通过FAERS数据库分析螺旋的现实世界不良事件
Guowei Lin1, Ru Chen2, Chaoning Wen1
1Department of Urology, Putian University Affiliated Hospital, Putian, Fujian, China.
PloS one
|September 17, 2025
概括
这项研究分析了FDA对螺旋乳的不良事件报告,识别了罕见的不良药物事件 (ADEs),如男性子宫内膜异位症. 研究结果强调需要进一步的研究来确认安全信号和指导临床管理.
科学领域:
- 药物监督 药物监督 药物监督
- 药物安全分析 药物安全分析
- 临床药理学 临床药理学
背景情况:
- 斯皮罗诺拉克是一种广泛使用的节性利尿剂,用于心力衰竭,高血压和高阿尔多斯特隆症.
- 了解其安全概况对于患者护理至关重要.
研究的目的:
- 分析斯皮罗诺拉克的安全性.
- 通过FDA不良事件报告系统 (FAERS) 的不良事件报告来识别潜在的安全信号.
主要方法:
- 从2004年第一季度到2024年第三季度对FAERS数据的回顾性药监测分析.
- 标识和分类与螺旋龙相关的不良药物事件 (ADEs).
- 使用比例报告比率 (PRR),报告几率比率 (ROR),贝叶斯信心传播神经网络 (BCPNN) 和经验贝叶斯几何平均值 (EBGM) 的统计信号检测.
主要成果:
- 鉴定了与螺旋乳相关的8,566个ADE报告.
- 在2409个首选术语和25个器官系统类别中观察到显著的不成比例.
- 检测到的罕见ADEs包括男性子宫内膜异位症 (ROR 13615.84),5-α-减少酶缺乏症 (ROR 1620.81),先天性球脊髓肌肉缩 (ROR 402.42) 和双击淋巴瘤 (ROR 243.12).
结论:
- 大多数发现与已知的螺旋拉克效应一致.
- 确定了与男性子宫内膜异位症的潜在关联,特别是在高危人群中.
- 建议进行进一步的研究,以验证这些信号,并加强长期安全评估.
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