基于文献的严重不良药物事件的案例分析与edoxaban相关
Xuanyu Luan1,2, Dongyang Zhou3, Qingxia Zhang4
1Department of Pharmacology, UCL School of Pharmacy, University College London, London, WC1N 1AX, UK.
European journal of clinical pharmacology
|June 7, 2025
概括
直接口服的XA因子抑制剂edoxaban的严重不良事件 (AEs) 包括出血和血栓事件. 处方者应考虑患者特异性因素和药物相互作用,以尽量减少风险.
科学领域:
- 药理学 药理学是指药理学的学科.
- 临床医学 临床医学
- 药品安全 药品安全
背景情况:
- 埃多克萨班是一种直接口服的XA因子抑制剂,用于预防非膜心房动的中风,以及治疗深静脉血栓和肺栓塞.
- 它提供了与华法林相比较的血栓塞栓保护,降低了严重出血的风险.
- 随着临床使用的增加,由于新出现的严重不良事件 (AE) 报告,需要进行全面的安全评估.
研究的目的:
- 通过分析报告的严重不良事件,对埃多克萨班进行全面的安全评估.
- 确定与严重的AE相关的特征和风险因素.
- 提供基于现实世界的证据的实用处方见解.
主要方法:
- 在6个数据库中进行了系统的文献搜索,截至2024年12月.
- 包括严重的副作用的病例报告,并使用结构化表格提取数据.
- 进行了描述性统计分析,以总结病例特征.
主要成果:
- 确定了41例严重的副作用,包括26例严重出血事件和2例血栓事件.
- 药物错误发生在7个案例中. 同时使用P-gp抑制剂 (9例) 会增加出血风险,而P-gp诱导剂 (2例) 可能会降低疗效.
- 在18例病例中,AE开始的中位时间为一个月内,有6例患者死亡,4例归因于AE.
结论:
- 埃多克萨班的使用与临床风险有关,特别是在老年患者,功能受损患者和同时服用P-gp抑制剂的患者中.
- 该研究证实了已知的风险因素,并提供了对药物错误,不适当的同时使用和非标签使用的实用见解.
- 调查结果强调了个性化风险评估和处方者持续药物监督的重要性.
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