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与他类药物相关的肝毒性:基于FAERS数据库的回顾性药监测研究
1Department of Pharmacy, Chengdu Second People's Hospital, Chengdu, Sichuan, China.
PloS one
|July 9, 2025
概括
类药物与药物诱导的肝损伤 (DILI) 有关. 弗卢瓦斯塔丁,阿托瓦斯塔丁和西姆瓦斯塔丁具有最高的DILI风险,特别是在老年人中. 这项研究使用现实世界的数据来评估药物安全性.
科学领域:
- 药物监督 药物监督 药物监督
- 肝病学 肝病学是一种肝病学.
- 药品安全 药品安全
背景情况:
- 类药物是被广泛处方的降胆固醇药物.
- 药物诱导性肝损伤 (DILI) 是与他类药物使用相关的已知风险.
- 现实世界的数据对于评估常用药物的安全性至关重要,如他类药物.
研究的目的:
- 调查与他类药物相关的药物诱导性肝损伤 (DILI) 的发生率和特征.
- 通过使用现实世界的数据,评估不同类他类药物之间DILI的比较风险.
- 在大量患者群体中评估他类药物的药物安全性.
主要方法:
- 从2004年到2023年利用美国食品和药物管理局的不良事件报告系统 (FAERS) 数据库.
- 提取了类他类药物是DILI的主要疑似原因的病例.
- 使用报告的赔率比率 (ROR) 和信息组件 (IC) 进行了不成比例分析,以确定显著的关联.
主要成果:
- 鉴定了7779例与他类药物相关的DILI.
- 65岁以上的患者和女性更经常受到影响.
- 弗鲁斯塔丁,阿托瓦斯塔丁和西姆瓦斯塔丁表现出最强的DILI信号 (ROR).
- 老年患者 (≥65岁) 对于几种他类药物显示出更强的DILI信号.
- 西姆瓦斯塔丁与最高的死亡率 (12.15%) 有关.
结论:
- 根据FAERS数据,六种他类药物与肝损伤有显著的关联.
- 弗鲁斯塔丁,阿托瓦斯塔丁和西姆瓦斯塔丁是DILI的最大风险.
- 这些研究结果强调了在使用他类药物治疗期间监测肝功能的重要性,尤其是在老年患者中.
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