抗VEGF治疗与已报告的眼部不良事件的关联:全球药监分析
Moiz Lakhani1, Angela T H Kwan1, Deeksha Kundapur2
1Faculty of Medicine, University of Ottawa, Ottawa, Ontario, Canada; The University of Ottawa Eye Institute, Ottawa, Ontario, Canada.
Ophthalmology. Retina
|September 3, 2025
概括
抗血管内皮生长因子 (VEGF) 治疗表现出不同的眼部不良事件概况. 布罗卢齐祖马布的眼内炎症风险最高,而阿弗利塞普特的眼内炎症风险最高.
科学领域:
- 眼科 眼科
- 药物监督管理
- 视网膜疾病
背景情况:
- 抗血管内皮生长因子 (VEGF) 治疗对于治疗新血管与年龄相关的黄斑变性,糖尿病黄斑胀和视网膜静脉封闭至关重要.
- 实际数据对于了解这些广泛使用的药物的安全性是必不可少的.
研究的目的:
- 评估和比较不同抗VEGF药物报告的眼部不良事件的不成比例.
- 为了确定与拉尼比祖马布,阿弗利伯塞普特,布罗卢齐祖马布和法里西马布相关的特定眼部AE概况.
主要方法:
- 一个基于人口的观察性药监研究,使用FDA不良事件报告系统 (FAERS) 的数据从2004年1月到2024年9月.
- 使用报告概率 (ROR) 的不成比例分析,将每个抗VEGF剂的眼睛AE报告与背景率进行比较.
- 在四种抗VEGF药物中评估眼部AE信号,包括眼内炎症和内炎.
主要成果:
- 布罗卢齐祖马布显示了最强的眼内炎症信号 (ROR=633. 32),其次是法里西马布,阿弗利伯塞普和拉尼祖马布.
- 法里西马布与前段炎症和视炎的信号增加有关.
- 其他药物也显示出这种严重并发症的信号.
结论:
- 抗VEGF药物的眼部不良事件概况存在显著的变异性.
- 布罗卢齐祖马布和阿弗利塞普特分别对炎症和内膜炎有明显的安全问题.
- 为了监测和确定这些关键疗法的不断变化的安全性,需要持续实践药物监测.
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