蒂罗菲班的现实安全性:使用FAERS和WHO-VigiAccess的数据进行不成比例分析
Jia Li1,2, Fang Wang3, Lingquan Zhong1
1Department of Pharmacy, Guangxi Hospital Division of The First Affiliated Hospital, Sun Yat-sen University, Nanning, China.
Frontiers in pharmacology
|December 29, 2025
概括
这项研究使用FAERS和WHO-VigiAccess数据库确定了与铁洛菲班相关的已知和潜在的新不良事件 (AE). 早期监测至关重要,因为AE如出血和血小板缺血的迅速发作.
科学领域:
- 药物监督 药物监督 药物监督
- 药品安全 药品安全
- 临床药理学 临床药理学
背景情况:
- 蒂罗菲班是一种用于急性冠状动脉综合征的抗血小板药物.
- 了解其不良事件 (AE) 概况对于安全的临床应用至关重要.
- 现实世界的数据分析可以揭示超出临床试验数据的安全信号.
研究的目的:
- 为了检测与tirofiban相关的不良事件 (AE) 信号.
- 识别目前药物标签中未列出的潜在的新安全问题.
- 通过全面的安全信号检测,支持提洛菲班更安全的临床使用.
主要方法:
- 使用FAERS和WHO-VigiAccess数据库进行AE报告.
- 使用不成比例分析 (ROR,PRR,BCPNN,MGPS) 来识别药物-AE关联.
- 使用韦布尔分布和卡普兰-梅尔方法评估发病时间,并根据报告者的类型,年龄和性别进行敏感性分析.
主要成果:
- 识别了FAERS提供的2421份报告和WHO-VigiAccess提供的3485份报告.
- 流血和血栓缩是最常见的副作用,符合药物标签.
- 检测到21个未在标签上的潜在AE信号,包括血管支架血栓瘤和心脏性死亡;平均发病时间为12小时.
结论:
- 确定已知和潜在的与铁洛非班相关的新型副作用.
- 强调早期监测迅速发作的AE的重要性,如出血和血小板缺血.
- 提供了现实世界的证据,以指导更安全的蒂罗菲班使用,需要进一步研究以确认因果关系.
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