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药物性心力衰竭:一项使用美国食品药品监督管理局不良事件报告系统数据库的真实世界药物警戒研究。

Drug-induced heart failure: a real-world pharmacovigilance study using the FDA adverse event reporting system database.

作者信息

Huang Youqi, Chen Xiaowen, Chen Mingyu, Lin Yuze, Chen Bingqi, Gao Hongjin, Chen Min

机构信息

Shengli Clinical College of Fujian Medical University, Department of Pharmacy, Fujian Provincial Hospital, Fuzhou University Affiliated Provincial Hospital, Fuzhou, China.

College of Pharmacy, Fujian Medical University, Fuzhou, China.

出版信息

Front Pharmacol. 2025 Jan 15;15:1523136. doi: 10.3389/fphar.2024.1523136. eCollection 2024.

DOI:10.3389/fphar.2024.1523136
PMID:39881876
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11775474/
Abstract

OBJECTIVE

Although there are certain drug categories associated with heart failure (HF), most of the associated risks are unclear. We investigated the top drugs associated with HF and acute HF (AHF) reported in the FDA Adverse Event Reporting System (FAERS).

METHODS

We reviewed publicly available FAERS databases from 2004 to 2023. Using the search terms "cardiac failure" or "cardiac failure acute" and classifying cases by drug name, we processed and analyzed drug reports related to HF or AHF.

RESULTS

From 2004 to 2023, 17,379,609 adverse drug events were reported by FAERS, of which 240,050 (1.38%) were reported as HF. Among those with HF, the male-to-female ratio was 0.94% and 52.37% were >65 years old; 46.2% were from the United States. There were 5,971 patients with AHF. We identified 38 drugs and 13 drug classes with a potential high risk of causing HF, and 41 drugs and 19 drug classes were associated with AHF. The median onset times of HF and AHF were 83 days (IQR: 11-416) and 49 days (IQR: 8-259), respectively. The Weibull shape parameter (WSP) test showed early failure-type profile characteristics.

CONCLUSION

This study highlights key drugs associated with drug-induced HF and AHF, emphasizing the importance of early risk assessment and close monitoring, particularly during the initial stages of treatment. These findings contribute to a better understanding of drug-induced HF and provide a basis for future research on its underlying mechanisms.

摘要

目的

尽管有某些药物类别与心力衰竭(HF)相关,但大多数相关风险尚不清楚。我们调查了美国食品药品监督管理局不良事件报告系统(FAERS)中报告的与HF和急性心力衰竭(AHF)相关的顶级药物。

方法

我们查阅了2004年至2023年公开可用的FAERS数据库。使用搜索词“心力衰竭”或“急性心力衰竭”,并按药物名称对病例进行分类,我们处理并分析了与HF或AHF相关的药物报告。

结果

2004年至2023年,FAERS报告了17379609例药物不良事件,其中240050例(1.38%)报告为HF。在HF患者中,男女比例为0.94%,52.37%的患者年龄>65岁;46.2%来自美国。有5971例AHF患者。我们确定了38种药物和13类药物有导致HF的潜在高风险,41种药物和19类药物与AHF相关。HF和AHF的中位发病时间分别为83天(四分位间距:11 - 416)和49天(四分位间距:8 - 259)。威布尔形状参数(WSP)测试显示出早期失效型特征。

结论

本研究突出了与药物性HF和AHF相关的关键药物,强调了早期风险评估和密切监测的重要性,尤其是在治疗初期。这些发现有助于更好地理解药物性HF,并为其潜在机制的未来研究提供基础。

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