怀孕前和怀孕期间的药物暴露和血栓栓塞事件:来自FAERS数据库的不成比例分析
Lei Wang1, Yinping Liu, Shujuan Zhao
1Department of Pharmacy, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, School of Clinical Medicine, Henan University, Zhengzhou, China.
International journal of surgery (London, England)
|December 5, 2025
概括
这项研究使用美国FDA数据确定了40种与怀孕相关的血栓栓塞事件 (PTEs) 风险信号药物. 研究结果强调在怀孕前和怀孕期间评估药物暴露风险.
科学领域:
- 药物监督和药物安全研究.
- 生殖健康和产科.
- 临床药理学和治疗学.
背景情况:
- 有限的现实世界数据存在于药物暴露后与怀孕相关的血栓栓塞事件 (PTEs).
- 以前的研究通常依赖于小规模的回顾性分析.
- 为了评估与药物相关的PTE风险,进行了一项药监测研究.
研究的目的:
- 使用现实数据识别与PTE相关的药物.
- 评估怀孕前或怀孕期间药物暴露与PTE之间的关联.
- 探索与PTE病例严重结局相关的因素.
主要方法:
- 分析来自美国食品和药物管理局的不良事件报告系统 (FAERS) 数据库的报告.
- 不成比例性分析用于检测具有对PTE积极风险信号的药物.
- 多变量后勤回归用于识别与严重结果相关的因素 (残疾,危及生命的事件,死亡).
主要成果:
- 分析了4122份报告,确定了40种具有PTE积极风险信号的药物.
- 乙烯二醇-乙格斯特,多斯匹伦-乙烯二醇和罗菲科西布显示出显著的风险信号.
- 乙inylestradiol-etonogestrel,rofecoxib和dinoprostone与严重的结果有显著的关联;多斯匹伦-乙inylestradiol显示有保护作用.
结论:
- 在FAERS数据库分析中,提供了具有PTE潜在风险信号的药物清单.
- 怀孕前和怀孕期间的药物暴露是血栓栓塞瘤风险评估的关键考虑因素.
- 对于与PTE有不清楚关联的药物,需要进行进一步的精心设计的研究.
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