与直接口服抗凝剂使用相关的痴呆相关的不良事件:基于FAERS数据库的现实世界药监测研究
Hanxu Zhang1, Mengya Li2, Wei Liu2
1Department of Pharmacy, Tianjin Medical University General Hospital, Tianjin, China.
Expert opinion on drug safety
|April 10, 2025
概括
直接口服抗凝剂 (DOAC) 与痴呆不良事件有关. 阿皮克萨班显示出最强的关联,而里瓦罗克萨班的风险较低,这凸显了对DOAC和认知健康的进一步研究的需要.
科学领域:
- 药物监督 药物监督 药物监督
- 神经学 神经学
- 临床药理学 临床药理学
背景情况:
- 直接口服抗凝剂 (DOAC) 是广泛用于血栓栓塞病的药物.
- 评估与DOAC相关的潜在不良事件 (AE) 对患者安全至关重要.
- 与痴呆症相关的副作用在使用抗凝血剂的老年人群中是一个重大问题.
研究的目的:
- 评估和比较与不同DOAC相关的痴呆相关不良事件 (AE).
- 确定哪些DOAC可能与认知障碍有更强的关联.
- 在患有痴呆风险的患者中选择抗凝剂的临床实践中提供信息.
主要方法:
- 利用FDA不良事件报告系统 (FAERS) 数据库从2014年1月到2023年6月的AE数据.
- 使用不成比例分析,包括报告几率比率 (ROR),以评估DOAC和与痴呆相关的AE之间的关联.
- 分析了特定的DOACs:达比加特兰,里瓦罗克萨班,阿皮克萨班和埃多克萨班.
主要成果:
- 阿皮克萨班与痴呆相关的副作用的关联最强 (ROR 7.66),而里瓦罗克萨班显示最低 (ROR 0.95).
- 妇女在所有DOAC中表现出较高的ROR,特别是与阿皮克萨班.
- 亚组分析证实了阿皮克萨班与各种形式的痴呆症 (包括阿尔茨海默氏症) 之间存在显著联系.
结论:
- 在研究的DOAC中,阿皮克萨班似乎与痴呆症相关的副作用的关联率最高.
- 与其他DOAC相比,利瓦罗克萨班可能会降低与痴呆相关的AE的风险.
- 需要进行前性研究来验证这些发现,并澄清DOAC和认知衰退之间的关系.
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