药物诱导的多囊卵巢综合征:基于FAERS数据库的现实世界药监测研究
Huiping Zhang1, Man Di2, Yu Wang3
1Department of Obstetrics and Gynecology, Northwest University First Hospital, Xi'an, Shaanxi, China.
Frontiers in endocrinology
|December 10, 2025
概括
这项研究使用FDA数据确定了与多囊卵巢综合征 (PCOS) 风险相关的18种药物. 影响神经和呼吸系统的药物显示了最高的关联,强调需要仔细监测患者.
科学领域:
- 药物监督 药物监督 药物监督
- 内分泌学 在内分泌学.
- 药品安全 药品安全
背景情况:
- 多囊卵巢综合征 (PCOS) 与各种药物有关,但缺乏系统的研究.
- 了解药物诱导的PCOS风险对于患者安全和临床实践至关重要.
研究的目的:
- 系统地识别和评估与增加PCOS风险相关的药物.
- 使用美国食品和药物管理局不良事件报告系统 (FAERS) 数据库进行全面分析.
主要方法:
- 从FAERS数据库 (2014年第一季度 - 2024年第四季度) 获取PCOS相关的不良事件.
- 使用四种统计方法 (ROR,PRR,BCPNN,MGPS) 进行失衡分析,以检测与药物相关的PCOS风险.
- 进行了延迟 (TTO) 分析,以确定PCOS相关不良反应的发病时间.
主要成果:
- 在1516例病例中,确定了18种与PCOS风险有显著关联的药物.
- 与风险相关的最重要的药物包括Mecasermin,Ciclesonide,Valproic acid和Olanzapine.
- 副作用发生在药物使用的30天内或360天后,平均发病时间因药物而异 (例如,酸:905天).
结论:
- 这是使用FAERS数据对PCOS药物信号进行的首次大规模系统研究.
- 已确定的药物主要影响神经和呼吸系统.
- 这些发现为加强对女性患者的监测提供了关键证据,这些女性患者被处方这些药物以减轻PCOS风险.
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