在现实世界中对ospemifene进行不成比例的分析:对FDA不良事件报告系统的公开版本的数据挖掘
Haixiao Wen1, Chong Lu2, Meng Zhang2
1Department of Obstetrics and Gynecology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China.
Expert opinion on drug safety
|August 14, 2023
概括
这项研究通过分析不良事件报告,发现了针对阴缩 (VVA) 的治疗方法ospemifene的新安全问题. 需要进一步的试验来确认这些潜在的眼睛和脏副作用.
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
- 临床研究 临床研究
背景情况:
- 奥斯佩米芬已被批准用于治疗 vulvovaginal 缩 (VVA).
- 这项研究旨在确定与ospemifene相关的不良事件 (AE).
- 使用了美国食品和药物管理局不良事件报告系统 (FAERS) 的数据挖掘.
研究的目的:
- 评估与ospemifene相关的不良事件 (AEs).
- 使用数据挖掘技术识别潜在的安全信号.
- 将发现与现有的临床观察进行比较.
主要方法:
- 使用不成比例分析来测量AE信号.
- 雇员报告概率比率 (ROR),比例报告比率 (PRR),贝叶斯信任传播神经网络 (BCPNN) 和多项马波桑缩小器 (MGPS) 算法.
- 分析了来自FAERS数据库的12,692,824份报告,重点关注奥斯佩米芬作为首要疑似AE.
主要成果:
- 鉴定了2283个首要疑似AE事件对ospemifene.
- 与奥斯佩米芬相关的副作用影响了25个器官系统.
- 检测到726个显著不成比例的首选术语 (PT),包括预期的药物不良反应 (ADR) 和眼睛和脏问题的新信号.
结论:
- 检测到对ospemifene的新型不良事件信号,与临床观察一致.
- 暗示了以前未知的副作用的可能性,特别是涉及眼睛和脏系统.
- 建议进一步进行前性临床试验,以验证这些发现,并支持未来的奥斯佩米芬安全研究.
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