在FDA不良事件报告系统 (FAERS) 中,对与循环利尿剂相关的不良事件进行不成比例分析
ZeHu Xue1, Xi Liu1, QiFeng Liu1
1Department of Nephrology, Affiliated Kunshan Hospital of Jiangsu University, Kunshan, China.
BMC pharmacology & toxicology
|March 18, 2025
概括
这项研究揭示了与循环利尿剂相关的新型不良事件,包括维生素B1缺乏与furosemide和免疫反应与bumetanide. 个性化监测对于这些常见药物的更安全的患者结果至关重要.
科学领域:
- 药监和药物安全 药监和药物安全
- 临床药理学 临床药理学
- 现实世界的证据研究研究.
背景情况:
- 循环利尿剂 (富洛塞米德,托塞米德,布梅他尼德) 对于控制液体过载至关重要.
- 虽然已知的风险如电解质失衡已被记录,但新的不良事件 (AE) 信号需要进一步调查.
研究的目的:
- 使用现实世界的数据,识别和描述与循环利尿剂相关的新奇或未被认可的不良事件 (AE) 信号.
- 为增强患者安全和个性化监测策略提供证据.
主要方法:
- 食品和药物管理局不良事件报告系统 (FAERS) 数据 (2004-2024) 的不成比例分析.
- 整合多种统计方法 (ROR,PRR,BCPNN,EBGM) 和多变量逻辑回归.
- 时间到发病 (TTO) 分析,以评估药物暴露和AE发生之间的时间关系.
主要成果:
- 对24,875份AE报告的分析发现了共同的风险 (电解质失衡,流体障碍,毒性) 和新的信号.
- 富罗塞米德与维生素B1缺乏,韦尼克脑病和肠道粘膜色素有关.
- 托塞米德与中性粒状皮肤炎,全身感染,皮虫,出血事件和延长的前列血时间有关.
- 布梅他尼德与血的增加,代谢性脑病变和免疫过敏反应 (SJS,皮虫) 有关.
结论:
- 循环利尿剂与常见和药物特定的不良事件有关,特别是长期使用的代谢和免疫相关问题.
- 建议采用个性化监测策略,包括维生素B1/用于罗塞米德,凝血用于托塞米德,以及代谢/免疫监测用于布米坦尼德.
- 研究结果支持个性化治疗和精确的药物监测,以更安全地使用循环利尿剂.
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