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房颤合并心力衰竭患者中普罗帕酮与胺碘酮相关的不良心脏结局

Propafenone- vs. amiodarone-associated adverse cardiac outcomes in patients with atrial fibrillation and heart failure.

作者信息

Lin Yi-Cheng, Chen Bi-Li, Hsu Chien-Yi, Chen Li-Ying, Lin Shing-Jong, Lip Gregory Y H, Chien Li-Nien, Huang Chun-Yao

机构信息

Department of Pharmacy, Taipei Medical University Hospital, Taipei, Taiwan.

School of Pharmacy, College of Pharmacy, Taipei Medical University, Taipei, Taiwan.

出版信息

Br J Clin Pharmacol. 2025 Sep;91(9):2567-2575. doi: 10.1002/bcp.70068. Epub 2025 Apr 27.

Abstract

AIMS

Clinical trials have shown an increased risk of death in patients with recent myocardial infarction who received antiarrhythmic drugs such as flecainide, encainide or moricizine, especially in the presence of associated structural heart disease such as cardiac dysfunction. This study aimed to evaluate the safety outcomes of propafenone use in atrial fibrillation patients with heart failure when compared to those of amiodarone use.

METHODS

This population-based cohort study used the National Health Insurance Research Database in Taiwan. Eligible patients were those who had atrial fibrillation or atrial flutter diagnosis, had heart failure diagnosis, and first received propafenone or amiodarone between 2002 and 2018. The primary endpoints were death due to arrhythmia and the composite proarrhythmic outcome, which consisted of sudden cardiac arrest, arrhythmic death, ventricular arrhythmia and implantation of defibrillator.

RESULTS

After propensity score matching, the study cohort consisted of 7235 propafenone and 14 470 amiodarone users. Compared to amiodarone, propafenone was associated with significantly lower risk of the composite proarrhythmic outcome (adjusted hazard ratio: 0.52; 95% confidence interval: 0.42-0.64; P < .001). Propafenone users also had lower risk of death owing to arrhythmia compared to amiodarone users (adjusted hazard ratio: 0.22; 95% confidence interval: 0.08-0.65; P = .006). Subgroup analysis and sensitivity analysis showed similar trends, favouring propafenone.

CONCLUSION

Propafenone was not significantly associated with increased risk of proarrhythmia and mortality when compared to amiodarone in atrial fibrillation patients with heart failure in contemporary real-world settings. Prospective studies are needed to determine whether propafenone should definitely be avoided in these patients.

摘要

目的

临床试验表明,近期发生心肌梗死的患者使用氟卡尼、恩卡尼或莫雷西嗪等抗心律失常药物后死亡风险增加,尤其是在伴有心脏功能障碍等结构性心脏病的情况下。本研究旨在评估与使用胺碘酮相比,普罗帕酮用于心力衰竭合并心房颤动患者的安全性结局。

方法

这项基于人群的队列研究使用了台湾的国民健康保险研究数据库。符合条件的患者为诊断为心房颤动或心房扑动、诊断为心力衰竭且在2002年至2018年间首次使用普罗帕酮或胺碘酮的患者。主要终点为心律失常导致的死亡以及心律失常综合结局,后者包括心脏骤停、心律失常性死亡、室性心律失常和植入除颤器。

结果

经过倾向评分匹配后,研究队列包括7235名使用普罗帕酮的患者和14470名使用胺碘酮的患者。与胺碘酮相比,普罗帕酮与心律失常综合结局的风险显著降低相关(调整后风险比:0.52;95%置信区间:0.42 - 0.64;P < 0.001)。与使用胺碘酮的患者相比,使用普罗帕酮的患者因心律失常导致的死亡风险也更低(调整后风险比:0.22;95%置信区间:0.08 - 0.65;P = 0.006)。亚组分析和敏感性分析显示了相似的趋势,支持普罗帕酮。

结论

在当代真实世界环境中,对于心力衰竭合并心房颤动的患者,与胺碘酮相比,普罗帕酮与心律失常和死亡风险增加无显著关联。需要进行前瞻性研究以确定在这些患者中是否绝对应避免使用普罗帕酮。

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