在现实世界中评估与他莫西芬相关的血栓栓塞风险
Jiajia Jia1, Chunyu Tian2, Wenchao Han3
1Department of Pharmacy, The Seventh People's Hospital of Zhengzhou, Zhengzhou, 450000, Henan, China. 1041148856@qq.com.
Scientific reports
|July 30, 2025
概括
塔莫西芬 (TAM) 的使用增加了血栓栓塞的风险. 确定了单边和视网膜动脉封闭等新风险,以及男性性别,年龄较大和肥胖症作为关键指标.
科学领域:
- 药物监督 药物监督 药物监督
- 在瘤学瘤学.
- 心血管医学 心血管医学
背景情况:
- 塔莫西芬 (TAM) 与血栓栓塞的风险有关,但需要加强监测的特定事件尚不清楚.
- 现有的处方信息可能不涵盖所有潜在的TAM相关的血栓栓塞事件.
- 利用现实世界的数据对于识别新出现的安全信号至关重要.
研究的目的:
- 通过使用FDA不良事件报告系统 (FAERS) 数据,调查他莫西芬使用与血栓栓塞事件之间的关联.
- 确定需要优先临床监测的特定血栓塞栓事件.
- 为了确定与他莫西芬相关的血栓栓塞结局相关的风险因素.
主要方法:
- 从FAERS (2004年1月 - 2024年12月) 中提取了与他莫西芬相关的不良事件 (AEs).
- 查血栓栓塞病例并应用不成比例分析来检测显著的信号.
- 利用临床优先级评分系统和多变量回归来进行风险因素分析.
主要成果:
- 在385个与他莫西芬相关的事件中,确定了28个显著的血栓栓塞信号.
- 新发现的信号包括单侧,视网膜动脉封闭和心房血栓.
- 男性性别,年龄较大和体重指数较高是血栓栓塞的重要风险指标.
结论:
- 结果表明,在使用塔莫西芬的患者中,加强了针对特定血栓栓塞事件的临床监测.
- 已识别的风险因素可以帮助对他莫西芬风险分层进行分层.
- 建议进行进一步的验证研究以确认这些安全信号.
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