药物诱导的尿:使用FDA和加拿大警数据库的真实世界药监测研究
Xianyu Dai1, Kai Yu1, Yu Chang2
1Department of Urology, The First Hospital of Jilin University, Changchun, China.
Frontiers in pharmacology
|January 21, 2025
概括
药物诱导的尿留 (UR) 报告正在增加. 关于阿比拉,素和恩帕格利弗洛辛的新信号凸显出需要持续的药物安全监测,以了解UR机制.
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:
- 尿 (UR) 是指无法完全清空膀的情况.
- 虽然许多药物与UR有关,但识别致病原体的全面研究有限.
研究的目的:
- 通过使用大型不良事件数据库,分析趋势并识别与UR相关的药物.
- 为了验证UR的潜在新药信号.
主要方法:
- 使用了FDA不良事件报告系统 (FAERS) 和加拿大警不良反应 (CVAR) 数据 (2004-Q1 2024).
- 分析了年度报告趋势,不成比例性 (ROR) 和开始时间.
- 与药物标签和CVAR数据相对应的验证信号.
主要成果:
- 报告了超过16000例UR病例;中位数年龄65岁,53.4%是男性.
- 与抗瘤和抗糖尿病药物相关的UR报告增加;与支气管扩展剂相关的UR报告减少.
- 34种药物的显著信号,最高的RORs是Fesoterodine,Mirabegron,Solifenacin.
- 对于阿比拉,瓦拉环,素,恩帕格利夫洛辛,克洛皮多格雷尔,阿姆洛迪平的新潜在信号;确认了阿比拉,素,恩帕格利夫洛辛.
- 到UR开始的中位时间为29天.
结论:
- 与毒品相关的UR报告显示,在过去二十年中出现了上升趋势.
- 对阿比拉特,素和恩帕格利弗洛辛的验证信号强调需要持续监测药物安全性.
- 进一步的研究对于阐明药物诱导的UR的机制至关重要.
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