与药物相关的眼部损伤的现实世界景观:一个回顾性药监测研究
Guangyao Li1, Zhihui Song1, Shuning Li2
1Department of Pharmacy, Beijing Tongren Hospital, Capital Medical University, Beijing, China.
Frontiers in pharmacology
|February 6, 2026
概括
感官器官药物和生物药物构成与药物相关的眼损伤的最高风险,特别是在治疗的早期. 监测女性和老年患者的眼睛症状对于药物监测至关重要.
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
- 流行病学 流行病学
背景情况:
- 药物诱导的眼睛损伤是一个重大的公共卫生问题.
- 了解流行病学模式和风险因素对于患者安全至关重要.
- 美国食品和药物管理局的不良事件报告系统 (FAERS) 是药物监测的宝贵资源.
研究的目的:
- 使用FAERS数据识别与药物相关的眼部损伤的风险信号.
- 描述这些不良事件的现实世界流行病学特征.
- 为药物的安全临床使用提供基于证据的指导.
主要方法:
- 从FAERS (2004年第一季度 - 2024年第四季度) 提取与"眼部疾病"相关的不良事件报告.
- 应用不相称性分析来检测药物和眼睛损伤的关联.
- 使用韦布尔分布建模对时间到发病 (TTO) 的分析.
主要成果:
- 在2696种可疑药物中,有359种符合信号检测标准.
- 感官器官药物 (ROR=4.93) 和抗瘤/免疫调节剂 (ROR=0.84) 是高风险类别.
- 布罗卢齐祖马布 (ROR=132.15),马克罗戈尔400 (ROR=117.96) 和塞内格林 (ROR=60.19) 的信号强度是最高的.
- 视力模糊,视力障碍和白内障是最常见的眼睛损伤.
- 大多数药物表现出"早期失效类型"TTO (β < 1).
结论:
- 与药物相关的眼部损伤与感官器官药物和生物药物有显著的联系.
- 在药物治疗的早期阶段观察到的风险最高.
- 建议在治疗开始时优先监测女性和老年患者的眼部症状,以加强药物监测和个性化药物治疗策略.
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