美国食品和药物管理局 (FDA) 的不良事件报告系统对ibuprofen的事件进行了现实世界的不成比例分析
Yikuan Du1, Zhuoming Guo2, Bijun Xu2
1Central Laboratory, The Tenth Affiliated Hospital of Southern Medical University, Dongguan, China.
Expert opinion on drug safety
|April 30, 2024
概括
这项研究确定了布洛芬的新不良事件,包括生殖和乳腺疾病,并建议管酸性和唇作为潜在的风险. 这些发现有助于安全使用布洛芬和合理的临床剂量.
科学领域:
- 药物监督 药物监督 药物监督
- 药品安全 药品安全
- 临床药理学 临床药理学
背景情况:
- 布洛芬是一种广泛使用的非处方药 (OTC) 抗发烧和止痛药.
- 增加的布洛芬使用与更多报告的不良事件 (AE) 相关联,需要系统报告和分析.
- 有效的药物监测对于评估药物的益处和风险至关重要.
研究的目的:
- 系统地识别和报告与布洛芬相关的潜在不良事件 (AE) 和不良药物反应 (ADR).
- 在器官系统类 (SOC) 和首选术语 (PT) 层面分析布洛芬AEs.
- 提供基于证据的参考资料,以合理的临床Ibuprofen剂量.
主要方法:
- 通过OpenVigil 2利用了FAERS数据库中的数据.
- 使用MySQL,Microsoft Excel和R语言进行了词汇映射.
- 应用了四个严格的算法来检测ibuprofen AEs的风险信号.
主要成果:
- 在18年内确定了878个与布洛芬相关的初级副作用.
- 在生殖系统和乳腺疾病中检测到意想不到的副作用作为显著的SOC.
- 建议管酸性和唇作为基于651个PT的新型布洛芬AE信号.
结论:
- 突出了在SOC和PT水平上显著的潜在副作用和异常反应.
- 提供了关于ibuprofen处方的知情决策的宝贵见解.
- 支持推广布洛芬的合理临床剂量实践.
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