与药物相关的深静脉血栓:FDA不良事件报告系统 (FAERS) 数据库的不成比例分析
Ying Liu1, Jintuo Zhou1, Lihuan Song2
1Department of Pharmacy, Fujian Maternity and Child Health Hospital College of Clinical Medicine for Obstetrics & Gynecology and Pediatrics, Fujian Medical University, #18 Daoshan Road, Fuzhou, China.
Naunyn-Schmiedeberg's archives of pharmacology
|January 27, 2026
概括
这项研究使用药物监测数据确定了88种与深静脉血栓症 (DVT) 相关的药物. 激素疗法,免疫调节剂和抗癌药物显示出显著的DVT风险,需要仔细监测.
科学领域:
- 药理学 药理学是指药理学的学科.
- 药品安全 药品安全
- 现实世界的证据.
背景情况:
- 与药物相关的深静脉血栓形成 (DVT) 是一个日益令人担忧的问题,其风险不完全理解.
- 现实世界的药监数据对于识别药物安全信号至关重要.
研究的目的:
- 系统地检测和描述DVT的药物安全信号.
- 分析已识别的与药物相关的DVT事件的时间到发病概况.
主要方法:
- 对FDA不良事件报告系统 (FAERS) 数据 (2004-2025) 的不成比例分析.
- 使用四个指标 (ROR,PRR,BCPNN,MGPS) 来识别DVT安全信号.
- 使用韦布尔分布和卡普兰-梅尔分析评估时间到发病 (TTO).
主要成果:
- 88种药物达到预定义的DVT信号值.
- 最重要的药物包括荷尔蒙避孕药,莱纳利多米德,和贝瓦西祖马布.
- 平均TTO为120天;25.87%的事件发生在第一个月内,早期发病频繁.
结论:
- 确定了强大的DVT信号,用于荷尔蒙疗法,免疫调节剂和向抗癌药物.
- 强调需要对这些药物类别进行主动的血栓形成风险评估和监测.
- 强调现实世界数据在药物安全监测中的重要性.
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