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基于FAERS数据库中不良事件分析的tamsulosin真实世界的安全评估

Zufa Zhang^1,2, Long Lv^1,3, Fengze Jiang^1,3

¹Department of Urology, Affiliated Zhongshan Hospital of Dalian University, Dalian, 116001, Liaoning, China.

Scientific reports

|October 21, 2025

概括

这项研究分析了FDA不良事件报告系统对tamsulosin的数据,揭示了治疗早期常见的副作用以及需要进一步调查的高和疼痛勃起等新安全信号.

科学领域:

药物监督药物监督药物监督
泌尿器科泌尿器科泌尿器科泌尿器科
药品安全药品安全

背景情况:

坦素是一种α-1-上腺体受体对抗剂,在泌尿病学中被广泛使用.
了解其安全概况对于患者护理至关重要.

研究的目的:

通过FDA不良事件报告系统 (FAERS) 数据库评估tamsulosin的安全性.
为了识别与tamsulosin使用相关的潜在安全信号和不良事件.

主要方法:

对FAERS数据的回顾性药监分析 (2004年第一季度 - 2024年第二季度).
使用不成比例分析,邦费罗尼校正,时间序列分析和子组分析.
确定了10,071份报告,其中tamsulosin是主要的可疑药物.

主要成果:

不良事件 (AEs) 呈现出极化分布,集中在早期治疗阶段.
在AE报告中观察到性别特异性差异,特别是在患有良性前列腺增生症 (BPH) 的男性和患有尿路结石的女性中.
除了已知的AE,还检测到了新的安全信号,包括过,囊炎,恐慌反应和疼痛勃起.

结论:

对tamsulosin安全性资料的分析确定了预期的不良事件,并突出了早期与治疗相关的AEs.
检测到的新型安全信号需要谨慎解释和进一步的临床验证.
亚组分析揭示了坦苏洛辛不良事件报告中的重要人口差异.

关键词:

不良事件 (AE) 是指不良事件的发生.良性前列腺增生症 (BPH) 是一种公平的人是公平的.最喜欢的术语 (PT)系统器官类 (SOC) 是一个系统器官类.坦姆苏洛辛 (tamsulosin) 是一种药物.发病时间 (TTO)

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