使用FDA不良事件报告系统对药物诱导的低纤维素生成血的药监测分析
1Department of Pharmacy, Medical Supplies Center of Chinese, PLA General Hospital, 28 Fu Xing Road, Beijing, 100853, China.
International journal of clinical pharmacy
|January 31, 2025
概括
这项研究使用FDA不良事件报告系统数据确定了52种与低纤维素生成症相关的药物. 大多数已识别的药物没有列出这种风险,强调需要纤维素素监测.
科学领域:
- 药物监督 药物监督 药物监督
- 临床药理学 临床药理学
- 药品安全 药品安全
背景情况:
- 药物诱导的低纤维素生成性是越来越令人担忧的,原因不明确的致病因子.
- 低纤维素生成症具有显著的临床风险,主要是增加出血.
研究的目的:
- 为了识别和分析经常与药物诱导的低纤维素生成血症相关的药物.
- 使用FDA不良事件报告系统 (FAERS) 数据库进行全面的药物安全分析.
主要方法:
- 对FAERS数据的不成比例分析 (2004年1月 - 2024年3月).
- 采用统计工具,包括报告几率比率 (ROR) 和贝叶斯信心传播神经网络.
主要成果:
- 在超过1760万个病例中,发现了1661例低纤维素生成血症病例.
- 按病例编号排名前列的药物:甲托雷克萨特,tigecycline,tocilizumab,pegaspargase,alteplase. 这几种药物是最常见的.
- 埃拉瓦环素,tigecycline和crotalidae多价免疫Fab显示出高信号强度的低纤维蛋白质血症.
结论:
- 52种药物与低纤维素生成血相关,其中88.5%在处方信息中缺乏此警告.
- 这些发现强调了监测血液中纤维素素水平的重要性.
- 为进一步研究药物诱导的低纤维素生成机制提供参考.
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