直接XA因子抑制剂的不良反应:FAERS数据库的不成比例分析
Yating Qian1, Xinxia Zhao1, Danyi Liu1
1School of Pharmaceutical Sciences, Zhengzhou University, Zhengzhou, Henan, China.
Expert opinion on drug safety
|June 18, 2024
概括
里瓦罗克萨班,阿皮克萨班和埃多克萨班是用于心房动 (AF) 的直接口服抗凝剂 (DOAC). 里瓦罗克萨班具有最高的出血风险,而阿皮克萨班与死亡和心脏/大脑事件有关,而埃多克萨班与脏问题有关.
科学领域:
- 药物监督 药物监督 药物监督
- 心血管医学 心血管医学
- 血液学 血液学 血液学
背景情况:
- 直接口服抗凝剂 (DOACs),如利瓦罗克萨班,阿皮克萨班和埃多克萨班,对于预防中风和心房动 (AF) 中静脉血栓栓塞事件至关重要.
- 了解这些DOAC的比较安全概况对于最佳的患者护理至关重要.
研究的目的:
- 评估和比较利瓦罗克萨班,阿皮克萨班和埃多克萨班的不良事件报告.
- 确定与每个DOAC相关的特定风险,包括出血和非出血事件.
主要方法:
- 使用了FDA不良事件报告系统 (FAERS) 数据库从2018年到2022年.
- 采用不成比例分析方法,包括报告几率比率 (ROR),比例报告比率 (PRR) 和信息组件 (IC).
主要成果:
- 里瓦罗克萨班显示出最显著的出血风险.
- 阿皮克萨班与较高的死亡,心脏和脑部不良事件发生率有关.
- 埃多克萨班对脏和泌尿系统不良事件的风险更为突出.
结论:
- 出血是XA因子抑制剂的关键风险,特别是里瓦洛克萨班.
- 阿皮克萨班和埃多克萨班也与显著的非出血性不良事件有关.
- 临床实践应增加对所有DOACs非出血不良事件的关注.
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