类固醇相关的神经认知障碍:基于FDA不良事件报告系统的现实世界药监测研究
Min Xiao1, Li Li1, Weiwei Zhu1
1Department of Pharmacy, West China Hospital, Sichuan University, Chengdu, China.
Expert review of clinical pharmacology
|January 26, 2024
概括
这项研究发现,他类药物使用与神经认知障碍之间存在显著联系. 这些不良事件的风险,特别是阿托瓦斯塔丁,西姆瓦斯塔丁和普拉瓦斯塔丁,随着年龄的增长而增加.
科学领域:
- 药物监督 药物监督 药物监督
- 神经科学是一个神经科学.
- 临床药理学 临床药理学
背景情况:
- 新出现的担忧将他类药物与神经认知障碍联系起来.
- 之前关于这种关联的研究已经产生了不一致的结果.
- 使用FDA不良事件报告系统 (FAERS) 数据库来调查这种关系.
研究的目的:
- 评估他类药物使用与神经认知障碍的发生之间的关联.
- 确定可能与神经认知障碍事件 (NCDEs) 相关的特定他类药物.
- 探索年龄对他类药物与神经认知障碍相关性的影响.
主要方法:
- 利用了FAERS数据库中的2004年至2022年的数据.
- 在数据标准化后,提取和分析了与他类药物使用相关的神经认知障碍事件 (NCDE) 病例.
- 使用报告几率比率 (ROR) 和信息组件来评估关联的统计意义.
主要成果:
- 确定了6,959个NCDE病例,其中他类药物是主要的疑似药物.
- 检测到对普拉瓦斯塔丁 (ROR 1.49),阿托瓦斯塔丁 (ROR 1.39) 和西姆瓦斯塔丁 (ROR 1.31) 的显著关联.
- 按年龄分层分析显示,65岁及以上的个人和65岁以下的个人都存在关联,老年人群的信号检测范围更广.
结论:
- 在他类药物使用和神经认知障碍事件 (NCDEs) 之间存在显著的关联.
- 特定的他类药物,包括阿托瓦斯塔丁,西姆瓦斯塔丁和普拉瓦斯塔丁,与NCDEs有着显著的关联.
- 观察到,他类药物和NCDEs之间的关联强度随着年龄的增长而增加.
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