小儿病人的XA因子抑制剂的不良事件:元分析和药监测研究
Shan Chong1,2,3, Lan Sun1,2,3, Guangyan Mu1,3
1Institute of Clinical Pharmacology, Peking University First Hospital, Beijing, China.
Paediatric drugs
|January 18, 2025
概括
审查了儿科患者与Xa因子 (FXa) 抑制剂相关的不良事件. 虽然通常可以接受,但常见的出血副作用包括表,在现实数据中指出了出血.
科学领域:
- 药理学 药理学是指药理学的学科.
- 儿科医学 儿科医学
- 临床试验 临床试验
背景情况:
- Xa因子 (FXa) 抑制剂在儿科患者中越来越多地使用.
- 对于安全的临床实践,在这个人口群体中对不良事件 (AE) 的全面数据至关重要.
研究的目的:
- 系统地审查和量化与小儿病患者的Xa因子 (FXa) 抑制剂相关的不良事件 (AEs).
- 为了比较临床试验中的AE概况和现实世界的药监数据.
主要方法:
- 在多个数据库 (PubMed,Embase等) 进行了搜索. 在2023年10月之前进行英语学习.
- 包括随机对照试验和单臂试验;使用贝叶斯等级模型分析了AE.
- 利用美国FDA不良事件报告系统数据 (2007-2023) 进行药监信号检测.
主要成果:
- 超过50%的儿科患者至少经历了一次副作用;9.9%的患者经历了严重的副作用.
- 常见的出血性副作用包括表 (8.4%),皮下血瘤 (6.4%) 和伤口出血 (3.7%).
- 药监数据显示出出血出血,血栓炎和深静脉血栓的显著AE信号.
结论:
- 在儿科患者中使用FXa抑制剂与可接受的AE率有关,表是最常见的出血事件.
- 出血是FXa抑制剂在现实世界的儿科使用中引人注目的问题.
- 建议量身定制的剂量,谨慎的使用和密切的监测,以确保在儿童中安全使用FXa抑制剂.
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