713" }, { "id": "fda-2026-week12-2", "kind": "fda", "issueId": "2026-week12", "year": 2026, "week": 12, "weekLabel": "第 12 週", "dateRange": "2026/03/16 – 03/22", "href": "2026-week12.html", "title": "FDA alerts patients, caregivers, and health care providers of cross-compatibility issues with autoinjector devices that are optional for use with glatiramer acetate injection", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/node/403159", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "alerts", "caregivers", "providers", "cross-compatibility", "issues", "autoinjector", "devices", "that", "optional", "glatiramer" ], "drugTerms": [], "searchText": "fda alerts patients, caregivers, and health care providers of cross-compatibility issues with autoinjector devices that are optional for use with glatiramer acetate injection fda drug safety 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/node/403159" }, { "id": "fda-2026-week12-4", "kind": "fda", "issueId": "2026-week12", "year": 2026, "week": 12, "weekLabel": "第 12 週", "dateRange": "2026/03/16 – 03/22", "href": "2026-week12.html", "title": "FDA Accepts First In Silico Drug Development Tool Under ISTAND Program to Help Predict Drug-Induced Liver Injury", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fda-accepts-first-silico-drug-development-tool-under-istand-program-help-predict-drug-induced-liver", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "accepts", "first", "silico", "development", "tool", "under", "istand", "program", "help", "predict" ], "drugTerms": [], "searchText": "fda accepts first in silico drug development tool under istand program to help predict drug-induced liver injury fda drug safety 2026-06-03 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/drugs/drug-alerts-and-statements/fda-accepts-first-silico-drug-development-tool-under-istand-program-help-predict-drug-induced-liver" }, { "id": "pmid-41812193", "kind": "article", "issueId": "2026-week11", "year": 2026, "week": 11, "weekLabel": "第 11 週", "dateRange": "2026/03/09 – 03/15", "href": "2026-week11.html", "title": "Romiplostim versus Placebo for Chemotherapy-Induced Thrombocytopenia", "journal": "NEJM", "type": "RCT", "typeLabel": "RCT", "author": "Al-Samkari", "doi": "10.1056/NEJMoa2511882", "url": "https://doi.org/10.1056/NEJMoa2511882", "summary": "藥師重點：結論顯示 romiplostim 可提高持續 CIT 病人維持化療劑量的機會；藥師需留意血栓栓塞風險、化療相關高等級不良事件，以及此結果主要來自接受 oxaliplatin-based 治療的胃腸道癌症族群。", "pubDate": "2026-03-12", "terms": [ "romiplostim", "placebo", "chemotherapy-induced", "thrombocytopenia", "nejm", "al-samkari", "nejmoa2511882", "recite", "oxaliplatin-based" ], "drugTerms": [], "searchText": "romiplostim versus placebo for chemotherapy-induced thrombocytopenia nejm rct al-samkari 10.1056/nejmoa2511882 研究背景：化療誘發血小板低下（cit）會增加出血風險，並可能造成化療劑量降低或延後；目前臨床上仍缺乏廣泛可用且核准的治療選項。 研究方法：recite 為 第 3 期、國際多中心、雙盲、隨機、安慰劑對照試驗，納入接受 oxaliplatin-based 多藥細胞毒性化療且持續 cit 的胃腸道癌症病人。165 名病人以 2:1 分配接受 romiplostim 或 安慰劑 三個化療週期，主要終點為第 2 與第 3 週期均未因 cit 調整化療劑量。 主要結果：未因 cit 調整化療劑量的比例為 romiplostim 組 84%（92/109）對 安慰劑 組 36%（20/56），or 10.16（95% ci 4.44-23.72；p<0.001），rr 2.77（95% ci 1.78-4.30；p<0.001）。等級 3 以上不良事件為 37% 對 22%，血栓栓塞事件為 2% 對 0%。 藥師重點：結論顯示 romiplostim 可提高持續 cit 病人維持化療劑量的機會；藥師需留意血栓栓塞風險、化療相關高等級不良事件，以及此結果主要來自接受 oxaliplatin-based 治療的胃腸道癌症族群。" }, { "id": "pmid-41796601", "kind": "article", "issueId": "2026-week11", "year": 2026, "week": 11, "weekLabel": "第 11 週", "dateRange": "2026/03/09 – 03/15", "href": "2026-week11.html", "title": "Pimicotinib versus placebo for tenosynovial giant cell tumour (MANEUVER): an international, randomised, placebo-controlled, phase 3 trial", "journal": "Lancet", "type": "RCT", "typeLabel": "RCT", "author": "Xu", "doi": "10.1016/S0140-6736(25)02602-9", "url": "https://doi.org/10.1016/S0140-6736(25)02602-9", "summary": "藥師重點：結論顯示 pimicotinib 在不可切除、有症狀 TGCT 可提高腫瘤反應率並改善症狀負擔；藥師需留意皮膚與水腫相關不良反應、creatine phosphokinase 監測，以及長期治療安全性仍需後續資料支持。", "pubDate": "2026-03-14", "terms": [ "pimicotinib", "placebo", "tenosynovial", "giant", "cell", "tumour", "maneuver", "international", "randomised", "placebo-controlled" ], "drugTerms": [ "pimicotinib" ], "searchText": "pimicotinib versus placebo for tenosynovial giant cell tumour (maneuver): an international, randomised, placebo-controlled, phase 3 trial lancet rct xu 10.1016/s0140-6736(25)02602-9 研究背景：腱鞘巨細胞瘤（tgct）為罕見且具局部侵襲性的腫瘤，部分病人無法手術且有症狀，目前全身性治療選項有限。pimicotinib 為選擇性 colony-stimulating factor-1 受體 抑制劑，本研究評估其療效與安全性。 研究方法：maneuver 為國際、多中心、隨機、安慰劑對照 第 3 期 試驗，於亞洲、歐洲與北美 40 家專科醫院進行。94 名不可切除且有症狀的成人 tgct 病人以 2:1、雙盲分配接受 pimicotinib 50 mg 每日一次 或 安慰劑 24 週，主要終點為第 25 週依 recist version 1.1 評估的 orr。 主要結果：第 25 週 orr 為 pimicotinib 組 54%（34/63）對 安慰劑 組 3%（1/31），absolute 差異 51%（95% ci 33-63；p<0.0001）。pimicotinib 常見不良事件多為輕度，包含搔癢、臉部水腫、皮疹、眼眶周圍水腫與疲倦；等級 3 或 4 creatine phosphokinase 增加發生於 13%。 藥師重點：結論顯示 pimicotinib 在不可切除、有症狀 tgct 可提高腫瘤反應率並改善症狀負擔；藥師需留意皮膚與水腫相關不良反應、creatine phosphokinase 監測，以及長期治療安全性仍需後續資料支持。" }, { "id": "pmid-41831847", "kind": "article", "issueId": "2026-week11", "year": 2026, "week": 11, "weekLabel": "第 11 週", "dateRange": "2026/03/09 – 03/15", "href": "2026-week11.html", "title": "Integrated community-based versus facility-based care for people with HIV, diabetes, and hypertension in sub-Saharan Africa (INTE-COMM): an open-label, multicountry, cluster-randomised trial", "journal": "Lancet", "type": "RCT", "typeLabel": "RCT", "author": "Kasujja", "doi": "10.1016/S0140-6736(25)02641-8", "url": "https://doi.org/10.1016/S0140-6736(25)02641-8", "summary": "藥師重點：研究結果說明，在資源有限且 HIV 與慢性病共存的地區，整合式社區照護可維持糖尿病或高血壓照護品質，且未不利影響 HIV 控制；藥師可留意此模式對慢性病續方、用藥整合與追蹤可近性的啟示。", "pubDate": "2026-03-14", "terms": [ "integrated", "community-based", "facility-based", "people", "diabetes", "hypertension", "sub-saharan", "africa", "inte-comm", "open-label" ], "drugTerms": [], "searchText": "integrated community-based versus facility-based care for people with hiv, diabetes, and hypertension in sub-saharan africa (inte-comm): an open-label, multicountry, cluster-randomised trial lancet rct kasujja 10.1016/s0140-6736(25)02641-8 研究背景：撒哈拉以南非洲同時面臨糖尿病、高血壓與 hiv 的照護負擔，是否能以社區模式整合慢性病與 hiv 照護仍需臨床證據。 研究方法：inte-comm 為開放標籤、多國、cluster-隨機試驗，於 tanzania 與 uganda 的 14 家基層醫療機構進行。1864 名臨床穩定且可接受社區照護的成人依群組分配至整合式社區照護或院所照護，追蹤 12 個月；共同主要終點為血壓或空腹血糖控制，以及 hiv 病人的 viral load suppression。 主要結果：糖尿病或高血壓病人的血壓或空腹血糖控制率兩組無顯著差異（55.2% vs 53.2%；校正 風險差 1.80，95% ci -4.52 to 8.12；p=0.58）。hiv 病人的 viral suppression 維持高比例（99.1% vs 98.7%；校正 風險差 0.44，95% ci -1.12 to 1.99；p不劣性<0.0001），兩組各有 7 例死亡。 藥師重點：研究結果說明，在資源有限且 hiv 與慢性病共存的地區，整合式社區照護可維持糖尿病或高血壓照護品質，且未不利影響 hiv 控制；藥師可留意此模式對慢性病續方、用藥整合與追蹤可近性的啟示。" }, { "id": "pmid-41812190", "kind": "article", "issueId": "2026-week11", "year": 2026, "week": 11, "weekLabel": "第 11 週", "dateRange": "2026/03/09 – 03/15", "href": "2026-week11.html", "title": "Inhaled Treprostinil for Idiopathic Pulmonary Fibrosis", "journal": "NEJM", "type": "OA", "typeLabel": "Original Article", "author": "Nathan", "doi": "10.1056/NEJMoa2512911", "url": "https://doi.org/10.1056/NEJMoa2512911", "summary": "藥師重點：結論顯示 inhaled treprostinil 可減少 IPF 病人 52 週內 FVC 下降並降低 臨床 worsening；藥師需留意吸入裝置使用、咳嗽與停藥風險，並確認病人是否同時使用背景抗纖維化治療。", "pubDate": "2026-03-11", "terms": [ "inhaled", "treprostinil", "idiopathic", "pulmonary", "fibrosis", "nejm", "nathan", "nejmoa2512911", "teton-2", "breaths" ], "drugTerms": [], "searchText": "inhaled treprostinil for idiopathic pulmonary fibrosis nejm original article nathan 10.1056/nejmoa2512911 研究背景：特發性肺纖維化（ipf）會造成肺功能逐步下降；吸入型 treprostinil 可能具抗纖維化作用，但其對 ipf 病人肺功能與臨床惡化的影響仍需驗證。 研究方法：teton-2 為 第 3 期、雙盲試驗，將 593 名 ipf 病人隨機分配接受 inhaled treprostinil 或 安慰劑，劑量為 12 breaths four times 每日，治療 52 週。主要終點為第 52 週 absolute fvc 相較基準值的變化，並依序評估 臨床 worsening、急性惡化與安全性。 主要結果：第 52 週 fvc 中位變化為 treprostinil 組 -49.9 ml 對 安慰劑 組 -136.4 ml，組間差異 95.6 ml（95% ci 52.2-139.0；p<0.001）。臨床 worsening 為 27.2% 對 39.0%（hr 0.71，95% ci 0.53-0.95；p=0.02）；最常見不良事件為咳嗽（48.3% vs 24.1%），停藥率為 33.6% 對 24.7%。 藥師重點：結論顯示 inhaled treprostinil 可減少 ipf 病人 52 週內 fvc 下降並降低 臨床 worsening；藥師需留意吸入裝置使用、咳嗽與停藥風險，並確認病人是否同時使用背景抗纖維化治療。" }, { "id": "pmid-41811336", "kind": "article", "issueId": "2026-week11", "year": 2026, "week": 11, "weekLabel": "第 11 週", "dateRange": "2026/03/09 – 03/15", "href": "2026-week11.html", "title": "Hospital Adoption and Pricing for Oncology Biosimilars", "journal": "JAMA", "type": "OA", "typeLabel": "Original Article", "author": "Robinson", "doi": "10.1001/jama.2026.1777", "url": "https://doi.org/10.1001/jama.2026.1777", "summary": "藥師重點：研究結果說明腫瘤 biosimilars 的採用增加，伴隨醫院 markup margin 上升；藥師與藥事管理團隊評估 biosimilars 導入時，除療效與安全性外，也需理解採購、給付與藥品政策對臨床使用的影響。", "pubDate": "2026-04-14", "terms": [ "hospital", "adoption", "pricing", "oncology", "biosimilars", "jama", "robinson", "blue", "cross", "shield" ], "drugTerms": [ "bevacizumab", "trastuzumab", "rituximab" ], "searchText": "hospital adoption and pricing for oncology biosimilars jama original article robinson 10.1001/jama.2026.1777 研究背景：多項由醫師給藥的腫瘤生物製劑即將面臨專利到期與 biosimilars 競爭，醫院採購價、保險給付價與節省成本如何分配，會影響 biosimilars 的採用。 研究方法：此觀察性研究使用 2020-2024 年 blue cross blue shield 保險病人資料，連結醫院向藥廠支付的採購價、保險人支付給醫院的 reimbursement prices、340b 資格，以及醫院、病人與市場特徵。主要評估 bevacizumab、trastuzumab 與 rituximab biosimilars 的採購價、給付價、醫院 markup margin 與採用情形。 主要結果：66139 名病人、1541 家醫院資料顯示，bevacizumab、trastuzumab 與 rituximab biosimilars 的醫院採購價分別下降 60%、72% 與 63%，但保險給付價僅下降 32%、36% 與 34%。同期 biosimilars 使用占比分別由 2020 年的 32%、37% 與 18%，上升至 2024 年的 93%、87% 與 84%。 藥師重點：研究結果說明腫瘤 biosimilars 的採用增加，伴隨醫院 markup margin 上升；藥師與藥事管理團隊評估 biosimilars 導入時，除療效與安全性外，也需理解採購、給付與藥品政策對臨床使用的影響。" }, { "id": "pmid-41819560", "kind": "article", "issueId": "2026-week11", "year": 2026, "week": 11, "weekLabel": "第 11 週", "dateRange": "2026/03/09 – 03/15", "href": "2026-week11.html", "title": "Camrelizumab plus CAPOX with camrelizumab based maintenance versus CAPOX alone as initial treatment for gastric or gastro-oesophageal junction adenocarcinoma: randomised phase 3 trial", "journal": "BMJ", "type": "RCT", "typeLabel": "RCT", "author": "Peng", "doi": "10.1136/bmj-2025-086115", "url": "https://doi.org/10.1136/bmj-2025-086115", "summary": "藥師重點：結論顯示 camrelizumab 併 CAPOX 後續 camrelizumab-based maintenance 可較 CAPOX 單用 改善存活；加入 apatinib 的探索性比較未見額外存活效益，且高等級治療相關不良事件較多，需審慎評估維持治療的效益與耐受性。", "pubDate": "2026-03-12", "terms": [ "camrelizumab", "plus", "capox", "maintenance", "alone", "initial", "gastric", "gastro-oesophageal", "junction", "adenocarcinoma" ], "drugTerms": [ "camrelizumab", "oxaliplatin", "apatinib" ], "searchText": "camrelizumab plus capox with camrelizumab based maintenance versus capox alone as initial treatment for gastric or gastro-oesophageal junction adenocarcinoma: randomised phase 3 trial bmj rct peng 10.1136/bmj-2025-086115 研究背景：her2 陰性、不可切除、局部晚期或轉移性胃癌與胃食道接合部腺癌，第一線治療仍需改善整體存活；本研究比較 camrelizumab 併 capox 後續不同維持策略與 capox 單獨治療。 研究方法：此隨機、開放標籤、第 3 期 試驗於中國 75 家醫院進行，納入 885 名先前未治療的成人病人。病人分配至 camre+capox followed by camre+apa、capox 單用，或中途新增的 camre+capox followed by camre，主要終點為 pd-l1 陽性 與整體族群的 整體存活期。 主要結果：相較 capox 單用，camre+capox followed by camre+apa 在 pd-l1 陽性 族群延長 整體存活期（中位數 15.0 vs 12.5 個月；hr 0.80，95% ci 0.65-0.98；one sided p=0.02），整體族群亦較佳（中位數 13.5 vs 12.1 個月；hr 0.80，95% ci 0.68-0.94；one sided p=0.004）。等級 ≥3 治療相關不良事件 為 67.9%、45.3% 與 46.9%。 藥師重點：結論顯示 camrelizumab 併 capox 後續 camrelizumab-based maintenance 可較 capox 單用 改善存活；加入 apatinib 的探索性比較未見額外存活效益，且高等級治療相關不良事件較多，需審慎評估維持治療的效益與耐受性。" }, { "id": "pmid-41812192", "kind": "article", "issueId": "2026-week11", "year": 2026, "week": 11, "weekLabel": "第 11 週", "dateRange": "2026/03/09 – 03/15", "href": "2026-week11.html", "title": "Bleeding Risk with Apixaban vs. Rivaroxaban in Acute Venous Thromboembolism", "journal": "NEJM", "type": "RCT", "typeLabel": "RCT", "author": "Castellucci", "doi": "10.1056/NEJMoa2510703", "url": "https://doi.org/10.1056/NEJMoa2510703", "summary": "藥師重點：結論顯示急性靜脈血栓栓塞治療 3 個月期間，apixaban 的臨床相關出血風險低於 rivaroxaban；藥師進行抗凝血藥選擇與衛教時，仍需同時評估腎功能、交互作用、服藥頻次與病人出血風險。", "pubDate": "2026-03-12", "terms": [ "bleeding", "apixaban", "rivaroxaban", "acute", "venous", "thromboembolism", "nejm", "castellucci", "nejmoa2510703", "cobrra" ], "drugTerms": [ "apixaban", "rivaroxaban" ], "searchText": "bleeding risk with apixaban vs. rivaroxaban in acute venous thromboembolism nejm rct castellucci 10.1056/nejmoa2510703 研究背景：apixaban 與 rivaroxaban 是急性靜脈血栓栓塞常用的口服抗凝血藥，但兩者在臨床相關出血風險上的差異仍需直接比較。 研究方法：cobrra 為國際、前瞻性、隨機、開放標籤且終點盲性評估試驗，納入急性有症狀肺栓塞或近端深部靜脈栓塞病人。2760 名病人以 1:1 分配接受 apixaban 或 rivaroxaban 3 個月，主要結果為 重大出血 或 clinically relevant non重大出血 的複合終點。 主要結果：主要出血相關終點發生率為 apixaban 組 3.3%（44/1345）對 rivaroxaban 組 7.1%（96/1355），相對風險 0.46（95% ci 0.33-0.65；p<0.001）。非出血或靜脈血栓相關的 嚴重不良事件 分別為 2.7% 與 2.2%。 藥師重點：結論顯示急性靜脈血栓栓塞治療 3 個月期間，apixaban 的臨床相關出血風險低於 rivaroxaban；藥師進行抗凝血藥選擇與衛教時，仍需同時評估腎功能、交互作用、服藥頻次與病人出血風險。" }, { "id": "fda-2026-week11-1", "kind": "fda", "issueId": "2026-week11", "year": 2026, "week": 11, "weekLabel": "第 11 週", "dateRange": "2026/03/09 – 03/15", "href": "2026-week11.html", "title": "FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "concerns", "unapproved", "glp-1", "drugs", "used", "weight", "loss", "https", "drug-alerts-and-statements", "fdas-concerns-unapproved-glp-1-drugs-used-weight-loss" ], "drugTerms": [ "glp-1" ], "searchText": "fda’s concerns with unapproved glp-1 drugs used for weight loss fda drug safety 2026-06-15 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss" }, { "id": "fda-2026-week11-3", "kind": "fda", "issueId": "2026-week11", "year": 2026, "week": 11, "weekLabel": "第 11 週", "dateRange": "2026/03/09 – 03/15", "href": "2026-week11.html", "title": "FDA issues final decision to withdraw approval of Pepaxto (melphalan flufenamide)", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/node/398713", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "issues", "final", "decision", "withdraw", "approval", "pepaxto", "melphalan", "flufenamide", "https", "node" ], "drugTerms": [], "searchText": "fda issues final decision to withdraw approval of pepaxto (melphalan flufenamide) fda drug safety 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/node/398713" }, { "id": "fda-2026-week11-2", "kind": "fda", "issueId": "2026-week11", "year": 2026, "week": 11, "weekLabel": "第 11 週", "dateRange": "2026/03/09 – 03/15", "href": "2026-week11.html", "title": "FDA alerts patients, caregivers, and health care providers of cross-compatibility issues with autoinjector devices that are optional for use with glatiramer acetate injection", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/node/403159", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "alerts", "caregivers", "providers", "cross-compatibility", "issues", "autoinjector", "devices", "that", "optional", "glatiramer" ], "drugTerms": [], "searchText": "fda alerts patients, caregivers, and health care providers of cross-compatibility issues with autoinjector devices that are optional for use with glatiramer acetate injection fda drug safety 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/node/403159" }, { "id": "fda-2026-week11-4", "kind": "fda", "issueId": "2026-week11", "year": 2026, "week": 11, "weekLabel": "第 11 週", "dateRange": "2026/03/09 – 03/15", "href": "2026-week11.html", "title": "FDA Accepts First In Silico Drug Development Tool Under ISTAND Program to Help Predict Drug-Induced Liver Injury", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fda-accepts-first-silico-drug-development-tool-under-istand-program-help-predict-drug-induced-liver", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "accepts", "first", "silico", "development", "tool", "under", "istand", "program", "help", "predict" ], "drugTerms": [], "searchText": "fda accepts first in silico drug development tool under istand program to help predict drug-induced liver injury fda drug safety 2026-06-03 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/drugs/drug-alerts-and-statements/fda-accepts-first-silico-drug-development-tool-under-istand-program-help-predict-drug-induced-liver" }, { "id": "pmid-41780062", "kind": "article", "issueId": "2026-week10", "year": 2026, "week": 10, "weekLabel": "第 10 週", "dateRange": "2026/03/02 – 03/08", "href": "2026-week10.html", "title": "Zorevunersen in Children and Adolescents with Dravet Syndrome", "journal": "NEJM", "type": "OA", "typeLabel": "Original Article", "author": "Laux", "doi": "10.1056/NEJMoa2506295", "url": "https://doi.org/10.1056/NEJMoa2506295", "summary": "藥師重點：早期資料支持 zorevunersen 持續開發作為 Dravet 症候群 可能的 疾病-modifying 治療，但目前為 開放標籤 第 1 期-2a 與延伸研究；藥師需注意鞘內給藥相關流程、腰椎穿刺後症候群、CSF protein 變化與長期安全性仍待確認。", "pubDate": "2026-03-05", "terms": [ "zorevunersen", "children", "adolescents", "dravet", "syndrome", "nejm", "laux", "nejmoa2506295", "scn1a", "haploinsufficiency" ], "drugTerms": [], "searchText": "zorevunersen in children and adolescents with dravet syndrome nejm original article laux 10.1056/nejmoa2506295 研究背景：dravet 症候群 多由 scn1a haploinsufficiency 造成，屬嚴重 developmental and epileptic encephalopathy，患者有較高 sudden unexpected 死亡 in epilepsy 與認知缺損風險；zorevunersen 為設計用來 up-regulate nav1.1 sodium channels 的 antisense oligonucleotide。 研究方法：monarch 與 admiral 為 第 1 期-2a、開放標籤、多中心研究，納入 2-18 歲且使用標準抗癲癇藥的 dravet 症候群 患者。受試者接受 single-ascending-dose zorevunersen 10-70 mg，或 multiple-ascending-dose 20-70 mg；符合條件者可進入 swallowtail 與 longwing extension 研究，持續每 4 個月接受 zorevunersen ≤45 mg。 主要結果：第 1 期-2a 研究共納入 81 名患者，75 名進入 extension 研究。多數不良事件為輕至中度；最常見為 lumbar puncture 後症候群（25%）與 extension 研究 中 cerebrospinal fluid protein 升高（45%）。接受 70 mg 後續 up to 45 mg 的患者，在 extension 研究 前 20 個月各 1 個月區間內 convulsive-seizure frequency 中位變化為 -58.82% 至 -90.91%，且整體臨床狀態、生活品質與適應行為有改善訊號。 藥師重點：早期資料支持 zorevunersen 持續開發作為 dravet 症候群 可能的 疾病-modifying 治療，但目前為 開放標籤 第 1 期-2a 與延伸研究；藥師需注意鞘內給藥相關流程、腰椎穿刺後症候群、csf protein 變化與長期安全性仍待確認。" }, { "id": "pmid-41786356", "kind": "article", "issueId": "2026-week10", "year": 2026, "week": 10, "weekLabel": "第 10 週", "dateRange": "2026/03/02 – 03/08", "href": "2026-week10.html", "title": "Prognostic score for predicting respiratory admissions among patients with chronic obstructive pulmonary disease in primary care: development and validation in population cohorts (Birmingham Lung Improvement Studies (BLISS))", "journal": "BMJ", "type": "OA", "typeLabel": "Original Article", "author": "Jordan", "doi": "10.1136/bmj-2025-084521", "url": "https://doi.org/10.1136/bmj-2025-084521", "summary": "藥師重點：BLISS score 可作為 COPD 患者兩年呼吸道住院風險分層工具的候選證據；藥師在吸入劑使用評估、急性惡化預防與共病管理時可參考其風險因子，但臨床導入前仍需 impact evaluation 確認是否改善照護結果。", "pubDate": "2026-03-05", "terms": [ "prognostic", "score", "predicting", "respiratory", "admissions", "chronic", "obstructive", "pulmonary", "development", "validation" ], "drugTerms": [], "searchText": "prognostic score for predicting respiratory admissions among patients with chronic obstructive pulmonary disease in primary care: development and validation in population cohorts (birmingham lung improvement studies (bliss)) bmj original article jordan 10.1136/bmj-2025-084521 研究背景：copd 患者未來呼吸道相關住院風險差異大，若能以臨床易取得變項建立預後分數，可能有助於基層照護中的風險分層與追蹤。 研究方法：此研究以 bliss 基層照護 世代 建立並內部驗證模型，另以 eclipse 國際 世代 與連結 hospital episode statistics 的 uk cprd aurum 資料庫進行外部驗證。研究納入 bliss 1894 名、eclipse 1749 名與 cprd 27,340 名 copd 患者，主要預測兩年內 respiratory admission 或 eclipse 世代 中 重度 exacerbation。 主要結果：bliss score 保留 6 個預測因子：age、copd assessment test score、過去 12 個月 respiratory admissions、body mass index、diabetes、forced expiratory volume in 1 second % predicted。模型判別力在內部驗證 c statistic 0.73（95% ci 0.70-0.77），外部驗證 eclipse c=0.73（0.71-0.76）、cprd c=0.71（0.70-0.72），校準表現良好，且優於個別預測因子與 bertens' score。 藥師重點：bliss score 可作為 copd 患者兩年呼吸道住院風險分層工具的候選證據；藥師在吸入劑使用評估、急性惡化預防與共病管理時可參考其風險因子，但臨床導入前仍需 impact evaluation 確認是否改善照護結果。" }, { "id": "pmid-41780001", "kind": "article", "issueId": "2026-week10", "year": 2026, "week": 10, "weekLabel": "第 10 週", "dateRange": "2026/03/02 – 03/08", "href": "2026-week10.html", "title": "Neoadjuvant GOLP in Resectable High-Risk Intrahepatic Cholangiocarcinoma", "journal": "NEJM", "type": "RCT", "typeLabel": "RCT", "author": "Shi", "doi": "10.1056/NEJMoa2513918", "url": "https://doi.org/10.1056/NEJMoa2513918", "summary": "藥師重點：結論顯示 neoadjuvant GOLP 可延長可切除高風險肝內膽管癌的 無事件存活期；藥師需留意 gemcitabine-oxaliplatin、lenvatinib、toripalimab 與 capecitabine 銜接時程、肝功能與免疫相關不良事件監測。", "pubDate": "2026-03-05", "terms": [ "neoadjuvant", "golp", "resectable", "high-risk", "intrahepatic", "cholangiocarcinoma", "nejm", "nejmoa2513918", "gemcitabine-oxaliplatin", "lenvatinib" ], "drugTerms": [ "gemcitabine-oxaliplatin", "lenvatinib", "anti-programmed", "toripalimab", "anti-pd-1" ], "searchText": "neoadjuvant golp in resectable high-risk intrahepatic cholangiocarcinoma nejm rct shi 10.1056/nejmoa2513918 研究背景：可切除但復發風險高的肝內膽管癌，目前尚無確立的標準術前輔助治療；golp 處方（gemcitabine-oxaliplatin、lenvatinib 與 anti-pd-1 抗體）先前在晚期肝內膽管癌與膽道癌已顯示初步活性。 研究方法：此 第 2 期-3 隨機試驗將 178 名可切除高風險肝內膽管癌患者，以 1:1 分配至 neoadjuvant golp 後接受根治性切除，或直接根治性切除且不接受術前治療。兩組術後皆接受 8 個療程 adjuvant capecitabine，主要終點為 無事件存活期。 主要結果：中位追蹤 16.9 個月時，neoadjuvant golp 組 中位數 無事件存活期 較對照組延長（18.0 vs 8.7 個月；p<0.001）。24 個月 整體存活期 為 79% vs 61%（hr for 死亡 0.43，95% ci 0.23-0.79；p=0.005），但未達預設顯著性門檻；術前治療期 等級 3 以上治療相關不良事件為 26%，未發生治療相關死亡。 藥師重點：結論顯示 neoadjuvant golp 可延長可切除高風險肝內膽管癌的 無事件存活期；藥師需留意 gemcitabine-oxaliplatin、lenvatinib、toripalimab 與 capecitabine 銜接時程、肝功能與免疫相關不良事件監測。" }, { "id": "pmid-41765025", "kind": "article", "issueId": "2026-week10", "year": 2026, "week": 10, "weekLabel": "第 10 週", "dateRange": "2026/03/02 – 03/08", "href": "2026-week10.html", "title": "Hormone therapy use and duration with postoperative radiotherapy for recurrent prostate cancer: an individual patient data meta-analysis", "journal": "Lancet", "type": "MA", "typeLabel": "Meta-analysis", "author": "Kishan", "doi": "10.1016/S0140-6736(26)00137-6", "url": "https://doi.org/10.1016/S0140-6736(26)00137-6", "summary": "藥師重點：研究結果說明 PSA 0.5 ng/mL 以下接受 PORT 的患者，加用短期或長期 hormone 治療 可能無明確 整體存活期 benefit；藥師協助治療討論時，需將 pre-PORT PSA、預期療效、代謝與心血管風險、骨骼健康與生活品質一起納入評估。", "pubDate": "2026-03-14", "terms": [ "hormone", "duration", "postoperative", "radiotherapy", "recurrent", "prostate", "cancer", "individual", "meta-analysis", "lancet" ], "drugTerms": [], "searchText": "hormone therapy use and duration with postoperative radiotherapy for recurrent prostate cancer: an individual patient data meta-analysis lancet meta-analysis kishan 10.1016/s0140-6736(26)00137-6 研究背景：局部攝護腺癌接受 definitive radiotherapy 時加用 hormone 治療 可改善 整體存活期，但根治性攝護腺切除後 postoperative radiotherapy（port）是否也有相同效益仍不確定。 研究方法：此 individual patient 資料 統合分析 納入 port 合併或不合併 hormone 治療 的隨機第三期試驗，透過 marcap consortium 取得 ipd。主要終點為 整體存活期，並分析 short-term hormone 治療（4-6 個月）、long-term hormone 治療（24 個月）與 pre-port psa 的交互作用。 主要結果：分析包含 6 項隨機試驗、6057 名患者，中位追蹤 9.0 年。port 加用 hormone 治療 未顯著改善 整體存活期（hr 0.87，95% ci 0.76-1.01；p=0.06）；hormone 治療 duration 與效果無顯著交互作用（pinteraction=0.17），但 pre-port psa >0.5 ng/ml 與 ≤0.5 ng/ml 有交互作用（pinteraction=0.02）。psa ≤0.5 ng/ml 時未見有意義 整體存活期 benefit；long-term hormone 治療 在 psa >1.6 ng/ml 時 95% ci 上限低於 1.0。 藥師重點：研究結果說明 psa 0.5 ng/ml 以下接受 port 的患者，加用短期或長期 hormone 治療 可能無明確 整體存活期 benefit；藥師協助治療討論時，需將 pre-port psa、預期療效、代謝與心血管風險、骨骼健康與生活品質一起納入評估。" }, { "id": "pmid-41781010", "kind": "article", "issueId": "2026-week10", "year": 2026, "week": 10, "weekLabel": "第 10 週", "dateRange": "2026/03/02 – 03/08", "href": "2026-week10.html", "title": "Glucagon-like peptide-1 receptor agonists and risk of substance use disorders among US veterans with type 2 diabetes: cohort study", "journal": "BMJ", "type": "OA", "typeLabel": "Original Article", "author": "Cai", "doi": "10.1136/bmj-2025-086886", "url": "https://doi.org/10.1136/bmj-2025-086886", "summary": "藥師重點：此觀察性研究提供 GLP-1 受體 agonists 與多類 SUD 風險下降的訊號，但不能直接推論因果或作為 SUD 治療建議；藥師解讀時需注意族群為美國退伍軍人第二型糖尿病患者、active comparator 選擇與殘餘混雜。", "pubDate": "2026-03-04", "terms": [ "glucagon-like", "peptide-1", "receptor", "agonists", "substance", "disorders", "veterans", "type", "diabetes", "bmj-2025-086886" ], "drugTerms": [ "glp-1", "cocaine" ], "searchText": "glucagon-like peptide-1 receptor agonists and risk of substance use disorders among us veterans with type 2 diabetes: cohort study bmj original article cai 10.1136/bmj-2025-086886 研究背景：glp-1 受體 agonists 是否與較低 substance 使用 疾患（suds）新發風險，以及既有 sud 患者較少不良臨床結果相關，仍需要大型真實世界資料評估。 研究方法：此美國退伍軍人電子病歷 世代研究 以 target 試驗 emulation 方式，比較第二型糖尿病患者新啟用 glp-1 受體 agonists 或 sglt-2 抑制劑。研究分為無 sud 病史者的新發 sud protocol，以及既有 sud 患者的不良結果 protocol，追蹤最長 3 年並以 inverse probability weighting cox models 分析。 主要結果：相較 sglt-2 抑制劑，glp-1 受體 agonists 與較低新發 alcohol 使用 疾患（hr 0.82，95% ci 0.78-0.85）、cannabis 使用 疾患（0.86，0.81-0.90）、cocaine 使用 疾患（0.80，0.72-0.88）、nicotine 使用 疾患（0.80，0.74-0.87）與 opioid 使用 疾患（0.75，0.67-0.85）風險相關。既有 sud 患者中，glp-1 受體 agonists 也與較低 sud-related emergency department visits（0.69，0.61-0.78）、hospital admissions（0.74，0.65-0.85）與 死亡率（0.50，0.32-0.79）相關。 藥師重點：此觀察性研究提供 glp-1 受體 agonists 與多類 sud 風險下降的訊號，但不能直接推論因果或作為 sud 治療建議；藥師解讀時需注意族群為美國退伍軍人第二型糖尿病患者、active comparator 選擇與殘餘混雜。" }, { "id": "pmid-41780000", "kind": "article", "issueId": "2026-week10", "year": 2026, "week": 10, "weekLabel": "第 10 週", "dateRange": "2026/03/02 – 03/08", "href": "2026-week10.html", "title": "Finerenone in Type 1 Diabetes and Chronic Kidney Disease", "journal": "NEJM", "type": "RCT", "typeLabel": "RCT", "author": "Heerspink", "doi": "10.1056/NEJMoa2512854", "url": "https://doi.org/10.1056/NEJMoa2512854", "summary": "藥師重點：研究結果說明 finerenone 可降低第一型糖尿病合併 CKD 成人的 albuminuria；臨床使用仍需謹慎評估 eGFR、血鉀、ACE 抑制劑 或 ARB 併用情形，並持續追蹤腎功能變化。", "pubDate": "2026-03-05", "terms": [ "finerenone", "type", "diabetes", "chronic", "kidney", "nejm", "heerspink", "nejmoa2512854", "egfr", "albuminuria" ], "drugTerms": [], "searchText": "finerenone in type 1 diabetes and chronic kidney disease nejm rct heerspink 10.1056/nejmoa2512854 研究背景：finerenone 已知可改善第二型糖尿病合併慢性腎臟病患者的腎臟與心血管結果，但在第一型糖尿病合併 ckd 的療效與安全性仍不明確。 研究方法：此 第 3 期 試驗納入 242 名第一型糖尿病、ckd（egfr 25 to <90 ml/min/1.73 m2）且有 albuminuria 的成人，且皆使用 ace 抑制劑 或 angiotensin-受體 blocker。受試者隨機接受 finerenone 10 或 20 mg/day 或 安慰劑，主要終點為 6 個月 urinary albumin-to-creatinine 比值 相對變化。 主要結果：6 個月內 urinary albumin-to-creatinine 比值 在 finerenone 組下降 34%，安慰劑 組下降 12%，相當於 finerenone 較 安慰劑 多下降 25%（geometric 平均值 比值 0.75，95% ci 0.65-0.87；p<0.001）。高血鉀為最常見不良事件（10.1% vs 3.3%），finerenone 組 1.7% 因高血鉀停藥；egfr 下降幅度較大但 washout 期間接近基準值。 藥師重點：研究結果說明 finerenone 可降低第一型糖尿病合併 ckd 成人的 albuminuria；臨床使用仍需謹慎評估 egfr、血鉀、ace 抑制劑 或 arb 併用情形，並持續追蹤腎功能變化。" }, { "id": "pmid-41765029", "kind": "article", "issueId": "2026-week10", "year": 2026, "week": 10, "weekLabel": "第 10 週", "dateRange": "2026/03/02 – 03/08", "href": "2026-week10.html", "title": "Efficacy and safety of once-daily oral orforglipron compared with oral semaglutide in adults with type 2 diabetes (ACHIEVE-3): a multinational, multicentre, non-inferiority, open-label, randomised, phase 3 trial", "journal": "Lancet", "type": "RCT", "typeLabel": "RCT", "author": "Rosenstock", "doi": "10.1016/S0140-6736(26)00202-3", "url": "https://doi.org/10.1016/S0140-6736(26)00202-3", "summary": "藥師重點：結論顯示 orforglipron 對 metformin 控制不佳的第二型糖尿病可提供較大的 HbA1c 降幅，但胃腸道耐受性、停藥率與心跳增加需納入用藥諮詢與追蹤；其每日口服且無飲食限制的特性也需與既有 口服 semaglutide 服用規則比較。", "pubDate": "2026-03-21", "terms": [ "efficacy", "once-daily", "oral", "orforglipron", "semaglutide", "adults", "type", "diabetes", "achieve-3", "multinational" ], "drugTerms": [ "semaglutide", "glp-1" ], "searchText": "efficacy and safety of once-daily oral orforglipron compared with oral semaglutide in adults with type 2 diabetes (achieve-3): a multinational, multicentre, non-inferiority, open-label, randomised, phase 3 trial lancet rct rosenstock 10.1016/s0140-6736(26)00202-3 研究背景：orforglipron 為每日一次口服、無食物或飲水限制的新型 非胜肽 glp-1 受體 致效劑；本研究比較其與 口服 semaglutide 用於 metformin 控制不佳第二型糖尿病的療效與安全性。 研究方法：achieve-3 為 52 週、隨機、開放標籤、活性對照、多國 第 3 期試驗，納入 metformin ≥1500 mg/day 後 hba1c 7.0%-10.5% 且 bmi ≥25 kg/m2 的成人。1698 名受試者以 1:1:1:1 分配至 orforglipron 12 mg 或 36 mg，或 semaglutide 7 mg 或 14 mg，每日口服；主要目標為第 52 週 hba1c 變化的 不劣性，達成後進行 superiority 分析。 主要結果：第 52 週 hba1c 平均下降為 orforglipron 12 mg -1.71%、36 mg -1.91%，semaglutide 7 mg -1.23%、14 mg -1.47%；兩劑 orforglipron 皆達 不劣性 且優於兩劑 semaglutide。胃腸道事件在 orforglipron 較常見（59% 與 58% vs 37% 與 45%），因不良事件停藥與脈搏增加也較多。 藥師重點：結論顯示 orforglipron 對 metformin 控制不佳的第二型糖尿病可提供較大的 hba1c 降幅，但胃腸道耐受性、停藥率與心跳增加需納入用藥諮詢與追蹤；其每日口服且無飲食限制的特性也需與既有 口服 semaglutide 服用規則比較。" }, { "id": "pmid-41789864", "kind": "article", "issueId": "2026-week10", "year": 2026, "week": 10, "weekLabel": "第 10 週", "dateRange": "2026/03/02 – 03/08", "href": "2026-week10.html", "title": "Efficacy and Safety of Obinutuzumab in Active Systemic Lupus Erythematosus", "journal": "NEJM", "type": "OA", "typeLabel": "Original Article", "author": "Furie", "doi": "10.1056/NEJMoa2516150", "url": "https://doi.org/10.1056/NEJMoa2516150", "summary": "藥師重點：結論顯示 obinutuzumab 加入標準治療可改善 active SLE 的主要與關鍵次要終點；藥師需留意 B-cell depletion 相關感染風險、輸注反應、疫苗接種時機、glucocorticoid 減量與既有 lupus nephritis 適應症外的族群差異。", "pubDate": "2026-03-06", "terms": [ "efficacy", "obinutuzumab", "active", "systemic", "lupus", "erythematosus", "nejm", "furie", "nejmoa2516150", "glycoengineered" ], "drugTerms": [ "obinutuzumab", "anti-cd20" ], "searchText": "efficacy and safety of obinutuzumab in active systemic lupus erythematosus nejm original article furie 10.1056/nejmoa2516150 研究背景：obinutuzumab 為 glycoengineered type ii anti-cd20 monoclonal 抗體，可造成 b-cell depletion，已核准用於 active lupus nephritis；其在 active systemic lupus erythematosus（sle）但無增生性或膜性 lupus nephritis 患者的療效與安全性仍需確認。 研究方法：allegory 為 第 3 期、多中心、雙盲、安慰劑對照 試驗，納入接受標準治療的 active sle 成人，排除 proliferative 或 membranous lupus nephritis。303 名患者以 1:1 隨機接受 obinutuzumab 1000 mg 或 安慰劑，於 第 1 天、week 2、24、26 給藥；主要終點為第 52 週 sle responder index 4（sri-4）反應。 主要結果：第 52 週 sri-4 反應 在 obinutuzumab 組為 76.7%，安慰劑 組為 53.5%（校正 差異 23.1 百分點，95% ci 12.5-33.6；p<0.001）。obinutuzumab 在 bilag-based 複合 lupus assessment 反應、glucocorticoid dose sustained reduction、sustained sri-4、sri-6 與首次 bilag-defined flare 時間等關鍵次要終點皆優於 安慰劑；不良事件為 88.7% vs 81.5%，嚴重不良事件 為 15.9% vs 11.9%。 藥師重點：結論顯示 obinutuzumab 加入標準治療可改善 active sle 的主要與關鍵次要終點；藥師需留意 b-cell depletion 相關感染風險、輸注反應、疫苗接種時機、glucocorticoid 減量與既有 lupus nephritis 適應症外的族群差異。" }, { "id": "pmid-41794437", "kind": "article", "issueId": "2026-week10", "year": 2026, "week": 10, "weekLabel": "第 10 週", "dateRange": "2026/03/02 – 03/08", "href": "2026-week10.html", "title": "Effect of baxdrostat on ambulatory blood pressure in patients with resistant hypertension (Bax24): a phase 3, randomised, double-blind, placebo-controlled trial", "journal": "Lancet", "type": "RCT", "typeLabel": "RCT", "author": "Azizi", "doi": "10.1016/S0140-6736(25)02549-8", "url": "https://doi.org/10.1016/S0140-6736(25)02549-8", "summary": "藥師重點：結論顯示 baxdrostat 可降低 resistant hypertension 患者的 24 小時動態收縮壓；藥師需留意背景降壓藥、diuretic 使用、血鉀與腎功能監測，特別是高血鉀風險。", "pubDate": "2026-03-07", "terms": [ "baxdrostat", "ambulatory", "blood", "pressure", "resistant", "hypertension", "bax24", "phase", "randomised", "double-blind" ], "drugTerms": [], "searchText": "effect of baxdrostat on ambulatory blood pressure in patients with resistant hypertension (bax24): a phase 3, randomised, double-blind, placebo-controlled trial lancet rct azizi 10.1016/s0140-6736(25)02549-8 研究背景：aldosterone dysregulation 是難治型高血壓的重要機轉之一；baxdrostat 為 selective aldosterone synthase 抑制劑，本研究評估其對 resistant hypertension 患者 24 小時動態血壓的影響。 研究方法：bax24 為國際多中心、第 3 期、隨機、雙盲、安慰劑對照 試驗，納入接受至少 3 種降壓藥且含 diuretic 後 seated sbp 仍 ≥140 且 <170 mm hg 的成人。經 2 週 安慰劑 run-in 後，患者隨機接受 baxdrostat 2 mg 每日一次 或 安慰劑 12 週，主要終點為 24 h ambulatory sbp 自基準至第 12 週的變化。 主要結果：217 名患者隨機接受治療；第 12 週 24 h ambulatory sbp 在 baxdrostat 組下降 -16.6 mm hg，安慰劑 組下降 -2.6 mm hg，安慰劑-corrected 差異 為 -14.0 mm hg（95% ci -17.2 to -10.8；p<0.0001）。不良事件發生率為 52% vs 37%，baxdrostat 組 3% 出現確認血鉀 >6 mmol/l。 藥師重點：結論顯示 baxdrostat 可降低 resistant hypertension 患者的 24 小時動態收縮壓；藥師需留意背景降壓藥、diuretic 使用、血鉀與腎功能監測，特別是高血鉀風險。" }, { "id": "pmid-41779422", "kind": "article", "issueId": "2026-week10", "year": 2026, "week": 10, "weekLabel": "第 10 週", "dateRange": "2026/03/02 – 03/08", "href": "2026-week10.html", "title": "A Decision-Support System to Personalize Antidepressant Treatment in Major Depressive Disorder: A Randomized Clinical Trial", "journal": "JAMA", "type": "RCT", "typeLabel": "RCT", "author": "Cipriani", "doi": "10.1001/jama.2026.1327", "url": "https://doi.org/10.1001/jama.2026.1327", "summary": "藥師重點：研究結果說明 PETRUSHKA tool 可協助個人化抗憂鬱藥選擇並降低早期停藥；藥師參與憂鬱症用藥追蹤時，可將其視為 shared decision-making 輔助工具，但仍需留意研究設計限制、追蹤資料缺漏與本地藥品可近性。", "pubDate": "2026-04-14", "terms": [ "decision-support", "system", "personalize", "antidepressant", "major", "depressive", "disorder", "jama", "cipriani", "evidence-based" ], "drugTerms": [], "searchText": "a decision-support system to personalize antidepressant treatment in major depressive disorder: a randomized clinical trial jama rct cipriani 10.1001/jama.2026.1327 研究背景：中重度 重大 depressive 疾患 患者常因抗憂鬱藥不適合個別病人而提早停藥，臨床指引也強調更精準的抗憂鬱藥選擇。 研究方法：此多中心 隨機臨床試驗 在巴西、加拿大與英國 47 個場域進行，納入 18-74 歲 重大 depressive 疾患 患者。540 名受試者以 1:1 分配至 evidence-based 臨床 decision-support system（petrushka tool）或 常規照護，主要終點為第 8 週因任何原因停止處方抗憂鬱藥。 主要結果：主要分析納入 493 名受試者；第 8 週 petrushka 組因任何原因停用抗憂鬱藥較 常規照護 低（17% vs 27%；校正 rr 0.62，95% ci 0.44-0.88；p=.007），因不良事件停藥亦較低（9% vs 16%；校正 rr 0.59，95% ci 0.36-0.97；p=.04）。第 24 週 phq-9 與 gad-7 分數也較 常規照護 改善，但缺乏 雙盲 design 且遺失資料較多。 藥師重點：研究結果說明 petrushka tool 可協助個人化抗憂鬱藥選擇並降低早期停藥；藥師參與憂鬱症用藥追蹤時，可將其視為 shared decision-making 輔助工具，但仍需留意研究設計限制、追蹤資料缺漏與本地藥品可近性。" }, { "id": "pmid-41794436", "kind": "article", "issueId": "2026-week10", "year": 2026, "week": 10, "weekLabel": "第 10 週", "dateRange": "2026/03/02 – 03/08", "href": "2026-week10.html", "title": "5-year results of hypofractionated locoregional radiotherapy in early breast cancer HypoG-01 (UNICANCER): a French multicentre, randomised, non-inferiority, phase 3, open-label, controlled trial", "journal": "Lancet", "type": "RCT", "typeLabel": "RCT", "author": "Rivera", "doi": "10.1016/S0140-6736(25)02597-8", "url": "https://doi.org/10.1016/S0140-6736(25)02597-8", "summary": "藥師重點：研究結果支持需 locoregional radiotherapy 的早期乳癌患者可考慮 3 週 hypofractionated 處方，且手臂淋巴水腫風險不劣於 5 週療程；臨床仍需依腫瘤科與放射腫瘤科評估照射範圍、晚期毒性與病人可近性。", "pubDate": "2026-03-07", "terms": [ "year", "hypofractionated", "locoregional", "radiotherapy", "early", "breast", "cancer", "hypog-01", "unicancer", "french" ], "drugTerms": [], "searchText": "5-year results of hypofractionated locoregional radiotherapy in early breast cancer hypog-01 (unicancer): a french multicentre, randomised, non-inferiority, phase 3, open-label, controlled trial lancet rct rivera 10.1016/s0140-6736(25)02597-8 研究背景：乳癌全乳放射治療已常用 hypofractionated radiotherapy，但需要淋巴結照射時，許多國家仍因晚期毒性疑慮使用 50 gy in 25 fractions 的 5 週療程。 研究方法：unicancer hypog-01 為法國 29 個中心進行的 開放標籤、隨機、第 3 期 不劣性 試驗，納入手術後需區域淋巴結照射的早期侵犯性乳癌女性。患者以 1:1 分配至 3-week radiotherapy（40 gy in 15 fractions）或 5-week radiotherapy（50 gy in 25 fractions），主要終點為同側手臂淋巴水腫。 主要結果：依計畫書分析納入 1221 名患者，中位追蹤 4.8 年。手臂淋巴水腫共 275 例，3 週療程相較 5 週療程達 不劣性（hr 1.02，95% ci 0.79-1.31；p不劣性<0.001），3 年累積發生率為 23.4% vs 22.2%；等級 3 以上不良事件為 8% vs 13%。 藥師重點：研究結果支持需 locoregional radiotherapy 的早期乳癌患者可考慮 3 週 hypofractionated 處方，且手臂淋巴水腫風險不劣於 5 週療程；臨床仍需依腫瘤科與放射腫瘤科評估照射範圍、晚期毒性與病人可近性。" }, { "id": "fda-2026-week10-1", "kind": "fda", "issueId": "2026-week10", "year": 2026, "week": 10, "weekLabel": "第 10 週", "dateRange": "2026/03/02 – 03/08", "href": "2026-week10.html", "title": "FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "concerns", "unapproved", "glp-1", "drugs", "used", "weight", "loss", "https", "drug-alerts-and-statements", "fdas-concerns-unapproved-glp-1-drugs-used-weight-loss" ], "drugTerms": [ "glp-1" ], "searchText": "fda’s concerns with unapproved glp-1 drugs used for weight loss fda drug safety 2026-06-15 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss" }, { "id": "fda-2026-week10-3", "kind": "fda", "issueId": "2026-week10", "year": 2026, "week": 10, "weekLabel": "第 10 週", "dateRange": "2026/03/02 – 03/08", "href": "2026-week10.html", "title": "FDA issues final decision to withdraw approval of Pepaxto (melphalan flufenamide)", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/node/398713", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "issues", "final", "decision", "withdraw", "approval", "pepaxto", "melphalan", "flufenamide", "https", "node" ], "drugTerms": [], "searchText": "fda issues final decision to withdraw approval of pepaxto (melphalan flufenamide) fda drug safety 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/node/398713" }, { "id": "fda-2026-week10-2", "kind": "fda", "issueId": "2026-week10", "year": 2026, "week": 10, "weekLabel": "第 10 週", "dateRange": "2026/03/02 – 03/08", "href": "2026-week10.html", "title": "FDA alerts patients, caregivers, and health care providers of cross-compatibility issues with autoinjector devices that are optional for use with glatiramer acetate injection", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/node/403159", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "alerts", "caregivers", "providers", "cross-compatibility", "issues", "autoinjector", "devices", "that", "optional", "glatiramer" ], "drugTerms": [], "searchText": "fda alerts patients, caregivers, and health care providers of cross-compatibility issues with autoinjector devices that are optional for use with glatiramer acetate injection fda drug safety 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/node/403159" }, { "id": "fda-2026-week10-4", "kind": "fda", "issueId": "2026-week10", "year": 2026, "week": 10, "weekLabel": "第 10 週", "dateRange": "2026/03/02 – 03/08", "href": "2026-week10.html", "title": "FDA Accepts First In Silico Drug Development Tool Under ISTAND Program to Help Predict Drug-Induced Liver Injury", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fda-accepts-first-silico-drug-development-tool-under-istand-program-help-predict-drug-induced-liver", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "accepts", "first", "silico", "development", "tool", "under", "istand", "program", "help", "predict" ], "drugTerms": [], "searchText": "fda accepts first in silico drug development tool under istand program to help predict drug-induced liver injury fda drug safety 2026-06-03 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/drugs/drug-alerts-and-statements/fda-accepts-first-silico-drug-development-tool-under-istand-program-help-predict-drug-induced-liver" }, { "id": "pmid-41739468", "kind": "article", "issueId": "2026-week09", "year": 2026, "week": 9, "weekLabel": "第 9 週", "dateRange": "2026/02/23 – 03/01", "href": "2026-week09.html", "title": "Worldwide Radiation Dose in Coronary Artery Disease Diagnostic Imaging", "journal": "JAMA", "type": "OA", "typeLabel": "Original Article", "author": "Einstein", "doi": "10.1001/jama.2026.0703", "url": "https://doi.org/10.1001/jama.2026.0703", "summary": "藥師重點：研究結果顯示 CAD 非侵入性影像檢查的 radiation dose 在地區、收入層級與檢查方式間差異大，特別影響低與中收入國家及接受 CCTA 的病人。藥師雖非影像檢查主要決策者，但在心血管共照與病人諮詢中可協助提醒檢查必要性、重複檢查紀錄與整體風險溝通。", "pubDate": "2026-04-07", "terms": [ "worldwide", "radiation", "dose", "coronary", "artery", "diagnostic", "imaging", "jama", "einstein", "ionizing" ], "drugTerms": [], "searchText": "worldwide radiation dose in coronary artery disease diagnostic imaging jama original article einstein 10.1001/jama.2026.0703 研究背景：冠狀動脈 動脈 疾病（cad）診斷檢查近年快速增加，其中多種影像檢查會使病人暴露於 ionizing radiation。了解不同國家、不同檢查方式的 輻射有效劑量，可作為改善檢查品質與降低不必要暴露的依據。 研究方法：此 worldwide 橫斷面研究 於 2023 年進行，納入 101 國 742 個中心在 2023 年 10 至 12 月單週內連續接受 noninvasive cad diagnostic testing 的 19,302 名成人。檢查包括 spect、pet、cacs 與 ccta；主要結果為病人 輻射有效劑量，以及各中心 中位數 effective dose ≤9 msv 的比例。 主要結果：受試者中 8515 人（44%）為女性，中位年齡 63 歲。各檢查 中位數 effective dose 差異明顯：cacs 1.2 msv、pet 2.0 msv、spect 6.5 msv、ccta 7.4 msv；nuclear cardiology 較 ccta 有較多中心與病人達到 ≤9 msv（81% vs 56%；79% vs 56%；皆 p<.001）。低與中收入國家 nuclear cardiology 劑量較高 20%（95% ci 3.6%-38.4%），ccta 劑量在低與中低收入國家可較高收入國家高達 96%（95% ci 41.7%-170.8%）。 藥師重點：研究結果顯示 cad 非侵入性影像檢查的 radiation dose 在地區、收入層級與檢查方式間差異大，特別影響低與中收入國家及接受 ccta 的病人。藥師雖非影像檢查主要決策者，但在心血管共照與病人諮詢中可協助提醒檢查必要性、重複檢查紀錄與整體風險溝通。" }, { "id": "pmid-41740032", "kind": "article", "issueId": "2026-week09", "year": 2026, "week": 9, "weekLabel": "第 9 週", "dateRange": "2026/02/23 – 03/01", "href": "2026-week09.html", "title": "Tecovirimat for the Treatment of Mpox", "journal": "NEJM", "type": "OA", "typeLabel": "Original Article", "author": "Zucker", "doi": "10.1056/NEJMoa2506495", "url": "https://doi.org/10.1056/NEJMoa2506495", "summary": "藥師重點：結論顯示 tecovirimat 未縮短成人 clade II mpox 的臨床緩解時間，也未改善疼痛、病灶癒合或 viral clearance。藥師在相關用藥評估時，應避免將動物模型或 smallpox 適應症直接外推至 clade II mpox，並協助確認支持療法、感染管制與研究性用藥條件。", "pubDate": "2026-02-26", "terms": [ "tecovirimat", "mpox", "nejm", "zucker", "nejmoa2506495", "food", "administration", "animal", "rule", "smallpox" ], "drugTerms": [], "searchText": "tecovirimat for the treatment of mpox nejm original article zucker 10.1056/nejmoa2506495 研究背景：tecovirimat 依據 food and drug administration animal rule 核准用於 smallpox，且非人類靈長類 mpox 模型顯示有效，但對人類 clade ii mpox 的臨床療效仍不明確。本研究評估口服 tecovirimat 是否能加速 clade ii mpox 的臨床緩解。 研究方法：此 第 3 期、international、雙盲、隨機、安慰劑對照 試驗 納入成人 laboratory-confirmed clade ii mpox。受試者以 2:1 分配接受 tecovirimat 或 安慰劑 14 天；主要終點為有皮膚或黏膜病灶者的 臨床 resolution time-to-event 分析，次要終點包括疼痛下降、病灶完全癒合、viral dna clearance 與安全性。 主要結果：412 名受試者隨機分組，344 人為 laboratory-confirmed mpox，336 人有活動性皮膚或黏膜病灶並納入主要分析。第 29 天 臨床 resolution cumulative incidence 為 83% vs 84%，competing-risks 風險比 0.98（95% ci 0.74 to 1.31；p=0.89）；嚴重疼痛下降、complete lesion healing（hr 0.97，95% ci 0.75 to 1.26）與 viral dna clearance 皆未見實質組間差異，等級 3 或以上不良事件為 4% vs 3%。 藥師重點：結論顯示 tecovirimat 未縮短成人 clade ii mpox 的臨床緩解時間，也未改善疼痛、病灶癒合或 viral clearance。藥師在相關用藥評估時，應避免將動物模型或 smallpox 適應症直接外推至 clade ii mpox，並協助確認支持療法、感染管制與研究性用藥條件。" }, { "id": "pmid-41763229", "kind": "article", "issueId": "2026-week09", "year": 2026, "week": 9, "weekLabel": "第 9 週", "dateRange": "2026/02/23 – 03/01", "href": "2026-week09.html", "title": "Switch to single-tablet bictegravir-lenacapavir from a complex HIV regimen (ARTISTRY-1): a randomised, open-label, phase 3 clinical trial", "journal": "Lancet", "type": "RCT", "typeLabel": "RCT", "author": "Orkin", "doi": "10.1016/S0140-6736(26)00307-7", "url": "https://doi.org/10.1016/S0140-6736(26)00307-7", "summary": "藥師重點：結論顯示 bictegravir-lenacapavir STR 可作為病毒量穩定但處方複雜之 HIV-1 病人的簡化選項，療效不劣於原複雜處方。藥師導入前仍需確認既往抗藥性、併用藥交互作用、用藥禁忌與病人對簡化處方的期待。", "pubDate": "2026-03-28", "terms": [ "switch", "single-tablet", "bictegravir-lenacapavir", "from", "complex", "regimen", "artistry-1", "randomised", "open-label", "phase" ], "drugTerms": [ "bictegravir-lenacapavir" ], "searchText": "switch to single-tablet bictegravir-lenacapavir from a complex hiv regimen (artistry-1): a randomised, open-label, phase 3 clinical trial lancet rct orkin 10.1016/s0140-6736(26)00307-7 研究背景：hiv-1 治療使用 single-tablet 處方（str）可簡化用藥並提升治療滿意度，但部分病人因抗藥性、禁忌症或 drug-drug interactions 仍需複雜多錠處方。本研究評估 bictegravir-lenacapavir str 用於病毒量已受控制且原本使用複雜治療處方者的療效與安全性。 研究方法：artistry-1 為 15 國多中心、隨機、開放標籤、活性對照、不劣性 第 3 期試驗，納入 hiv-1 rna 已受控制且使用複雜抗反轉錄病毒處方的病人。受試者以 2:1 分配至 每日一次 口服 bictegravir-lenacapavir 75 mg/50 mg str 或持續原複雜處方；主要終點為第 48 週 hiv-1 rna ≥50 copies per ml 的比例。 主要結果：557 名受試者接受治療，bictegravir-lenacapavir 組 371 人、複雜處方組 186 人；基線中位年齡 60 歲、hiv 治療時間中位數 28 年，原本每日抗病毒藥錠中位數為 3 顆。第 48 週 hiv-1 rna ≥50 copies per ml 為 1% vs 1%（差異 -0.3%；95.002% ci -2.3 to 1.8），達到 4% 不劣性 margin；未出現抗藥性，兩組不良事件相近，轉換後治療滿意度增加。 藥師重點：結論顯示 bictegravir-lenacapavir str 可作為病毒量穩定但處方複雜之 hiv-1 病人的簡化選項，療效不劣於原複雜處方。藥師導入前仍需確認既往抗藥性、併用藥交互作用、用藥禁忌與病人對簡化處方的期待。" }, { "id": "pmid-41763743", "kind": "article", "issueId": "2026-week09", "year": 2026, "week": 9, "weekLabel": "第 9 週", "dateRange": "2026/02/23 – 03/01", "href": "2026-week09.html", "title": "Survivorship of modern total hip replacement to 30 years: systematic review, meta-analysis, and extrapolation of global joint registry data", "journal": "Lancet", "type": "MA", "typeLabel": "Meta-analysis", "author": "Pentland", "doi": "10.1016/S0140-6736(25)02305-0", "url": "https://doi.org/10.1016/S0140-6736(25)02305-0", "summary": "藥師重點：研究結果說明 contemporary 全髖關節置換術 估計 30 年仍約有 92% 未因全因原因翻修，可作為病人期待設定與醫療規劃背景。藥師在骨科共照時仍應聚焦圍手術期止痛、抗凝、感染預防與高齡多重用藥管理，並注意此研究主要反映植入物耐久性而非藥物療效。", "pubDate": "2026-02-28", "terms": [ "survivorship", "modern", "total", "replacement", "years", "meta-analysis", "extrapolation", "global", "joint", "registry" ], "drugTerms": [], "searchText": "survivorship of modern total hip replacement to 30 years: systematic review, meta-analysis, and extrapolation of global joint registry data lancet meta-analysis pentland 10.1016/s0140-6736(25)02305-0 研究背景：全髖關節置換術 可改善髖關節功能與生活品質，長期植入物存活率會影響病人諮詢、手術規劃與醫療資源配置。近 20 年 現代承載面材料 已改變磨耗與可能的耐久性，因此需要整合長期資料評估現代人工髖關節壽命。 研究方法：此 systematic review、統合分析 與 registry extrapolation 聚焦現代 bearing surfaces，包括 highly cross-linked polyethylene 搭配金屬或第三、四代 ceramic heads，以及 ceramic-on-ceramic 主要 全髖關節置換術。研究搜尋 medline 與 embase 至 2024 年 6 月 13 日，納入至少 10 年 survivorship 資料，並整合 8 個 national joint registries 估計 all-cause revision 與 30 年存活率。 主要結果：共納入 29 項臨床研究與 8 個 national joint registries，涵蓋 1,904,237 例 total hip arthroplasties。臨床研究 pooled all-cause implant survivorship 為 0.97（0.96-0.98）；registry 資料 顯示 20 年 survivorship 為 93.6%（95% ci 92.3-94.7），外推 25 年與 30 年 survivorship 分別為 92.8%（91.2-94.2）與 92.1%（90.1-93.7）。 藥師重點：研究結果說明 contemporary 全髖關節置換術 估計 30 年仍約有 92% 未因全因原因翻修，可作為病人期待設定與醫療規劃背景。藥師在骨科共照時仍應聚焦圍手術期止痛、抗凝、感染預防與高齡多重用藥管理，並注意此研究主要反映植入物耐久性而非藥物療效。" }, { "id": "pmid-41740031", "kind": "article", "issueId": "2026-week09", "year": 2026, "week": 9, "weekLabel": "第 9 週", "dateRange": "2026/02/23 – 03/01", "href": "2026-week09.html", "title": "Phase 1 Study of Rezatapopt, a p53 Reactivator, in TP53 Y220C-Mutated Tumors", "journal": "NEJM", "type": "OA", "typeLabel": "Original Article", "author": "Dumbrava", "doi": "10.1056/NEJMoa2508820", "url": "https://doi.org/10.1056/NEJMoa2508820", "summary": "藥師重點：研究結果提供 TP53 Y220C-mutated tumors 中 p53 reactivation 的早期 proof of concept，但目前仍屬 第 1 期 單臂資料。藥師若於臨床試驗或後續研究場域參與照護，需特別留意 nausea、vomiting、anemia、creatinine 上升、with food 給藥要求與 TP53 Y220C/KRAS biomarker 條件。", "pubDate": "2026-02-26", "terms": [ "phase", "rezatapopt", "reactivator", "tp53", "y220c-mutated", "tumors", "nejm", "dumbrava", "nejmoa2508820", "investigational" ], "drugTerms": [], "searchText": "phase 1 study of rezatapopt, a p53 reactivator, in tp53 y220c-mutated tumors nejm original article dumbrava 10.1056/nejmoa2508820 研究背景：rezatapopt 是 investigational、first-in-class、口服 selective p53 reactivator，可結合 y220c-mutated p53 並穩定其 wild-type conformation，以恢復 p53 功能。本研究評估 rezatapopt 用於 tp53 y220c-mutated advanced or 轉移性 solid tumors 的安全性、建議劑量與初步抗腫瘤活性。 研究方法：此 第 1 期、single-group、dose-escalation and dose-optimization 研究 納入多線治療後、局部晚期或轉移性且帶有 tp53 y220c mutation 的實體腫瘤病人，於連續 21 天治療週期 接受 rezatapopt。主要目標為 最大耐受劑量 與 recommended 第 2 期 dose，主要終點包括 dose-limiting toxic effects 與 不良事件，次要終點包括初步療效與 pharmacokinetics。 主要結果：77 名病人接受 150 mg 至 2500 mg 每日一次 或 1500 mg 每日兩次 等劑量；最大耐受劑量 為 1500 mg 每日兩次，recommended 第 2 期 dose 選定為 2000 mg 每日一次 with food。治療期間 99% 至少發生一項 不良事件，常見為 nausea 58%、vomiting 44%、血中 creatinine 增加 39%、fatigue 39% 與 anemia 36%；等級 3 或以上 anemia 為 16%。整體 反應率 為 20%，在 kras wild-type 且劑量至少 1150 mg 每日一次 者為 30%。 藥師重點：研究結果提供 tp53 y220c-mutated tumors 中 p53 reactivation 的早期 proof of concept，但目前仍屬 第 1 期 單臂資料。藥師若於臨床試驗或後續研究場域參與照護，需特別留意 nausea、vomiting、anemia、creatinine 上升、with food 給藥要求與 tp53 y220c/kras biomarker 條件。" }, { "id": "pmid-41763744", "kind": "article", "issueId": "2026-week09", "year": 2026, "week": 9, "weekLabel": "第 9 週", "dateRange": "2026/02/23 – 03/01", "href": "2026-week09.html", "title": "Feasibility and safety of cellular therapy for in-utero repair of myelomeningocele (CuRe Trial): a first-in-human, phase 1, single-arm study", "journal": "Lancet", "type": "OA", "typeLabel": "Original Article", "author": "Farmer", "doi": "10.1016/S0140-6736(25)02466-3", "url": "https://doi.org/10.1016/S0140-6736(25)02466-3", "summary": "藥師重點：結論顯示此 allogeneic live stem cell 介入在 6 例 first-in-human 經驗中未見 cell-related adverse effects，安全性足以進入非 staggered enrollment 的 第 1 期/2a 試驗。由於樣本數極小且為產前手術合併細胞治療，藥師解讀時需保守，並關注感染預防、圍產期用藥、細胞產品保存與後續長期追蹤資料。", "pubDate": "2026-02-28", "terms": [ "feasibility", "cellular", "in-utero", "repair", "myelomeningocele", "cure", "first-in-human", "phase", "single-arm", "lancet" ], "drugTerms": [], "searchText": "feasibility and safety of cellular therapy for in-utero repair of myelomeningocele (cure trial): a first-in-human, phase 1, single-arm study lancet original article farmer 10.1016/s0140-6736(25)02466-3 研究背景：moms 試驗 已證實 myelomeningocele 進行 in-utero repair 可降低 ventriculoperitoneal shunt 需求，但多數患者運動功能仍有限。placenta-derived mesenchymal stem cells（pmscs）置於 extracellular matrix 上，在 fetal ovine model 顯示可能改善神經功能，本研究評估其加強 prenatal repair 的安全性。 研究方法：此 第 1 期、first-in-human、single-dose、單臂 研究 於 uc davis 進行，納入胎兒診斷為 myelomeningocele 的孕婦。資格包括 gestational age 19 至 26 週、缺損上緣介於 t1 至 s1、mri 顯示 hindbrain herniation 且 karyotype 正常；手術時局部使用 allogeneic human pmscs seeded on extracellular matrix，主要安全性終點為修補部位癒合、cerebrospinal fluid leak、infection、異常增生或 tumor formation。 主要結果：2021 年 6 月 21 日至 2022 年 12 月 5 日共納入 6 名孕婦，胎兒 gestational age 為 24+5 至 25+5 週；新生兒於中位 34+5 週剖腹產出生。出生時所有嬰兒修補部位完整，未見 cerebrospinal fluid leak、infection 或 abnormal tissue growth；治療後 mri 顯示 hindbrain herniation reversal 且無 tumor formation，未發生 cell-mediated 不良事件。 藥師重點：結論顯示此 allogeneic live stem cell 介入在 6 例 first-in-human 經驗中未見 cell-related adverse effects，安全性足以進入非 staggered enrollment 的 第 1 期/2a 試驗。由於樣本數極小且為產前手術合併細胞治療，藥師解讀時需保守，並關注感染預防、圍產期用藥、細胞產品保存與後續長期追蹤資料。" }, { "id": "pmid-41740992", "kind": "article", "issueId": "2026-week09", "year": 2026, "week": 9, "weekLabel": "第 9 週", "dateRange": "2026/02/23 – 03/01", "href": "2026-week09.html", "title": "Extended follow-up of invasive cervical cancer risk after quadrivalent HPV vaccination: nationwide, register based study", "journal": "BMJ", "type": "OA", "typeLabel": "Original Article", "author": "Wu", "doi": "10.1136/bmj-2025-087326", "url": "https://doi.org/10.1136/bmj-2025-087326", "summary": "藥師重點：結論顯示 quadrivalent HPV vaccination 與 invasive cervical 癌症 長期風險降低相關，且未見明顯保護力衰退訊號，早期與 school based vaccination 的族群效益較明顯。藥師進行疫苗諮詢時，可強調及早接種的重要性，同時提醒仍需依建議接受子宮頸癌篩檢。", "pubDate": "2026-02-25", "terms": [ "extended", "follow-up", "invasive", "cervical", "cancer", "quadrivalent", "vaccination", "nationwide", "register", "bmj-2025-087326" ], "drugTerms": [], "searchText": "extended follow-up of invasive cervical cancer risk after quadrivalent hpv vaccination: nationwide, register based study bmj original article wu 10.1136/bmj-2025-087326 研究背景：quadrivalent human papillomavirus（hpv）疫苗 可降低 hpv 相關病變風險，但其對 invasive cervical 癌症 的長期保護、是否隨時間減弱，以及 school based vaccination programme 的族群影響仍需長期資料確認。 研究方法：此瑞典 nationwide register based 世代研究 追蹤 2006 年 1 月 1 日至 2023 年 12 月 31 日間 926,362 名女孩與女性，依出生世代區分 opportunistic、subsidised、catch-up 與 school based cohorts。研究以 poisson regression 估計接種 quadrivalent hpv 疫苗 者相較未接種者的 invasive cervical 癌症 發生率比s，並依接種年齡與接種後時間分層。 主要結果：追蹤期間 365,502 人（39.5%）至少接種一劑 quadrivalent hpv 疫苗，共發現 930 例 invasive cervical 癌症，其中接種者 97 例、未接種者 833 例。17 歲前接種者相較未接種者的 fully 校正 發生率比 為 0.21（95% ci 0.13 to 0.32），接種後 13-15 年仍維持保護（irr 0.23，95% ci 0.11 to 0.46）；17 歲或以上接種者整體 irr 為 0.63（95% ci 0.49 to 0.81）。 藥師重點：結論顯示 quadrivalent hpv vaccination 與 invasive cervical 癌症 長期風險降低相關，且未見明顯保護力衰退訊號，早期與 school based vaccination 的族群效益較明顯。藥師進行疫苗諮詢時，可強調及早接種的重要性，同時提醒仍需依建議接受子宮頸癌篩檢。" }, { "id": "pmid-41729549", "kind": "article", "issueId": "2026-week09", "year": 2026, "week": 9, "weekLabel": "第 9 週", "dateRange": "2026/02/23 – 03/01", "href": "2026-week09.html", "title": "Does This Patient Have Volume Overload?: The Rational Clinical Examination", "journal": "JAMA", "type": "SR", "typeLabel": "Systematic Review", "author": "Drum", "doi": "10.1001/jama.2026.0446", "url": "https://doi.org/10.1001/jama.2026.0446", "summary": "藥師重點：結論顯示 BNP ≥100 ng/mL 與胸部 X 光 vascular congestion 可協助確認 容積負荷過多，而缺乏 pulmonary B-lines 或 BNP <100 ng/mL 有助於排除。藥師協助調整利尿劑、輸液或心衰竭用藥時，應將檢查結果與症狀、腎功能、電解質及血流動力狀態一起判讀。", "pubDate": "2026-04-07", "terms": [ "does", "this", "have", "volume", "overload", "rational", "examination", "jama", "drum", "medline" ], "drugTerms": [], "searchText": "does this patient have volume overload?: the rational clinical examination jama systematic review drum 10.1001/jama.2026.0446 研究背景：準確評估 血管內容積 可協助判斷體液管理、利尿或補液策略，尤其對疑似 容積負荷過多 且仍可自主呼吸的病人更具臨床價值。本研究整理身體診察、影像與實驗室檢查對 容積負荷過多 的診斷準確性。 研究方法：此 systematic review 搜尋 medline 1946 年至 2026 年 1 月 6 日，納入 peer-reviewed english-language 研究，對象為非插管且自主呼吸、疑似 intravascular 容積負荷過多 的病人。三位作者獨立抽取資料並計算 sensitivity、specificity 與 likelihood ratios（lrs），再以 2-level mixed logistic regression model 合併估計值。 主要結果：共納入 40 項研究、11,490 名成人，容積負荷過多 盛行率為 35% 至 69%。bnp ≥100 ng/ml 最能支持 容積負荷過多（lr 6.9，95% ci 2.4-20.4），正常 bnp 則降低可能性（lr 0.14，95% ci 0.08-0.24）；胸部 x 光 vascular congestion（lr 5.9）、頸靜脈怒張超過胸骨角上方 3 cm（lr 4.1）、bilateral pulmonary b-lines（lr 4.0）與 inferior vena cava collapsibility index <50%（lr 3.9）亦增加診斷可能性。 藥師重點：結論顯示 bnp ≥100 ng/ml 與胸部 x 光 vascular congestion 可協助確認 容積負荷過多，而缺乏 pulmonary b-lines 或 bnp <100 ng/ml 有助於排除。藥師協助調整利尿劑、輸液或心衰竭用藥時，應將檢查結果與症狀、腎功能、電解質及血流動力狀態一起判讀。" }, { "id": "pmid-41763745", "kind": "article", "issueId": "2026-week09", "year": 2026, "week": 9, "weekLabel": "第 9 週", "dateRange": "2026/02/23 – 03/01", "href": "2026-week09.html", "title": "Comparative efficacy and tolerability of antidopaminergic and muscarinic antipsychotics for acute schizophrenia: a network meta-analysis of randomised controlled trials indexed in international English and Chinese databases", "journal": "Lancet", "type": "MA", "typeLabel": "Meta-analysis", "author": "Schneider-Thoma", "doi": "10.1016/S0140-6736(25)02365-7", "url": "https://doi.org/10.1016/S0140-6736(25)02365-7", "summary": "藥師重點：研究結果說明急性 schizophrenia 用藥之間存在小至中等但具臨床意義的療效差異，選藥不宜只看平均療效。藥師需同步評估體重、代謝、錐體外症狀、鎮靜、cholinergic 或 anticholinergic 不良事件，以及 partial dopamine agonists 與 xanomeline-trospium 的耐受性差異。", "pubDate": "2026-02-28", "terms": [ "comparative", "efficacy", "tolerability", "antidopaminergic", "muscarinic", "antipsychotics", "acute", "schizophrenia", "network", "meta-analysis" ], "drugTerms": [ "clozapine", "olanzapine" ], "searchText": "comparative efficacy and tolerability of antidopaminergic and muscarinic antipsychotics for acute schizophrenia: a network meta-analysis of randomised controlled trials indexed in international english and chinese databases lancet meta-analysis schneider-thoma 10.1016/s0140-6736(25)02365-7 研究背景：急性思覺失調症常以 antipsychotic drugs 治療，但各藥物受體結合特性、療效與耐受性差異明顯；xanomeline-trospium 作為 muscarinic 受體 致效劑 也帶來不同於傳統 antidopaminergic agents 的治療選項。本研究以 network 統合分析 比較多種 antipsychotics 的療效與耐受性。 研究方法：此 systematic review（prospero crd42022380708）納入 blinded 與 open rcts，研究對象為任何年齡、急性 schizophrenia psychotic symptoms 3 週至 3 個月者。納入 23 種主要 dopamine-受體 blocking medications 與 xanomeline-trospium，主要結果為量表評估的整體 schizophrenia symptoms，並以 random-effects frequentist network 統合分析 分析。 主要結果：研究篩選 18,859 筆文獻並納入 438 項 rct，其中 388 項、78,193 名受試者至少提供一項可用結果；主要終點分析來自 256 項 雙盲 研究、58,948 人。所有 antipsychotics 均較 安慰劑 減少症狀，standardised 平均差s 介於 -0.90（95% ci -1.03 to -0.77）至 -0.23（-0.39 to -0.06）；clozapine、amisulpride、olanzapine 與 risperidone 的療效優於至少三種其他藥物，但信心等級多為 low-to-moderate，耐受性則依藥物而異。 藥師重點：研究結果說明急性 schizophrenia 用藥之間存在小至中等但具臨床意義的療效差異，選藥不宜只看平均療效。藥師需同步評估體重、代謝、錐體外症狀、鎮靜、cholinergic 或 anticholinergic 不良事件，以及 partial dopamine agonists 與 xanomeline-trospium 的耐受性差異。" }, { "id": "pmid-41740998", "kind": "article", "issueId": "2026-week09", "year": 2026, "week": 9, "weekLabel": "第 9 週", "dateRange": "2026/02/23 – 03/01", "href": "2026-week09.html", "title": "Adherence to legislation and recommendations to publicly post protocols and results of post-authorisation studies registered with European Medicines Agency: cross sectional study", "journal": "BMJ", "type": "OA", "typeLabel": "Original Article", "author": "Ramezani", "doi": "10.1136/bmj-2025-086693", "url": "https://doi.org/10.1136/bmj-2025-086693", "summary": "藥師重點：研究結果說明 EMA 登錄上市後研究的公開程度仍不足，尤其是僅受建議而非法律義務約束的研究。藥師使用 post-authorisation 或 real-world evidence 支持用藥決策時，應確認 protocol、結果報告與研究限制是否可取得，避免只依摘要或登錄資訊判斷藥品風險。", "pubDate": "2026-02-25", "terms": [ "adherence", "legislation", "recommendations", "publicly", "post", "protocols", "post-authorisation", "studies", "registered", "european" ], "drugTerms": [], "searchText": "adherence to legislation and recommendations to publicly post protocols and results of post-authorisation studies registered with european medicines agency: cross sectional study bmj original article ramezani 10.1136/bmj-2025-086693 研究背景：上市後研究 可補足藥品上市後安全性與真實世界使用證據，但若研究 protocol 與 results 未公開，會影響研究透明度與臨床解讀。本研究評估 european medicines agency（ema）登錄之上市後研究是否遵循公開 protocol 與 results 的法規及建議。 研究方法：此 cross sectional 研究 使用 2024 年 2 月 ema catalogue of real-world 資料 研究，納入 2010 年 11 月後登錄的 上市後研究。研究評估 2300 項 進行中 或 finalised 研究 的 protocol availability，以及 1482 項 finalised 研究 的 results availability，並依 eu risk management plan（rmp）類別分層。 主要結果：整體而言，1370/2300 項 進行中 與 finalised 研究（59.6%）可取得 protocol，1014/1482 項 finalised 研究（68.4%）可取得 results。eu rmp category 1 與 2 finalised 研究 的 results available 均為 90%，但未納入 rmp 的 上市後研究 protocol available 僅 55.3%，results available 為 64.1%。 藥師重點：研究結果說明 ema 登錄上市後研究的公開程度仍不足，尤其是僅受建議而非法律義務約束的研究。藥師使用 post-authorisation 或 real-world evidence 支持用藥決策時，應確認 protocol、結果報告與研究限制是否可取得，避免只依摘要或登錄資訊判斷藥品風險。" }, { "id": "fda-2026-week09-1", "kind": "fda", "issueId": "2026-week09", "year": 2026, "week": 9, "weekLabel": "第 9 週", "dateRange": "2026/02/23 – 03/01", "href": "2026-week09.html", "title": "FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "concerns", "unapproved", "glp-1", "drugs", "used", "weight", "loss", "https", "drug-alerts-and-statements", "fdas-concerns-unapproved-glp-1-drugs-used-weight-loss" ], "drugTerms": [ "glp-1" ], "searchText": "fda’s concerns with unapproved glp-1 drugs used for weight loss fda drug safety 2026-06-15 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss" }, { "id": "fda-2026-week09-3", "kind": "fda", "issueId": "2026-week09", "year": 2026, "week": 9, "weekLabel": "第 9 週", "dateRange": "2026/02/23 – 03/01", "href": "2026-week09.html", "title": "FDA issues final decision to withdraw approval of Pepaxto (melphalan flufenamide)", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/node/398713", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "issues", "final", "decision", "withdraw", "approval", "pepaxto", "melphalan", "flufenamide", "https", "node" ], "drugTerms": [], "searchText": "fda issues final decision to withdraw approval of pepaxto (melphalan flufenamide) fda drug safety 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/node/398713" }, { "id": "fda-2026-week09-2", "kind": "fda", "issueId": "2026-week09", "year": 2026, "week": 9, "weekLabel": "第 9 週", "dateRange": "2026/02/23 – 03/01", "href": "2026-week09.html", "title": "FDA alerts patients, caregivers, and health care providers of cross-compatibility issues with autoinjector devices that are optional for use with glatiramer acetate injection", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/node/403159", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "alerts", "caregivers", "providers", "cross-compatibility", "issues", "autoinjector", "devices", "that", "optional", "glatiramer" ], "drugTerms": [], "searchText": "fda alerts patients, caregivers, and health care providers of cross-compatibility issues with autoinjector devices that are optional for use with glatiramer acetate injection fda drug safety 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/node/403159" }, { "id": "fda-2026-week09-4", "kind": "fda", "issueId": "2026-week09", "year": 2026, "week": 9, "weekLabel": "第 9 週", "dateRange": "2026/02/23 – 03/01", "href": "2026-week09.html", "title": "FDA Accepts First In Silico Drug Development Tool Under ISTAND Program to Help Predict Drug-Induced Liver Injury", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fda-accepts-first-silico-drug-development-tool-under-istand-program-help-predict-drug-induced-liver", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "accepts", "first", "silico", "development", "tool", "under", "istand", "program", "help", "predict" ], "drugTerms": [], "searchText": "fda accepts first in silico drug development tool under istand program to help predict drug-induced liver injury fda drug safety 2026-06-03 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/drugs/drug-alerts-and-statements/fda-accepts-first-silico-drug-development-tool-under-istand-program-help-predict-drug-induced-liver" }, { "id": "pmid-41702641", "kind": "article", "issueId": "2026-week08", "year": 2026, "week": 8, "weekLabel": "第 8 週", "dateRange": "2026/02/16 – 02/22", "href": "2026-week08.html", "title": "Vitamin D supplementation before in vitro fertilisation in women with polycystic ovary syndrome: multicentre, double blind, placebo controlled, randomised clinical trial", "journal": "BMJ", "type": "RCT", "typeLabel": "RCT", "author": "Hu", "doi": "10.1136/bmj-2025-087438", "url": "https://doi.org/10.1136/bmj-2025-087438", "summary": "藥師重點：結論顯示 vitamin D 4000 IU/day 可提高血清 25-OHD，但未轉化為第一次胚胎植入後活產率改善；藥師可將其視為校正缺乏的營養補充資訊，不宜期待可單獨改善 IVF 活產結果。", "pubDate": "2026-02-17", "terms": [ "vitamin", "supplementation", "vitro", "fertilisation", "women", "polycystic", "ovary", "syndrome", "multicentre", "double" ], "drugTerms": [], "searchText": "vitamin d supplementation before in vitro fertilisation in women with polycystic ovary syndrome: multicentre, double blind, placebo controlled, randomised clinical trial bmj rct hu 10.1136/bmj-2025-087438 研究背景：多囊性卵巢症候群女性接受體外受精時，vitamin d 補充是否能改善活產率仍不明確。 研究方法：此中國 24 個生殖中心進行的 多中心、雙盲、安慰劑對照 rct，納入 876 名多囊性卵巢症候群且接受體外受精的女性。受試者以 1:1 隨機接受 vitamin d 4000 iu/day 或 安慰劑，最長治療 90 天至 trigger day；主要終點為第一次胚胎植入後活產。 主要結果：修正 意向治療分析共 865 人，vitamin d 組 trigger day 的 25-ohd 較高（32.3±11.2 vs 18.2±7.6 ng/ml；校正 平均差 13.6，95% ci 10.9 to 16.3），但活產率未增加（52.0% vs 50.2%；校正 rr 1.03，95% ci 0.91 to 1.18）。嚴重卵巢過度刺激症候群為 3 例 vs 6 例。 藥師重點：結論顯示 vitamin d 4000 iu/day 可提高血清 25-ohd，但未轉化為第一次胚胎植入後活產率改善；藥師可將其視為校正缺乏的營養補充資訊，不宜期待可單獨改善 ivf 活產結果。" }, { "id": "pmid-41712219", "kind": "article", "issueId": "2026-week08", "year": 2026, "week": 8, "weekLabel": "第 8 週", "dateRange": "2026/02/16 – 02/22", "href": "2026-week08.html", "title": "Treatment for Brain Metastases With Stereotactic Radiation vs Hippocampal-Avoidance Whole Brain Radiation: A Randomized Clinical Trial", "journal": "JAMA", "type": "RCT", "typeLabel": "RCT", "author": "Aizer", "doi": "10.1001/jama.2026.0076", "url": "https://doi.org/10.1001/jama.2026.0076", "summary": "藥師重點：研究支持在 5-20 顆腦轉移患者中，立體定位放射治療 較 海馬迴避全腦放射治療 更能改善症狀與日常功能干擾；臨床解讀需注意 6 個月完成率偏低，並與腫瘤科、放射腫瘤科共同評估病灶數量與整體預後。", "pubDate": "2026-04-07", "terms": [ "brain", "metastases", "stereotactic", "radiation", "hippocampal-avoidance", "whole", "jama", "aizer", "anderson", "symptom" ], "drugTerms": [], "searchText": "treatment for brain metastases with stereotactic radiation vs hippocampal-avoidance whole brain radiation: a randomized clinical trial jama rct aizer 10.1001/jama.2026.0076 研究背景：多發腦轉移患者常需放射治療，但 5-20 顆腦轉移時，局部 立體定位放射治療 與 海馬迴避全腦放射治療 對症狀與生活功能的差異仍需釐清。 研究方法：此美國 4 中心 第 3 期 開放標籤 rct 納入 196 名 5-20 顆腦轉移且未接受過腦部放射治療的患者，隨機接受 立體定位放射治療 或 海馬迴避全腦放射治療。主要終點為 6 個月內 md anderson symptom inventory-brain tumor 加權症狀嚴重度與日常功能干擾分數變化。 主要結果：僅 83 人（42%）完成 6 個月評估。立體定位放射治療 組分數由 2.69 變為 2.37，海馬迴避全腦放射治療 組由 2.29 變為 3.03，平均差 -1.06（95% ci -1.54 to -0.58；p<.001）。治療相關 等級 3-5 不良事件 為 12% vs 13%，疲倦較常見於全腦放射組（28% vs 44%）。 藥師重點：研究支持在 5-20 顆腦轉移患者中，立體定位放射治療 較 海馬迴避全腦放射治療 更能改善症狀與日常功能干擾；臨床解讀需注意 6 個月完成率偏低，並與腫瘤科、放射腫瘤科共同評估病灶數量與整體預後。" }, { "id": "pmid-41707170", "kind": "article", "issueId": "2026-week08", "year": 2026, "week": 8, "weekLabel": "第 8 週", "dateRange": "2026/02/16 – 02/22", "href": "2026-week08.html", "title": "Perioperative Enfortumab Vedotin and Pembrolizumab in Bladder Cancer", "journal": "NEJM", "type": "RCT", "typeLabel": "RCT", "author": "Vulsteke", "doi": "10.1056/NEJMoa2511674", "url": "https://doi.org/10.1056/NEJMoa2511674", "summary": "藥師重點：結論顯示 perioperative enfortumab vedotin 加 pembrolizumab 可改善 cisplatin 不適合族群的 無事件存活期、整體存活期 與病理完全反應；藥師需同步監測皮膚毒性、周邊神經病變、高血糖與免疫相關不良事件。", "pubDate": "2026-04-02", "terms": [ "perioperative", "enfortumab", "vedotin", "pembrolizumab", "bladder", "cancer", "nejm", "vulsteke", "nejmoa2511674", "cisplatin-based" ], "drugTerms": [ "enfortumab", "pembrolizumab", "vedotin-pembrolizumab", "cisplatin" ], "searchText": "perioperative enfortumab vedotin and pembrolizumab in bladder cancer nejm rct vulsteke 10.1056/nejmoa2511674 研究背景：無法接受或拒絕 cisplatin-based chemotherapy 的 muscle-invasive bladder 癌症 患者常直接接受 radical cystectomy，perioperative systemic 治療 是否可改善預後是重要問題。 研究方法：此 第 3 期 開放標籤試驗 將 344 名 muscle-invasive bladder 癌症 患者隨機分配至 perioperative enfortumab vedotin 加 pembrolizumab 合併手術，或單純手術。治療包含 enfortumab vedotin 1.25 mg/kg 天 1 and 8 與 pembrolizumab 200 mg 第 1 天 每 3 週，手術安排於 3 cycles 後；主要終點為 無事件存活期。 主要結果：中位追蹤 25.6 個月，2 年 無事件存活期 為 74.7% vs 39.4%（hr 0.40，95% ci 0.28-0.57；p<0.001），整體存活期 為 79.7% vs 63.1%（hr 0.50，95% ci 0.33-0.74；p<0.001）。pathological 完全反應 為 57.1% vs 8.6%；enfortumab vedotin-pembrolizumab 組 等級 ≥3 drug-related 不良事件 為 45.5%。 藥師重點：結論顯示 perioperative enfortumab vedotin 加 pembrolizumab 可改善 cisplatin 不適合族群的 無事件存活期、整體存活期 與病理完全反應；藥師需同步監測皮膚毒性、周邊神經病變、高血糖與免疫相關不良事件。" }, { "id": "pmid-41708152", "kind": "article", "issueId": "2026-week08", "year": 2026, "week": 8, "weekLabel": "第 8 週", "dateRange": "2026/02/16 – 02/22", "href": "2026-week08.html", "title": "Menopausal hormone therapy and long term mortality: nationwide, register based cohort study", "journal": "BMJ", "type": "OA", "typeLabel": "Original Article", "author": "Mikkelsen", "doi": "10.1136/bmj-2025-085998", "url": "https://doi.org/10.1136/bmj-2025-085998", "summary": "藥師重點：此全國世代研究未發現 停經荷爾蒙治療 與死亡率增加相關；用藥諮詢仍應回到症狀嚴重度、乳癌與血栓風險、用藥期間及個別禁忌症，而非單以全因死亡率判斷是否使用。", "pubDate": "2026-02-18", "terms": [ "menopausal", "hormone", "long", "term", "mortality", "nationwide", "register", "mikkelsen", "bmj-2025-085998", "registry-based" ], "drugTerms": [], "searchText": "menopausal hormone therapy and long term mortality: nationwide, register based cohort study bmj original article mikkelsen 10.1136/bmj-2025-085998 研究背景：停經荷爾蒙治療是否增加長期全因死亡風險仍是用藥諮詢常見問題，本研究以全國登錄資料評估其關聯。 研究方法：此丹麥 nationwide registry-based 世代研究 納入 876,805 名 1950-1977 年出生且 45 歲仍存活的女性，追蹤至 2023 年 7 月 31 日。研究比較曾領取 systemic 停經荷爾蒙治療 處方與未暴露者的全因死亡及 cause-specific 死亡率，並以 cox regression 校正共變項。 主要結果：共有 104,086 人（11.9%）曾使用 停經荷爾蒙治療，47,594 人（5.4%）死亡，中位追蹤 14.3 年。使用者與未暴露者死亡率為 54.9 vs 35.5 per 10,000 person-years，校正後 hr 0.96（95% ci 0.93-0.98）；不同累積使用期間未見死亡風險增加，cause-specific 死亡率 也未見明確差異。 藥師重點：此全國世代研究未發現 停經荷爾蒙治療 與死亡率增加相關；用藥諮詢仍應回到症狀嚴重度、乳癌與血栓風險、用藥期間及個別禁忌症，而非單以全因死亡率判斷是否使用。" }, { "id": "pmid-41692020", "kind": "article", "issueId": "2026-week08", "year": 2026, "week": 8, "weekLabel": "第 8 週", "dateRange": "2026/02/16 – 02/22", "href": "2026-week08.html", "title": "Lisocabtagene maraleucel in patients with relapsed or refractory marginal zone lymphoma (TRANSCEND FL): primary analysis results from the global, multicohort, single-arm, phase 2 study", "journal": "Lancet", "type": "OA", "typeLabel": "Original Article", "author": "Palomba", "doi": "10.1016/S0140-6736(25)02435-3", "url": "https://doi.org/10.1016/S0140-6736(25)02435-3", "summary": "藥師重點：研究結果顯示 lisocabtagene maraleucel 在 復發或難治性 MZL 有高反應率且未見新安全性訊號，但資料來自 單臂 第 2 期 研究；藥師需留意 CAR-T 前處置、cytokine release 症候群、神經毒性、感染風險與長期追蹤安排。", "pubDate": "2026-03-07", "terms": [ "lisocabtagene", "maraleucel", "relapsed", "refractory", "marginal", "zone", "lymphoma", "transcend", "from", "global" ], "drugTerms": [ "car-t" ], "searchText": "lisocabtagene maraleucel in patients with relapsed or refractory marginal zone lymphoma (transcend fl): primary analysis results from the global, multicohort, single-arm, phase 2 study lancet original article palomba 10.1016/s0140-6736(25)02435-3 研究背景：復發或難治性 marginal zone 淋巴瘤（mzl）缺乏可帶來深度且持久反應的治療，本研究評估 cd19-directed car t-cell 治療 lisocabtagene maraleucel 的療效與安全性。 研究方法：transcend fl 為 第 2 期 單臂 multi世代研究，納入美國、加拿大、歐洲與日本 30 個中心、曾接受至少兩線全身治療的 復發或難治性 mzl 患者。符合條件者接受 lisocabtagene maraleucel 100×10^6 car+ t cells，允許 bridging 治療；主要終點為 independent review committee 依 lugano 2014 criteria 評估的 整體反應率。 主要結果：77 名接受 leukapheresis 患者中，67 人接受 lisocabtagene maraleucel，66 人可評估療效；mzl 亞型包括 nodal 48%、splenic 27%、extranodal malt 25%。中位追蹤 24.1 個月，整體反應率 為 95%（95% ci 87.3-99.1；one-sided p<0.0001）。所有患者均有 治療-related 不良事件；等級 3 cytokine release 症候群 與 neurological 事件 各為 4%，未見 等級 4-5 事件，等級 ≥3 infections 為 16%。 藥師重點：研究結果顯示 lisocabtagene maraleucel 在 復發或難治性 mzl 有高反應率且未見新安全性訊號，但資料來自 單臂 第 2 期 研究；藥師需留意 car-t 前處置、cytokine release 症候群、神經毒性、感染風險與長期追蹤安排。" }, { "id": "pmid-41707137", "kind": "article", "issueId": "2026-week08", "year": 2026, "week": 8, "weekLabel": "第 8 週", "dateRange": "2026/02/16 – 02/22", "href": "2026-week08.html", "title": "Hematopoietic Stem-Cell Gene Therapy for Cystinosis", "journal": "NEJM", "type": "OA", "typeLabel": "Original Article", "author": "Barshop", "doi": "10.1056/NEJMoa2506431", "url": "https://doi.org/10.1056/NEJMoa2506431", "summary": "藥師重點：此小型早期研究顯示 CTNS-RD-04 後白血球 cystine levels 下降，安全性多與 myeloablative 處方 及原疾病相關；臨床解讀應保守，需持續追蹤長期造血重建、插入突變風險與是否能轉化為器官功能效益。", "pubDate": "2026-02-19", "terms": [ "hematopoietic", "stem-cell", "gene", "cystinosis", "nejm", "barshop", "nejmoa2506431", "ctns", "pathogenic", "variants" ], "drugTerms": [], "searchText": "hematopoietic stem-cell gene therapy for cystinosis nejm original article barshop 10.1056/nejmoa2506431 研究背景：cystinosis 是 ctns pathogenic variants 造成的多系統 溶小體儲積疾病，cysteamine 可延緩但無法阻止疾病進展；ctns-rd-04 為針對 cystinosis 的 ex vivo gene 治療。 研究方法：此 第 1 期-2 開放標籤 進行中 研究 初步評估 ctns-rd-04，內容為以 lentiviral vectors 帶入 ctns complementary dna 的 autologous cd34+ cells。研究納入 cystinosis 患者，主要終點為安全性與副作用型態，次要終點包括白血球 cystine levels 與 cystine storage depletion。 主要結果：6 名 20-46 歲受試者接受 ctns-rd-04，追蹤 29-63 個月；劑量為 3.63×10^6 至 9.59×10^6 cd34+ cells/kg。所有患者均有持續且高度 polyclonal hematopoietic reconstitution；共發生 217 件 不良事件，多為輕至中度且與處置或原疾病相符，未見 monoclonal expansion。除 vector copy number 最低的 patient 4 外，白血球 cystine levels 較基線下降。 藥師重點：此小型早期研究顯示 ctns-rd-04 後白血球 cystine levels 下降，安全性多與 myeloablative 處方 及原疾病相關；臨床解讀應保守，需持續追蹤長期造血重建、插入突變風險與是否能轉化為器官功能效益。" }, { "id": "pmid-41722967", "kind": "article", "issueId": "2026-week08", "year": 2026, "week": 8, "weekLabel": "第 8 週", "dateRange": "2026/02/16 – 02/22", "href": "2026-week08.html", "title": "Cumulative incidence of advanced breast cancer in women aged 40-49 years in the Japan Strategic Anti-cancer Randomised Trial (J-START) of adjunctive ultrasonography: a prespecified secondary analysis", "journal": "Lancet", "type": "RCT", "typeLabel": "RCT", "author": "Harada-Shoji", "doi": "10.1016/S0140-6736(25)02319-0", "url": "https://doi.org/10.1016/S0140-6736(25)02319-0", "summary": "藥師重點：結果顯示超音波輔助乳房攝影可降低 40-49 歲女性晚期乳癌累積發生率，尤其對乳房緻密族群與亞洲篩檢策略具參考價值；解讀時仍需注意此為篩檢介入，並非藥物治療研究。", "pubDate": "2026-02-21", "terms": [ "cumulative", "incidence", "advanced", "breast", "cancer", "women", "aged", "years", "japan", "strategic" ], "drugTerms": [ "anti-cancer" ], "searchText": "cumulative incidence of advanced breast cancer in women aged 40-49 years in the japan strategic anti-cancer randomised trial (j-start) of adjunctive ultrasonography: a prespecified secondary analysis lancet rct harada-shoji 10.1016/s0140-6736(25)02319-0 研究背景：j-start 先前顯示乳房超音波輔助篩檢可提高乳癌偵測率，本分析評估其對 40-49 歲女性晚期乳癌累積發生率的長期影響。 研究方法：研究納入日本 42 個研究據點、40-49 歲且無乳癌病史的無症狀女性，1:1 分配接受超音波加乳房攝影或單用乳房攝影，於 2 年篩檢期間進行兩次篩檢。此預先設定次要分析追蹤至 2024 年 10 月 4 日，評估 tnm stage 2 或以上乳癌累積發生率。 主要結果：共 72,661 名女性隨機分組，中位追蹤約 11 年。介入組偵測到 894 例乳癌，其中 234 例（26%）為晚期；對照組 843 例中有 277 例（33%）為晚期，hr 0.83（95.6% ci 0.70-0.98；p=0.026）。差異約在第 4 年後出現，至第 8 年擴大後趨於穩定。 藥師重點：結果顯示超音波輔助乳房攝影可降低 40-49 歲女性晚期乳癌累積發生率，尤其對乳房緻密族群與亞洲篩檢策略具參考價值；解讀時仍需注意此為篩檢介入，並非藥物治療研究。" }, { "id": "pmid-41707171", "kind": "article", "issueId": "2026-week08", "year": 2026, "week": 8, "weekLabel": "第 8 週", "dateRange": "2026/02/16 – 02/22", "href": "2026-week08.html", "title": "Cabotegravir plus Rilpivirine for Persons with HIV and Adherence Challenges", "journal": "NEJM", "type": "OA", "typeLabel": "Original Article", "author": "Rana", "doi": "10.1056/NEJMoa2508228", "url": "https://doi.org/10.1056/NEJMoa2508228", "summary": "藥師重點：結論顯示每月 cabotegravir-rilpivirine 對已先達病毒抑制但有 adherence 挑戰者，可降低 處方 failure；藥師需確認注射回診可近性、missed dose 處理、口服 lead-in 需求與抗藥性監測。", "pubDate": "2026-02-26", "terms": [ "cabotegravir", "plus", "rilpivirine", "persons", "adherence", "challenges", "nejm", "rana", "nejmoa2508228", "long-acting" ], "drugTerms": [ "cabotegravir" ], "searchText": "cabotegravir plus rilpivirine for persons with hiv and adherence challenges nejm original article rana 10.1056/nejmoa2508228 研究背景：對口服 art adherence 困難的 hiv 感染者，long-acting injectable art 是否優於持續標準口服治療，過去缺乏隨機試驗資料。 研究方法：此 開放標籤 隨機試驗 納入 adherence 不佳或曾失聯的 hiv 感染者。step 1 先提供最長 24 週 adherence support、conditional economic incentives 與標準口服 art；hiv-1 rna 降至 ≤200 copies/ml 者進入 step 2，隨機接受每月 long-acting cabotegravir 加上 rilpivirine 注射或標準照護，主要終點為 處方 failure。 主要結果：step 1 共納入 453 人，step 2 有 306 人隨機分組；cabotegravir-rilpivirine 組 152 人、標準照護 組 154 人。中位追蹤 48 週時因次要結果達優勢而提前停止；48 週 處方 failure 累積發生率為 22.8% vs 41.2%（差異 -18.4 百分點；98.4% ci -32.4 to -4.3；p=0.002）。不良事件 累積發生率相近（43.5% vs 42.4%），兩組各有 2 名 confirmed virologic failure 者出現 resistance-associated mutations。 藥師重點：結論顯示每月 cabotegravir-rilpivirine 對已先達病毒抑制但有 adherence 挑戰者，可降低 處方 failure；藥師需確認注射回診可近性、missed dose 處理、口服 lead-in 需求與抗藥性監測。" }, { "id": "pmid-41708134", "kind": "article", "issueId": "2026-week08", "year": 2026, "week": 8, "weekLabel": "第 8 週", "dateRange": "2026/02/16 – 02/22", "href": "2026-week08.html", "title": "Analysis of non-prospective trial registration in clinical trials submitted to The BMJ: observational study", "journal": "BMJ", "type": "OA", "typeLabel": "Original Article", "author": "Blanco", "doi": "10.1136/bmj-2025-086467", "url": "https://doi.org/10.1136/bmj-2025-086467", "summary": "藥師重點：研究結果提醒臨床試驗登錄狀態會影響證據判讀；藥師在閱讀治療研究時，除療效數字外，也應檢查 試驗 registration、登錄時間與 結果指標 是否前後一致，以降低選擇性報告偏差的影響。", "pubDate": "2026-02-18", "terms": [ "non-prospective", "registration", "trials", "submitted", "observational", "blanco", "bmj-2025-086467", "icmje", "consort", "funding" ], "drugTerms": [], "searchText": "analysis of non-prospective trial registration in clinical trials submitted to the bmj: observational study bmj original article blanco 10.1136/bmj-2025-086467 研究背景：臨床試驗未前瞻性登錄會影響研究透明度與可信度，本研究分析提交至 the bmj 且疑似未符合登錄要求試驗的後續情形。 研究方法：此 observational 研究 比較 2019-2023 年提交至 the bmj、被編輯標記為可能未前瞻性登錄的 239 項臨床試驗，與同期間隨機抽樣且已於 icmje 接受登錄平台前瞻性登錄的 239 項試驗。主要評估非前瞻性登錄相關因素、登錄缺失類型、後續發表狀態與是否揭露登錄問題。 主要結果：較大樣本數、作者數較多、提及 consort、較近期投稿與有 funding 與較低非前瞻性登錄 odds 相關；亞洲通訊作者則較高。2019-2021 年間 176 項未前瞻性登錄試驗中，83% 為回溯登錄、13% 未登錄、4% 登錄於非 icmje 接受平台；88% 後續仍發表，僅約六分之一明確揭露登錄缺失。 藥師重點：研究結果提醒臨床試驗登錄狀態會影響證據判讀；藥師在閱讀治療研究時，除療效數字外，也應檢查 試驗 registration、登錄時間與 結果指標 是否前後一致，以降低選擇性報告偏差的影響。" }, { "id": "pmid-41707138", "kind": "article", "issueId": "2026-week08", "year": 2026, "week": 8, "weekLabel": "第 8 週", "dateRange": "2026/02/16 – 02/22", "href": "2026-week08.html", "title": "An Antibody-Oligonucleotide Conjugate for Myotonic Dystrophy Type 1", "journal": "NEJM", "type": "RCT", "typeLabel": "RCT", "author": "Johnson", "doi": "10.1056/NEJMoa2407326", "url": "https://doi.org/10.1056/NEJMoa2407326", "summary": "藥師重點：研究結果支持 del-desiran 可進入肌肉並在部分患者改善 aberrant alternative splicing，但仍屬早期小型試驗且已有 嚴重不良事件；後續臨床應重點追蹤輸注安全性、劑量反應與功能性臨床效益。", "pubDate": "2026-02-19", "terms": [ "antibody-oligonucleotide", "conjugate", "myotonic", "dystrophy", "type", "nejm", "johnson", "nejmoa2407326", "del-desiran", "oligonucleotide" ], "drugTerms": [], "searchText": "an antibody-oligonucleotide conjugate for myotonic dystrophy type 1 nejm rct johnson 10.1056/nejmoa2407326 研究背景：myotonic dystrophy type 1 是罕見且逐漸惡化的遺傳性神經肌肉疾病，目前缺乏核准治療；del-desiran 以 抗體-oligonucleotide conjugate 方式標的 dmpk mrna。 研究方法：此 第 1 期-2、多中心、雙盲、隨機、安慰劑對照 試驗，將 myotonic dystrophy type 1 患者分配接受 del-desiran 單劑 1 mg/kg、三劑 2 mg/kg 或 4 mg/kg 靜脈輸注，或 安慰劑。主要終點為安全性，次要終點包括藥動學、藥效學，以及肌肉切片中 aberrant splicing 變化。 主要結果：del-desiran 1、2、4 mg/kg 組分別有 6、9、13 人，安慰劑 組 10 人；35/38 名接受輸注者發生輕至中度不良事件。2 名受試者發生 重度 嚴重不良事件，其中 1 名停止試驗；dmpk mrna 在 1、2、4 mg/kg 組分別下降 46%、44%、37%，安慰劑 為 0.9%。 藥師重點：研究結果支持 del-desiran 可進入肌肉並在部分患者改善 aberrant alternative splicing，但仍屬早期小型試驗且已有 嚴重不良事件；後續臨床應重點追蹤輸注安全性、劑量反應與功能性臨床效益。" }, { "id": "fda-2026-week08-1", "kind": "fda", "issueId": "2026-week08", "year": 2026, "week": 8, "weekLabel": "第 8 週", "dateRange": "2026/02/16 – 02/22", "href": "2026-week08.html", "title": "FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "concerns", "unapproved", "glp-1", "drugs", "used", "weight", "loss", "https", "drug-alerts-and-statements", "fdas-concerns-unapproved-glp-1-drugs-used-weight-loss" ], "drugTerms": [ "glp-1" ], "searchText": "fda’s concerns with unapproved glp-1 drugs used for weight loss fda drug safety 2026-06-15 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss" }, { "id": "fda-2026-week08-3", "kind": "fda", "issueId": "2026-week08", "year": 2026, "week": 8, "weekLabel": "第 8 週", "dateRange": "2026/02/16 – 02/22", "href": "2026-week08.html", "title": "FDA issues final decision to withdraw approval of Pepaxto (melphalan flufenamide)", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/node/398713", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "issues", "final", "decision", "withdraw", "approval", "pepaxto", "melphalan", "flufenamide", "https", "node" ], "drugTerms": [], "searchText": "fda issues final decision to withdraw approval of pepaxto (melphalan flufenamide) fda drug safety 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/node/398713" }, { "id": "fda-2026-week08-2", "kind": "fda", "issueId": "2026-week08", "year": 2026, "week": 8, "weekLabel": "第 8 週", "dateRange": "2026/02/16 – 02/22", "href": "2026-week08.html", "title": "FDA alerts patients, caregivers, and health care providers of cross-compatibility issues with autoinjector devices that are optional for use with glatiramer acetate injection", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/node/403159", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "alerts", "caregivers", "providers", "cross-compatibility", "issues", "autoinjector", "devices", "that", "optional", "glatiramer" ], "drugTerms": [], "searchText": "fda alerts patients, caregivers, and health care providers of cross-compatibility issues with autoinjector devices that are optional for use with glatiramer acetate injection fda drug safety 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/node/403159" }, { "id": "fda-2026-week08-4", "kind": "fda", "issueId": "2026-week08", "year": 2026, "week": 8, "weekLabel": "第 8 週", "dateRange": "2026/02/16 – 02/22", "href": "2026-week08.html", "title": "FDA Accepts First In Silico Drug Development Tool Under ISTAND Program to Help Predict Drug-Induced Liver Injury", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fda-accepts-first-silico-drug-development-tool-under-istand-program-help-predict-drug-induced-liver", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "accepts", "first", "silico", "development", "tool", "under", "istand", "program", "help", "predict" ], "drugTerms": [], "searchText": "fda accepts first in silico drug development tool under istand program to help predict drug-induced liver injury fda drug safety 2026-06-03 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/drugs/drug-alerts-and-statements/fda-accepts-first-silico-drug-development-tool-under-istand-program-help-predict-drug-induced-liver" }, { "id": "pmid-41655588", "kind": "article", "issueId": "2026-week07", "year": 2026, "week": 7, "weekLabel": "第 7 週", "dateRange": "2026/02/09 – 02/15", "href": "2026-week07.html", "title": "Tenecteplase versus standard medical treatment for basilar artery occlusion within 24 h (TRACE-5): a multicentre, prospective, randomised, open-label, blinded-endpoint, superiority, phase 3 trial", "journal": "Lancet", "type": "RCT", "typeLabel": "RCT", "author": "Xiong", "doi": "10.1016/S0140-6736(25)02633-9", "url": "https://doi.org/10.1016/S0140-6736(25)02633-9", "summary": "藥師重點：研究結果說明 tenecteplase 於基底動脈阻塞中風 24 h 內使用，可能改善 90 天功能預後且未增加症狀性顱內出血；實務應依中風團隊流程評估給藥時間窗、出血風險、後續 血管內取栓 與 alteplase 替代策略。", "pubDate": "2026-02-21", "terms": [ "tenecteplase", "standard", "basilar", "artery", "occlusion", "within", "trace-5", "multicentre", "prospective", "randomised" ], "drugTerms": [], "searchText": "tenecteplase versus standard medical treatment for basilar artery occlusion within 24 h (trace-5): a multicentre, prospective, randomised, open-label, blinded-endpoint, superiority, phase 3 trial lancet rct xiong 10.1016/s0140-6736(25)02633-9 研究背景：基底動脈阻塞造成的缺血性中風預後不佳，症狀發生 24 h 內使用 tenecteplase 靜脈血栓溶解的療效與安全性仍缺乏大型證據。 研究方法：trace-5 為中國 66 個中風中心進行的前瞻性、隨機、開放標籤、盲性終點評估 superiority 第 3 期試驗，收錄 18 歲以上、基底動脈阻塞且發病或最後正常時間 24 h 內可接受靜脈血栓溶解的患者。患者分配至 tenecteplase 0.25 mg/kg（最高 25 mg）單次靜脈 bolus，或標準醫療治療，可合併或不合併 血管內取栓；主要終點為 90 天 mrs 0-1 或回到基線 mrs。 主要結果：共 452 人納入分析，tenecteplase 組 221 人、標準治療組 231 人，其中 49% 後續接受 血管內取栓。90 天達主要終點者為 38% vs 29%（校正 relative 比率 1.50，95% ci 1.09-2.08，p=0.014）；36 h 內 有症狀 顱內出血 為 2% vs 3%，90 天全因死亡率為 29% vs 31%。 藥師重點：研究結果說明 tenecteplase 於基底動脈阻塞中風 24 h 內使用，可能改善 90 天功能預後且未增加症狀性顱內出血；實務應依中風團隊流程評估給藥時間窗、出血風險、後續 血管內取栓 與 alteplase 替代策略。" }, { "id": "pmid-41667193", "kind": "article", "issueId": "2026-week07", "year": 2026, "week": 7, "weekLabel": "第 7 週", "dateRange": "2026/02/09 – 02/15", "href": "2026-week07.html", "title": "Standard chemoradiotherapy with concurrent and adjuvant camrelizumab in patients with high risk nasopharyngeal carcinoma: multicentre, randomised, open label, phase 3 trial", "journal": "BMJ", "type": "RCT", "typeLabel": "RCT", "author": "You", "doi": "10.1136/bmj-2025-085863", "url": "https://doi.org/10.1136/bmj-2025-085863", "summary": "藥師重點：結論顯示 camrelizumab 加入同步化放療並作為維持治療，可改善誘導化療後高風險鼻咽癌患者的 無惡化存活期；藥師需留意免疫相關不良事件、治療週期長度與病人是否符合試驗族群。", "pubDate": "2026-02-10", "terms": [ "standard", "chemoradiotherapy", "concurrent", "adjuvant", "camrelizumab", "high", "nasopharyngeal", "carcinoma", "multicentre", "randomised" ], "drugTerms": [ "camrelizumab", "cisplatin" ], "searchText": "standard chemoradiotherapy with concurrent and adjuvant camrelizumab in patients with high risk nasopharyngeal carcinoma: multicentre, randomised, open label, phase 3 trial bmj rct you 10.1136/bmj-2025-085863 研究背景：高風險鼻咽癌在誘導化療後仍有復發風險，camrelizumab 作為 pd-1 抑制劑 併入同步化放療與維持治療，是否能改善疾病控制仍需臨床試驗驗證。 研究方法：研究為中國 7 家醫院進行的多中心、隨機、開放標籤 第 3 期試驗，收錄 18-70 歲、接受 3 個療程 gemcitabine/cisplatin 誘導化療後的新診斷高風險鼻咽癌患者。患者以 1:1 分配至 cisplatin 為主的標準同步化放療，或標準治療加上 camrelizumab 200 mg 每 3 週一次共 19 個療程，主要終點為 無惡化存活期。 主要結果：共 390 人隨機分配至 camrelizumab 組 194 人與標準治療組 196 人；中位追蹤 39.9 個月時，36 個月 無惡化存活期 為 83.4% vs 71.3%（stratified hr 0.51，95% ci 0.34-0.77，p=0.001）。等級 3 或 4 急性與晚期不良事件分別為 50.5%/3.2% vs 48.7%/3.7%，camrelizumab 組 等級 3 或 4 免疫相關不良事件為 10.2%。 藥師重點：結論顯示 camrelizumab 加入同步化放療並作為維持治療，可改善誘導化療後高風險鼻咽癌患者的 無惡化存活期；藥師需留意免疫相關不良事件、治療週期長度與病人是否符合試驗族群。" }, { "id": "pmid-41670966", "kind": "article", "issueId": "2026-week07", "year": 2026, "week": 7, "weekLabel": "第 7 週", "dateRange": "2026/02/09 – 02/15", "href": "2026-week07.html", "title": "Emergency Department-Initiated Buprenorphine for Opioid Use Disorder: A Randomized Clinical Trial", "journal": "JAMA", "type": "RCT", "typeLabel": "RCT", "author": "D'Onofrio", "doi": "10.1001/jama.2025.27019", "url": "https://doi.org/10.1001/jama.2025.27019", "summary": "藥師重點：結論顯示急診啟動 7 天 extended-release buprenorphine 未提高第 7 天治療參與率，但兩種 buprenorphine 形式皆具可接受耐受性；藥師需協助銜接後續治療、評估 fentanyl 使用背景下的 precipitated withdrawal 風險與衛教給藥形式差異。", "pubDate": "2026-03-17", "terms": [ "emergency", "department-initiated", "buprenorphine", "opioid", "disorder", "jama", "onofrio", "extended-release", "injectable", "withdrawal" ], "drugTerms": [], "searchText": "emergency department-initiated buprenorphine for opioid use disorder: a randomized clinical trial jama rct d'onofrio 10.1001/jama.2025.27019 研究背景：opioid 使用 疾患 患者常在急診接觸醫療體系，extended-release injectable buprenorphine 可能讓高風險或較難追蹤的患者在較低 withdrawal 程度下啟動治療。 研究方法：研究為美國 29 家急診進行的多中心隨機臨床試驗，收錄未治療 opioid 使用 疾患 且 臨床 opiate withdrawal scale（cows）至少 4 分的成人。患者分配至 7 天 extended-release buprenorphine 24 mg 注射（約等同 16 mg/d）或 sublingual buprenorphine，兩組皆安排 7 天內後續治療門診；主要終點為第 7 天仍參與 opioid 使用 疾患 治療。 主要結果：排除重複收案後共分析 1994 人，extended-release 組 991 人、sublingual 組 1003 人，76% fentanyl 檢測陽性。第 7 天治療參與率為 40.5% vs 38.5%（校正 差異 1.6%，95% ci -2.8% to 6.0%），第 30 天亦相近；precipitated withdrawal 罕見（0.6% vs 0.8%），30 天內 overdose 兩組各 18 人。 藥師重點：結論顯示急診啟動 7 天 extended-release buprenorphine 未提高第 7 天治療參與率，但兩種 buprenorphine 形式皆具可接受耐受性；藥師需協助銜接後續治療、評估 fentanyl 使用背景下的 precipitated withdrawal 風險與衛教給藥形式差異。" }, { "id": "pmid-41655584", "kind": "article", "issueId": "2026-week07", "year": 2026, "week": 7, "weekLabel": "第 7 週", "dateRange": "2026/02/09 – 02/15", "href": "2026-week07.html", "title": "Efimosfermin alfa (BOS-580) once per month in people with metabolic dysfunction-associated steatohepatitis with F2 or F3 fibrosis: results from a 24-week, randomised, double-blind, placebo-controlled, phase 2 trial", "journal": "Lancet", "type": "RCT", "typeLabel": "RCT", "author": "Noureddin", "doi": "10.1016/S0140-6736(25)02276-7", "url": "https://doi.org/10.1016/S0140-6736(25)02276-7", "summary": "藥師重點：結論顯示每月一次 efimosfermin 在切片確認 MASH 且 F2/F3 fibrosis 患者中整體耐受性尚可，但目前仍屬小型 第 2 期 證據；藥師可重點追蹤胃腸道症狀、肝功能與後續抗纖維化療效資料。", "pubDate": "2026-02-21", "terms": [ "efimosfermin", "alfa", "bos-580", "once", "month", "people", "metabolic", "dysfunction-associated", "steatohepatitis", "fibrosis" ], "drugTerms": [], "searchText": "efimosfermin alfa (bos-580) once per month in people with metabolic dysfunction-associated steatohepatitis with f2 or f3 fibrosis: results from a 24-week, randomised, double-blind, placebo-controlled, phase 2 trial lancet rct noureddin 10.1016/s0140-6736(25)02276-7 研究背景：metabolic 功能障礙-associated steatohepatitis（mash）盛行率上升，具 f2 或 f3 fibrosis 的患者仍需要安全且具肝臟標的性的抗纖維化治療。efimosfermin alfa（bos-580）為每月一次給藥的 fgf21 analogue，本研究評估其安全性與療效訊號。 研究方法：研究為 24 週、隨機、雙盲、安慰劑對照 第 2 期 試驗，於美國 34 個研究中心收錄 18-75 歲、bmi 至少 27 kg/m2、肝切片確認 mash 且 f2 或 f3 fibrosis 的成人。受試者以 1:1 分配至 efimosfermin 300 mg q4w 皮下注射或 安慰劑，主要終點為安全性與耐受性。 主要結果：1171 人篩選後，84 人隨機分配至 efimosfermin 組 43 人與 安慰劑 組 41 人；57% 為 f2 fibrosis、43% 為 f3 fibrosis。治療後不良事件為 67% vs 55%，多為輕度或中度，最常見為短暫胃腸道事件；兩組未見具臨床意義的生命徵象差異、等級 3 以上實驗室異常、死亡或 等級 3 以上不良事件。 藥師重點：結論顯示每月一次 efimosfermin 在切片確認 mash 且 f2/f3 fibrosis 患者中整體耐受性尚可，但目前仍屬小型 第 2 期 證據；藥師可重點追蹤胃腸道症狀、肝功能與後續抗纖維化療效資料。" }, { "id": "pmid-41690769", "kind": "article", "issueId": "2026-week07", "year": 2026, "week": 7, "weekLabel": "第 7 週", "dateRange": "2026/02/09 – 02/15", "href": "2026-week07.html", "title": "Effectiveness of drug interventions to prevent delirium after surgery for older adults: systematic review and network meta-analysis of randomised controlled trials", "journal": "BMJ", "type": "MA", "typeLabel": "Meta-analysis", "author": "Luney", "doi": "10.1136/bmj-2025-085539", "url": "https://doi.org/10.1136/bmj-2025-085539", "summary": "藥師重點：研究結果支持 dexmedetomidine 可預防術後 delirium，其他藥物雖有潛在效益但證據品質從中等到極低不等；藥師參與圍手術期用藥時，應同時評估鎮靜深度、低血壓、心搏過緩與納入研究異質性。", "pubDate": "2026-02-12", "terms": [ "effectiveness", "interventions", "prevent", "delirium", "surgery", "older", "adults", "network", "meta-analysis", "randomised" ], "drugTerms": [ "olanzapine" ], "searchText": "effectiveness of drug interventions to prevent delirium after surgery for older adults: systematic review and network meta-analysis of randomised controlled trials bmj meta-analysis luney 10.1136/bmj-2025-085539 研究背景：術後 delirium 會增加高齡手術患者照護負擔，但哪些藥物能有效預防 delirium，以及對死亡率與其他臨床結果的影響仍不一致。 研究方法：研究為 systematic review 與 network 統合分析，搜尋 embase、medline 與 cochrane library 至 2024 年 3 月 4 日。納入接受全身或區域麻醉、年齡至少 60 歲、使用藥物預防術後 delirium 且以 validated delirium assessment tool 評估結果的隨機試驗。 主要結果：共納入 158 項試驗、41,084 名參與者與 52 種藥物介入，術後 delirium 整體風險為 14.5%。在非高風險偏差試驗中，dexmedetomidine（or 0.46，95% 可信區間 0.36-0.57）、corticosteroids（0.53，0.31-0.87）、melatonin 受體 agonists（0.54，0.34-0.85）、parecoxib（0.34，0.16-0.74）、olanzapine（0.27，0.07-0.94）與 intranasal insulin（0.13，0.04-0.34）較可能降低 delirium；dexmedetomidine 較常見 hypotension 與 bradycardia。 藥師重點：研究結果支持 dexmedetomidine 可預防術後 delirium，其他藥物雖有潛在效益但證據品質從中等到極低不等；藥師參與圍手術期用藥時，應同時評估鎮靜深度、低血壓、心搏過緩與納入研究異質性。" }, { "id": "pmid-41671481", "kind": "article", "issueId": "2026-week07", "year": 2026, "week": 7, "weekLabel": "第 7 週", "dateRange": "2026/02/09 – 02/15", "href": "2026-week07.html", "title": "Dengue Suppression by Male Wolbachia-Infected Mosquitoes", "journal": "NEJM", "type": "RCT", "typeLabel": "RCT", "author": "Lim", "doi": "10.1056/NEJMoa2503304", "url": "https://doi.org/10.1056/NEJMoa2503304", "summary": "藥師重點：研究結果說明釋放 sterile wolbachia-infected male A. aegypti 可降低病媒蚊族群與新加坡登革熱感染風險；此屬公共衛生病媒控制證據，藥師可用於社區衛教與登革熱防治溝通，但不等同個別病人的藥物治療介入。", "pubDate": "2026-03-26", "terms": [ "dengue", "suppression", "male", "wolbachia-infected", "mosquitoes", "nejm", "nejmoa2503304", "walbb", "strain", "wolbachia" ], "drugTerms": [], "searchText": "dengue suppression by male wolbachia-infected mosquitoes nejm rct lim 10.1056/nejmoa2503304 研究背景：帶有 walbb strain wolbachia pipientis 的雄性 aedes aegypti 與野生型雌蚊交配後可產生不具存活力的後代，重複釋放此類雄蚊可能抑制病媒蚊族群並降低登革熱感染風險。 研究方法：研究在新加坡進行，採 cluster-隨機試驗 並搭配 test-negative controls，將 15 個地理人口群聚分為 8 個釋放 wolbachia-infected male mosquitoes 的介入群與 7 個未釋放的對照群。主要終點為任一血清型、任一嚴重度的有症狀且實驗室確認登革熱感染。 主要結果：介入群與對照群居民分別為 393,236 人與 331,192 人；介入後第 3 個月至 24 個月期間，成蚊平均豐度為 0.041 vs 0.277。意向治療分析中，介入群登革熱陽性比例低於對照群（354/5722，6% vs 1519/7080，21%），3 至 12 個月以上 wolbachia exposure 的 protective efficacy 約 71-72%（or 0.28-0.29）。 藥師重點：研究結果說明釋放 sterile wolbachia-infected male a. aegypti 可降低病媒蚊族群與新加坡登革熱感染風險；此屬公共衛生病媒控制證據，藥師可用於社區衛教與登革熱防治溝通，但不等同個別病人的藥物治療介入。" }, { "id": "pmid-41661604", "kind": "article", "issueId": "2026-week07", "year": 2026, "week": 7, "weekLabel": "第 7 週", "dateRange": "2026/02/09 – 02/15", "href": "2026-week07.html", "title": "Coffee and Tea Intake, Dementia Risk, and Cognitive Function", "journal": "JAMA", "type": "OA", "typeLabel": "Original Article", "author": "Zhang", "doi": "10.1001/jama.2025.27259", "url": "https://doi.org/10.1001/jama.2025.27259", "summary": "藥師重點：結論顯示含咖啡因咖啡與茶的適量攝取和較低 dementia 風險及些微較佳認知表現相關，但 世代 結果不能視為預防 dementia 的治療建議；藥師衛教時仍需考量睡眠、焦慮、心悸、胃食道逆流與藥物交互作用。", "pubDate": "2026-03-17", "terms": [ "coffee", "intake", "dementia", "cognitive", "function", "jama", "zhang", "nurses", "professionals", "parkinson" ], "drugTerms": [], "searchText": "coffee and tea intake, dementia risk, and cognitive function jama original article zhang 10.1001/jama.2025.27259 研究背景：咖啡與茶攝取和認知健康的關係仍未定論，過去研究也常未區分含咖啡因與不含咖啡因咖啡。本研究評估咖啡與茶攝取和 dementia 風險、主觀認知下降及客觀認知表現的關聯。 研究方法：研究為美國 nurses' 健康 研究 與 健康 professionals 追蹤 研究 的前瞻性 世代，納入基線無癌症、parkinson 疾病 或 dementia 的 131,821 名參與者。主要暴露為 caffeinated coffee、decaffeinated coffee 與 tea 攝取量，每 2-4 年以 validated food frequency questionnaires 收集；主要結果為 dementia。 主要結果：最長追蹤 43 年期間共發生 11,033 例 incident dementia；調整潛在干擾因子後，caffeinated coffee 攝取最高四分位相較最低四分位與較低 dementia 風險相關（141 vs 330 cases per 100,000 person-years；hr 0.82，95% ci 0.76-0.89），主觀認知下降盛行率也較低（7.8% vs 9.5%；prevalence 比值 0.85，95% ci 0.78-0.93）。tea 呈現類似關聯，decaffeinated coffee 則未與較低 dementia 風險或較佳認知表現相關；最明顯差異約見於每日 2-3 杯 caffeinated coffee 或 1-2 杯 tea。 藥師重點：結論顯示含咖啡因咖啡與茶的適量攝取和較低 dementia 風險及些微較佳認知表現相關，但 世代 結果不能視為預防 dementia 的治療建議；藥師衛教時仍需考量睡眠、焦慮、心悸、胃食道逆流與藥物交互作用。" }, { "id": "pmid-41655587", "kind": "article", "issueId": "2026-week07", "year": 2026, "week": 7, "weekLabel": "第 7 週", "dateRange": "2026/02/09 – 02/15", "href": "2026-week07.html", "title": "Assessment of adverse effects attributed to statin therapy in product labels: a meta-analysis of double-blind randomised controlled trials", "journal": "Lancet", "type": "MA", "typeLabel": "Meta-analysis", "author": "N/A", "doi": "10.1016/S0140-6736(25)01578-8", "url": "https://doi.org/10.1016/S0140-6736(25)01578-8", "summary": "藥師重點：結論顯示雙盲隨機試驗資料不支持 statin 與多數仿單列載症狀之間存在因果關係，包括 cognitive impairment、depression、sleep disturbance 與 peripheral neuropathy；藥師可用於風險溝通與提升用藥持續性，同時仍需依臨床狀況監測肝功能與肌肉相關症狀。", "pubDate": "2026-02-14", "terms": [ "assessment", "adverse", "attributed", "statin", "product", "labels", "meta-analysis", "double-blind", "randomised", "trials" ], "drugTerms": [ "statin", "atorvastatin", "fluvastatin", "pravastatin", "rosuvastatin", "simvastatin" ], "searchText": "assessment of adverse effects attributed to statin therapy in product labels: a meta-analysis of double-blind randomised controlled trials lancet meta-analysis 10.1016/s0140-6736(25)01578-8 研究背景：statin 仿單常列出多種可能不良反應，但部分資料主要來自非隨機或非盲性研究，可能受到偏差影響。本研究以大型雙盲隨機試驗的 individual participant 資料 重新評估這些不良事件與 statin 的關聯。 研究方法：研究為個別受試者資料 統合分析，先從電子藥品彙編整理 atorvastatin、fluvastatin、pravastatin、rosuvastatin 與 simvastatin 仿單列出的 undesirable effect terms。納入至少 1000 人、預定治療至少 2 年，且為 statin vs 安慰劑 或較高強度 vs 較低強度 statin 的雙盲隨機試驗，並以 fdr 5% 控制多重檢定。 主要結果：19 項 statin vs 安慰劑 試驗共 123,940 人，中位追蹤 4.5 年；除既知肌肉事件與糖尿病外，66 項額外被歸因於 statin 的不良結果中僅 4 項達 fdr 顯著：abnormal liver transaminases（rr 1.41，95% ci 1.26-1.57）、其他 liver function test abnormalities（rr 1.26，1.12-1.41；combined liver function test abnormality 年絕對增加 0.13%）、urinary composition alteration（rr 1.18，1.04-1.33）與 oedema（rr 1.07，1.02-1.12）。 藥師重點：結論顯示雙盲隨機試驗資料不支持 statin 與多數仿單列載症狀之間存在因果關係，包括 cognitive impairment、depression、sleep disturbance 與 peripheral neuropathy；藥師可用於風險溝通與提升用藥持續性，同時仍需依臨床狀況監測肝功能與肌肉相關症狀。" }, { "id": "pmid-41679324", "kind": "article", "issueId": "2026-week07", "year": 2026, "week": 7, "weekLabel": "第 7 週", "dateRange": "2026/02/09 – 02/15", "href": "2026-week07.html", "title": "Adult obesity and risk of severe infections: a multicohort study with global burden estimates", "journal": "Lancet", "type": "OA", "typeLabel": "Original Article", "author": "Nyberg", "doi": "10.1016/S0140-6736(25)02474-2", "url": "https://doi.org/10.1016/S0140-6736(25)02474-2", "summary": "藥師重點：研究結果說明成人肥胖與多類病原造成的感染住院與死亡風險增加有關；藥師可在慢病照護、疫苗接種與感染風險衛教中納入體重管理觀點，但因屬 世代 與 burden modelling，仍需避免解讀為單一因果證據。", "pubDate": "2026-03-07", "terms": [ "adult", "obesity", "severe", "infections", "multicohort", "global", "burden", "estimates", "lancet", "nyberg" ], "drugTerms": [], "searchText": "adult obesity and risk of severe infections: a multicohort study with global burden estimates lancet original article nyberg 10.1016/s0140-6736(25)02474-2 研究背景：成人肥胖已被認為與部分感染有關，但跨越多種細菌、病毒、寄生蟲與黴菌感染的整體證據仍有限。本研究評估肥胖與 925 種感染性疾病之發生、住院與死亡的關聯，並估算全球與區域可歸因影響。 研究方法：研究整合兩個芬蘭 世代 並以 uk biobank 重複分析，依基線 bmi 分為 healthy weight、overweight 與 obesity class i-iii。研究透過國家住院與死亡登錄追蹤感染相關住院與死亡，並結合 global burden of diseases 資料估算 2018、2021 與 2023 年肥胖可歸因的感染死亡比例。 主要結果：芬蘭 世代 納入 67,766 人，uk biobank 納入 479,498 人；與健康體重者相比，class iii obesity 的感染相關住院風險約增加 3 倍（芬蘭 hr 2.75，95% ci 2.24-3.37；uk biobank hr 3.07，2.95-3.19），死亡風險亦較高（hr 3.06，1.25-7.49；hr 3.54，3.15-3.98）。任一 obesity class 對嚴重感染的 pooled hr 為 1.7（1.7-1.8），全球感染相關死亡中肥胖可歸因比例估計為 2018 年 8.6%、2021 年 15.0%、2023 年 10.8%。 藥師重點：研究結果說明成人肥胖與多類病原造成的感染住院與死亡風險增加有關；藥師可在慢病照護、疫苗接種與感染風險衛教中納入體重管理觀點，但因屬 世代 與 burden modelling，仍需避免解讀為單一因果證據。" }, { "id": "pmid-41671482", "kind": "article", "issueId": "2026-week07", "year": 2026, "week": 7, "weekLabel": "第 7 週", "dateRange": "2026/02/09 – 02/15", "href": "2026-week07.html", "title": "Adenoviral Inciting Antigen and Somatic Hypermutation in VITT", "journal": "NEJM", "type": "OA", "typeLabel": "Original Article", "author": "Wang", "doi": "10.1056/NEJMoa2514824", "url": "https://doi.org/10.1056/NEJMoa2514824", "summary": "藥師重點：研究結果說明 VITT 可能源於具特定 IGLV3-21 allele 者產生 K31E somatic hypermutation，使原本辨識 adenovirus pVII epitope 的抗體轉向 PF4；此證據主要用於理解機轉與風險辨識，臨床仍需依血小板、血栓表現與 anti-PF4 檢測處理疑似個案。", "pubDate": "2026-02-12", "terms": [ "adenoviral", "inciting", "antigen", "somatic", "hypermutation", "vitt", "nejm", "wang", "nejmoa2514824", "induced" ], "drugTerms": [ "anti-pf4", "anti-adenovirus" ], "searchText": "adenoviral inciting antigen and somatic hypermutation in vitt nejm original article wang 10.1056/nejmoa2514824 研究背景：疫苗-induced immune thrombocytopenia and thrombosis（vitt）是腺病毒載體 covid-19 疫苗後罕見但具血栓風險的併發症，少數也可發生於自然腺病毒感染後；其與活化血小板的 anti-pf4 抗體 有關，但觸發抗原與免疫病理機轉仍不清楚。 研究方法：研究以 抗體 proteomics 分析 21 名 vitt 患者的 anti-pf4 抗體 胺基酸序列，並定序 100 名 vitt 患者的 immunoglobulin light-chain hypervariable region 基因。研究者再以 anti-pf4 與 anti-adenovirus protein 抗體 的 antigen-binding fingerprints 尋找共同 serum clonotype，並用 adenovirus protein peptides 與 recombinant anti-pf4 vitt 抗體 定位 mimic linear epitope。 主要結果：vitt 抗體 的基因體與蛋白質體分析顯示共同 immunoglobulin light-chain allele iglv3-21*02 或 *03，且帶有關鍵 somatic hypermutation k31e。只有針對 adenoviral core protein vii（pvii）純化的抗體含有符合 vitt fingerprint 的 anti-pf4 species；將 pathogenic anti-pf4 vitt 抗體 回復為 germline k31 後，體內外 prothrombotic activity 消失並較偏向結合 pvii。 藥師重點：研究結果說明 vitt 可能源於具特定 iglv3-21 allele 者產生 k31e somatic hypermutation，使原本辨識 adenovirus pvii epitope 的抗體轉向 pf4；此證據主要用於理解機轉與風險辨識，臨床仍需依血小板、血栓表現與 anti-pf4 檢測處理疑似個案。" }, { "id": "pmid-41665410", "kind": "article", "issueId": "2026-week07", "year": 2026, "week": 7, "weekLabel": "第 7 週", "dateRange": "2026/02/09 – 02/15", "href": "2026-week07.html", "title": "AAV9 Gene Therapy in Type II GM1 Gangliosidosis - A Phase 1-2 Trial", "journal": "NEJM", "type": "OA", "typeLabel": "Original Article", "author": "Lewis", "doi": "10.1056/NEJMoa2510935", "url": "https://doi.org/10.1056/NEJMoa2510935", "summary": "藥師重點：結論顯示單次 AAV9 encoding β-galactosidase 輸注在 9 名 type II GM1 gangliosidosis 兒童中伴隨肝酵素上升、嚴重嘔吐等安全性事件，同時出現生化與影像改善訊號；此仍屬早期小型試驗，藥師需關注免疫抑制、肝功能與長期神經發展追蹤。", "pubDate": "2026-03-26", "terms": [ "aav9", "gene", "type", "gangliosidosis", "phase", "nejm", "lewis", "nejmoa2510935", "glb1", "lysosomal" ], "drugTerms": [], "searchText": "aav9 gene therapy in type ii gm1 gangliosidosis - a phase 1-2 trial nejm original article lewis 10.1056/nejmoa2510935 研究背景：type ii gm1 gangliosidosis 由 glb1 雙等位基因變異造成 lysosomal β-galactosidase 缺乏，導致 gm1 ganglioside 無法正常分解，是目前缺乏有效治療的致命神經退化疾病。 研究方法：研究為 第 1 期-2、開放標籤、劑量遞增試驗，評估免疫抑制後單次靜脈輸注 adeno-associated virus serotype 9（aav9）encoding β-galactosidase，用於 late-infantile 或 juvenile onset 的 type ii gm1 gangliosidosis 兒童。主要終點為安全性，次要終點包括 csf gm1 ganglioside、β-galactosidase activity、臨床 global impression-improvement（cgi-i）與神經影像變化。 主要結果：共 9 名受試者納入，3 年期間發生 124 件不良事件，其中 30 件被判定可能、很可能或確定與 gene 治療 相關；5 件 嚴重不良事件 中，1 件因嘔吐住院被歸因於治療。所有受試者 ast/alt 皆上升並於 18 個月回到基線；csf β-galactosidase 上升、csf gm1 ganglioside 下降，部分發展量表與神經影像呈現穩定或改善訊號。 藥師重點：結論顯示單次 aav9 encoding β-galactosidase 輸注在 9 名 type ii gm1 gangliosidosis 兒童中伴隨肝酵素上升、嚴重嘔吐等安全性事件，同時出現生化與影像改善訊號；此仍屬早期小型試驗，藥師需關注免疫抑制、肝功能與長期神經發展追蹤。" }, { "id": "fda-2026-week07-1", "kind": "fda", "issueId": "2026-week07", "year": 2026, "week": 7, "weekLabel": "第 7 週", "dateRange": "2026/02/09 – 02/15", "href": "2026-week07.html", "title": "FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "concerns", "unapproved", "glp-1", "drugs", "used", "weight", "loss", "https", "drug-alerts-and-statements", "fdas-concerns-unapproved-glp-1-drugs-used-weight-loss" ], "drugTerms": [ "glp-1" ], "searchText": "fda’s concerns with unapproved glp-1 drugs used for weight loss fda drug safety 2026-06-15 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss" }, { "id": "fda-2026-week07-3", "kind": "fda", "issueId": "2026-week07", "year": 2026, "week": 7, "weekLabel": "第 7 週", "dateRange": "2026/02/09 – 02/15", "href": "2026-week07.html", "title": "FDA issues final decision to withdraw approval of Pepaxto (melphalan flufenamide)", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/node/398713", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "issues", "final", "decision", "withdraw", "approval", "pepaxto", "melphalan", "flufenamide", "https", "node" ], "drugTerms": [], "searchText": "fda issues final decision to withdraw approval of pepaxto (melphalan flufenamide) fda drug safety 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/node/398713" }, { "id": "fda-2026-week07-2", "kind": "fda", "issueId": "2026-week07", "year": 2026, "week": 7, "weekLabel": "第 7 週", "dateRange": "2026/02/09 – 02/15", "href": "2026-week07.html", "title": "FDA alerts patients, caregivers, and health care providers of cross-compatibility issues with autoinjector devices that are optional for use with glatiramer acetate injection", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/node/403159", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "alerts", "caregivers", "providers", "cross-compatibility", "issues", "autoinjector", "devices", "that", "optional", "glatiramer" ], "drugTerms": [], "searchText": "fda alerts patients, caregivers, and health care providers of cross-compatibility issues with autoinjector devices that are optional for use with glatiramer acetate injection fda drug safety 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/node/403159" }, { "id": "fda-2026-week07-4", "kind": "fda", "issueId": "2026-week07", "year": 2026, "week": 7, "weekLabel": "第 7 週", "dateRange": "2026/02/09 – 02/15", "href": "2026-week07.html", "title": "FDA Accepts First In Silico Drug Development Tool Under ISTAND Program to Help Predict Drug-Induced Liver Injury", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fda-accepts-first-silico-drug-development-tool-under-istand-program-help-predict-drug-induced-liver", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "accepts", "first", "silico", "development", "tool", "under", "istand", "program", "help", "predict" ], "drugTerms": [], "searchText": "fda accepts first in silico drug development tool under istand program to help predict drug-induced liver injury fda drug safety 2026-06-03 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/drugs/drug-alerts-and-statements/fda-accepts-first-silico-drug-development-tool-under-istand-program-help-predict-drug-induced-liver" }, { "id": "pmid-41638711", "kind": "article", "issueId": "2026-week06", "year": 2026, "week": 6, "weekLabel": "第 6 週", "dateRange": "2026/02/02 – 02/08", "href": "2026-week06.html", "title": "Time trends in the male to female ratio for autism incidence: population based, prospectively collected, birth cohort study", "journal": "BMJ", "type": "OA", "typeLabel": "Original Article", "author": "Fyfe", "doi": "10.1136/bmj-2025-084164", "url": "https://doi.org/10.1136/bmj-2025-084164", "summary": "藥師重點：研究結果說明 ASD 男女診斷比例會受年齡與時間趨勢影響，女性可能較晚被診斷且過去負擔可能被低估；此研究屬流行病學證據，較適合作為照護可近性、篩檢與衛教討論背景，而非藥物治療決策依據。", "pubDate": "2026-02-04", "terms": [ "time", "trends", "male", "female", "ratio", "autism", "incidence", "population", "prospectively", "collected" ], "drugTerms": [], "searchText": "time trends in the male to female ratio for autism incidence: population based, prospectively collected, birth cohort study bmj original article fyfe 10.1136/bmj-2025-084164 研究背景：自閉症類群障礙（asd）的男女診斷比例過去常被認為男性較高，但診斷年齡與世代變化可能影響此比例，需以長期族群資料重新評估。 研究方法：此瑞典 族群-based、prospectively collected birth 世代研究 納入 1985-2020 年出生於瑞典醫療出生登記的 2,756,779 名兒童。研究以 age-period 世代 分析 評估 asd 與診斷年齡、曆年期間、出生世代與性別的關聯，並估算 發生率比 與 cumulative male to female 比值（cmfr）。 主要結果：截至 2022 年追蹤結束，78,522 人（2.8%）診斷 asd。asd incidence 比率 隨兒童期每 5 歲年齡區間增加，2020-2022 年男性於 10-14 歲達 645.5 per 100,000 person-years，女性於 15-19 歲達 602.6 per 100,000 person-years；男性對女性比例隨診斷年齡增加而下降，2022 年追蹤時 20 歲 cmfr 為 1.2，趨勢推估 2024 年 20 歲時可能接近平衡。 藥師重點：研究結果說明 asd 男女診斷比例會受年齡與時間趨勢影響，女性可能較晚被診斷且過去負擔可能被低估；此研究屬流行病學證據，較適合作為照護可近性、篩檢與衛教討論背景，而非藥物治療決策依據。" }, { "id": "pmid-41638692", "kind": "article", "issueId": "2026-week06", "year": 2026, "week": 6, "weekLabel": "第 6 週", "dateRange": "2026/02/02 – 02/08", "href": "2026-week06.html", "title": "Testing menstrual blood for human papillomavirus during cervical cancer screening in China: cross sectional population based study", "journal": "BMJ", "type": "OA", "typeLabel": "Original Article", "author": "Tian", "doi": "10.1136/bmj-2025-084831", "url": "https://doi.org/10.1136/bmj-2025-084831", "summary": "藥師重點：結論顯示以 minipad 收集經血進行 HPV testing 對 CIN2+/CIN3+ 的診斷準確度與臨床人員採集子宮頸檢體相近；若未來導入篩檢流程，需留意採檢說明、陽性後轉介追蹤，以及此研究族群與本地篩檢制度的差異。", "pubDate": "2026-02-04", "terms": [ "testing", "menstrual", "blood", "human", "papillomavirus", "cervical", "cancer", "screening", "china", "cross" ], "drugTerms": [], "searchText": "testing menstrual blood for human papillomavirus during cervical cancer screening in china: cross sectional population based study bmj original article tian 10.1136/bmj-2025-084831 研究背景：hpv 檢測是子宮頸癌篩檢的重要工具，若能以 minipad 收集經血進行檢測，可能提高採檢便利性；其對 cin2+/cin3+ 的診斷準確度需與臨床人員採集子宮頸檢體比較。 研究方法：此中國湖北省 4 個都市與 3 個鄉村社區進行的 族群-based 橫斷面研究，納入 3068 名 20-54 歲且月經規則女性。研究比較 以衛生棉收集的經血 hpv testing、clinician collected cervical hpv testing 與 thinprep cytology；任一 hpv 檢測陽性或 cytology 達 atypical squamous cells of undetermined significance 以上者接受 colposcopy-directed biopsy，以評估 cin2+ 與 cin3+ 診斷準確度。 主要結果：minipad hpv testing 偵測 cin2+ 的 sensitivity 為 94.7%（95% ci 80.9%-99.1%），與 clinician-based hpv testing 的 92.1%（95% ci 77.5%-97.9%；p=1.00）相近。minipad hpv testing specificity 較低（89.1% vs 90.0%；p=0.001），但 negative predictive value 相同（99.9% vs 99.9%；p=1.00），陽性 predictive value 與 screening efficiency 亦相近。 藥師重點：結論顯示以 minipad 收集經血進行 hpv testing 對 cin2+/cin3+ 的診斷準確度與臨床人員採集子宮頸檢體相近；若未來導入篩檢流程，需留意採檢說明、陽性後轉介追蹤，以及此研究族群與本地篩檢制度的差異。" }, { "id": "pmid-41642827", "kind": "article", "issueId": "2026-week06", "year": 2026, "week": 6, "weekLabel": "第 6 週", "dateRange": "2026/02/02 – 02/08", "href": "2026-week06.html", "title": "Tenecteplase for Acute Non-Large Vessel Occlusion 4.5 to 24 Hours After Ischemic Stroke: The OPTION Randomized Clinical Trial", "journal": "JAMA", "type": "RCT", "typeLabel": "RCT", "author": "Ma", "doi": "10.1001/jama.2026.0210", "url": "https://doi.org/10.1001/jama.2026.0210", "summary": "藥師重點：研究結果說明在影像篩選且非 大血管阻塞 的急性缺血性中風病人中，4.5-24 小時給予 tenecteplase 可增加 90 天良好功能結局機會，但會提高 有症狀 intracranial hemorrhage 風險；臨床應嚴格依影像條件、出血禁忌與劑量上限評估。", "pubDate": "2026-04-07", "terms": [ "tenecteplase", "acute", "non-large", "vessel", "occlusion", "hours", "ischemic", "stroke", "option", "jama" ], "drugTerms": [], "searchText": "tenecteplase for acute non-large vessel occlusion 4.5 to 24 hours after ischemic stroke: the option randomized clinical trial jama rct ma 10.1001/jama.2026.0210 研究背景：急性缺血性中風若超過 4.5 小時治療窗，且非 大血管阻塞，靜脈 tenecteplase 是否仍可改善功能結局並維持安全性仍不確定。 研究方法：option 為中國 48 個中心進行的隨機、開放標籤、blinded end-point 試驗，納入 非大血管阻塞 stroke 且 perfusion imaging 顯示仍有可挽救腦組織、最後正常時間後 4.5-24 小時內就醫的病人。受試者 1:1 接受 intravenous tenecteplase 0.25 mg/kg（maximum 25 mg）或 標準醫療治療；主要療效終點為 90 天 mrs 0-1 分，安全性包括 36 小時 有症狀 intracranial hemorrhage 與 90 天死亡率。 主要結果：570 人隨機分組，566 人納入主要分析。90 天 excellent functional 結果指標 為 tenecteplase 組 43.6% vs 對照組 34.2%（rr 1.28，95% ci 1.04-1.57；p=.02）；有症狀 intracranial hemorrhage 較 tenecteplase 組高（2.8% vs 0%；風險差 2.85%，95% ci 1.16%-5.54%；p=.004），90 天死亡率為 5.0% vs 3.2%（rr 1.57，95% ci 0.69-3.57；p=.28）。 藥師重點：研究結果說明在影像篩選且非 大血管阻塞 的急性缺血性中風病人中，4.5-24 小時給予 tenecteplase 可增加 90 天良好功能結局機會，但會提高 有症狀 intracranial hemorrhage 風險；臨床應嚴格依影像條件、出血禁忌與劑量上限評估。" }, { "id": "pmid-41654374", "kind": "article", "issueId": "2026-week06", "year": 2026, "week": 6, "weekLabel": "第 6 週", "dateRange": "2026/02/02 – 02/08", "href": "2026-week06.html", "title": "Switch to fixed-dose doravirine (100 mg) and islatravir (0·25 mg) once daily in virologically suppressed adults with HIV-1 on oral antiretroviral therapy: 48-week results of a phase 3, multicentre, randomised, open-label, non-inferiority trial", "journal": "Lancet", "type": "RCT", "typeLabel": "RCT", "author": "Orkin", "doi": "10.1016/S0140-6736(25)01945-2", "url": "https://doi.org/10.1016/S0140-6736(25)01945-2", "summary": "藥師重點：研究結果說明 doravirine/islatravir 作為轉換治療可維持 48 週病毒控制，並提供非 INSTI-based 雙藥單錠的潛在選項；臨床評估時需確認 hepatitis B 狀態、既往 ART 與抗藥性紀錄，並追蹤不良事件與病毒量。", "pubDate": "2026-02-07", "terms": [ "switch", "fixed-dose", "doravirine", "islatravir", "once", "daily", "virologically", "suppressed", "adults", "hiv-1" ], "drugTerms": [ "islatravir" ], "searchText": "switch to fixed-dose doravirine (100 mg) and islatravir (0·25 mg) once daily in virologically suppressed adults with hiv-1 on oral antiretroviral therapy: 48-week results of a phase 3, multicentre, randomised, open-label, non-inferiority trial lancet rct orkin 10.1016/s0140-6736(25)01945-2 研究背景：doravirine/islatravir 為 investigational 每日一次 single-tablet 處方，可能提供非 insti-based 的雙藥 hiv-1 治療選項；其由穩定口服 art 轉換後的療效與安全性仍需大型試驗確認。 研究方法：此 第 3 期、隨機、活性對照、開放標籤、不劣性 試驗 於 8 國 53 個據點進行。納入 18 歲以上、任何口服雙藥或三藥 art 下 hiv-1 rna <50 copies per ml 至少 3 個月、無治療失敗史、無已知 doravirine 抗藥性且無活動性 hepatitis b 的成人，依 2:1 分配至 doravirine 100 mg/islatravir 0.25 mg 每日一次 或續用 基準值 art 48 週；主要終點為第 48 週 hiv-1 rna ≥50 copies per ml。 主要結果：共 553 人隨機分組，551 人接受至少一劑研究治療。第 48 週 hiv-1 rna ≥50 copies per ml 為 doravirine/islatravir 組 1.4% vs 基準值 art 組 4.9%，差異 -3.6%（multiplicity-校正 95% ci -7.8 to -0.8），符合 不劣性；治療相關不良事件 較常見於 doravirine/islatravir 組（12.0% vs 4.9%），但任何 不良事件、嚴重不良事件 與因不良事件停藥比例相近。 藥師重點：研究結果說明 doravirine/islatravir 作為轉換治療可維持 48 週病毒控制，並提供非 insti-based 雙藥單錠的潛在選項；臨床評估時需確認 hepatitis b 狀態、既往 art 與抗藥性紀錄，並追蹤不良事件與病毒量。" }, { "id": "pmid-41654375", "kind": "article", "issueId": "2026-week06", "year": 2026, "week": 6, "weekLabel": "第 6 週", "dateRange": "2026/02/02 – 02/08", "href": "2026-week06.html", "title": "Switch to fixed-dose doravirine (100 mg) and islatravir (0·25 mg) once daily in virologically suppressed adults with HIV-1 on bictegravir, emtricitabine, and tenofovir alafenamide: 48-week results of a phase 3, multicentre, randomised, controlled, double-blind, non-inferiority trial", "journal": "Lancet", "type": "RCT", "typeLabel": "RCT", "author": "Colson", "doi": "10.1016/S0140-6736(25)01948-8", "url": "https://doi.org/10.1016/S0140-6736(25)01948-8", "summary": "藥師重點：結論顯示 doravirine 100 mg/islatravir 0.25 mg 每日一次 在病毒已控制且適合轉換治療的成人中，48 週病毒控制與安全性與 bictegravir/emtricitabine/tenofovir alafenamide 相近；藥師需留意既往治療失敗、抗藥性資料與轉換後病毒量追蹤。", "pubDate": "2026-02-07", "terms": [ "switch", "fixed-dose", "doravirine", "islatravir", "once", "daily", "virologically", "suppressed", "adults", "hiv-1" ], "drugTerms": [ "islatravir", "bictegravir", "tenofovir" ], "searchText": "switch to fixed-dose doravirine (100 mg) and islatravir (0·25 mg) once daily in virologically suppressed adults with hiv-1 on bictegravir, emtricitabine, and tenofovir alafenamide: 48-week results of a phase 3, multicentre, randomised, controlled, double-blind, non-inferiority trial lancet rct colson 10.1016/s0140-6736(25)01948-8 研究背景：doravirine 與 islatravir 固定劑量單錠複方正被評估作為 hiv-1 治療選項，本研究探討病毒已受控制者由 bictegravir、emtricitabine、tenofovir alafenamide 轉換至 doravirine/islatravir 的療效與安全性。 研究方法：此 第 3 期、隨機、雙盲、活性對照、不劣性 試驗 於 6 國 49 個研究、社區與醫院據點進行。納入 18 歲以上、使用 bictegravir/emtricitabine/tenofovir alafenamide 且 hiv-1 rna <50 copies per ml 至少 3 個月的成人，依 2:1 分配轉換至 doravirine 100 mg/islatravir 0.25 mg 每日一次 或續用原療法；主要終點為第 48 週 hiv-1 rna ≥50 copies per ml 的比例。 主要結果：共 514 人隨機分組、513 人接受治療，其中 342 人轉換至 doravirine/islatravir，171 人續用 bictegravir/emtricitabine/tenofovir alafenamide。第 48 週 hiv-1 rna ≥50 copies per ml 為 1.5% vs 0.6%，治療差異 0.9%（multiplicity-校正 95% ci -1.9 to 2.9），符合 不劣性；任何 不良事件、治療相關不良事件、嚴重不良事件 與因不良事件停藥比例相近，且未通報死亡。 藥師重點：結論顯示 doravirine 100 mg/islatravir 0.25 mg 每日一次 在病毒已控制且適合轉換治療的成人中，48 週病毒控制與安全性與 bictegravir/emtricitabine/tenofovir alafenamide 相近；藥師需留意既往治療失敗、抗藥性資料與轉換後病毒量追蹤。" }, { "id": "pmid-41653933", "kind": "article", "issueId": "2026-week06", "year": 2026, "week": 6, "weekLabel": "第 6 週", "dateRange": "2026/02/02 – 02/08", "href": "2026-week06.html", "title": "Recombinant factor VIIa versus placebo for spontaneous intracerebral haemorrhage within 2 h of symptom onset (FASTEST): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial", "journal": "Lancet", "type": "RCT", "typeLabel": "RCT", "author": "Broderick", "doi": "10.1016/S0140-6736(26)00097-8", "url": "https://doi.org/10.1016/S0140-6736(26)00097-8", "summary": "藥師重點：結論顯示 recombinant factor VIIa 於 ICH 發生 2 小時內給藥可減緩血腫成長，但未改善 180 天功能結局且增加嚴重血栓栓塞風險；藥師解讀時需把影像學止血效果與病人功能結局、安全性分開評估。", "pubDate": "2026-02-21", "terms": [ "recombinant", "factor", "viia", "placebo", "spontaneous", "intracerebral", "haemorrhage", "within", "symptom", "onset" ], "drugTerms": [], "searchText": "recombinant factor viia versus placebo for spontaneous intracerebral haemorrhage within 2 h of symptom onset (fastest): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial lancet rct broderick 10.1016/s0140-6736(26)00097-8 研究背景：recombinant factor viia 可減緩腦內出血擴大，但過去止血藥物尚未明確改善臨床功能結局；fastest 評估其於急性自發性腦內出血早期給藥的療效與安全性。 研究方法：fastest 為多國 93 個據點進行的多中心、前瞻性、雙盲、隨機、安慰劑對照、adaptive 第 3 期試驗。納入 18-80 歲、spontaneous ich 2-60 ml、符合 ivh 與 gcs 條件且可於發病或最後正常時間 2 小時內給藥者，隨機接受 recombinant factor viia 80 μg/kg 靜脈注射或 安慰劑；主要終點為 180 天 mrs 功能結局，主要安全性終點為前 4 天 危及生命的血栓栓塞 事件。 主要結果：共 626 人納入 意向治療分析，安慰劑 組 298 人、intervention 組 328 人；平均發病至給藥時間為 100 分鐘。試驗於第二次 interim 分析 因 futility 達停止標準；180 天 mrs 主要臨床結局無顯著差異（校正 common 勝算比 1.09，95% ci 0.79-1.51；p=0.61），但前 4 天 危及生命的血栓栓塞 complications 較高（<5% vs 1%；rr 3.41，95% ci 1.14-10.15；p=0.020），24 小時 ich 與 ich 加上 ivh 體積成長則較少。 藥師重點：結論顯示 recombinant factor viia 於 ich 發生 2 小時內給藥可減緩血腫成長，但未改善 180 天功能結局且增加嚴重血栓栓塞風險；藥師解讀時需把影像學止血效果與病人功能結局、安全性分開評估。" }, { "id": "pmid-41628627", "kind": "article", "issueId": "2026-week06", "year": 2026, "week": 6, "weekLabel": "第 6 週", "dateRange": "2026/02/02 – 02/08", "href": "2026-week06.html", "title": "Efficacy and safety of minocycline in patients with acute ischaemic stroke (EMPHASIS): a multicentre, double-blind, randomised controlled trial", "journal": "Lancet", "type": "RCT", "typeLabel": "RCT", "author": "Lu", "doi": "10.1016/S0140-6736(25)01862-8", "url": "https://doi.org/10.1016/S0140-6736(25)01862-8", "summary": "藥師重點：結論顯示急性缺血性中風 72 小時內加用短療程 minocycline 可能改善 90 天功能結局，且本研究未觀察到明確安全性疑慮；實務應留意此證據仍需外部確認，並評估病人中風嚴重度、吞服能力、抗生素相關不良反應與交互作用。", "pubDate": "2026-02-14", "terms": [ "efficacy", "minocycline", "acute", "ischaemic", "stroke", "emphasis", "multicentre", "double-blind", "randomised", "lancet" ], "drugTerms": [ "minocycline", "anti-neuroinflammatory" ], "searchText": "efficacy and safety of minocycline in patients with acute ischaemic stroke (emphasis): a multicentre, double-blind, randomised controlled trial lancet rct lu 10.1016/s0140-6736(25)01862-8 研究背景：minocycline 在前臨床與小型臨床研究中被認為具有抗神經發炎等多重作用，對急性缺血性中風的功能恢復效益仍需較大型隨機試驗驗證。 研究方法：emphasis 為中國 58 家醫院進行的多中心、雙盲、隨機、安慰劑對照試驗，納入 72 小時內發生缺血性中風、nihss 4-25 分且意識量表符合條件的病人。受試者 1:1 接受 routine 治療 加口服 minocycline（loading dose 200 mg，之後 100 mg every 12 h 共 4 天）或 安慰劑；主要終點為 90 天 modified rankin scale（mrs）0-1 分。 主要結果：共 1724 人隨機分配至 minocycline 或 安慰劑，各 862 人。90 天 mrs 0-1 分為 52.6% vs 47.4%（校正 風險比 1.11，95% ci 1.03-1.20；p=0.0061），mrs 全範圍 ordinal 分析 亦有利於 minocycline（校正 common 勝算比 1.19，95% ci 1.03-1.38；p=0.018）；24 小時與 6 天 有症狀 顱內出血 以及 嚴重不良事件 未見顯著差異。 藥師重點：結論顯示急性缺血性中風 72 小時內加用短療程 minocycline 可能改善 90 天功能結局，且本研究未觀察到明確安全性疑慮；實務應留意此證據仍需外部確認，並評估病人中風嚴重度、吞服能力、抗生素相關不良反應與交互作用。" }, { "id": "pmid-41631724", "kind": "article", "issueId": "2026-week06", "year": 2026, "week": 6, "weekLabel": "第 6 週", "dateRange": "2026/02/02 – 02/08", "href": "2026-week06.html", "title": "Dual antiplatelet therapy after percutaneous coronary intervention according to bleeding risk (HOST-BR): an open-label, multicentre, randomised clinical trial", "journal": "Lancet", "type": "RCT", "typeLabel": "RCT", "author": "Kang", "doi": "10.1016/S0140-6736(25)01571-5", "url": "https://doi.org/10.1016/S0140-6736(25)01571-5", "summary": "藥師重點：結論顯示東亞 HBR 病人支架後 1 個月 DAPT 不能取代 3 個月 DAPT；非 HBR 病人使用 3 個月 DAPT 可維持主要缺血事件控制並降低出血，藥師需依病人出血風險、支架後缺血風險與抗血小板療程計畫協助評估。", "pubDate": "2025-11-08", "terms": [ "dual", "antiplatelet", "percutaneous", "coronary", "intervention", "according", "bleeding", "host-br", "open-label", "multicentre" ], "drugTerms": [], "searchText": "dual antiplatelet therapy after percutaneous coronary intervention according to bleeding risk (host-br): an open-label, multicentre, randomised clinical trial lancet rct kang 10.1016/s0140-6736(25)01571-5 研究背景：冠狀動脈支架置放後 雙重抗血小板治療（dapt）的最佳療程需兼顧缺血與出血風險，依 高出血風險（hbr）分層調整療程仍缺乏明確證據。 研究方法：host-br 為韓國 50 個心臟中心進行的 開放標籤、多中心、隨機臨床試驗，納入 19 歲以上接受 drug-eluting stent pci 的病人。hbr 族群隨機接受 1 個月或 3 個月 dapt，非 hbr 族群隨機接受 3 個月或 12 個月 dapt；共同主要終點包括 淨不良臨床事件、重大 adverse cardiac or cerebral 事件 與需處置的非手術出血。 主要結果：共 4897 人納入研究，hbr 族群 1598 人、非 hbr 族群 3299 人。hbr 族群中，1 個月 dapt 對 淨不良臨床事件 未達 3 個月 dapt 的 不劣性（18.4% vs 14.0%；hr 1.337，95% ci 1.043-1.713；p=0.82 for 不劣性）；非 hbr 族群中，3 個月 dapt 對 淨不良臨床事件 不劣於 12 個月 dapt（2.9% vs 4.4%；hr 0.657，95% ci 0.455-0.949），且出血較少（7.4% vs 11.7%；hr 0.631，95% ci 0.502-0.793；p<0.0001）。 藥師重點：結論顯示東亞 hbr 病人支架後 1 個月 dapt 不能取代 3 個月 dapt；非 hbr 病人使用 3 個月 dapt 可維持主要缺血事件控制並降低出血，藥師需依病人出血風險、支架後缺血風險與抗血小板療程計畫協助評估。" }, { "id": "fda-2026-week06-1", "kind": "fda", "issueId": "2026-week06", "year": 2026, "week": 6, "weekLabel": "第 6 週", "dateRange": "2026/02/02 – 02/08", "href": "2026-week06.html", "title": "FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "concerns", "unapproved", "glp-1", "drugs", "used", "weight", "loss", "https", "drug-alerts-and-statements", "fdas-concerns-unapproved-glp-1-drugs-used-weight-loss" ], "drugTerms": [ "glp-1" ], "searchText": "fda’s concerns with unapproved glp-1 drugs used for weight loss fda drug safety 2026-06-15 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss" }, { "id": "fda-2026-week06-3", "kind": "fda", "issueId": "2026-week06", "year": 2026, "week": 6, "weekLabel": "第 6 週", "dateRange": "2026/02/02 – 02/08", "href": "2026-week06.html", "title": "FDA issues final decision to withdraw approval of Pepaxto (melphalan flufenamide)", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/node/398713", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "issues", "final", "decision", "withdraw", "approval", "pepaxto", "melphalan", "flufenamide", "https", "node" ], "drugTerms": [], "searchText": "fda issues final decision to withdraw approval of pepaxto (melphalan flufenamide) fda drug safety 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/node/398713" }, { "id": "fda-2026-week06-2", "kind": "fda", "issueId": "2026-week06", "year": 2026, "week": 6, "weekLabel": "第 6 週", "dateRange": "2026/02/02 – 02/08", "href": "2026-week06.html", "title": "FDA alerts patients, caregivers, and health care providers of cross-compatibility issues with autoinjector devices that are optional for use with glatiramer acetate injection", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/node/403159", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "alerts", "caregivers", "providers", "cross-compatibility", "issues", "autoinjector", "devices", "that", "optional", "glatiramer" ], "drugTerms": [], "searchText": "fda alerts patients, caregivers, and health care providers of cross-compatibility issues with autoinjector devices that are optional for use with glatiramer acetate injection fda drug safety 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/node/403159" }, { "id": "fda-2026-week06-4", "kind": "fda", "issueId": "2026-week06", "year": 2026, "week": 6, "weekLabel": "第 6 週", "dateRange": "2026/02/02 – 02/08", "href": "2026-week06.html", "title": "FDA Accepts First In Silico Drug Development Tool Under ISTAND Program to Help Predict Drug-Induced Liver Injury", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fda-accepts-first-silico-drug-development-tool-under-istand-program-help-predict-drug-induced-liver", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "accepts", "first", "silico", "development", "tool", "under", "istand", "program", "help", "predict" ], "drugTerms": [], "searchText": "fda accepts first in silico drug development tool under istand program to help predict drug-induced liver injury fda drug safety 2026-06-03 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/drugs/drug-alerts-and-statements/fda-accepts-first-silico-drug-development-tool-under-istand-program-help-predict-drug-induced-liver" }, { "id": "pmid-41604179", "kind": "article", "issueId": "2026-week05", "year": 2026, "week": 5, "weekLabel": "第 5 週", "dateRange": "2026/01/26 – 02/01", "href": "2026-week05.html", "title": "US State-Level Prevalence of Adult Obesity by Race and Ethnicity From 1990 to 2022 and Forecasted to 2035", "journal": "JAMA", "type": "OA", "typeLabel": "Original Article", "author": "DeCleene", "doi": "10.1001/jama.2025.26817", "url": "https://doi.org/10.1001/jama.2025.26817", "summary": "藥師重點：研究結果顯示美國成人肥胖負擔高且預期持續增加，並存在明顯族群、性別、年齡與州別差異；藥師在體重管理、慢性病用藥與 GLP-1 類藥物衛教時，需將個別風險與照護可近性納入討論。", "pubDate": "2026-03-17", "terms": [ "state-level", "prevalence", "adult", "obesity", "race", "ethnicity", "from", "forecasted", "jama", "decleene" ], "drugTerms": [ "glp-1" ], "searchText": "us state-level prevalence of adult obesity by race and ethnicity from 1990 to 2022 and forecasted to 2035 jama original article decleene 10.1001/jama.2025.26817 研究背景：美國成人肥胖盛行率長期上升且族群與地區差異明顯，需更細緻的人口層級估計與預測以支援公共衛生與資源配置。 研究方法：研究整合 national 健康 and nutrition examination survey 的實測 bmi，以及 behavioral risk factor surveillance system 與 gallup 每日 survey 經偏差校正的自陳身高體重資料。分析以 spatiotemporal gaussian process regression、annualized 比率 of change 與 meta-regression bayesian spline models，估計 1990-2022 年並預測至 2035 年，主要結果為 obesity prevalence（bmi ≥30）。 主要結果：2022 年美國估計有 107 百萬 成人肥胖（95% ui 101-113），占成人 42.5%（95% ui 40.2%-45.0%），高於 1990 年的 34.7 百萬（19.3%）。預測至 2035 年將增至 126 百萬（46.9%，95% ui 43.9%-49.9%）；2022 年年齡標準化盛行率由 non-hispanic white males 40.1% 至 non-hispanic black females 56.9% 不等，且州別與族群差異明顯。 藥師重點：研究結果顯示美國成人肥胖負擔高且預期持續增加，並存在明顯族群、性別、年齡與州別差異；藥師在體重管理、慢性病用藥與 glp-1 類藥物衛教時，需將個別風險與照護可近性納入討論。" }, { "id": "pmid-41619752", "kind": "article", "issueId": "2026-week05", "year": 2026, "week": 5, "weekLabel": "第 5 週", "dateRange": "2026/01/26 – 02/01", "href": "2026-week05.html", "title": "Triple cardiovascular disease detection with an artificial intelligence-enabled stethoscope (TRICORDER) in the UK: a cluster-randomised controlled implementation trial", "journal": "Lancet", "type": "RCT", "typeLabel": "RCT", "author": "Kelshiker", "doi": "10.1016/S0140-6736(25)02156-7", "url": "https://doi.org/10.1016/S0140-6736(25)02156-7", "summary": "藥師重點：結論顯示將 AI-stethoscope 納入例行基層照護 12 個月，整體並未顯著增加心衰竭診斷；此結果提醒新型偵測工具的效益取決於導入流程、使用率與後續轉介，不能只依工具本身性能推論臨床成效。", "pubDate": "2026-02-14", "terms": [ "triple", "cardiovascular", "detection", "artificial", "intelligence-enabled", "stethoscope", "tricorder", "cluster-randomised", "implementation", "lancet" ], "drugTerms": [], "searchText": "triple cardiovascular disease detection with an artificial intelligence-enabled stethoscope (tricorder) in the uk: a cluster-randomised controlled implementation trial lancet rct kelshiker 10.1016/s0140-6736(25)02156-7 研究背景：心衰竭、心房顫動與瓣膜性心臟病早期偵測是基層照護的重要議題；ai-enabled stethoscope 在實際例行照護導入後是否能提高診斷率仍需 實務型 試驗 評估。 研究方法：tricorder 為英國 基層照護 cluster-隨機 controlled implementation 試驗，205 個診所 1:1 分配至導入 ai-stethoscope 或 routine care。ai 聽診器在心臟檢查時記錄 15 秒 single-lead electrocardiogram 與 phonocardiogram，主要終點為每 1000 patient-years 新編碼心衰竭診斷率（irr）。 主要結果：介入診所共記錄 12,725 次 ai-stethoscope 檢查；意向治療分析顯示心衰竭偵測率未較對照組增加（irr 0.94，95% ci 0.86-1.02），社區或住院診斷分層亦無差異。ai-stethoscope 實際使用與較高的心衰竭、atrial fibrillation 與 vhd 偵測率獨立相關。 藥師重點：結論顯示將 ai-stethoscope 納入例行基層照護 12 個月，整體並未顯著增加心衰竭診斷；此結果提醒新型偵測工具的效益取決於導入流程、使用率與後續轉介，不能只依工具本身性能推論臨床成效。" }, { "id": "pmid-41616795", "kind": "article", "issueId": "2026-week05", "year": 2026, "week": 5, "weekLabel": "第 5 週", "dateRange": "2026/01/26 – 02/01", "href": "2026-week05.html", "title": "TRPC6 inhibition for the treatment of focal segmental glomerulosclerosis: a randomised, placebo-controlled, phase 2 trial of BI 764198", "journal": "Lancet", "type": "RCT", "typeLabel": "RCT", "author": "Trachtman", "doi": "10.1016/S0140-6736(25)02255-X", "url": "https://doi.org/10.1016/S0140-6736(25)02255-X", "summary": "藥師重點：結論顯示 BI 764198 在 FSGS 可降低蛋白尿且短期耐受性尚可，但樣本數小、療程僅 12 週且劑量反應不一致；藥師解讀時應視為早期 podocyte-targeted 治療 訊號，仍需等待較大型與較長期試驗確認腎臟結局。", "pubDate": "2026-02-07", "terms": [ "trpc6", "inhibition", "focal", "segmental", "glomerulosclerosis", "randomised", "placebo-controlled", "phase", "lancet", "trachtman" ], "drugTerms": [], "searchText": "trpc6 inhibition for the treatment of focal segmental glomerulosclerosis: a randomised, placebo-controlled, phase 2 trial of bi 764198 lancet rct trachtman 10.1016/s0140-6736(25)02255-x 研究背景：局部節段性腎絲球硬化症（fsgs）中，trpc6 過度活化可能造成 podocyte loss 與腎功能惡化；口服 selective trpc6 抑制劑 bi 764198 的療效與安全性仍屬早期探索。 研究方法：此多中心 第 2 期、雙盲、安慰劑對照、隨機試驗，納入 18-75 歲、切片確認 主要 fsgs 或帶有致病性 trpc6 variant 的病人。受試者以 1:1:1:1 分配接受 bi 764198 20 mg、40 mg、80 mg 每日一次 或 安慰劑 12 週；主要終點為第 12 週 proteinuria 反應（upcr 較基準下降 ≥25%）。 主要結果：62 人接受治療，bi 764198 20 mg、40 mg、80 mg 組與 安慰劑 組 proteinuria 反應 分別為 44%、14%、43% 與 7%；所有 bi 764198 劑量合併相對 安慰劑 的 or 為 4.9（95% ci 1.0-48.8）。治療期間出現的不良事件 發生率在 安慰劑 與 bi 764198 組皆約 71%，未見明顯組間差異。 藥師重點：結論顯示 bi 764198 在 fsgs 可降低蛋白尿且短期耐受性尚可，但樣本數小、療程僅 12 週且劑量反應不一致；藥師解讀時應視為早期 podocyte-targeted 治療 訊號，仍需等待較大型與較長期試驗確認腎臟結局。" }, { "id": "pmid-41605542", "kind": "article", "issueId": "2026-week05", "year": 2026, "week": 5, "weekLabel": "第 5 週", "dateRange": "2026/01/26 – 02/01", "href": "2026-week05.html", "title": "Reliability of urological telesurgery compared with local surgery: multicentre randomised controlled trial", "journal": "BMJ", "type": "RCT", "typeLabel": "RCT", "author": "Wang", "doi": "10.1136/bmj-2024-083588", "url": "https://doi.org/10.1136/bmj-2024-083588", "summary": "藥師重點：研究結果說明在特定泌尿科機器人手術與穩定網路條件下，telesurgery 的短期可靠度可達不劣於現場手術；此研究非藥物介入，解讀時應注意中心經驗、設備條件與術後追蹤時間限制。", "pubDate": "2026-01-28", "terms": [ "reliability", "urological", "telesurgery", "local", "surgery", "multicentre", "randomised", "wang", "bmj-2024-083588", "margin" ], "drugTerms": [], "searchText": "reliability of urological telesurgery compared with local surgery: multicentre randomised controlled trial bmj rct wang 10.1136/bmj-2024-083588 研究背景：遠距手術可擴大機器人手術資源可近性，但其可靠度是否不劣於現場泌尿科機器人手術仍需臨床試驗資料支持。 研究方法：此中國五家醫院多中心、不劣性、隨機對照試驗，納入預定接受根除性攝護腺切除或部分腎切除的病人。受試者 1:1 分配至 telesurgery 或 local surgery，主要終點為依預先標準判定的手術成功機率，不劣性 margin 為成功機率絕對下降 0.1。 主要結果：共 72 名受試者進入 意向治療分析；telesurgery 在手術成功機率上不劣於 local surgery（success probability 差異 0.02，95% 可信區間 -0.03 to 0.15；不劣性 posterior probability 0.99）。1000-2800 km 距離下系統穩定，平均 round trip network latency 為 20.1-47.5 ms，臨床次要結果與醫療團隊工作負荷未見明顯差異。 藥師重點：研究結果說明在特定泌尿科機器人手術與穩定網路條件下，telesurgery 的短期可靠度可達不劣於現場手術；此研究非藥物介入，解讀時應注意中心經驗、設備條件與術後追蹤時間限制。" }, { "id": "pmid-41587822", "kind": "article", "issueId": "2026-week05", "year": 2026, "week": 5, "weekLabel": "第 5 週", "dateRange": "2026/01/26 – 02/01", "href": "2026-week05.html", "title": "Provision of knee bracing for knee osteoarthritis (PROP OA): multicentre, parallel group, superiority, statistician blinded, randomised controlled trial", "journal": "BMJ", "type": "RCT", "typeLabel": "RCT", "author": "Holden", "doi": "10.1136/bmj-2025-086005", "url": "https://doi.org/10.1136/bmj-2025-086005", "summary": "藥師重點：結論顯示 compartment specific knee bracing 加上依從性介入可為膝關節退化性關節炎帶來小幅病人自評改善；臨床應將其視為非藥物輔助選項，並留意病人疼痛目標、配戴意願與長期依從性。", "pubDate": "2026-01-26", "terms": [ "provision", "knee", "bracing", "osteoarthritis", "prop", "multicentre", "parallel", "superiority", "statistician", "blinded" ], "drugTerms": [], "searchText": "provision of knee bracing for knee osteoarthritis (prop oa): multicentre, parallel group, superiority, statistician blinded, randomised controlled trial bmj rct holden 10.1136/bmj-2025-086005 研究背景：膝關節退化性關節炎常以衛教、書面資訊與運動指導作為初始處置，但加上依病灶區室選擇的 knee brace 與依從性介入，是否能進一步改善病人自評結果仍需驗證。 研究方法：此英國多中心、平行組、superiority、評估統計人員盲性隨機試驗，納入 466 名 45 歲以上且有膝關節退化性關節炎症狀的成人。受試者 1:1 分配接受 advice、written information、exercise instruction（aie），或 aie 加上 compartment specific knee bracing、兩週追蹤與依從性支持；主要終點為 6 個月 koos-5。 主要結果：6 個月時 aie+b 組 koos-5 改善幅度高於 aie 組（校正 平均差 3.39，95% ci 0.96 to 5.82；effect size 0.24），疼痛分項差異較明顯（koos pain 校正 平均差 6.13，95% ci 3.36 to 8.91；effect size 0.39）。次要結果顯示效益隨時間減弱，不良事件多為輕微且符合預期。 藥師重點：結論顯示 compartment specific knee bracing 加上依從性介入可為膝關節退化性關節炎帶來小幅病人自評改善；臨床應將其視為非藥物輔助選項，並留意病人疼痛目標、配戴意願與長期依從性。" }, { "id": "pmid-41620233", "kind": "article", "issueId": "2026-week05", "year": 2026, "week": 5, "weekLabel": "第 5 週", "dateRange": "2026/01/26 – 02/01", "href": "2026-week05.html", "title": "Prediction of mortality, bleeding, and ischaemic events in patients with cancer and acute coronary syndrome: a model development and validation study", "journal": "Lancet", "type": "OA", "typeLabel": "Original Article", "author": "Wenzl", "doi": "10.1016/S0140-6736(25)02020-3", "url": "https://doi.org/10.1016/S0140-6736(25)02020-3", "summary": "藥師重點：結論顯示 ONCO-ACS score 可協助癌症合併急性冠心症患者同時評估死亡、出血與缺血風險；藥師在抗血小板療程、clopidogrel 使用與出血監測建議上，可將其視為輔助工具，但仍需結合腫瘤狀態、腎功能與治療目標。", "pubDate": "2026-01-31", "terms": [ "prediction", "mortality", "bleeding", "ischaemic", "events", "cancer", "acute", "coronary", "syndrome", "model" ], "drugTerms": [ "clopidogrel" ], "searchText": "prediction of mortality, bleeding, and ischaemic events in patients with cancer and acute coronary syndrome: a model development and validation study lancet original article wenzl 10.1016/s0140-6736(25)02020-3 研究背景：癌症合併急性冠心症患者同時面臨死亡、出血與缺血事件風險，但目前缺乏可同時評估這些 competing risks 的標準化工具。 研究方法：此 model development and validation 研究 整合英格蘭、瑞典與瑞士 2004 年至 2023 年急性冠心症資料，共 1,017,759 名病人，其中英格蘭資料含 36,771 名癌症患者。研究以 machine learning 建立 onco-acs score，預測 6 個月 全因死亡率、重大出血 事件 與 ischaemic 事件，並於地理上獨立資料集外部驗證。 主要結果：癌症合併急性冠心症患者 6 個月累積死亡率為 27.8%（95% ci 27.3-28.3）、重大出血 為 7.3%（7.0-7.5）、ischaemic 事件 為 16.1%（15.7-16.4）。onco-acs 在內部驗證的 6 個月 tauc 分別為 全因死亡率 0.84、重大出血 0.70、ischaemic 事件 0.79，外部驗證表現相近且校準良好。 藥師重點：結論顯示 onco-acs score 可協助癌症合併急性冠心症患者同時評估死亡、出血與缺血風險；藥師在抗血小板療程、clopidogrel 使用與出血監測建議上，可將其視為輔助工具，但仍需結合腫瘤狀態、腎功能與治療目標。" }, { "id": "pmid-41604639", "kind": "article", "issueId": "2026-week05", "year": 2026, "week": 5, "weekLabel": "第 5 週", "dateRange": "2026/01/26 – 02/01", "href": "2026-week05.html", "title": "Palbociclib for Hormone-Receptor-Positive, HER2-Positive Advanced Breast Cancer", "journal": "NEJM", "type": "RCT", "typeLabel": "RCT", "author": "Metzger", "doi": "10.1056/NEJMoa2511218", "url": "https://doi.org/10.1056/NEJMoa2511218", "summary": "藥師重點：結論顯示 palbociclib 加入維持 anti-HER2 與內分泌治療可延長此族群 無惡化存活期，但毒性尤其 neutropenia 明顯增加；藥師需協助監測血球、感染風險、劑量調整與病人對長期維持治療的耐受性。", "pubDate": "2026-01-29", "terms": [ "palbociclib", "hormone-receptor-positive", "her2-positive", "advanced", "breast", "cancer", "nejm", "metzger", "nejmoa2511218", "her2" ], "drugTerms": [ "anti-human", "anti-her2" ], "searchText": "palbociclib for hormone-receptor-positive, her2-positive advanced breast cancer nejm rct metzger 10.1056/nejmoa2511218 研究背景：荷爾蒙受體陽性、her2 陽性轉移性乳癌第一線治療常以雙重 anti-her2 治療加化療後接續 anti-her2 與內分泌維持治療；加入 cdk4/6 抑制劑 palbociclib 是否能延緩抗藥性仍需第三期證據。 研究方法：patina 為 第 3 期、開放標籤、隨機試驗，納入接受 4-8 個週期化療加 her2-targeted 治療 後未惡化的 hormone-受體-陽性、her2-陽性 轉移性 breast 癌症 病人。受試者 1:1 分配接受維持 her2-targeted 與 endocrine therapies，或加用 palbociclib；主要終點為 investigator-assessed 無惡化存活期。 主要結果：共 518 人隨機分組，中位追蹤 53.5 個月時，palbociclib 組 無惡化存活期 較長（44.3 vs 29.1 個月；hr 0.75，95% ci 0.59 to 0.96；p=0.02）。palbociclib 組 等級 3 與 等級 4 不良事件 分別為 79.7% 與 10.0%，標準治療組為 30.6% 與 3.6%，主要增加為 neutropenia。 藥師重點：結論顯示 palbociclib 加入維持 anti-her2 與內分泌治療可延長此族群 無惡化存活期，但毒性尤其 neutropenia 明顯增加；藥師需協助監測血球、感染風險、劑量調整與病人對長期維持治療的耐受性。" }, { "id": "pmid-41604640", "kind": "article", "issueId": "2026-week05", "year": 2026, "week": 5, "weekLabel": "第 5 週", "dateRange": "2026/01/26 – 02/01", "href": "2026-week05.html", "title": "Mental Health Outcomes in Children after Parental Firearm Injury", "journal": "NEJM", "type": "OA", "typeLabel": "Original Article", "author": "Karandinos", "doi": "10.1056/NEJMsa2502702", "url": "https://doi.org/10.1056/NEJMsa2502702", "summary": "藥師重點：研究結果說明父母 firearm injury 後，兒少心理健康診斷與就診率可能上升；藥師與醫療團隊在照護受影響家庭時，可留意兒少創傷、睡眠、焦慮與精神科藥物使用訊號，並及早連結心理支持資源。", "pubDate": "2026-01-29", "terms": [ "mental", "children", "parental", "firearm", "injury", "nejm", "karandinos", "nejmsa2502702", "in-differences", "post-traumatic" ], "drugTerms": [], "searchText": "mental health outcomes in children after parental firearm injury nejm original article karandinos 10.1056/nejmsa2502702 研究背景：美國每年有許多兒少因父母 firearm injury 而失去照顧者或暴露於創傷事件，但父母受傷對兒少心理健康與醫療利用的影響仍不清楚。 研究方法：研究使用 2007-2022 年美國商業健康保險理賠資料，辨識 1-19 歲且父母曾因 firearm injury 接受治療的兒少，並以最多 1:5 配對對照組。主要終點為精神疾病診斷率，並以 差異-in-differences 模型比較父母受傷前後 12 個月的變化。 主要結果：分析 3790 名暴露兒少與 18,535 名配對對照，父母 firearm injury 與每 1000 名兒少增加 8.4 件精神科診斷（95% ci 4.8 to 12.0）及 23.1 次心理健康就診（95% ci 8.2 to 38.1）相關。增加幅度最大者為創傷相關疾患，包括 post-traumatic stress 疾患，每 1000 名兒少增加 8.5 件診斷（95% ci 6.0 to 10.9）。 藥師重點：研究結果說明父母 firearm injury 後，兒少心理健康診斷與就診率可能上升；藥師與醫療團隊在照護受影響家庭時，可留意兒少創傷、睡眠、焦慮與精神科藥物使用訊號，並及早連結心理支持資源。" }, { "id": "pmid-41611528", "kind": "article", "issueId": "2026-week05", "year": 2026, "week": 5, "weekLabel": "第 5 週", "dateRange": "2026/01/26 – 02/01", "href": "2026-week05.html", "title": "Machine learning based screening of potential paper mill publications in cancer research: methodological and cross sectional study", "journal": "BMJ", "type": "OA", "typeLabel": "Original Article", "author": "Scancar", "doi": "10.1136/bmj-2025-087581", "url": "https://doi.org/10.1136/bmj-2025-087581", "summary": "藥師重點：研究結果提醒癌症文獻中可能存在大量 paper mill 相似文章，閱讀單篇研究或系統性回顧時需更重視撤稿紀錄、影像完整性、研究可重現性與期刊審查品質；此模型結果本身仍不等同於判定單篇文章造假。", "pubDate": "2026-01-29", "terms": [ "machine", "learning", "screening", "potential", "paper", "mill", "publications", "cancer", "research", "methodological" ], "drugTerms": [], "searchText": "machine learning based screening of potential paper mill publications in cancer research: methodological and cross sectional study bmj original article scancar 10.1136/bmj-2025-087581 研究背景：paper mill publications 可能污染癌症研究文獻並影響臨床與研究判讀；以機器學習大規模篩檢可協助估計其盛行程度。 研究方法：此 methodological and cross sectional 研究 使用以 bert 為基礎的文字分類模型，依文章標題與摘要區分 retracted paper mill publications 與 genuine 癌症 research articles。模型以 2202 篇已撤回 paper mill papers 訓練，並套用於 1999-2024 年 pubmed 中 2.6 百萬 篇 original 癌症 research papers。 主要結果：模型 accuracy 為 0.91；套用於癌症研究文獻後，2,647,471 篇中有 261,245 篇被標記為與 paper mill papers 相似（9.87%，95% ci 9.83 to 9.90）。1999 至 2024 年被標記文獻明顯增加，且不侷限於低 impact journals；基礎研究與胃癌、骨癌、肝癌領域比例較高。 藥師重點：研究結果提醒癌症文獻中可能存在大量 paper mill 相似文章，閱讀單篇研究或系統性回顧時需更重視撤稿紀錄、影像完整性、研究可重現性與期刊審查品質；此模型結果本身仍不等同於判定單篇文章造假。" }, { "id": "pmid-41620232", "kind": "article", "issueId": "2026-week05", "year": 2026, "week": 5, "weekLabel": "第 5 週", "dateRange": "2026/01/26 – 02/01", "href": "2026-week05.html", "title": "Interval cancer, sensitivity, and specificity comparing AI-supported mammography screening with standard double reading without AI in the MASAI study: a randomised, controlled, non-inferiority, single-blinded, population-based, screening-accuracy trial", "journal": "Lancet", "type": "RCT", "typeLabel": "RCT", "author": "Gommers", "doi": "10.1016/S0140-6736(25)02464-X", "url": "https://doi.org/10.1016/S0140-6736(25)02464-X", "summary": "藥師重點：研究結果說明 AI-supported mammography screening 可在不增加 區間 癌症 比率 的情況下提高敏感度並維持特異度；此為篩檢流程證據，臨床導入仍需考量影像判讀人力、品質管制與不同族群外推性。", "pubDate": "2026-01-31", "terms": [ "interval", "cancer", "sensitivity", "specificity", "comparing", "ai-supported", "mammography", "screening", "standard", "double" ], "drugTerms": [], "searchText": "interval cancer, sensitivity, and specificity comparing ai-supported mammography screening with standard double reading without ai in the masai study: a randomised, controlled, non-inferiority, single-blinded, population-based, screening-accuracy trial lancet rct gommers 10.1016/s0140-6736(25)02464-x 研究背景：ai 支援乳房攝影篩檢可提高癌症偵測並降低判讀工作量，但對 區間 癌症 的影響較少有隨機試驗資料。 研究方法：masai 為瑞典 族群-based、single-blinded、隨機 controlled 不劣性 screening-accuracy 試驗，受試者 1:1 分配至 ai-supported mammography screening 或標準雙人判讀。此預先定義分析以 區間 癌症 比率 為主要終點，不劣性 margin 為 20%，並評估 區間 癌症 特徵、sensitivity 與 specificity。 主要結果：105,934 名女性隨機分組，區間 癌症 比率 於 ai 組與對照組分別為每 1000 人 1.55（95% ci 1.23-1.92）與 1.76（1.42-2.15），proportion 比值 0.88（95% ci 0.65-1.18；p=0.41），符合 不劣性。ai 組 sensitivity 較高（80.5% vs 73.8%；p=0.031），specificity 兩組皆為 98.5%。 藥師重點：研究結果說明 ai-supported mammography screening 可在不增加 區間 癌症 比率 的情況下提高敏感度並維持特異度；此為篩檢流程證據，臨床導入仍需考量影像判讀人力、品質管制與不同族群外推性。" }, { "id": "pmid-41609788", "kind": "article", "issueId": "2026-week05", "year": 2026, "week": 5, "weekLabel": "第 5 週", "dateRange": "2026/01/26 – 02/01", "href": "2026-week05.html", "title": "Electronic Health Record Intervention and Deprescribing for Older Adults: A Randomized Clinical Trial", "journal": "JAMA", "type": "RCT", "typeLabel": "RCT", "author": "Lauffenburger", "doi": "10.1001/jama.2025.26967", "url": "https://doi.org/10.1001/jama.2025.26967", "summary": "藥師重點：研究結果說明運用行為科學設計的 EHR 提醒可提高高齡者潛在不適當用藥 deprescribing；藥師可將其視為減藥討論輔助工具，實務仍需個別評估戒斷、症狀復發與病人偏好。", "pubDate": "2026-03-24", "terms": [ "electronic", "record", "intervention", "deprescribing", "older", "adults", "jama", "lauffenburger", "potentially", "inappropriate" ], "drugTerms": [ "nonbenzodiazepine" ], "searchText": "electronic health record intervention and deprescribing for older adults: a randomized clinical trial jama rct lauffenburger 10.1001/jama.2025.26967 研究背景：高齡者常被處方 potentially inappropriate medications，包括 benzodiazepines、nonbenzodiazepine sedative hypnotics 與 anticholinergic medications；ehr 行為科學介入是否能促進 deprescribing 仍需驗證。 研究方法：此三組平行 cluster-隨機臨床試驗 於美國麻州一所學術醫療中心進行，201 名 基層照護 physicians 被分配至 常規照護、precommitment intervention 或 boostering intervention。介入對象為 65 歲以上且近期使用目標潛在不適當藥物的病人，主要終點為追蹤期間至少停用或 tapering 一項藥物。 主要結果：共 1146 名病人納入分析，至少一項藥物 deprescribed 的比例為 precommitment 36.8%、boostering 34.3%、常規照護 26.8%。相較 常規照護，precommitment 組 deprescribing 較可能發生（rr 1.40，95% ci 1.14-1.73；absolute 差異 10.4%），boostering 組亦較高（rr 1.26，95% ci 1.01-1.57；absolute 差異 6.5%）；未通報 嚴重不良事件。 藥師重點：研究結果說明運用行為科學設計的 ehr 提醒可提高高齡者潛在不適當用藥 deprescribing；藥師可將其視為減藥討論輔助工具，實務仍需個別評估戒斷、症狀復發與病人偏好。" }, { "id": "pmid-41587047", "kind": "article", "issueId": "2026-week05", "year": 2026, "week": 5, "weekLabel": "第 5 週", "dateRange": "2026/01/26 – 02/01", "href": "2026-week05.html", "title": "Donation After Circulatory Death Heart Transplant Without Preimplant Reanimation Using Rapid Ultraoxygenated Recovery", "journal": "JAMA", "type": "OA", "typeLabel": "Original Article", "author": "Williams", "doi": "10.1001/jama.2025.25169", "url": "https://doi.org/10.1001/jama.2025.25169", "summary": "藥師重點：研究結果說明 REUP 在此單中心 DCD 心臟移植經驗中具可行性且短期結果良好；由於為 24 例 case series，仍需較大規模研究確認長期存活、排斥風險與不同中心導入條件。", "pubDate": "2026-03-10", "terms": [ "donation", "circulatory", "death", "heart", "transplant", "preimplant", "reanimation", "rapid", "ultraoxygenated", "recovery" ], "drugTerms": [], "searchText": "donation after circulatory death heart transplant without preimplant reanimation using rapid ultraoxygenated recovery jama original article williams 10.1001/jama.2025.25169 研究背景：donation after circulatory 死亡（dcd）心臟移植可增加供心來源，但傳統回收策略成本與複雜度高；rapid recovery with extended ultraoxygenated preservation（reup）在較年輕捐贈者或較短缺血時間下已有初步經驗。 研究方法：此美國單一高量心臟移植中心 case series，納入 2024 年 11 月至 2025 年 7 月接受 reup-recovered dcd 成人心臟移植的 24 名病人。reup 用於 dcd cardiac allograft recovery，未進行 preimplant donor heart reanimation 或 machine perfusion；主要觀察 重度 主要 graft 功能障礙、30-day 存活期 與首次 endomyocardial biopsy 急性排斥。 主要結果：24 顆 reup-recovered dcd hearts 完成移植，捐贈者平均年齡 32 歲，38% 超過 40 歲；60% donor hearts total ischemic time 超過 4 小時。接受者 30-day 存活期 為 96%，重度 主要 graft 功能障礙 為 1 例（4%），次要 graft 功能障礙 為 1 例（4%）；首次切片 1 例（4%）為 急性 cellular rejection 等級 2r，未見 抗體-mediated rejection。 藥師重點：研究結果說明 reup 在此單中心 dcd 心臟移植經驗中具可行性且短期結果良好；由於為 24 例 case series，仍需較大規模研究確認長期存活、排斥風險與不同中心導入條件。" }, { "id": "pmid-41605528", "kind": "article", "issueId": "2026-week05", "year": 2026, "week": 5, "weekLabel": "第 5 週", "dateRange": "2026/01/26 – 02/01", "href": "2026-week05.html", "title": "Diagnostic tests for ovarian cancer in premenopausal women with non-specific symptoms (ROCkeTS): prospective, multicentre, cohort study", "journal": "BMJ", "type": "OA", "typeLabel": "Original Article", "author": "Sundar", "doi": "10.1136/bmj-2024-083912", "url": "https://doi.org/10.1136/bmj-2024-083912", "summary": "藥師重點：結論顯示多數測試可提高卵巢癌偵測敏感度但會降低特異度，其中 ultrasound triage 搭配 IOTA ADNEX 10% 有最高敏感度增益；臨床採用需同步考量假陽性、轉診負荷、人員訓練與品質保證。", "pubDate": "2026-01-28", "terms": [ "diagnostic", "tests", "ovarian", "cancer", "premenopausal", "women", "non-specific", "symptoms", "rockets", "prospective" ], "drugTerms": [], "searchText": "diagnostic tests for ovarian cancer in premenopausal women with non-specific symptoms (rockets): prospective, multicentre, cohort study bmj original article sundar 10.1136/bmj-2024-083912 研究背景：停經前女性出現非特異症狀且檢查異常時，如何準確分流卵巢癌風險會影響轉診與後續處置；多種 risk prediction models 與分數的診斷表現需要 head-to-head 比較。 研究方法：rockets 為英國 23 家 次要 care 醫院的前瞻性多中心 世代研究，納入 1211 名停經前女性，並比較 risk of malignancy index 1、risk of malignancy algorithm、iota adnex、iota simple rules、iota simple rules risk model 與 ca 125。主要評估為預測 主要 invasive ovarian 癌症 對良性或正常病理的 sensitivity、specificity 與相關診斷指標。 主要結果：1211 人中 88 人診斷為 主要 ovarian 癌症。risk of malignancy index 1 threshold 250 的 sensitivity 為 42.6%（95% ci 28.3 to 57.8）、specificity 為 96.5%（94.7 to 97.8）；相較之下，iota adnex threshold 10% sensitivity 最高（89.1%，95% ci 76.4 to 96.4；p<0.001），但 specificity 較低（75.1%，71.4 to 78.6；p<0.001）。 藥師重點：結論顯示多數測試可提高卵巢癌偵測敏感度但會降低特異度，其中 ultrasound triage 搭配 iota adnex 10% 有最高敏感度增益；臨床採用需同步考量假陽性、轉診負荷、人員訓練與品質保證。" }, { "id": "pmid-41604638", "kind": "article", "issueId": "2026-week05", "year": 2026, "week": 5, "weekLabel": "第 5 週", "dateRange": "2026/01/26 – 02/01", "href": "2026-week05.html", "title": "A Randomized Trial of Tenecteplase in Acute Central Retinal Artery Occlusion", "journal": "NEJM", "type": "RCT", "typeLabel": "RCT", "author": "Ryan", "doi": "10.1056/NEJMoa2508515", "url": "https://doi.org/10.1056/NEJMoa2508515", "summary": "藥師重點：結論顯示急性中央視網膜動脈阻塞發作 4.5 小時內使用 IV tenecteplase 未優於 aspirin 改善 30 天視力恢復，且有嚴重安全性疑慮；藥師應特別留意溶栓相關出血風險與適用情境限制。", "pubDate": "2026-01-29", "terms": [ "tenecteplase", "acute", "central", "retinal", "artery", "occlusion", "nejm", "ryan", "nejmoa2508515", "tencraos" ], "drugTerms": [], "searchText": "a randomized trial of tenecteplase in acute central retinal artery occlusion nejm rct ryan 10.1056/nejmoa2508515 研究背景：急性中央視網膜動脈阻塞可能造成永久視力喪失，目前有效治療有限；tenecteplase 於症狀發生 4.5 小時內使用是否能改善視力恢復仍不確定。 研究方法：tencraos 為 第 3 期、雙盲、double-dummy、隨機對照試驗，納入症狀發生 4.5 小時內的急性非動脈炎性中央視網膜動脈阻塞成人。病人 1:1 分配接受 iv tenecteplase 0.25 mg/kg 加口服 安慰劑，或 iv 安慰劑 加 aspirin 300 mg；主要終點為 30 天受影響眼 bcva 恢復至 ≤0.7 logmar。 主要結果：共 78 人隨機分組，30 天視力恢復率 tenecteplase 組與 aspirin 組為 20% vs 24%（風險差 -3.7 百分點，95% ci -22.0 to 14.7；p=0.69）。次要視覺終點未見明顯差異，tenecteplase 組不良事件較多，包含 1 例致死性顱內出血。 藥師重點：結論顯示急性中央視網膜動脈阻塞發作 4.5 小時內使用 iv tenecteplase 未優於 aspirin 改善 30 天視力恢復，且有嚴重安全性疑慮；藥師應特別留意溶栓相關出血風險與適用情境限制。" }, { "id": "fda-2026-week05-1", "kind": "fda", "issueId": "2026-week05", "year": 2026, "week": 5, "weekLabel": "第 5 週", "dateRange": "2026/01/26 – 02/01", "href": "2026-week05.html", "title": "FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "concerns", "unapproved", "glp-1", "drugs", "used", "weight", "loss", "https", "drug-alerts-and-statements", "fdas-concerns-unapproved-glp-1-drugs-used-weight-loss" ], "drugTerms": [ "glp-1" ], "searchText": "fda’s concerns with unapproved glp-1 drugs used for weight loss fda drug safety 2026-06-15 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss" }, { "id": "fda-2026-week05-3", "kind": "fda", "issueId": "2026-week05", "year": 2026, "week": 5, "weekLabel": "第 5 週", "dateRange": "2026/01/26 – 02/01", "href": "2026-week05.html", "title": "FDA issues final decision to withdraw approval of Pepaxto (melphalan flufenamide)", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/node/398713", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "issues", "final", "decision", "withdraw", "approval", "pepaxto", "melphalan", "flufenamide", "https", "node" ], "drugTerms": [], "searchText": "fda issues final decision to withdraw approval of pepaxto (melphalan flufenamide) fda drug safety 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/node/398713" }, { "id": "fda-2026-week05-2", "kind": "fda", "issueId": "2026-week05", "year": 2026, "week": 5, "weekLabel": "第 5 週", "dateRange": "2026/01/26 – 02/01", "href": "2026-week05.html", "title": "FDA alerts patients, caregivers, and health care providers of cross-compatibility issues with autoinjector devices that are optional for use with glatiramer acetate injection", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/node/403159", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "alerts", "caregivers", "providers", "cross-compatibility", "issues", "autoinjector", "devices", "that", "optional", "glatiramer" ], "drugTerms": [], "searchText": "fda alerts patients, caregivers, and health care providers of cross-compatibility issues with autoinjector devices that are optional for use with glatiramer acetate injection fda drug safety 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/node/403159" }, { "id": "fda-2026-week05-4", "kind": "fda", "issueId": "2026-week05", "year": 2026, "week": 5, "weekLabel": "第 5 週", "dateRange": "2026/01/26 – 02/01", "href": "2026-week05.html", "title": "FDA Accepts First In Silico Drug Development Tool Under ISTAND Program to Help Predict Drug-Induced Liver Injury", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fda-accepts-first-silico-drug-development-tool-under-istand-program-help-predict-drug-induced-liver", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "accepts", "first", "silico", "development", "tool", "under", "istand", "program", "help", "predict" ], "drugTerms": [], "searchText": "fda accepts first in silico drug development tool under istand program to help predict drug-induced liver injury fda drug safety 2026-06-03 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/drugs/drug-alerts-and-statements/fda-accepts-first-silico-drug-development-tool-under-istand-program-help-predict-drug-induced-liver" }, { "id": "pmid-41565343", "kind": "article", "issueId": "2026-week04", "year": 2026, "week": 4, "weekLabel": "第 4 週", "dateRange": "2026/01/19 – 01/25", "href": "2026-week04.html", "title": "Time trends in newly recorded diagnoses of 19 long term conditions before, during, and after the covid-19 pandemic: population based cohort study in England using OpenSAFELY", "journal": "BMJ", "type": "OA", "typeLabel": "Original Article", "author": "Russell", "doi": "10.1136/bmj-2025-086393", "url": "https://doi.org/10.1136/bmj-2025-086393", "summary": "藥師重點：此研究提示疫情後慢性病診斷缺口仍可能影響用藥開始、追蹤與疾病控制；藥師在處方審查與慢病照護時，可特別留意 depression、asthma、COPD、osteoporosis 及 慢性腎臟病 的未診斷或追蹤延遲風險。", "pubDate": "2026-01-21", "terms": [ "time", "trends", "newly", "recorded", "diagnoses", "long", "term", "conditions", "covid-19", "pandemic" ], "drugTerms": [], "searchText": "time trends in newly recorded diagnoses of 19 long term conditions before, during, and after the covid-19 pandemic: population based cohort study in england using opensafely bmj original article russell 10.1136/bmj-2025-086393 研究背景：covid-19 pandemic 可能改變慢性病新診斷率與醫療可近性，本研究評估英格蘭 19 種 long term conditions 在疫情前、中、後的診斷趨勢與族群差異。 研究方法：此 族群 based 世代研究 使用 opensafely-tpp 平台的基層照護與住院資料，涵蓋 29,995,025 名英格蘭一般科登錄民眾。研究比較 2016 年 4 月 1 日至 2024 年 11 月 30 日的年齡與性別標準化 incident 與 prevalent diagnosis rates，並以疫情前趨勢建立預期值。 主要結果：19 種疾病在疫情第一年新診斷皆明顯下降，之後恢復程度不一；截至 2024 年 11 月，depression 少 734,800 例（27.7%）、asthma 少 152,900 例（16.4%）、copd 少 90,100 例（15.8%）、osteoporosis 少 54,100 例（11.5%）。相對地，慢性腎臟病 診斷較預期增加 34.8%，約多 359,000 例。 藥師重點：此研究提示疫情後慢性病診斷缺口仍可能影響用藥開始、追蹤與疾病控制；藥師在處方審查與慢病照護時，可特別留意 depression、asthma、copd、osteoporosis 及 慢性腎臟病 的未診斷或追蹤延遲風險。" }, { "id": "pmid-41576983", "kind": "article", "issueId": "2026-week04", "year": 2026, "week": 4, "weekLabel": "第 4 週", "dateRange": "2026/01/19 – 01/25", "href": "2026-week04.html", "title": "Surgical fixation versus non-surgical care for children with a displaced medial epicondyle fracture of the elbow (the SCIENCE study): a multicentre, randomised controlled, superiority trial and economic evaluation", "journal": "Lancet", "type": "RCT", "typeLabel": "RCT", "author": "Perry", "doi": "10.1016/S0140-6736(25)02098-7", "url": "https://doi.org/10.1016/S0140-6736(25)02098-7", "summary": "藥師重點：研究結果說明 surgical fixation 未帶來具臨床意義的功能改善，且增加手術相關風險與成本；照護團隊可優先考慮非手術策略，若進入手術流程仍需留意麻醉、術後止痛與併發症用藥管理。", "pubDate": "2026-02-07", "terms": [ "surgical", "fixation", "non-surgical", "children", "displaced", "medial", "epicondyle", "fracture", "elbow", "science" ], "drugTerms": [], "searchText": "surgical fixation versus non-surgical care for children with a displaced medial epicondyle fracture of the elbow (the science study): a multicentre, randomised controlled, superiority trial and economic evaluation lancet rct perry 10.1016/s0140-6736(25)02098-7 研究背景：兒童肘部 displaced medial epicondyle fracture 是否需手術固定長期存在爭議，臨床上手術使用增加，但支持其優於非手術照護的證據有限。 研究方法：science 為英國、澳洲與紐西蘭 59 家醫院進行的 實務型 多中心 隨機 優越性試驗，納入 7-15 歲 displaced medial epicondyle fracture 兒童，隨機接受 surgical fixation 或 non-surgical care。主要終點為 12 個月時以 promis upper extremity score for children 評估的上肢功能，並進行 12 個月成本效果評估。 主要結果：335 名兒童接受隨機分配，12 個月 promis 分數在非手術組與手術組分別為 53.1 與 54.3，平均差 1.57（95% ci -0.01 to 3.14；p=0.052），低於預設臨床重要差異 4 分。手術組額外手術較多（24 名 vs 3 名），平均每人照護成本高 £2435，且達 cost-effective 的機率為 0%。 藥師重點：研究結果說明 surgical fixation 未帶來具臨床意義的功能改善，且增加手術相關風險與成本；照護團隊可優先考慮非手術策略，若進入手術流程仍需留意麻醉、術後止痛與併發症用藥管理。" }, { "id": "pmid-41564397", "kind": "article", "issueId": "2026-week04", "year": 2026, "week": 4, "weekLabel": "第 4 週", "dateRange": "2026/01/19 – 01/25", "href": "2026-week04.html", "title": "Sacituzumab Govitecan plus Pembrolizumab for Advanced Triple-Negative Breast Cancer", "journal": "NEJM", "type": "RCT", "typeLabel": "RCT", "author": "Tolaney", "doi": "10.1056/NEJMoa2508959", "url": "https://doi.org/10.1056/NEJMoa2508959", "summary": "藥師重點：結論顯示 sacituzumab govitecan 加上 pembrolizumab 可延長此族群第一線治療的 無惡化存活期；用藥評估需確認 PD-L1 狀態、ADC 相關不良反應風險、合併 pembrolizumab 的免疫相關監測，以及整體存活資料尚未成熟。", "pubDate": "2026-01-22", "terms": [ "sacituzumab", "govitecan", "plus", "pembrolizumab", "advanced", "triple-negative", "breast", "cancer", "nejm", "tolaney" ], "drugTerms": [ "sacituzumab", "pembrolizumab" ], "searchText": "sacituzumab govitecan plus pembrolizumab for advanced triple-negative breast cancer nejm rct tolaney 10.1056/nejmoa2508959 研究背景：triple-negative breast 癌症 侵襲性高，對於未治療過、pd-l1 陽性、局部晚期不可切除或轉移性患者，第一線治療仍需要提升疾病控制效果。 研究方法：此 第 3 期、開放標籤、國際多中心試驗將患者 1:1 隨機分配至 sacituzumab govitecan 加上 pembrolizumab，或 化療加上 pembrolizumab。主要終點為 盲性獨立中央審查 評估的 無惡化存活期，次要終點包含 整體存活期、objective 反應、duration of 反應 與安全性。 主要結果：共 443 名患者隨機分組；中位數 無惡化存活期 為 11.2 個月與 7.8 個月（hr 0.65，95% ci 0.51-0.84；p<0.001）。objective 反應 為 60% 與 53%，等級 3 以上不良事件為 71% 與 70%，因不良事件停藥為 12% 與 31%，整體存活期 資料仍未成熟。 藥師重點：結論顯示 sacituzumab govitecan 加上 pembrolizumab 可延長此族群第一線治療的 無惡化存活期；用藥評估需確認 pd-l1 狀態、adc 相關不良反應風險、合併 pembrolizumab 的免疫相關監測，以及整體存活資料尚未成熟。" }, { "id": "pmid-41569557", "kind": "article", "issueId": "2026-week04", "year": 2026, "week": 4, "weekLabel": "第 4 週", "dateRange": "2026/01/19 – 01/25", "href": "2026-week04.html", "title": "Oral Nalbuphine in Idiopathic Pulmonary Fibrosis-Associated Cough: The CORAL Randomized Clinical Trial", "journal": "JAMA", "type": "RCT", "typeLabel": "RCT", "author": "Molyneaux", "doi": "10.1001/jama.2025.26179", "url": "https://doi.org/10.1001/jama.2025.26179", "summary": "藥師重點：結論顯示 nalbuphine ER 在 6 週內可降低 IPF 相關慢性咳嗽，且較高劑量在病人自評症狀亦有改善；臨床應留意 opioid 相關耐受性、嗜睡或便祕等監測需求，並確認長期療效與安全性資料。", "pubDate": "2026-03-24", "terms": [ "oral", "nalbuphine", "idiopathic", "pulmonary", "fibrosis-associated", "cough", "coral", "jama", "molyneaux", "opioid" ], "drugTerms": [], "searchText": "oral nalbuphine in idiopathic pulmonary fibrosis-associated cough: the coral randomized clinical trial jama rct molyneaux 10.1001/jama.2025.26179 研究背景：特發性肺纖維化 (ipf) 相關慢性咳嗽會影響生活品質，目前仍缺乏效果明確的治療選項；nalbuphine er 具 κ opioid 受體 致效劑 與 μ-opioid 受體 拮抗劑 作用，可能降低咳嗽頻率。 研究方法：coral 為 10 國 52 個中心進行的 隨機、雙盲、安慰劑對照 第 2b 期 試驗，納入 ipf、慢性咳嗽至少 8 週且 cough severity numerical rating scale ≥4 分患者。患者隨機接受 nalbuphine er 27 mg、54 mg、108 mg 或 安慰劑 每日兩次 6 週，主要終點為 24 小時客觀咳嗽頻率相對變化。 主要結果：165 名患者隨機分組；nalbuphine er 27 mg、54 mg、108 mg 組客觀咳嗽頻率分別下降 47.9%、53.4%、60.2%，安慰劑 組下降 16.9%（p=0.008、p<0.001、p<0.001）。病人自評咳嗽頻率在 54 mg 與 108 mg 組也較 安慰劑 改善（p=0.004、p<0.005）。 藥師重點：結論顯示 nalbuphine er 在 6 週內可降低 ipf 相關慢性咳嗽，且較高劑量在病人自評症狀亦有改善；臨床應留意 opioid 相關耐受性、嗜睡或便祕等監測需求，並確認長期療效與安全性資料。" }, { "id": "pmid-41565309", "kind": "article", "issueId": "2026-week04", "year": 2026, "week": 4, "weekLabel": "第 4 週", "dateRange": "2026/01/19 – 01/25", "href": "2026-week04.html", "title": "Natural ovulation versus programmed regimens before frozen embryo transfer in ovulatory women: multicentre, randomised clinical trial", "journal": "BMJ", "type": "RCT", "typeLabel": "RCT", "author": "Wei", "doi": "10.1136/bmj-2025-087045", "url": "https://doi.org/10.1136/bmj-2025-087045", "summary": "藥師重點：結論顯示 自然排卵週期 的健康活產率與 人工準備週期 相近，且可能降低部分孕產婦併發症；臨床諮詢時需同時說明監測自然排卵、週期取消風險與個別不孕治療條件。", "pubDate": "2026-01-21", "terms": [ "natural", "ovulation", "programmed", "regimens", "frozen", "embryo", "transfer", "ovulatory", "women", "multicentre" ], "drugTerms": [], "searchText": "natural ovulation versus programmed regimens before frozen embryo transfer in ovulatory women: multicentre, randomised clinical trial bmj rct wei 10.1136/bmj-2025-087045 研究背景：排卵正常女性接受 frozen embryo transfer 前，子宮內膜準備可採自然排卵或 programmed hormone replacement 處方；兩者對健康活產與妊娠高血壓併發症的影響仍需大型試驗確認。 研究方法：研究為中國 24 個生殖醫學中心進行的多中心、隨機、平行分組、評估者盲法臨床試驗，共納入 4376 名 20-40 歲、預計接受 frozen single blastocyst transfer 的排卵正常女性，1:1 分配至 自然排卵週期 或 人工準備週期。主要終點為 healthy live birth，以及 frozen embryo transfer 後 pre-eclampsia 或 eclampsia。 主要結果：healthy live birth 在 自然排卵週期 與 人工準備週期 分別為 41.6% 與 40.6%（rr 1.03，95% ci 0.96-1.10；p=0.49）。達臨床懷孕者中，自然排卵週期 的 pre-eclampsia 較低（2.9% vs 4.6%；rr 0.63，95% ci 0.43-0.94；p=0.02），但週期取消率較高（16.2% vs 11.5%；p<0.001）。 藥師重點：結論顯示 自然排卵週期 的健康活產率與 人工準備週期 相近，且可能降低部分孕產婦併發症；臨床諮詢時需同時說明監測自然排卵、週期取消風險與個別不孕治療條件。" }, { "id": "pmid-41565320", "kind": "article", "issueId": "2026-week04", "year": 2026, "week": 4, "weekLabel": "第 4 週", "dateRange": "2026/01/19 – 01/25", "href": "2026-week04.html", "title": "Long term use of proton pump inhibitors and risk of stomach cancer: population based case-control study in five Nordic countries", "journal": "BMJ", "type": "OA", "typeLabel": "Original Article", "author": "Duru", "doi": "10.1136/bmj-2025-086384", "url": "https://doi.org/10.1136/bmj-2025-086384", "summary": "藥師重點：結論顯示在校正多項偏差後，長期 PPI 使用可能未增加 gastric adenocarcinoma 風險；藥師仍應依適應症定期檢視 PPI 必要性、療程長度、Helicobacter pylori 相關病史與長期用藥監測。", "pubDate": "2026-01-21", "terms": [ "long", "term", "proton", "pump", "inhibitors", "stomach", "cancer", "population", "case-control", "five" ], "drugTerms": [ "anti-inflammatory" ], "searchText": "long term use of proton pump inhibitors and risk of stomach cancer: population based case-control study in five nordic countries bmj original article duru 10.1136/bmj-2025-086384 研究背景：proton pump 抑制劑 長期使用是否增加 gastric adenocarcinoma 風險仍有爭議，過去研究可能受到適應症偏差、短期暴露與診斷前使用等方法學問題影響。 研究方法：此 族群 based 病例對照研究 使用丹麥、芬蘭、冰島、挪威與瑞典全國登錄資料，納入 17,232 名 gastric non-cardia adenocarcinoma 個案與 172,297 名依年齡、性別、年份及國家配對的對照。暴露定義為長期（>1 年）ppi 使用，並排除診斷或納入前 12 個月使用，以降低反向因果與適應症偏差。 主要結果：長期 ppi 使用在個案與對照分別為 10.2% 與 9.5%，未觀察到與 gastric adenocarcinoma 的關聯（校正 or 1.01，95% ci 0.96-1.07）。histamine-2-受體 拮抗劑 的風險估計亦相近（校正 or 1.03，95% ci 0.86-1.23）。 藥師重點：結論顯示在校正多項偏差後，長期 ppi 使用可能未增加 gastric adenocarcinoma 風險；藥師仍應依適應症定期檢視 ppi 必要性、療程長度、helicobacter pylori 相關病史與長期用藥監測。" }, { "id": "pmid-41565311", "kind": "article", "issueId": "2026-week04", "year": 2026, "week": 4, "weekLabel": "第 4 週", "dateRange": "2026/01/19 – 01/25", "href": "2026-week04.html", "title": "Impact of shifting blood donation policy from gift to honour model: staggered difference-in-differences analysis in China", "journal": "BMJ", "type": "OA", "typeLabel": "Original Article", "author": "Liu", "doi": "10.1136/bmj-2025-084999", "url": "https://doi.org/10.1136/bmj-2025-084999", "summary": "藥師重點：研究結果說明以社會認可為核心的政策可增加捐血量，且未降低捐血者適格率；此證據較偏公共衛生與血品供應政策，臨床解讀時應避免直接外推至不同制度或文化情境。", "pubDate": "2026-01-21", "terms": [ "impact", "shifting", "blood", "donation", "policy", "from", "gift", "honour", "model", "staggered" ], "drugTerms": [], "searchText": "impact of shifting blood donation policy from gift to honour model: staggered difference-in-differences analysis in china bmj original article liu 10.1136/bmj-2025-084999 研究背景：血液供應穩定性仰賴持續捐血，單純禮品式誘因可能有侷限；中國導入以社會認可為主的 榮譽模式，以提升捐血數量並維持捐血品質。 研究方法：研究採 staggered 差異-in-differences 分析，分析 2012-2018 年中國 30 個省份的捐血政策、年度捐血資料與人口社經指標。介入為 honour card 等社會認可誘因，主要評估年度總捐血次數、全血捐血次數與 donor eligibility 比率。 主要結果：榮譽模式 實施第 2 年使捐血次數增加 3.55%（95% ci 1.30%-5.80%；p=0.003），第 5 年增加 7.70%（95% ci 2.42%-12.98%；p=0.006）。增加主要來自全血捐血，donor eligibility 比率 未見顯著改變，敏感度分析支持結果穩健。 藥師重點：研究結果說明以社會認可為核心的政策可增加捐血量，且未降低捐血者適格率；此證據較偏公共衛生與血品供應政策，臨床解讀時應避免直接外推至不同制度或文化情境。" }, { "id": "pmid-41563747", "kind": "article", "issueId": "2026-week04", "year": 2026, "week": 4, "weekLabel": "第 4 週", "dateRange": "2026/01/19 – 01/25", "href": "2026-week04.html", "title": "Antibiotic Therapy for Uncomplicated Acute Appendicitis: Ten-Year Follow-Up of the APPAC Randomized Clinical Trial", "journal": "JAMA", "type": "RCT", "typeLabel": "RCT", "author": "Salminen", "doi": "10.1001/jama.2025.25921", "url": "https://doi.org/10.1001/jama.2025.25921", "summary": "藥師重點：研究結果支持抗生素可作為成人 uncomplicated 急性 appendicitis 的治療選項之一；藥師需協助評估抗生素過敏、交互作用、不良反應與抗藥性風險，並提醒病人仍有長期復發與後續手術可能。", "pubDate": "2026-03-24", "terms": [ "antibiotic", "uncomplicated", "acute", "appendicitis", "ten-year", "follow-up", "appac", "jama", "salminen", "appendectomy" ], "drugTerms": [ "ertapenem", "levofloxacin", "metronidazole" ], "searchText": "antibiotic therapy for uncomplicated acute appendicitis: ten-year follow-up of the appac randomized clinical trial jama rct salminen 10.1001/jama.2025.25921 研究背景：成人 uncomplicated 急性 appendicitis 可使用抗生素作為非手術選項，但超過 5 年的隨機試驗追蹤資料有限，復發與後續 appendectomy 風險是臨床決策重點。 研究方法：本研究為 appac 多中心 隨機臨床試驗 的 10 年觀察性追蹤，原試驗於芬蘭 6 家醫院納入 530 名 18-60 歲、ct 診斷 uncomplicated 急性 appendicitis 患者，隨機接受 appendectomy 或 antibiotics。抗生素組使用 ertapenem sodium 1 g/day 靜脈注射 3 天，接續 levofloxacin 500 mg 每日一次 與 metronidazole 500 mg 每日 3 次 共 7 天。 主要結果：抗生素組 253/257 名患者完成復發評估，10 年 true appendicitis recurrence 為 37.8%（95% ci 31.6%-44.1%），累積 appendectomy 比率 為 44.3%（95% ci 38.2%-50.4%）。10 年累積併發症率在 appendectomy 組與抗生素組分別為 27.4% 與 8.5%（p<0.001），生活品質未見顯著差異。 藥師重點：研究結果支持抗生素可作為成人 uncomplicated 急性 appendicitis 的治療選項之一；藥師需協助評估抗生素過敏、交互作用、不良反應與抗藥性風險，並提醒病人仍有長期復發與後續手術可能。" }, { "id": "fda-2026-week04-1", "kind": "fda", "issueId": "2026-week04", "year": 2026, "week": 4, "weekLabel": "第 4 週", "dateRange": "2026/01/19 – 01/25", "href": "2026-week04.html", "title": "FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "concerns", "unapproved", "glp-1", "drugs", "used", "weight", "loss", "https", "drug-alerts-and-statements", "fdas-concerns-unapproved-glp-1-drugs-used-weight-loss" ], "drugTerms": [ "glp-1" ], "searchText": "fda’s concerns with unapproved glp-1 drugs used for weight loss fda drug safety 2026-06-15 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss" }, { "id": "fda-2026-week04-3", "kind": "fda", "issueId": "2026-week04", "year": 2026, "week": 4, "weekLabel": "第 4 週", "dateRange": "2026/01/19 – 01/25", "href": "2026-week04.html", "title": "FDA issues final decision to withdraw approval of Pepaxto (melphalan flufenamide)", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/node/398713", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "issues", "final", "decision", "withdraw", "approval", "pepaxto", "melphalan", "flufenamide", "https", "node" ], "drugTerms": [], "searchText": "fda issues final decision to withdraw approval of pepaxto (melphalan flufenamide) fda drug safety 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/node/398713" }, { "id": "fda-2026-week04-2", "kind": "fda", "issueId": "2026-week04", "year": 2026, "week": 4, "weekLabel": "第 4 週", "dateRange": "2026/01/19 – 01/25", "href": "2026-week04.html", "title": "FDA alerts patients, caregivers, and health care providers of cross-compatibility issues with autoinjector devices that are optional for use with glatiramer acetate injection", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/node/403159", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "alerts", "caregivers", "providers", "cross-compatibility", "issues", "autoinjector", "devices", "that", "optional", "glatiramer" ], "drugTerms": [], "searchText": "fda alerts patients, caregivers, and health care providers of cross-compatibility issues with autoinjector devices that are optional for use with glatiramer acetate injection fda drug safety 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/node/403159" }, { "id": "fda-2026-week04-4", "kind": "fda", "issueId": "2026-week04", "year": 2026, "week": 4, "weekLabel": "第 4 週", "dateRange": "2026/01/19 – 01/25", "href": "2026-week04.html", "title": "FDA Accepts First In Silico Drug Development Tool Under ISTAND Program to Help Predict Drug-Induced Liver Injury", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fda-accepts-first-silico-drug-development-tool-under-istand-program-help-predict-drug-induced-liver", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "accepts", "first", "silico", "development", "tool", "under", "istand", "program", "help", "predict" ], "drugTerms": [], "searchText": "fda accepts first in silico drug development tool under istand program to help predict drug-induced liver injury fda drug safety 2026-06-03 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/drugs/drug-alerts-and-statements/fda-accepts-first-silico-drug-development-tool-under-istand-program-help-predict-drug-induced-liver" }, { "id": "pmid-41534914", "kind": "article", "issueId": "2026-week03", "year": 2026, "week": 3, "weekLabel": "第 3 週", "dateRange": "2026/01/12 – 01/18", "href": "2026-week03.html", "title": "The impact of skin tone on performance of pulse oximeters used by NHS England COVID Oximetry @home scheme: measurement and diagnostic accuracy study", "journal": "BMJ", "type": "OA", "typeLabel": "Original Article", "author": "Martin", "doi": "10.1136/bmj-2025-085535", "url": "https://doi.org/10.1136/bmj-2025-085535", "summary": "藥師重點：結果顯示部分 pulse oximeter 在深膚色患者可能高估 SpO2，造成低血氧偵測的 false negative 風險；臨床與居家監測衛教應提醒若症狀與讀值不一致，需回到整體臨床評估並考慮 SaO2 等確認方式。", "pubDate": "2026-01-14", "terms": [ "impact", "skin", "tone", "performance", "pulse", "oximeters", "used", "england", "covid", "oximetry" ], "drugTerms": [], "searchText": "the impact of skin tone on performance of pulse oximeters used by nhs england covid oximetry @home scheme: measurement and diagnostic accuracy study bmj original article martin 10.1136/bmj-2025-085535 研究背景：covid oximetry @home 等居家監測方案仰賴指尖 pulse oximeter，但膚色是否影響 spo2 測量與低血氧診斷準確度，仍是重要安全議題。 研究方法：exakt 為 measurement and diagnostic accuracy 研究，於英格蘭 24 間加護病房納入 903 名重症成人，分析 5 種 nhs england covid oximetry @home 使用的指尖 pulse oximeters。研究比較 pulse oximetry derived spo2 與 co-oximetry 測得的 paired arterial oxygen saturation（sao2），並以 spectrophotometer 客觀測量膚色。 主要結果：共分析 11,018 組 paired spo2-sao2 測量。所有 pulse oximeters 在較低 sao2 時高估、較高 sao2 時低估；深膚色患者的 spo2 平均比淺膚色患者高 0.6-1.5 百分點。以 spo2 ≤92% 或 ≤94% 閾值判定時，深膚色者 false negative rates 較高；sao2 ≤92% 但 spo2 >94% 的比例差距為 5.3-35.3 百分點。 藥師重點：結果顯示部分 pulse oximeter 在深膚色患者可能高估 spo2，造成低血氧偵測的 false negative 風險；臨床與居家監測衛教應提醒若症狀與讀值不一致，需回到整體臨床評估並考慮 sao2 等確認方式。" }, { "id": "pmid-41525083", "kind": "article", "issueId": "2026-week03", "year": 2026, "week": 3, "weekLabel": "第 3 週", "dateRange": "2026/01/12 – 01/18", "href": "2026-week03.html", "title": "The US Food and Drug Administration's Regulation of Mifepristone", "journal": "JAMA", "type": "OA", "typeLabel": "Original Article", "author": "Dilek", "doi": "10.1001/jama.2025.23091", "url": "https://doi.org/10.1001/jama.2025.23091", "summary": "藥師重點：結論顯示 2011-2023 年 FDA 對 mifepristone 的監管主要受科學證據與審慎監管取向影響；此文屬監管政策分析，非療效或安全性試驗，藥師解讀時需回到當地法規、REMS 要求與臨床使用情境。", "pubDate": "2026-02-17", "terms": [ "food", "administration", "regulation", "mifepristone", "jama", "dilek", "misoprostol", "rems", "qualitative", "freedom" ], "drugTerms": [], "searchText": "the us food and drug administration's regulation of mifepristone jama original article dilek 10.1001/jama.2025.23091 研究背景：mifepristone 與 misoprostol 合併使用是美國常見藥物流產 處方，也因 fda 監管、rems 與法律爭議而成為生殖健康政策焦點。 研究方法：研究為 qualitative 分析，分析 freedom of information act 取得的 5239 頁 fda 文件，包括 sponsor rems assessment reports、fda reviews、internal memos 與 regulatory correspondence（2011-2023），並補充公開資料。分析重點為 fda 對上市後安全措施建立、維持或調整的理由與引用證據。 主要結果：研究辨識出 5 個 mifepristone 監管關鍵時點：2011 年 6 月轉入 rems framework、2013 年 10 月重新評估 rems 必要性、2015 年 5 月 sponsor-requested label change、2020-2021 年因應 covid-19 pandemic，以及 2021 年 11 月全面重新評估 rems。整體主題包括安全性結論一致、staff scientists 建議未見意識形態偏差，以及政治干預至今影響有限。 藥師重點：結論顯示 2011-2023 年 fda 對 mifepristone 的監管主要受科學證據與審慎監管取向影響；此文屬監管政策分析，非療效或安全性試驗，藥師解讀時需回到當地法規、rems 要求與臨床使用情境。" }, { "id": "pmid-41544643", "kind": "article", "issueId": "2026-week03", "year": 2026, "week": 3, "weekLabel": "第 3 週", "dateRange": "2026/01/12 – 01/18", "href": "2026-week03.html", "title": "Savolitinib plus osimertinib versus chemotherapy for advanced, EGFR mutation-positive, MET-amplified non-small-cell lung cancer in China (SACHI): interim analysis of a multicentre, open-label, phase 3 randomised controlled trial", "journal": "Lancet", "type": "RCT", "typeLabel": "RCT", "author": "Lu", "doi": "10.1016/S0140-6736(25)01811-2", "url": "https://doi.org/10.1016/S0140-6736(25)01811-2", "summary": "藥師重點：結論顯示 savolitinib-osimertinib 可延長 EGFR 突變陽性、MET 擴增 NSCLC 經 EGFR TKI 後進展患者的 無惡化存活期；臨床應確認 EGFR/MET 檢測結果、既往 TKI 暴露與合併標靶治療相關不良反應監測。", "pubDate": "2026-01-24", "terms": [ "savolitinib", "plus", "osimertinib", "chemotherapy", "advanced", "egfr", "mutation-positive", "met-amplified", "non-small-cell", "lung" ], "drugTerms": [ "savolitinib", "osimertinib", "savolitinib-osimertinib", "cisplatin", "carboplatin" ], "searchText": "savolitinib plus osimertinib versus chemotherapy for advanced, egfr mutation-positive, met-amplified non-small-cell lung cancer in china (sachi): interim analysis of a multicentre, open-label, phase 3 randomised controlled trial lancet rct lu 10.1016/s0140-6736(25)01811-2 研究背景：egfr 突變陽性 nsclc 在 egfr tki 治療後若出現 met amplification，後續治療選擇有限；savolitinib 合併 osimertinib 可能提供 biomarker-selected 族群的口服治療選項。 研究方法：sachi 為中國 68 家醫院進行的 多中心、隨機、活性對照、開放標籤 第 3 期試驗。局部晚期或轉移性 egfr 突變陽性、met 擴增 nsclc 且 egfr tki 治療失敗的成人，1:1 分配至每日口服 savolitinib-osimertinib 或 pemetrexed 加 cisplatin/carboplatin 化療，每 21 天一療程；主要終點為 investigator-assessed 無惡化存活期。 主要結果：共 211 人納入，106 人分配至 savolitinib-osimertinib、105 人分配至化療，所有受試者均為 asian。第三代 egfr tki-naive 族群 中位數 無惡化存活期 為 9.8 vs 5.4 個月（hr 0.34，95% ci 0.21-0.56；p<0.0001），itt 族群為 8.2 vs 4.5 個月（hr 0.34，95% ci 0.23-0.49；p<0.0001）。等級 3 或以上 治療期間出現的不良事件 兩組皆為 57%。 藥師重點：結論顯示 savolitinib-osimertinib 可延長 egfr 突變陽性、met 擴增 nsclc 經 egfr tki 後進展患者的 無惡化存活期；臨床應確認 egfr/met 檢測結果、既往 tki 暴露與合併標靶治療相關不良反應監測。" }, { "id": "pmid-41539323", "kind": "article", "issueId": "2026-week03", "year": 2026, "week": 3, "weekLabel": "第 3 週", "dateRange": "2026/01/12 – 01/18", "href": "2026-week03.html", "title": "Profiling vaccine attitudes and subsequent uptake in 1·1 million people in England: a nationwide cohort study", "journal": "Lancet", "type": "OA", "typeLabel": "Original Article", "author": "Whitaker", "doi": "10.1016/S0140-6736(25)01912-9", "url": "https://doi.org/10.1016/S0140-6736(25)01912-9", "summary": "藥師重點：研究結果說明多數 COVID-19 疫苗 hesitancy 來自可被資訊與時間處理的具體疑慮，但低信任與反疫苗態度較難改變；藥師進行疫苗諮詢時，應先辨識猶豫原因，再提供針對性的風險溝通。", "pubDate": "2026-01-24", "terms": [ "profiling", "vaccine", "attitudes", "subsequent", "uptake", "million", "people", "england", "nationwide", "lancet" ], "drugTerms": [ "anti-vaccine" ], "searchText": "profiling vaccine attitudes and subsequent uptake in 1·1 million people in england: a nationwide cohort study lancet original article whitaker 10.1016/s0140-6736(25)01912-9 研究背景：即使 sars-cov-2 疫苗具高度保護力，英格蘭疫情期間仍有部分族群對 covid-19 疫苗 hesitancy；其比例與原因會隨人口特徵而不同，影響後續疫苗推廣策略。 研究方法：研究使用 real-time assessment of community transmission（react）資料，先進行 基準值 疫苗 hesitancy 的 cross-sectional 分析，再以 linked nhs vaccination records 對猶豫族群進行 longitudinal 分析。成人受試者自陳社會人口資料、接種狀態與疫苗態度，並以 logistic regression 與 consensus clustering 分析猶豫類型及後續接種。 主要結果：分析納入 1,137,927 名成人，37,982 人（3.3%）表示某種形式 疫苗 hesitancy；比例於 2021 年初達 8.0%，2022 年初降至 1.1%，之後回升至 2.2%。在 24,229 名表示猶豫且同意 nhs 資料 linkage 者中，15,744 人（65.0%）後續接種至少一劑。cluster 分析 辨識 8 類穩定猶豫原因，其中對效果與健康疑慮的猶豫較會隨時間下降；低信任、低風險感知與一般反疫苗態度則較持續。 藥師重點：研究結果說明多數 covid-19 疫苗 hesitancy 來自可被資訊與時間處理的具體疑慮，但低信任與反疫苗態度較難改變；藥師進行疫苗諮詢時，應先辨識猶豫原因，再提供針對性的風險溝通。" }, { "id": "pmid-41533371", "kind": "article", "issueId": "2026-week03", "year": 2026, "week": 3, "weekLabel": "第 3 週", "dateRange": "2026/01/12 – 01/18", "href": "2026-week03.html", "title": "Minor Papillotomy for Treatment of Idiopathic Acute Pancreatitis With Pancreas Divisum: A Randomized Clinical Trial", "journal": "JAMA", "type": "RCT", "typeLabel": "RCT", "author": "Coté", "doi": "10.1001/jama.2025.23988", "url": "https://doi.org/10.1001/jama.2025.23988", "summary": "藥師重點：結論顯示對 unexplained 急性 recurrent pancreatitis 合併 pancreas divisum 患者，ERCP 合併副乳頭切開術 未降低再發急性胰臟炎或相關後遺症；照護上需留意 ERCP 後急性胰臟炎風險與程序相關用藥管理。", "pubDate": "2026-02-24", "terms": [ "minor", "papillotomy", "idiopathic", "acute", "pancreatitis", "pancreas", "divisum", "jama", "ercp", "sham" ], "drugTerms": [], "searchText": "minor papillotomy for treatment of idiopathic acute pancreatitis with pancreas divisum: a randomized clinical trial jama rct coté 10.1001/jama.2025.23988 研究背景：pancreas divisum 可能造成胰液引流阻塞並與急性胰臟炎相關；ercp 合併 minor papillotomy 雖已在臨床使用，但過去多仰賴觀察性資料。 研究方法：此美國與加拿大 21 個轉診中心進行的 多中心、假治療對照、雙盲 隨機臨床試驗，納入有 2 次以上急性胰臟炎且合併 pancreas divisum 的成人，排除其他急性胰臟炎病因或慢性鈣化性胰臟炎。受試者 1:1 分配至 ercp 合併副乳頭切開術 或 sham ercp；主要終點為隨機分組 30 天後再發急性胰臟炎。 主要結果：共 148 人隨機分組，中位數 追蹤 34 個月。ercp 合併副乳頭切開術 組 26/75 人（34.7%）再發急性胰臟炎，sham ercp 組為 32/73 人（43.8%）（校正 hr 0.83，95% ci 0.49 to 1.41）；慢性鈣化性胰臟炎、糖尿病與外分泌胰臟功能不全皆無組間差異。隨機後 30 天內急性胰臟炎不良事件為 14.7% vs 8.2%。 藥師重點：結論顯示對 unexplained 急性 recurrent pancreatitis 合併 pancreas divisum 患者，ercp 合併副乳頭切開術 未降低再發急性胰臟炎或相關後遺症；照護上需留意 ercp 後急性胰臟炎風險與程序相關用藥管理。" }, { "id": "pmid-41544642", "kind": "article", "issueId": "2026-week03", "year": 2026, "week": 3, "weekLabel": "第 3 週", "dateRange": "2026/01/12 – 01/18", "href": "2026-week03.html", "title": "Low-dose yellow fever vaccination in infants: a randomised, double-blind, non-inferiority trial", "journal": "Lancet", "type": "RCT", "typeLabel": "RCT", "author": "Kimathi", "doi": "10.1016/S0140-6736(25)02069-0", "url": "https://doi.org/10.1016/S0140-6736(25)02069-0", "summary": "藥師重點：結論顯示成人 分劑量 的最低劑量資料不能直接外推至嬰兒；常規 WHO Expanded Programme on Immunization 族群仍應使用標準黃熱病疫苗劑量，疫苗短缺時需特別區分 outbreak 應急策略與嬰兒常規接種。", "pubDate": "2026-01-31", "terms": [ "low-dose", "yellow", "fever", "vaccination", "infants", "randomised", "double-blind", "non-inferiority", "lancet", "kimathi" ], "drugTerms": [], "searchText": "low-dose yellow fever vaccination in infants: a randomised, double-blind, non-inferiority trial lancet rct kimathi 10.1016/s0140-6736(25)02069-0 研究背景：黃熱病疫苗短缺時，who 建議 outbreak 情境可使用 分劑量；成人已有 500 iu 劑量不劣於標準劑量的資料，但嬰兒最低有效劑量仍不清楚。 研究方法：此 kenya 與 uganda 兩中心、隨機、雙盲、不劣性 試驗 納入 9-12 個月、未曾接種或感染黃熱病的嬰兒。受試者 1:1 接受標準劑量（>13,000 iu）或 500 iu institut pasteur de dakar 17d-204 yellow fever 疫苗，並與 measles-rubella 疫苗 共同接種；主要終點為接種後第 28 天 seroconversion。 主要結果：共 420 名嬰兒隨機分組。per-protocol 族群 中，第 28 天 血清轉換率 為標準劑量 99%（95% ci 96-100；177/179）與 500 iu 93%（88-96；166/179），差異為 -6.15 百分點（95% ci -10.27 to -2.02），未達 不劣性。研究期間通報 12 件 嚴重不良事件，皆被判定與疫苗無關。 藥師重點：結論顯示成人 分劑量 的最低劑量資料不能直接外推至嬰兒；常規 who expanded programme on immunization 族群仍應使用標準黃熱病疫苗劑量，疫苗短缺時需特別區分 outbreak 應急策略與嬰兒常規接種。" }, { "id": "pmid-41534042", "kind": "article", "issueId": "2026-week03", "year": 2026, "week": 3, "weekLabel": "第 3 週", "dateRange": "2026/01/12 – 01/18", "href": "2026-week03.html", "title": "Fremanezumab in Children and Adolescents with Episodic Migraine", "journal": "NEJM", "type": "RCT", "typeLabel": "RCT", "author": "Hershey", "doi": "10.1056/NEJMoa2504546", "url": "https://doi.org/10.1056/NEJMoa2504546", "summary": "藥師重點：結論顯示 fremanezumab 可降低兒童與青少年 episodic migraine 的偏頭痛與頭痛天數；用藥評估仍需留意體重分層劑量、注射部位反應，以及兒科族群長期療效與安全性資料仍有限。", "pubDate": "2026-01-15", "terms": [ "fremanezumab", "children", "adolescents", "episodic", "migraine", "nejm", "hershey", "nejmoa2504546", "calcitonin", "gene-related" ], "drugTerms": [ "fremanezumab" ], "searchText": "fremanezumab in children and adolescents with episodic migraine nejm rct hershey 10.1056/nejmoa2504546 研究背景：fremanezumab 為選擇性作用於 calcitonin gene-related peptide 的 humanized monoclonal 抗體，成人偏頭痛預防已有適應資料，但兒童與青少年族群仍需隨機對照試驗證據。 研究方法：此試驗納入 6-17 歲、episodic migraine 至少 6 個月且每月頭痛日數不超過 14 天者，隨機接受每月皮下注射 fremanezumab（體重 <45 kg 為 120 mg，≥45 kg 為 225 mg）或 安慰劑，共 3 個月。主要終點為每月偏頭痛天數相對基準值的變化。 主要結果：237 人隨機分組，234 人納入 完整分析族群。fremanezumab 組每月偏頭痛天數減少 2.5 天，安慰劑 組減少 1.4 天（差異 1.1；p=0.02）；每月中重度頭痛天數亦較 安慰劑 多減少 1.1 天（p=0.02），達到偏頭痛天數減少 ≥50% 者為 47.2% vs 27.0%（p=0.002）。最常見不良事件為注射部位紅斑（9.8% vs 5.4%）。 藥師重點：結論顯示 fremanezumab 可降低兒童與青少年 episodic migraine 的偏頭痛與頭痛天數；用藥評估仍需留意體重分層劑量、注射部位反應，以及兒科族群長期療效與安全性資料仍有限。" }, { "id": "pmid-41534904", "kind": "article", "issueId": "2026-week03", "year": 2026, "week": 3, "weekLabel": "第 3 週", "dateRange": "2026/01/12 – 01/18", "href": "2026-week03.html", "title": "Experiences of access to general practice in England: qualitative study and implications for the NHS 10 year plan", "journal": "BMJ", "type": "OA", "typeLabel": "Original Article", "author": "Sinnott", "doi": "10.1136/bmj-2025-087367", "url": "https://doi.org/10.1136/bmj-2025-087367", "summary": "藥師重點：研究結果說明醫療可近性改革不能只以數位工具或服務重組取代人際連結與連續照護；藥師參與社區照護、慢病管理或數位分流時，需留意弱勢族群排除、照護片段化與跨專業工作量分配。", "pubDate": "2026-01-14", "terms": [ "experiences", "access", "general", "practice", "england", "qualitative", "implications", "year", "plan", "sinnott" ], "drugTerms": [], "searchText": "experiences of access to general practice in england: qualitative study and implications for the nhs 10 year plan bmj original article sinnott 10.1136/bmj-2025-087367 研究背景：英格蘭 nhs 10 year plan 擬透過數位化、轉向社區與預防導向改善 基層醫療 可近性，但病人、照顧者與基層醫療工作者的實際需求可能不同。 研究方法：研究為 質性訪談研究，訪談 devon、medway、blackpool、luton、lancashire 的病人與照顧者，以及英格蘭東部 基層醫療 工作人員，共 70 次訪談。分析使用 持續比較法，並將主題對應至 10 year plan 提出的 digital、community、prevention 三項轉向。 主要結果：受訪病人涵蓋 12 個族群與多元個人及醫療特徵。數位化可提升部分病人的便利性與行政效率，但未解決 gp 約診不足，也可能造成新的排除；轉向社區可能增加服務量能，但也有協調困難與削弱長期醫病關係的風險。預防導向雖被認為重要，卻可能造成照護片段化並增加 基層醫療 工作量。 藥師重點：研究結果說明醫療可近性改革不能只以數位工具或服務重組取代人際連結與連續照護；藥師參與社區照護、慢病管理或數位分流時，需留意弱勢族群排除、照護片段化與跨專業工作量分配。" }, { "id": "pmid-41544645", "kind": "article", "issueId": "2026-week03", "year": 2026, "week": 3, "weekLabel": "第 3 週", "dateRange": "2026/01/12 – 01/18", "href": "2026-week03.html", "title": "Deaths potentially averted by small changes in physical activity and sedentary time: an individual participant data meta-analysis of prospective cohort studies", "journal": "Lancet", "type": "MA", "typeLabel": "Meta-analysis", "author": "Ekelund", "doi": "10.1016/S0140-6736(25)02219-6", "url": "https://doi.org/10.1016/S0140-6736(25)02219-6", "summary": "藥師重點：研究結果說明很小幅度的 MVPA 增加也可能具公共衛生意義，減少久坐亦有較小但仍可觀的效益；藥師進行慢病與用藥衛教時可納入可達成的活動目標，但解讀需注意此為 世代 統合分析 與族群層級估計。", "pubDate": "2026-01-24", "terms": [ "deaths", "potentially", "averted", "small", "changes", "physical", "activity", "sedentary", "time", "individual" ], "drugTerms": [], "searchText": "deaths potentially averted by small changes in physical activity and sedentary time: an individual participant data meta-analysis of prospective cohort studies lancet meta-analysis ekelund 10.1016/s0140-6736(25)02219-6 研究背景：小幅增加中高強度身體活動或減少久坐時間，對族群層級死亡可避免比例的影響仍不明確；本研究估計每日增加 5-10 分鐘 mvpa 或減少 30-60 分鐘久坐的可能效益。 研究方法：研究為 prospective 世代 研究 的 個別參與者資料統合分析，納入以裝置測量身體活動與久坐時間的資料。分析分為約 20% 最不活躍者的 高風險策略，以及排除約 20% 最活躍者後全族群的 族群策略，並以 校正風險比 估算 potential impact fractions（pifs）。 主要結果：分析納入挪威、瑞典與美國 7 個 世代（n=40,327；4895 deaths），uk biobank（n=94,719；3487 deaths）另行分析。最不活躍者每日增加 5 分鐘 mvpa 可能避免 6.0%（95% ci 4.3-7.4）死亡；若應用於除最活躍者外的全族群，可能避免 10.0%（6.3-13.4）死亡。每日減少 30 分鐘久坐則估計可避免 3.0%（2.0-4.1）與 7.3%（4.8-9.6）死亡。 藥師重點：研究結果說明很小幅度的 mvpa 增加也可能具公共衛生意義，減少久坐亦有較小但仍可觀的效益；藥師進行慢病與用藥衛教時可納入可達成的活動目標，但解讀需注意此為 世代 統合分析 與族群層級估計。" }, { "id": "pmid-41534905", "kind": "article", "issueId": "2026-week03", "year": 2026, "week": 3, "weekLabel": "第 3 週", "dateRange": "2026/01/12 – 01/18", "href": "2026-week03.html", "title": "Cast immobilisation versus surgery for unstable lateral malleolus fractures (SUPER-FIN): randomised non-inferiority clinical trial", "journal": "BMJ", "type": "RCT", "typeLabel": "RCT", "author": "Kortekangas", "doi": "10.1136/bmj-2025-085295", "url": "https://doi.org/10.1136/bmj-2025-085295", "summary": "藥師重點：結果顯示此類外踝骨折以石膏固定治療不劣於手術，且治療相關傷害較少；臨床照護可將疼痛控制、活動功能追蹤與手術傷口感染風險納入共同決策。", "pubDate": "2026-01-14", "terms": [ "cast", "immobilisation", "surgery", "unstable", "lateral", "malleolus", "fractures", "super-fin", "randomised", "non-inferiority" ], "drugTerms": [], "searchText": "cast immobilisation versus surgery for unstable lateral malleolus fractures (super-fin): randomised non-inferiority clinical trial bmj rct kortekangas 10.1136/bmj-2025-085295 研究背景：初始 x 光顯示踝關節榫對位良好的單踝 weber b 外踝骨折，若外旋壓力測試判定不穩定，是否一定需要手術仍有臨床爭議。 研究方法：super-fin 為芬蘭單一創傷中心 實務型、隨機、不劣性 試驗，納入 126 名骨骼成熟且外旋壓力測試不穩定的單獨 weber b 腓骨骨折患者，分配至 6 週石膏固定或 開放復位內固定鋼板 後 6 週石膏固定。主要終點為 2 年 olerud-molander ankle score（omas），不劣性 margin 為 -8 分。 主要結果：121/126 名隨機分組者（96%）完成研究。2 年時石膏固定組與手術組平均 omas 為 89 vs 87，組間差 1.3 分（95% ci -4.8 to 7.3），次要終點亦未見顯著差異；手術組另有表淺傷口感染、傷口癒合延遲與 9 例移除內固定物手術。 藥師重點：結果顯示此類外踝骨折以石膏固定治療不劣於手術，且治療相關傷害較少；臨床照護可將疼痛控制、活動功能追蹤與手術傷口感染風險納入共同決策。" }, { "id": "pmid-41534043", "kind": "article", "issueId": "2026-week03", "year": 2026, "week": 3, "weekLabel": "第 3 週", "dateRange": "2026/01/12 – 01/18", "href": "2026-week03.html", "title": "CD19 CAR T-Cell Therapy for Autoimmune Hemolytic Anemia", "journal": "NEJM", "type": "OA", "typeLabel": "Original Article", "author": "Li", "doi": "10.1056/NEJMoa2509820", "url": "https://doi.org/10.1056/NEJMoa2509820", "summary": "藥師重點：結果顯示 CD19 CAR T-cell 治療 在 multirefractory AIHA 可能帶來持續緩解，但資料來自 11 人早期研究與 compassionate 使用；臨床解讀需保守，並重視 CRS、ICANS、感染與 hematotoxicity 等 CAR T 相關毒性監測。", "pubDate": "2026-01-15", "terms": [ "cd19", "t-cell", "autoimmune", "hemolytic", "anemia", "nejm", "nejmoa2509820", "aiha", "autoreactive", "b-cell" ], "drugTerms": [], "searchText": "cd19 car t-cell therapy for autoimmune hemolytic anemia nejm original article li 10.1056/nejmoa2509820 研究背景：autoimmune hemolytic anemia（aiha）可能因持續存在的 autoreactive b-cell activity 而復發；對至少三線治療無效的 multirefractory aiha，cd19-directed car t-cell 治療 可能藉由深度 b 細胞耗竭達到免藥緩解。 研究方法：研究納入 恩慈使用 program 與 第 1 期 研究 中的 原發難治且多重難治 aiha 患者，每位接受單次 autologous cd19 car t cells 輸注。主要目標為安全性，包括 cytokine-release 症候群 與 immune effector cell-associated neurotoxicity 症候群；次要目標包含療效與 pharmacokinetic features。 主要結果：共 11 名患者接受 cd19 car t cells，中位數 追蹤 12.2 個月。所有患者皆達 完全反應，中位數 time to 完全反應 為 45 天，中位數 duration of drug-free 緩解 為 11.5 個月；等級 1 或 2 cytokine-release 症候群 發生於 9 人，等級 1 immune effector cell-associated neurotoxicity 症候群 發生於 1 人，7 人共發生 15 件感染，無 等級 4 或以上感染。 藥師重點：結果顯示 cd19 car t-cell 治療 在 multirefractory aiha 可能帶來持續緩解，但資料來自 11 人早期研究與 compassionate 使用；臨床解讀需保守，並重視 crs、icans、感染與 hematotoxicity 等 car t 相關毒性監測。" }, { "id": "pmid-41520674", "kind": "article", "issueId": "2026-week03", "year": 2026, "week": 3, "weekLabel": "第 3 週", "dateRange": "2026/01/12 – 01/18", "href": "2026-week03.html", "title": "Abluminus DES+ sirolimus-eluting stent versus everolimus-eluting stent in patients with diabetes and coronary artery disease (ABILITY Diabetes Global): results from a multicentre, randomised controlled trial", "journal": "Lancet", "type": "RCT", "typeLabel": "RCT", "author": "Abizaid", "doi": "10.1016/S0140-6736(25)02157-9", "url": "https://doi.org/10.1016/S0140-6736(25)02157-9", "summary": "藥師重點：結果顯示糖尿病患者 PCI 使用 Abluminus DES+ SES 未能證明不劣於 XIENCE EES，且 12 個月 target-lesion 相關事件較高；藥師在照護此族群時仍需重視 殘餘缺血風險、雙重抗血小板治療 遵從性與出血風險平衡。", "pubDate": "2026-01-17", "terms": [ "abluminus", "sirolimus-eluting", "stent", "everolimus-eluting", "diabetes", "coronary", "artery", "ability", "global", "from" ], "drugTerms": [], "searchText": "abluminus des+ sirolimus-eluting stent versus everolimus-eluting stent in patients with diabetes and coronary artery disease (ability diabetes global): results from a multicentre, randomised controlled trial lancet rct abizaid 10.1016/s0140-6736(25)02157-9 研究背景：糖尿病會增加冠狀動脈疾病患者 pci 後再狹窄與心血管事件風險；abluminus des+ sirolimus-eluting stent 是否可優於或不劣於既有 xience everolimus-eluting stent 仍需大型試驗驗證。 研究方法：ability diabetes global 為 16 國 74 中心、prospective、開放標籤、隨機對照試驗，納入接受 pci 的第 1 型或第 2 型糖尿病成人，因慢性冠心症或 non-st-elevation 急性 冠狀動脈 症候群 治療至少一處 de novo 冠狀動脈 lesion。受試者 1:1 分配至 abluminus des+ ses 或 xience ees，主要假設為 12 個月 ischaemia-driven target-lesion revascularisation 與 目標病灶失敗 的 不劣性。 主要結果：共 3032 人隨機分組，2931 人完成死亡或 24 個月追蹤。12 個月 依計畫書分析 中，abluminus des+ ses 未達 不劣性：ischaemia-driven target-lesion revascularisation 為 4.8% vs 2.1%（absolute 風險差 2.7%，95% ci 1.3-4.1；p不劣性=0.44），目標病灶失敗 為 9.7% vs 6.2%（3.5%，95% ci 1.5-5.5；p不劣性=0.68）。target-vessel myocardial infarction 亦較高（5.2% vs 3.1%），但 心血管 死亡 與 all-cause 死亡 未見顯著差異。 藥師重點：結果顯示糖尿病患者 pci 使用 abluminus des+ ses 未能證明不劣於 xience ees，且 12 個月 target-lesion 相關事件較高；藥師在照護此族群時仍需重視 殘餘缺血風險、雙重抗血小板治療 遵從性與出血風險平衡。" }, { "id": "fda-2026-week03-1", "kind": "fda", "issueId": "2026-week03", "year": 2026, "week": 3, "weekLabel": "第 3 週", "dateRange": "2026/01/12 – 01/18", "href": "2026-week03.html", "title": "FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "concerns", "unapproved", "glp-1", "drugs", "used", "weight", "loss", "https", "drug-alerts-and-statements", "fdas-concerns-unapproved-glp-1-drugs-used-weight-loss" ], "drugTerms": [ "glp-1" ], "searchText": "fda’s concerns with unapproved glp-1 drugs used for weight loss fda drug safety 2026-06-15 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss" }, { "id": "fda-2026-week03-3", "kind": "fda", "issueId": "2026-week03", "year": 2026, "week": 3, "weekLabel": "第 3 週", "dateRange": "2026/01/12 – 01/18", "href": "2026-week03.html", "title": "FDA issues final decision to withdraw approval of Pepaxto (melphalan flufenamide)", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/node/398713", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "issues", "final", "decision", "withdraw", "approval", "pepaxto", "melphalan", "flufenamide", "https", "node" ], "drugTerms": [], "searchText": "fda issues final decision to withdraw approval of pepaxto (melphalan flufenamide) fda drug safety 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/node/398713" }, { "id": "fda-2026-week03-2", "kind": "fda", "issueId": "2026-week03", "year": 2026, "week": 3, "weekLabel": "第 3 週", "dateRange": "2026/01/12 – 01/18", "href": "2026-week03.html", "title": "FDA alerts patients, caregivers, and health care providers of cross-compatibility issues with autoinjector devices that are optional for use with glatiramer acetate injection", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/node/403159", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "alerts", "caregivers", "providers", "cross-compatibility", "issues", "autoinjector", "devices", "that", "optional", "glatiramer" ], "drugTerms": [], "searchText": "fda alerts patients, caregivers, and health care providers of cross-compatibility issues with autoinjector devices that are optional for use with glatiramer acetate injection fda drug safety 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/node/403159" }, { "id": "fda-2026-week03-4", "kind": "fda", "issueId": "2026-week03", "year": 2026, "week": 3, "weekLabel": "第 3 週", "dateRange": "2026/01/12 – 01/18", "href": "2026-week03.html", "title": "FDA Accepts First In Silico Drug Development Tool Under ISTAND Program to Help Predict Drug-Induced Liver Injury", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fda-accepts-first-silico-drug-development-tool-under-istand-program-help-predict-drug-induced-liver", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "accepts", "first", "silico", "development", "tool", "under", "istand", "program", "help", "predict" ], "drugTerms": [], "searchText": "fda accepts first in silico drug development tool under istand program to help predict drug-induced liver injury fda drug safety 2026-06-03 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/drugs/drug-alerts-and-statements/fda-accepts-first-silico-drug-development-tool-under-istand-program-help-predict-drug-induced-liver" }, { "id": "pmid-41513265", "kind": "article", "issueId": "2026-week02", "year": 2026, "week": 2, "weekLabel": "第 2 週", "dateRange": "2026/01/05 – 01/11", "href": "2026-week02.html", "title": "When I use a word . . . Medical anniversaries in 2026", "journal": "BMJ", "type": "OA", "typeLabel": "Original Article", "author": "Aronson", "doi": "10.1136/bmj.s58", "url": "https://doi.org/10.1136/bmj.s58", "summary": "藥師重點：此文可作為藥學教育、醫學史或院內刊物延伸閱讀素材，但不屬於臨床試驗或治療建議；引用時應避免把歷史事件解讀為現行用藥決策證據。", "pubDate": "2026-01-09", "terms": [ "when", "word", "anniversaries", "aronson", "nobel", "prizes", "averroes", "avogadro", "laennec", "pinel" ], "drugTerms": [], "searchText": "when i use a word . . . medical anniversaries in 2026 bmj original article aronson 10.1136/bmj.s58 研究背景：此 bmj 專欄整理 2026 年與醫學、藥學及生物醫學相關的週年事件，重點在歷史脈絡與醫學文化，而非新的臨床治療證據。 研究方法：文章以年份尾數為 '26 與 '76 的事件為主，彙整出生、逝世、醫學文本出版、臨床療法、基礎科學觀察、機構成立、流行病與 nobel prizes 等項目。 主要結果：列舉內容包括 averroes、avogadro、laennec、pinel、golgi、kraepelin 等人物，以及 1926 年以肝臟治療 pernicious anaemia、1776 年腎結石中 uric acid 觀察、1876 年 anthrax bacillus、1726 年 edinburgh medical school 成立與 1976 年 伊波拉病毒感染 等醫學相關事件。 藥師重點：此文可作為藥學教育、醫學史或院內刊物延伸閱讀素材，但不屬於臨床試驗或治療建議；引用時應避免把歷史事件解讀為現行用藥決策證據。" }, { "id": "pmid-41500720", "kind": "article", "issueId": "2026-week02", "year": 2026, "week": 2, "weekLabel": "第 2 週", "dateRange": "2026/01/05 – 01/11", "href": "2026-week02.html", "title": "Weight regain after cessation of medication for weight management: systematic review and meta-analysis", "journal": "BMJ", "type": "MA", "typeLabel": "Meta-analysis", "author": "West", "doi": "10.1136/bmj-2025-085304", "url": "https://doi.org/10.1136/bmj-2025-085304", "summary": "藥師重點：研究結果說明 體重管理藥物 停用後常伴隨快速體重回升與心血管代謝效益消退；藥師應協助病人理解此類藥物不宜只作短期處方，並同步安排飲食、活動、共病監測與停藥後追蹤。", "pubDate": "2026-01-07", "terms": [ "weight", "regain", "cessation", "medication", "management", "meta-analysis", "west", "bmj-2025-085304", "cardiometabolic", "markers" ], "drugTerms": [], "searchText": "weight regain after cessation of medication for weight management: systematic review and meta-analysis bmj meta-analysis west 10.1136/bmj-2025-085304 研究背景：體重管理藥物可協助減重，但停藥後體重回升速度與心血管代謝指標是否反彈，是用藥規劃與病人期待管理的重要問題。 研究方法：此 系統性回顧與統合分析 搜尋資料庫與試驗登錄至 2025 年 2 月，納入成人過重或肥胖者使用 體重管理藥物（≥8 週）且停藥後追蹤 ≥4 週的 rct、非隨機試驗與觀察性研究。主要結果為停藥後體重回升速率，次要結果為 cardiometabolic markers 變化，並與 行為體重管理計畫（bwmps）停用後情形比較。 主要結果：9288 篇題名中納入 37 項研究、63 個介入組、9341 名參與者；平均治療 39 週、平均追蹤 32 週。停用 wmm 後平均每月體重回升 0.4 kg（95% ci 0.3 to 0.5），rct mixed model 顯示相較對照每月多 0.3 kg；所有 cardiometabolic markers 預估在停藥後 1.4 年內回到基線，且 wmm 後回升速度快於 bwmp。 藥師重點：研究結果說明 體重管理藥物 停用後常伴隨快速體重回升與心血管代謝效益消退；藥師應協助病人理解此類藥物不宜只作短期處方，並同步安排飲食、活動、共病監測與停藥後追蹤。" }, { "id": "pmid-41499135", "kind": "article", "issueId": "2026-week02", "year": 2026, "week": 2, "weekLabel": "第 2 週", "dateRange": "2026/01/05 – 01/11", "href": "2026-week02.html", "title": "Prenatal Exposure to Acid-Suppressive Medications and Risk of Neuropsychiatric Disorders in Children", "journal": "JAMA", "type": "OA", "typeLabel": "Original Article", "author": "Hong", "doi": "10.1001/jama.2025.23956", "url": "https://doi.org/10.1001/jama.2025.23956", "summary": "藥師重點：結論顯示控制手足共享因素後，孕期酸抑制藥物暴露未與子代 ADHD、ASD 或其他神經精神疾患風險增加相關；孕期用藥諮詢仍應避免不必要長期使用，但有適應症時不宜僅因初步觀察性關聯而自行停藥。", "pubDate": "2026-02-17", "terms": [ "prenatal", "exposure", "acid-suppressive", "medications", "neuropsychiatric", "disorders", "children", "jama", "hong", "south" ], "drugTerms": [], "searchText": "prenatal exposure to acid-suppressive medications and risk of neuropsychiatric disorders in children jama original article hong 10.1001/jama.2025.23956 研究背景：孕期常使用 ppi 或 h2 受體 拮抗劑 控制胃酸相關症狀，但其與子代神經精神疾患風險的關聯仍需大型資料與家族內比較釐清。 研究方法：此 south korean national 健康 insurance service 回溯性世代研究 納入 2010 年 1 月至 2017 年 12 月出生的母子配對，子代追蹤至 2023 年 12 月。暴露定義為孕期至少一次 ppi 或 h2 受體 拮抗劑 處方，分析採 propensity score-based overlap-weighted 世代 與 sibling-matched 世代，結果包括 adhd、asd、intellectual disability、重度 neuropsychiatric 疾患 與 obsessive-compulsive 疾患。 主要結果：共納入 2,777,119 對母子，其中 507,845 對有孕期酸抑制藥物暴露，平均追蹤 10.3 年。overlap-weighted 世代 顯示暴露組風險略高，如 adhd 校正 hr 1.14（95% ci 1.12-1.17）、asd 1.07（95% ci 1.03-1.11）；但 sibling-control 分析 未見顯著關聯，adhd hr 0.98（95% ci 0.95-1.02）、asd 0.98（95% ci 0.92-1.04）。 藥師重點：結論顯示控制手足共享因素後，孕期酸抑制藥物暴露未與子代 adhd、asd 或其他神經精神疾患風險增加相關；孕期用藥諮詢仍應避免不必要長期使用，但有適應症時不宜僅因初步觀察性關聯而自行停藥。" }, { "id": "pmid-41494769", "kind": "article", "issueId": "2026-week02", "year": 2026, "week": 2, "weekLabel": "第 2 週", "dateRange": "2026/01/05 – 01/11", "href": "2026-week02.html", "title": "Oral ivermectin versus 5% permethrin cream to treat children and adults with classic scabies: multicentre, assessor blinded, cluster randomised clinical trial", "journal": "BMJ", "type": "RCT", "typeLabel": "RCT", "author": "Boralevi", "doi": "10.1136/bmj-2025-086277", "url": "https://doi.org/10.1136/bmj-2025-086277", "summary": "藥師重點：結論顯示 口服 ivermectin 在此典型疥瘡家戶群聚試驗中未達 5% permethrin cream 的 不劣性，且 permethrin 統計上較佳；藥師衛教時仍需強調全家戶同步治療、外用藥正確塗抹與第二次療程完成。", "pubDate": "2026-01-06", "terms": [ "oral", "ivermectin", "permethrin", "cream", "treat", "children", "adults", "classic", "scabies", "multicentre" ], "drugTerms": [], "searchText": "oral ivermectin versus 5% permethrin cream to treat children and adults with classic scabies: multicentre, assessor blinded, cluster randomised clinical trial bmj rct boralevi 10.1136/bmj-2025-086277 研究背景：典型疥瘡治療需同時處理指標個案與家戶成員，口服 ivermectin 較方便，但相較 5% permethrin cream 是否能達到相近臨床治癒率仍不確定。 研究方法：此法國 28 家醫院進行的 多中心、評估者盲性、群集隨機試驗，納入經皮膚鏡確認疥瘡且體重 >15 kg 的成人與兒童指標個案，家戶成員原則上接受同組治療。介入為 口服 ivermectin 200 µg/kg 或 5% permethrin cream，皆於 第 0 天 與 第 10 天 使用；主要終點為 第 28 天 全家戶臨床治癒。 主要結果：ivermectin 組 142 戶、507 人，permethrin 組 147 戶、568 人；家戶層級治癒率為 71.8% vs 88.5%（percentage point 差異 -16.7，95% ci -26.3 to -7.1）。指標個案與個人層級分析亦顯示 ivermectin 較差，皮膚不良事件為 11.9% vs 15.6%。 藥師重點：結論顯示 口服 ivermectin 在此典型疥瘡家戶群聚試驗中未達 5% permethrin cream 的 不劣性，且 permethrin 統計上較佳；藥師衛教時仍需強調全家戶同步治療、外用藥正確塗抹與第二次療程完成。" }, { "id": "pmid-41494781", "kind": "article", "issueId": "2026-week02", "year": 2026, "week": 2, "weekLabel": "第 2 週", "dateRange": "2026/01/05 – 01/11", "href": "2026-week02.html", "title": "Effects of lifestyle interventions in pregnancy on gestational diabetes: individual participant data and network meta-analysis", "journal": "BMJ", "type": "MA", "typeLabel": "Meta-analysis", "author": "Allotey", "doi": "10.1136/bmj-2025-084159", "url": "https://doi.org/10.1136/bmj-2025-084159", "summary": "藥師重點：研究結果說明孕期生活型態介入可能預防妊娠糖尿病，但效果會受診斷標準與執行方式影響；藥師參與孕期照護時，可強化運動與飲食衛教、團體介入及轉介資源，同時留意低教育程度族群可能較難取得同等效益。", "pubDate": "2026-01-06", "terms": [ "lifestyle", "interventions", "pregnancy", "gestational", "diabetes", "individual", "participant", "network", "meta-analysis", "allotey" ], "drugTerms": [], "searchText": "effects of lifestyle interventions in pregnancy on gestational diabetes: individual participant data and network meta-analysis bmj meta-analysis allotey 10.1136/bmj-2025-084159 研究背景：孕期生活型態介入可能降低妊娠糖尿病風險，但效果是否受診斷標準、孕婦特性或介入形式影響，仍需整合個別受試者資料評估。 研究方法：此 individual participant 資料 與 network 統合分析 納入 1990 年 1 月至 2025 年 4 月的隨機試驗，評估孕期 physical activity based、diet based 或 mixed lifestyle interventions 對妊娠糖尿病的影響。主要結果包括任一標準、uk nice、iadpsg 與 modified iadpsg 定義的妊娠糖尿病，並以兩階段 ipd 統合分析 與 network 統合分析 估計效果及排名。 主要結果：共納入 104 項隨機試驗、35,993 名女性，其中 54 項提供 24,391 人 ipd。lifestyle interventions 在 ipd 試驗 中使任一標準妊娠糖尿病 勝算比 為 0.90（95% ci 0.80 to 1.02），合併 ipd 與 non-ipd 試驗 後為 0.80（95% ci 0.73 to 0.88）；以 nice 標準則未見降低（or 0.98，95% ci 0.84 to 1.13），physical activity based interventions 排名最高。 藥師重點：研究結果說明孕期生活型態介入可能預防妊娠糖尿病，但效果會受診斷標準與執行方式影響；藥師參與孕期照護時，可強化運動與飲食衛教、團體介入及轉介資源，同時留意低教育程度族群可能較難取得同等效益。" }, { "id": "pmid-41500725", "kind": "article", "issueId": "2026-week02", "year": 2026, "week": 2, "weekLabel": "第 2 週", "dateRange": "2026/01/05 – 01/11", "href": "2026-week02.html", "title": "Edaravone dexborneol versus placebo on functional outcomes in patients with acute ischaemic stroke undergoing endovascular thrombectomy (TASTE-2): randomised controlled trial", "journal": "BMJ", "type": "RCT", "typeLabel": "RCT", "author": "Wang", "doi": "10.1136/bmj-2025-086850", "url": "https://doi.org/10.1136/bmj-2025-086850", "summary": "藥師重點：結論顯示 edaravone dexborneol 用於發病 24 小時內且接受 血管內取栓 的急性缺血性中風患者，可小幅提高 90 天功能獨立比例且未增加明確安全性疑慮；解讀時需留意效果主要來自 mismatch 次族群與療程給藥時機。", "pubDate": "2026-01-07", "terms": [ "edaravone", "dexborneol", "placebo", "functional", "acute", "ischaemic", "stroke", "undergoing", "endovascular", "thrombectomy" ], "drugTerms": [ "anti-inflammatory" ], "searchText": "edaravone dexborneol versus placebo on functional outcomes in patients with acute ischaemic stroke undergoing endovascular thrombectomy (taste-2): randomised controlled trial bmj rct wang 10.1136/bmj-2025-086850 研究背景：急性缺血性中風接受 血管內取栓 後仍可能有功能恢復不佳，edaravone dexborneol 具抗氧化與抗發炎作用，是否能改善 90 天功能結果需以隨機試驗確認。 研究方法：taste-2 為中國 106 家醫院進行的 多中心、雙盲、隨機、安慰劑對照 試驗，納入發病 24 小時內、18-80 歲、前循環大血管阻塞且預計接受 血管內取栓 的急性缺血性中風患者。受試者於 血管內取栓 前接受 edaravone dexborneol 37.5 mg 或 安慰劑，之後每日 2 次持續 10-14 天；主要終點為 第 90 天 modified rankin scale 0-2。 主要結果：1360 人納入 意向治療分析，第 90 天 功能獨立比例為 55.0% vs 49.6%（風險比 1.11，95% ci 1.00 to 1.23；p=0.05；風險差 5.4%）。入院時有 mismatch 的次族群效果較明顯（55.5% vs 42.9%；風險比 1.29，95% ci 1.10 to 1.52；p for interaction=0.003），嚴重不良事件 為 27.2% vs 25.7%。 藥師重點：結論顯示 edaravone dexborneol 用於發病 24 小時內且接受 血管內取栓 的急性缺血性中風患者，可小幅提高 90 天功能獨立比例且未增加明確安全性疑慮；解讀時需留意效果主要來自 mismatch 次族群與療程給藥時機。" }, { "id": "pmid-41505155", "kind": "article", "issueId": "2026-week02", "year": 2026, "week": 2, "weekLabel": "第 2 週", "dateRange": "2026/01/05 – 01/11", "href": "2026-week02.html", "title": "Acetaminophen (Paracetamol) or Opioid Analgesia Added to Ibuprofen for Children's Musculoskeletal Injury: Two Randomized Clinical Trials", "journal": "JAMA", "type": "RCT", "typeLabel": "RCT", "author": "Ali", "doi": "10.1001/jama.2025.25033", "url": "https://doi.org/10.1001/jama.2025.25033", "summary": "藥師重點：結論顯示兒童急性非手術肌肉骨骼傷害中，單次加用 acetaminophen 或 hydromorphone 未較 ibuprofen 單用 改善 60 分鐘疼痛分數；hydromorphone 不良事件較多，藥師可協助避免常規加用 opioid，並確認兒童止痛藥依體重給藥與安全上限。", "pubDate": "2026-03-10", "terms": [ "acetaminophen", "paracetamol", "opioid", "analgesia", "added", "ibuprofen", "children", "musculoskeletal", "injury", "trials" ], "drugTerms": [], "searchText": "acetaminophen (paracetamol) or opioid analgesia added to ibuprofen for children's musculoskeletal injury: two randomized clinical trials jama rct ali 10.1001/jama.2025.25033 研究背景：ibuprofen 是兒童肌肉骨骼疼痛常用第一線藥物，但中重度急性肢體傷害時，加用 acetaminophen 或 opioid 是否能進一步止痛仍不清楚。 研究方法：研究包含兩項加拿大 6 家兒科急診進行的 隨機、雙遮蔽、安慰劑對照 試驗，納入 6-17 歲、非手術急性肢體傷害 <24 小時且 vnrs 疼痛分數 ≥5 的兒童。opioid 試驗 比較 ibuprofen 加 hydromorphone、ibuprofen 加 acetaminophen 與 ibuprofen 單用；nonopioid 試驗 比較 ibuprofen 加 acetaminophen 與 ibuprofen 單用，主要療效終點為給藥後 60 分鐘 vnrs。 主要結果：699 人隨機分組，653 人納入療效分析；給藥後 60 分鐘平均 vnrs 為 ibuprofen 加 hydromorphone 4.8、ibuprofen 加 acetaminophen 4.6、ibuprofen 單用 4.6（p=.78）。任一不良事件在 hydromorphone 合併組為 28.2%，高於 acetaminophen 合併組 6.1% 與 ibuprofen 單用 5.8%，且未發生 嚴重不良事件。 藥師重點：結論顯示兒童急性非手術肌肉骨骼傷害中，單次加用 acetaminophen 或 hydromorphone 未較 ibuprofen 單用 改善 60 分鐘疼痛分數；hydromorphone 不良事件較多，藥師可協助避免常規加用 opioid，並確認兒童止痛藥依體重給藥與安全上限。" }, { "id": "fda-2026-week02-1", "kind": "fda", "issueId": "2026-week02", "year": 2026, "week": 2, "weekLabel": "第 2 週", "dateRange": "2026/01/05 – 01/11", "href": "2026-week02.html", "title": "FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "concerns", "unapproved", "glp-1", "drugs", "used", "weight", "loss", "https", "drug-alerts-and-statements", "fdas-concerns-unapproved-glp-1-drugs-used-weight-loss" ], "drugTerms": [ "glp-1" ], "searchText": "fda’s concerns with unapproved glp-1 drugs used for weight loss fda drug safety 2026-06-15 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss" }, { "id": "fda-2026-week02-3", "kind": "fda", "issueId": "2026-week02", "year": 2026, "week": 2, "weekLabel": "第 2 週", "dateRange": "2026/01/05 – 01/11", "href": "2026-week02.html", "title": "FDA issues final decision to withdraw approval of Pepaxto (melphalan flufenamide)", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/node/398713", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "issues", "final", "decision", "withdraw", "approval", "pepaxto", "melphalan", "flufenamide", "https", "node" ], "drugTerms": [], "searchText": "fda issues final decision to withdraw approval of pepaxto (melphalan flufenamide) fda drug safety 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/node/398713" }, { "id": "fda-2026-week02-2", "kind": "fda", "issueId": "2026-week02", "year": 2026, "week": 2, "weekLabel": "第 2 週", "dateRange": "2026/01/05 – 01/11", "href": "2026-week02.html", "title": "FDA alerts patients, caregivers, and health care providers of cross-compatibility issues with autoinjector devices that are optional for use with glatiramer acetate injection", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/node/403159", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "alerts", "caregivers", "providers", "cross-compatibility", "issues", "autoinjector", "devices", "that", "optional", "glatiramer" ], "drugTerms": [], "searchText": "fda alerts patients, caregivers, and health care providers of cross-compatibility issues with autoinjector devices that are optional for use with glatiramer acetate injection fda drug safety 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/node/403159" }, { "id": "fda-2026-week02-4", "kind": "fda", "issueId": "2026-week02", "year": 2026, "week": 2, "weekLabel": "第 2 週", "dateRange": "2026/01/05 – 01/11", "href": "2026-week02.html", "title": "FDA Accepts First In Silico Drug Development Tool Under ISTAND Program to Help Predict Drug-Induced Liver Injury", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fda-accepts-first-silico-drug-development-tool-under-istand-program-help-predict-drug-induced-liver", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "accepts", "first", "silico", "development", "tool", "under", "istand", "program", "help", "predict" ], "drugTerms": [], "searchText": "fda accepts first in silico drug development tool under istand program to help predict drug-induced liver injury fda drug safety 2026-06-03 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/drugs/drug-alerts-and-statements/fda-accepts-first-silico-drug-development-tool-under-istand-program-help-predict-drug-induced-liver" }, { "id": "pmid-41460638", "kind": "article", "issueId": "2026-week01", "year": 2026, "week": 1, "weekLabel": "第 1 週", "dateRange": "2025/12/29 – 01/04", "href": "2026-week01.html", "title": "Spinal Manipulation and Clinician-Supported Biopsychosocial Self-Management for Acute Back Pain: The PACBACK Randomized Clinical Trial", "journal": "JAMA", "type": "RCT", "typeLabel": "RCT", "author": "Bronfort", "doi": "10.1001/jama.2025.21990", "url": "https://doi.org/10.1001/jama.2025.21990", "summary": "藥師重點：結論顯示醫療人員支持的身心社會自我管理可帶來統計上顯著但幅度小的失能改善，未改善疼痛強度；藥師參與下背痛照護時，可將非藥物自我管理納入衛教，但不宜將單獨脊椎操作視為優於指引導向醫療照護。", "pubDate": "2026-02-10", "terms": [ "spinal", "manipulation", "clinician-supported", "biopsychosocial", "self-management", "acute", "back", "pain", "pacback", "jama" ], "drugTerms": [], "searchText": "spinal manipulation and clinician-supported biopsychosocial self-management for acute back pain: the pacback randomized clinical trial jama rct bronfort 10.1001/jama.2025.21990 研究背景：下背痛受身體、心理與社會因素交互影響，但臨床治療常著重症狀緩解，較少處理病人的身心社會需求；pacback 試驗評估脊椎操作與醫療人員支持的自我管理是否能改善急性或亞急性下背痛。 研究方法：此 2 × 2 因子設計隨機臨床試驗於明尼蘇達大學與匹茲堡大學 3 個研究診所進行，納入依 start back tool 評估具中高慢性化風險的急性或亞急性下背痛成人。受試者隨機分配至脊椎操作治療、醫療人員支持的自我管理、兩者合併，或指引導向醫療照護，介入最長 8 週，主要終點為 1 年追蹤期間平均 roland-morris disability questionnaire 與疼痛強度。 主要結果：共 1000 人隨機分組，93% 完成試驗。四組在失能分數有顯著差異（p = .001），但疼痛強度無顯著差異（p = .16）；相較一般醫療照護，醫療人員支持的自我管理可降低下背痛失能（平均差 -1.2，95% ci -1.9 to -0.5），合併脊椎操作亦較低（平均差 -1.1，95% ci -1.9 to -0.3），單獨脊椎操作則未達顯著差異。 藥師重點：結論顯示醫療人員支持的身心社會自我管理可帶來統計上顯著但幅度小的失能改善，未改善疼痛強度；藥師參與下背痛照護時，可將非藥物自我管理納入衛教，但不宜將單獨脊椎操作視為優於指引導向醫療照護。" }, { "id": "pmid-41467650", "kind": "article", "issueId": "2026-week01", "year": 2026, "week": 1, "weekLabel": "第 1 週", "dateRange": "2025/12/29 – 01/04", "href": "2026-week01.html", "title": "An Intravenous Brain-Penetrant Enzyme Therapy for Mucopolysaccharidosis II", "journal": "NEJM", "type": "OA", "typeLabel": "Original Article", "author": "Muenzer", "doi": "10.1056/NEJMoa2508681", "url": "https://doi.org/10.1056/NEJMoa2508681", "summary": "藥師重點：結論顯示 tividenofusp alfa 在 MPS II 受試者中常伴隨不良事件，尤其需注意輸注相關反應，即使常規給藥前預防用藥仍可能發生；heparan sulfate 下降屬早期開放性研究訊號，仍需等待進行中的隨機試驗確認臨床效益。", "pubDate": "2026-01-01", "terms": [ "intravenous", "brain-penetrant", "enzyme", "mucopolysaccharidosis", "nejm", "muenzer", "nejmoa2508681", "tividenofusp", "alfa", "iduronate-2-sulfatase" ], "drugTerms": [], "searchText": "an intravenous brain-penetrant enzyme therapy for mucopolysaccharidosis ii nejm original article muenzer 10.1056/nejmoa2508681 研究背景：第二型黏多醣症（mps ii）為罕見溶小體儲積疾病，會造成多系統與神經功能逐漸退化；tividenofusp alfa 將 iduronate-2-sulfatase 與工程化 transferrin 受體-binding fc domain 融合，目標是處理神經與周邊表現。 研究方法：此第 1/2 期開放標籤研究納入 18 歲以下男性 mps ii 受試者，接受每週靜脈 tividenofusp alfa 24 週，之後進入 80 週安全性延伸期與 157 週開放標籤延伸期。主要目標為安全性，次要目標包括 csf 與尿液 heparan sulfate、vineland adaptive behavior scales 及肝臟體積等中樞與周邊效果。 主要結果：共 47 名男性受試者納入；24 週主要分析時，所有人皆通報至少一項治療期間不良事件，最常見為輸注相關反應，發燒、蕁麻疹與嘔吐皆超過 40%。3 人發生嚴重治療相關不良事件，但均持續治療；csf 與尿液 heparan sulfate 較基準值分別下降 91% 與 88%，且至第 153 週仍大致維持，適應行為穩定或改善，肝臟體積則正常化或維持正常。 藥師重點：結論顯示 tividenofusp alfa 在 mps ii 受試者中常伴隨不良事件，尤其需注意輸注相關反應，即使常規給藥前預防用藥仍可能發生；heparan sulfate 下降屬早期開放性研究訊號，仍需等待進行中的隨機試驗確認臨床效益。" }, { "id": "pmid-41468027", "kind": "article", "issueId": "2026-week01", "year": 2026, "week": 1, "weekLabel": "第 1 週", "dateRange": "2025/12/29 – 01/04", "href": "2026-week01.html", "title": "A Lay Health Worker-Led Symptom Intervention and Acute Care Use in Older Adults With Cancer: A Randomized Clinical Trial", "journal": "JAMA", "type": "RCT", "typeLabel": "RCT", "author": "Patel", "doi": "10.1001/jama.2025.23403", "url": "https://doi.org/10.1001/jama.2025.23403", "summary": "藥師重點：研究結果說明由社區健康工作者主動電話評估並回報高分症狀，可能降低高齡癌症病人的急性照護使用；藥師可將此視為症狀監測與用藥調整流程的支持證據，尤其需留意疼痛、噁心、便秘與鎮靜等可介入症狀。", "pubDate": "2026-02-24", "terms": [ "worker-led", "symptom", "intervention", "acute", "older", "adults", "cancer", "jama", "patel", "medicare" ], "drugTerms": [], "searchText": "a lay health worker-led symptom intervention and acute care use in older adults with cancer: a randomized clinical trial jama rct patel 10.1001/jama.2025.23403 研究背景：高齡癌症病人常有症狀控制不足，若能早期辨識並介入，可能減少急診與住院等急性照護使用。 研究方法：此多中心隨機臨床試驗於加州與亞利桑那 43 家腫瘤診所進行，納入 75 歲以上、具 medicare advantage、且新診斷、復發或惡化之癌症病人。受試者 1:1 分配至常規照護加社區健康工作者電話症狀評估 12 個月，或單純常規照護；評估使用 edmonton symptom assessment system，主要結果為急診使用與住院。 主要結果：共 416 名病人，年齡中位數 82 歲，41.1% 為第 4 期疾病。症狀評估組較對照組急診使用較低（30.5% vs 47.7%；校正 or 0.47，95% ci 0.32-0.71），住院亦較低（18.5% vs 39.8%；or 0.32，95% ci 0.20-0.51），每人平均總成本少 $12,000（p = .01）。在死亡者中，症狀評估組死亡前 30 天急診使用與急性照護機構死亡也較低。 藥師重點：研究結果說明由社區健康工作者主動電話評估並回報高分症狀，可能降低高齡癌症病人的急性照護使用；藥師可將此視為症狀監測與用藥調整流程的支持證據，尤其需留意疼痛、噁心、便秘與鎮靜等可介入症狀。" }, { "id": "fda-2026-week01-1", "kind": "fda", "issueId": "2026-week01", "year": 2026, "week": 1, "weekLabel": "第 1 週", "dateRange": "2025/12/29 – 01/04", "href": "2026-week01.html", "title": "FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "concerns", "unapproved", "glp-1", "drugs", "used", "weight", "loss", "https", "drug-alerts-and-statements", "fdas-concerns-unapproved-glp-1-drugs-used-weight-loss" ], "drugTerms": [ "glp-1" ], "searchText": "fda’s concerns with unapproved glp-1 drugs used for weight loss fda drug safety 2026-06-15 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss" }, { "id": "fda-2026-week01-3", "kind": "fda", "issueId": "2026-week01", "year": 2026, "week": 1, "weekLabel": "第 1 週", "dateRange": "2025/12/29 – 01/04", "href": "2026-week01.html", "title": "FDA issues final decision to withdraw approval of Pepaxto (melphalan flufenamide)", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/node/398713", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "issues", "final", "decision", "withdraw", "approval", "pepaxto", "melphalan", "flufenamide", "https", "node" ], "drugTerms": [], "searchText": "fda issues final decision to withdraw approval of pepaxto (melphalan flufenamide) fda drug safety 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/node/398713" }, { "id": "fda-2026-week01-2", "kind": "fda", "issueId": "2026-week01", "year": 2026, "week": 1, "weekLabel": "第 1 週", "dateRange": "2025/12/29 – 01/04", "href": "2026-week01.html", "title": "FDA alerts patients, caregivers, and health care providers of cross-compatibility issues with autoinjector devices that are optional for use with glatiramer acetate injection", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/node/403159", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "alerts", "caregivers", "providers", "cross-compatibility", "issues", "autoinjector", "devices", "that", "optional", "glatiramer" ], "drugTerms": [], "searchText": "fda alerts patients, caregivers, and health care providers of cross-compatibility issues with autoinjector devices that are optional for use with glatiramer acetate injection fda drug safety 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/node/403159" }, { "id": "fda-2026-week01-4", "kind": "fda", "issueId": "2026-week01", "year": 2026, "week": 1, "weekLabel": "第 1 週", "dateRange": "2025/12/29 – 01/04", "href": "2026-week01.html", "title": "FDA Accepts First In Silico Drug Development Tool Under ISTAND Program to Help Predict Drug-Induced Liver Injury", "journal": "FDA", "type": "FDA", "typeLabel": "FDA Drug Safety", "author": "FDA", "doi": "", "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fda-accepts-first-silico-drug-development-tool-under-istand-program-help-predict-drug-induced-liver", "summary": "請開啟 FDA 原文確認警訊內容、適用藥品、受影響產品與建議處置。", "terms": [ "accepts", "first", "silico", "development", "tool", "under", "istand", "program", "help", "predict" ], "drugTerms": [], "searchText": "fda accepts first in silico drug development tool under istand program to help predict drug-induced liver injury fda drug safety 2026-06-03 請開啟 fda 原文確認警訊內容、適用藥品、受影響產品與建議處置。 https://www.fda.gov/drugs/drug-alerts-and-statements/fda-accepts-first-silico-drug-development-tool-under-istand-program-help-predict-drug-induced-liver" } ] }