药监察对与药物相关的静脉血栓栓塞的见解
Xiaojin Cai1, Guoquan Chen2, Haiping Wang3
1Department of Pharmacy, The Third Affiliated Hospital, Wenzhou Medical University, Wenzhou, China.
International journal of surgery (London, England)
|July 3, 2025
概括
这项研究确定了135种与静脉血栓塞栓症 (VTE) 风险相关的药物,其中58种缺乏VTE警告. 抗瘤药物和免疫调节剂构成最高风险,突出显示需要更新临床指导.
科学领域:
- 药物监督 药物监督 药物监督
- 药品安全 药品安全
- 血栓栓塞瘤研究研究
背景情况:
- 静脉血栓栓塞 (VTE) 是住院和死亡的重要原因,药物使用是获得的风险因素.
- 这项研究解决了对与药物相关的VTE风险进行系统评估的需要.
研究的目的:
- 使用大型不良事件数据库系统评估与药物相关的VTE风险.
- 确定具有显著VTE风险的特定药物和药物类别.
主要方法:
- 利用了美国食品和药物管理局不良事件报告系统数据 (2004-2024) 的不成比例分析.
- 使用Weibull分布建模进行时间到事件分析.
- 按解剖治疗化学分类分层的药物.
主要成果:
- 确定了135种具有显著VTE风险信号的药物,58种药物在包装插件中没有提到.
- 抗瘤药物和免疫调节剂的风险最高 (47.4%),其次是生殖-泌尿系统/性激素 (25.2%).
- 随着时间的推移,VTE报告和死亡人数有所增加,主要影响45-64岁的女性.
结论:
- 135种药物显示出对VTE风险的积极信号,58种药物缺乏足够的警告.
- 抗瘤剂和免疫调节剂代表了VTE的高风险概况.
- 结果提供了基于数据的指导,以减轻临床药物治疗中的VTE风险.
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