与帕利皮里棕酸盐相关的不良事件的多维评估:使用FAERS和JADER数据库进行现实世界药监测研究
Siyu Lou1, Zhiwei Cui2, Yingyong Ou1
1Department of Respiratory and Critical Care Medicine, Affiliated Hospital of Zunyi Medical University, 149 Dalian Road, huichuan district, Zunyi, Guizhou, 563003, People's Republic of China.
BMC psychiatry
|January 20, 2025
概括
这项研究使用大型数据库分析了帕利皮里棕酸盐的真实世界不良药物事件 (ADEs). 它确定了已知的和意想不到的副作用,包括性别特异性风险,以提高患者的安全性.
科学领域:
- 药物监督 药物监督 药物监督
- 临床药理学 临床药理学
- 数据挖掘 数据挖掘
背景情况:
- 帕利皮里棕酸是一种广泛使用的第二代抗精神病药物.
- 有限的现实世界的安全数据存在于 paliperidone palmitate 在大量人群中.
- 评估现实世界药物不良事件 (ADEs) 对于理解安全性概况至关重要.
研究的目的:
- 为了全面评估与paliperidone palmitate相关的现实世界的ADEs.
- 使用数据挖掘技术识别重要的安全信号.
- 为加强临床监测提供性别特异性风险见解.
主要方法:
- 在美国FDA不良事件报告系统 (FAERS) 和日本不良药事件报告 (JADER) 数据库中利用数据挖掘.
- 使用不成比例分析,包括ROR,PRR,BCPNN和MGPS来检测显著的ADE信号.
- 分析了2009-2024年 (FAERS) 和2013-2024年 (JADER) 的ADE报告.
主要成果:
- 在FAERS中确定了27,672份ADE报告,在JADER中确定了1,065份ADE报告.
- 在FAERS中检测到285个显著的ADE信号,在JADER中检测到51个,有35个重叠信号.
- 常见的ADEs包括增加的益乳素和银河;意想不到的信号包括心理性障碍和突然死亡.
- 观察到的性别差异:女性更容易患上高血和体重增加,男性更容易患上性功能障碍.
结论:
- 来自FAERS和JADER的现实世界数据为帕利皮里棕酸盐提供了关键的安全见解.
- 确定了预期的和新的ADE信号,提高了对该药物的安全性概况的理解.
- 针对性别的监测建议可以改善帕利皮里棕酸盐的临床监测和风险管理.
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