芬达巴素的不良事件概况:基于FAERS,JADER和VigiAccess数据库的不成比例分析
Wei Jin1, Jianwei Pan2, Lin Yu2
1Department of Pharmacy, The Fourth Affiliated Hospital of School of Medicine, and International School of Medicine, International Institutes of Medicine, Zhejiang University, Yiwu, China.
Frontiers in medicine
|February 23, 2026
概括
芬达巴素与早期出血和其他不良事件有关,特别是在女性和老年人中. 这项药监测研究突出了临床监测的潜在安全信号.
科学领域:
- 药监和药物安全 药监和药物安全
- 现实世界的证据分析 证据分析
- 临床药理学 临床药理学
背景情况:
- 合成糖酸的Fondaparinux是一种强大的XA因子抑制剂.
- 它在临床上用于预防静脉血栓栓塞并治疗急性冠状动脉综合征.
- 由于其广泛的临床使用,全面的安全评估至关重要.
研究的目的:
- 系统地评估市场营销后的 fondaparinux 的安全性.
- 使用现实数据识别潜在的不良事件信号.
- 评估特定的人口分组的安全性.
主要方法:
- 从2004年第一季度到2024年第三季度利用了FDA不良事件报告系统 (FAERS) 数据库.
- 与VigiAccess和日本药物不良事件报告 (JADER) 数据库进行交叉引用.
- 雇员不成比例分析 (ROR,PRR,BCPNN,MGPS) 和时间风险建模.
主要成果:
- 鉴定了5,700份与 fondaparinux 相关的不良事件报告.
- 确认出血并发症的积极信号,早期发病 (中位数为7天).
- 观察到女性出血风险增加,老年人贫血/皮肤缩,儿科患者肝毒性.
结论:
- 这些发现与已知的不良反应一致,并表明芬达巴素的新安全信号.
- 强调需要加强临床监测,特别是在特殊人群中.
- 需要进一步的流行病学研究来确定因果关系.
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