通过FAERS和vigibase的先进信号检测,对GLP-1受体主因子相关的眼科风险进行多数据库药监测评估
Xiao Cheng1, Ziwei Jiang2, Guangyao Li1
1Department of Pharmacy, Beijing Tongren Hospital, Capital Medical University, Beijing, China.
Journal of endocrinological investigation
|September 29, 2025
概括
类似葡萄糖类-1受体激动剂 (GLP-1RA) 显示出新出现的眼睛风险,特别是NAION与塞马格卢提德和视力损伤与杜拉格卢提德. 对于这些糖尿病和肥胖药物,需要加强警和标签更新.
科学领域:
- 药监和药物安全 药监和药物安全
- 眼科医生 眼科 眼科
- 内分泌学 在内分泌学.
背景情况:
- 扩大GLP-1RA用于2型糖尿病和肥胖的使用,引发了对眼部不良事件 (AE) 的担忧.
- 现有的关于GLP-1RA眼部毒性的药监数据是零碎的,而且在方法上有限.
- 需要对眼睛毒性信号进行系统评估,以全面描述风险.
研究的目的:
- 系统地评估与五种GLP-1RA (exenatide,liraglutide,dulaglutide,semaglutide,lixisenatide) 相关的眼部毒性信号.
- 分析来自FAERS和VigiBase的数据,以寻找与GLP-1RA相关的眼部AE.
- 为了描述眼睛AEs的风险概况和时间模式.
主要方法:
- 分析了来自FAERS (2005-2025) 和VigiBase (1987-2025) 的五个GLP-1RA的眼睛AE.
- 采用贝叶斯式 (IC025 > 0) 和频率式 (ROR 95% CI > 1) 的不成比例分析来识别显著的信号.
- 不包括重复报告和不完整的数据;在R和Excel中进行统计处理.
主要成果:
- 对于NAION (非动脉炎前部缺血光学神经病变) 的信号最强;对于视力障碍和糖尿病视网膜病变的信号最强的是dulaglutide.
- 早期发病的副作用 (≤30天) 常见于杜拉格卢提德和塞马格卢提德;晚期发病 (>360天) 埃克萨纳提德.
- 处方信息不完全描述了眼睛的AE,数据库之间存在差异.
结论:
- GLP-1RAs,特别是半黄和双黄,与未被认可的眼部安全信号有关.
- 独特的AE概况和时间模式突显了GLP-1RA眼部毒性的复杂性.
- 建议加强临床警,有针对性的监测和标签更新,以解决新出现的眼部安全问题.
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