通过FDA不良事件报告系统进行阿杜卡努马布的真实安全监测研究
Jingjing Huang1, Xiaohong Long2, Chunyong Chen2
1Cardiac Intensive Care Unit, The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, China.
Frontiers in pharmacology
|April 2, 2025
概括
治疗阿尔茨海默病的药物阿杜卡努马布显示,与粉样蛋白相关的成像异常 (ARIA) 是一个关键的安全问题,特别是在老年人中. 严格的监测对于安全使用至关重要.
科学领域:
- 神经科学是一个神经科学.
- 药理学 药理学是指药理学的学科.
- 公共卫生 公共卫生
背景情况:
- 阿尔茨海默氏症 (AD) 是一个重大的全球健康挑战.
- 于2021年批准的阿杜卡努马布是阿尔茨海默病的第一个疾病修饰疗法,需要进行安全性评估.
- 现实世界的安全数据对于了解阿杜卡努马布的临床概况至关重要.
研究的目的:
- 评估阿杜卡努马布的现实安全概况.
- 为了确定与阿杜卡努马布治疗相关的潜在风险因素.
- 使用大型药监数据库分析不良事件模式.
主要方法:
- 一项利用FAERS数据库 (2004-2024) 的药监测研究.
- 分析了510份与aducanumab相关的不良事件报告.
- 使用四种不成比例方法 (ROR,PRR,BCPNN,MGPS) 和按年龄和性别分层分析.
主要成果:
- 神经系统疾病是最常见的不良事件 (53.24%).
- 与粉样蛋白相关的成像异常 (ARIA-E和ARIA-H) 是最重要的安全信号.
- 在75岁以上的患者中观察到ARIA事件的风险增加,中位数发生在146天.
结论:
- 与ARIA相关的事件是aducanumab的主要安全问题.
- 阿杜卡努马布证明是一种可行的治疗选择,在两性之间具有可比的安全性.
- 强调需要严格监测,特别是在治疗的第一年内对ARIA事件进行严格监测.
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