Dronedarone
證據等級: L2 | 預測適應症: 10 個
## 藥師評估報告
Dronedarone：從心房纖維顫動到中風疾病
一句話總結
Dronedarone 原本用於治療陣發性或持續性心房纖維顫動/心房撲動。 TxGNN 模型預測它可能對**中風疾病 (stroke disorder)** 有效， 目前有 **多個臨床試驗**和 **多篇文獻**支持這個方向。
快速總覽
| 項目 | 內容 |
|---|---|
| 原適應症 | 心房纖維顫動、心房撲動 |
| 預測新適應症 | stroke disorder、obsolete susceptibility to ischemic stroke、ABri amyloidosis、cerebrovascular disorder、brain stem infarction、atrial fibrillation (disease)、sick sinus syndrome 2, autosomal dominant、duodenal obstruction、cerebral artery occlusion、sarcoglycanopathy |
| TxGNN 預測分數 | 99.97% |
| 證據等級 | L2 |
| 台灣上市 | 已上市 |
| 許可證數 | 1 張 |
| 建議決策 | Proceed with Guardrails |
預測適應症詳細分析
1. stroke disorder L1 99.97% 主要分析
為什麼這個預測合理？
Dronedarone 是 amiodarone 的衍生物，具有多通道阻斷作用，能維持竇性心律。
心房纖維顫動是中風的主要危險因素，透過維持竇性心律可減少心房血栓形成。
ATHENA 試驗的事後分析顯示 dronedarone 可降低中風和暫時性腦缺血發作風險，
且研究發現其具有獨立於抗心律不整作用之外的抗凝血和抗血小板效應。
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此預測基於藥物的作用機轉，與現有臨床證據方向一致。
臨床試驗
| 試驗編號 | 階段 | 狀態 | 人數 | 主要發現 |
|---|---|---|---|---|
| NCT01151137 | PHASE3 | TERMINATED | 3236 | A Randomized, Double Blind, Placebo Controlled, Parallel Group Trial for Assessi... |
| NCT03489395 | PHASE2 | COMPLETED | 25 | A Pilot Study on Edoxaban for the Resolution of Left Atrial Thrombosis in Patien... |
| NCT02294955 | NA | UNKNOWN | 152 | Catheter Ablation Compared With Pharmacological Therapy for Atrial Fibrillation ... |
| NCT04704050 | PHASE4 | TERMINATED | 22 | Effect of Dronedarone on Atrial Fibrosis Progression and Atrial Fibrillation Rec... |
| NCT03993119 | N/A | COMPLETED | 500 | Non-Interventional, Cross-sectional Study to Describe NOACs Management in Elderl... |
| NCT05279833 | N/A | COMPLETED | 87810 | SLR/NMA of Multaq® vs Sotalol to Assess for Safety in Patients With Atrial Fibri... |
| NCT01288352 | PHASE4 | COMPLETED | 2789 | Early Therapy of Atrial Fibrillation for Stroke Prevention Trial (EAST). |
| NCT01266681 | NA | UNKNOWN | 100 | Amiodarone Compared to Dronedarone , Post Cardioversion Maintenance of Sinus |
| NCT02618577 | PHASE3 | TERMINATED | 2608 | Non-vitamin K Antagonist Oral Anticoagulants in Patients With Atrial High Rate E... |
| NCT07242326 | N/A | NOT_YET_RECRUITING | 1000 | SNAP AF-52 - An Ambidirectional Observational Study to Assess Label-Concordant D... |
| NCT01856075 | N/A | COMPLETED | 1015 | Relative Effectiveness of Dronedarone vs. Other Treatments of Atrial Fibrillatio... |
| NCT07270848 | PHASE4 | NOT_YET_RECRUITING | 1898 | A Multicenter Prospective Study on the Efficacy, Safety, and Quality of Life Imp... |
| NCT03840291 | PHASE4 | COMPLETED | 36 | Resolution of Thrombi in Left Atrial Appendage With Edoxaban |
| NCT06125925 | NA | RECRUITING | 436 | Catheter Ablation in Atrial Fibrillation Patients With Heart Failure With Preser... |
| NCT05293080 | PHASE3 | NOT_YET_RECRUITING | 1746 | Early Treatment of Atrial Fibrillation for Stroke Prevention Trial in Acute STRO... |
| NCT05130268 | PHASE4 | COMPLETED | 339 | Pragmatic Randomized Clinical Trial of Early Dronedarone Versus Usual Care to Ch... |
| NCT06096337 | NA | ACTIVE_NOT_RECRUITING | 484 | A Prospective Randomized Multicenter Global Study Comparing Pulsed Field Ablatio... |
| NCT05939076 | PHASE3 | NOT_YET_RECRUITING | 220 | First-line Cryoablation for Early Treatment of Persistent Atrial Fibrillation - ... |
| NCT00911508 | NA | COMPLETED | 2204 | Catheter Ablation vs Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial |
相關文獻
| PMID | 年份 | 類型 | 期刊 | 主要發現 |
|---|---|---|---|---|
| 22166900 | 2012 | Article | Lancet (London, England) | Atrial fibrillation. |
| 40387892 | 2025 | Article | Clinical research in cardiolog | Safety and efficacy of amiodarone and dronedarone for early rhythm control in EA... |
| 22920480 | 2012 | Article | Current cardiology reviews | Stroke prevention in atrial fibrillation: concepts and controversies. |
| 20730068 | 2010 | Article | Vascular health and risk manag | Dronedarone for the treatment of atrial fibrillation and atrial flutter: approva... |
| 21930637 | 2011 | Article | American journal of health-sys | Drug-induced heart failure. |
| 37777298 | 2023 | Article | The American journal of cardio | Chapter 2: Rate Versus Rhythm Control. |
| 28992468 | 2017 | Article | Atherosclerosis | Dronedarone exerts anticoagulant and antiplatelet effects independently of its a... |
| 35293087 | 2022 | Article | European journal of heart fail | Dronedarone for the treatment of atrial fibrillation with concomitant heart fail... |
| 28496906 | 2013 | Article | Journal of atrial fibrillation | Risk of Cardiovascular Events, Stroke, Congestive Heart Failure, Interstitial Lu... |
| 22433576 | 2012 | Article | The Canadian journal of cardio | Focused 2012 update of the Canadian Cardiovascular Society atrial fibrillation g... |
| 37485722 | 2023 | Article | Circulation. Arrhythmia and el | Dronedarone Versus Sotalol in Antiarrhythmic Drug-Naive Veterans With Atrial Fib... |
| 33888353 | 2021 | Article | Clinical therapeutics | Evaluating the Risk of Digitalis Intoxication Associated With Concomitant Use of... |
| 22082198 | 2011 | Article | The New England journal of med | Dronedarone in high-risk permanent atrial fibrillation. |
| 37676022 | 2024 | Article | Journal of cardiovascular elec | Are antiarrhythmic agents indicated in premature ventricular complex-induced car... |
| 24810388 | 2014 | Article | European heart journal | Edoxaban: a focused review of its clinical pharmacology. |
| 25428811 | 2015 | Article | Kardiologia polska | Analysis of the cost-effectiveness of dronedarone versus amiodarone, propafenone... |
| 24469871 | 2013 | Article | Cardiology journal | Efficacy and tolerability of dronedarone for patients with atrial fibrillation. |
| 22576674 | 2012 | Article | Current hypertension reports | Recent clinical trials in atrial fibrillation in hypertensive patients. |
| 38782070 | 2024 | Article | International journal of cardi | The effect of antiarrhythmic medications on the risk of cardiovascular outcomes ... |
| 19678722 | 2009 | Article | Journal of managed care pharma | Pharmacologic management of atrial fibrillation: established and emerging option... |
2. obsolete susceptibility to ischemic stroke L5 99.96%
目前尚無針對此適應症的專門臨床研究。此為 TxGNN 模型預測結果，需進一步驗證。
3. ABri amyloidosis L5 99.92%
目前尚無針對此適應症的專門臨床研究。此為 TxGNN 模型預測結果，需進一步驗證。
4. cerebrovascular disorder L1 99.71%
臨床試驗（6 項）
| 試驗編號 | 階段 | 狀態 | 人數 | 主要發現 |
|---|---|---|---|---|
| NCT03993119 | N/A | COMPLETED | 500 | Non-Interventional, Cross-sectional Study to Describe NOACs Management in Elderl... |
| NCT01288352 | PHASE4 | COMPLETED | 2789 | Early Therapy of Atrial Fibrillation for Stroke Prevention Trial (EAST). |
| NCT01856075 | N/A | COMPLETED | 1015 | Relative Effectiveness of Dronedarone vs. Other Treatments of Atrial Fibrillatio... |
| NCT06125925 | NA | RECRUITING | 436 | Catheter Ablation in Atrial Fibrillation Patients With Heart Failure With Preser... |
| NCT05293080 | PHASE3 | NOT_YET_RECRUITING | 1746 | Early Treatment of Atrial Fibrillation for Stroke Prevention Trial in Acute STRO... |
| NCT06096337 | NA | ACTIVE_NOT_RECRUITING | 484 | A Prospective Randomized Multicenter Global Study Comparing Pulsed Field Ablatio... |
相關文獻（20 篇）
| PMID | 年份 | 類型 | 期刊 | 主要發現 |
|---|---|---|---|---|
| 22166900 | 2012 | Article | Lancet (London, England) | Atrial fibrillation. |
| 22149318 | 2011 | Article | American journal of cardiovasc | Dronedarone and the incidence of stroke in patients with paroxysmal or persisten... |
| 22682206 | 2012 | Article | Neurologia (Barcelona, Spain) | [Prevention of cardioembolic stroke]. |
| 20396635 | 2010 | Article | Clinical interventions in agin | Impact of dronedarone in atrial fibrillation and flutter on stroke reduction. |
| 30528621 | 2019 | Article | International journal of cardi | Impact of dronedarone on the risk of myocardial infarction and stroke in atrial ... |
| 27693025 | 2017 | Article | Revista espanola de cardiologi | Concomitant Rivaroxaban and Dronedarone Administration in Patients With Nonvalvu... |
| 21296333 | 2011 | Article | The American journal of cardio | Rhythm- and rate-controlling effects of dronedarone in patients with atrial fibr... |
| 25820938 | 2015 | Article | The Cochrane database of syste | Antiarrhythmics for maintaining sinus rhythm after cardioversion of atrial fibri... |
| 25004988 | 2014 | Article | Current cardiology reviews | Are we at the goal line with the novel oral anticoagulants and have we reached t... |
| 36398362 | 2022 | Article | Expert opinion on pharmacother | Pharmacotherapy for stroke prevention in nonvalvular atrial fibrillation: curren... |
| 31898737 | 2020 | Article | Europace : European pacing, ar | Do amiodarone and dronedarone prevent thrombo-embolic stroke by treating the atr... |
| 23709402 | 2013 | Article | Drugs & aging | Atrial fibrillation in the elderly. |
| 40295782 | 2025 | Article | Europace : European pacing, ar | Dronedarone provides effective early rhythm control: post-hoc analysis of the AT... |
| 22082198 | 2011 | Article | The New England journal of med | Dronedarone in high-risk permanent atrial fibrillation. |
| 22920480 | 2012 | Article | Current cardiology reviews | Stroke prevention in atrial fibrillation: concepts and controversies. |
| 22366819 | 2012 | Article | Cardiovascular drugs and thera | Pleiotropic effects of dronedarone on ischemia/reperfusion injury in heart and b... |
| 21323608 | 2011 | Article | Expert opinion on pharmacother | Antiarrhythmic drugs for atrial fibrillation. |
| 37000581 | 2023 | Article | Europace : European pacing, ar | Cardiovascular outcomes in patients with atrial fibrillation concomitantly treat... |
| 29776576 | 2018 | Article | International journal of cardi | Safety of apixaban in combination with dronedarone in patients with atrial fibri... |
| 30578095 | 2019 | Article | International journal of cardi | Apples will never be oranges, but when you go fishing you may get a bite. |
5. brain stem infarction L5 99.71%
目前尚無針對此適應症的專門臨床研究。此為 TxGNN 模型預測結果，需進一步驗證。
6. sick sinus syndrome 2, autosomal dominant L5 99.63%
目前尚無針對此適應症的專門臨床研究。此為 TxGNN 模型預測結果，需進一步驗證。
7. duodenal obstruction L5 99.56%
目前尚無針對此適應症的專門臨床研究。此為 TxGNN 模型預測結果，需進一步驗證。
8. cerebral artery occlusion L2 99.44%
臨床試驗（1 項）
| 試驗編號 | 階段 | 狀態 | 人數 | 主要發現 |
|---|---|---|---|---|
| NCT05130268 | PHASE4 | COMPLETED | 339 | Pragmatic Randomized Clinical Trial of Early Dronedarone Versus Usual Care to Ch... |
9. sarcoglycanopathy L5 99.43%
目前尚無針對此適應症的專門臨床研究。此為 TxGNN 模型預測結果，需進一步驗證。
10. Wildervanck syndrome L5 99.37%
目前尚無針對此適應症的專門臨床研究。此為 TxGNN 模型預測結果，需進一步驗證。
資料來源：DDInter 2.0（原文內容請參閱該網站）
**葡萄柚汁** 🟢 Minor
- 影響：影響藥物代謝。可能增加藥物血中濃度。
- 建議：建議避免併用。避免食用葡萄柚或葡萄柚汁。
### 藥物-草藥交互作用 (DHI)
**聖約翰草（貫葉連翹）** 🔴 Major
- 影響：聖約翰草降低 Dronedarone 血中濃度
- 建議：禁止併用
### 藥物-疾病注意事項 (DDSI)
資料來源：DDInter 2.0（原文內容請參閱該網站）
**Cardiomyopathies** 🟢 Minor
- 本藥物在此情況下禁用。可能有致命風險。
**肝臟疾病** 🟢 Minor
- 本藥物在此情況下禁用。可能需要調整劑量。可能有嚴重不良反應。
## 結論與下一步
**決策：Proceed with Guardrails**
**理由：**
Dronedarone 透過維持竇性心律和潛在的抗血栓機制，可能對中風預防有效。
ATHENA 試驗已顯示其在中風/TIA 預防方面的益處，但需注意適應症限制。
**若要推進需要：**
- 排除永久性心房纖維顫動和嚴重心衰竭患者
- 嚴格的肝功能監測計畫
- 與抗凝血藥物併用策略的優化研究
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本報告僅供學術研究參考，不構成醫療建議。藥物使用請遵循醫師指示，切勿自行調整用藥。任何老藥新用決策需經過完整的臨床驗證與法規審查。
最後審核：2026-02-20 | 審核者：TwTxGNN Research Team
本報告僅供學術研究參考，不構成醫療建議。藥物使用請遵循醫師指示，切勿自行調整用藥。任何老藥新用決策需經過完整的臨床驗證與法規審查。
最後審核：2026-02-20 | 審核者：TwTxGNN Research Team
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