与塔克罗利斯相关的出血事件:现实世界的药监测研究
Haolin Teng1, Honglan Zhou1, Faping Li1
1Department of Urology, The First Hospital of Jilin University, Changchun, Jilin Province, China.
Expert opinion on drug safety
|July 16, 2024
概括
这项研究分析了来自FAERS数据库的1500多起与tacrolimus相关的出血事件. 胃肠道出血是最常见的,超过三分之一的病例发生死亡,特别是脑出血.
科学领域:
- 药物监督 药物监督 药物监督
- 临床医学 临床医学
- 免疫抑制是一种免疫抑制.
背景情况:
- 塔克罗利马斯是预防器官移植排斥的重要免疫抑制剂.
- 出血是塔克罗利木斯治疗的已知但未被描述的副作用.
- 关于与塔克罗利斯相关的出血事件特征的数据有限.
研究的目的:
- 为了全面描述FAERS数据库中报告的与tacrolimus相关的出血事件.
- 描述塔克罗利斯诱导出血的发生率,类型和结果.
- 确定与这些不良事件相关的潜在模式和风险因素.
主要方法:
- 从2004年到2022年对美国FDA不良事件报告系统 (FAERS) 数据库的回顾性分析.
- 包括与塔克罗利斯相关的不良事件,重点是出血.
- 对出血事件的子组分析,以确定特定的特征和结果.
主要成果:
- 在总的75,310个不良事件中,确定了与塔克罗利斯相关的1,511个出血病例.
- 胃肠道出血是最常见的类型,占病例的27.93%.
- 在36.93%的出血病例中报告了死亡率,其中脑出血是最致命的.
结论:
- 这项研究提供了迄今为止最大的塔克罗利斯相关出血事件描述系列.
- 确定了与塔克罗利斯相关的以前未报告的出血事件.
- 研究结果强调了与塔克罗利斯诱导出血相关的显著发病率和死亡率,强调了需要警监测的必要性.
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