使用自发报告数据库评估眼内抗血管内皮生长因子 (VEGF) 与药物相关的不良事件
Mugita Sato1, Koichi Kageyama1, Seiichiro Ito1
1Laboratory of Drug Informatics, Gifu Pharmaceutical University, Gifu, JPN.
Cureus
|October 3, 2025
概括
抗血管内皮生长因子 (VEGF) 药物与罕见但严重的不良事件,如脑梗塞有关. 这项研究发现,若使用拉尼比祖马布 (IVR),脑梗塞可能比使用阿弗利伯塞普 (IVA) 早发生.
科学领域:
- 眼科医生 眼科 眼科
- 药物监督 药物监督 药物监督
- 神经学 神经学
背景情况:
- 抗血管内皮生长因子 (VEGF) 药物是视网膜疾病的标准治疗方法,如黄斑.
- 虽然这些药物是有效的,但它们存在罕见但严重的不良事件的风险,例如脑梗塞.
- 调查这些风险对于患者安全至关重要.
研究的目的:
- 评估与抗VEGF药物相关的不良事件,特别是脑梗塞的风险和发病时间.
- 使用日本药物不良事件报告 (JADER) 数据库进行全面分析.
主要方法:
- 使用"监管活动医学词典" (MedDRA) 编码不良事件.
- 报告几率比率 (ROR) 被计算出来以评估事件频率.
- 使用生存分析,包括日志等级和通用威尔科克森测试,以确定发病时间.
主要成果:
- 分析了2004年4月至2025年1月965286份报告.
- 脑梗塞报告:阿弗利伯塞普特 (IVA) 200例,拉尼比祖马布 (IVR) 154例,布罗卢齐祖马布 (IVB) 16例,法里西马布 (IVF) 20例.
- 与IVA (79.0天) 相比,IVR (48.5天) 的中位时间到脑梗塞的发病时间明显较早.
结论:
- 与aflibercept (IVA) 相比,拉尼比祖马布 (IVR) 可能更早地表现出脑梗塞.
- 强调对抗VEGF治疗进行警监测的重要性.
- 强调在临床实践中需要个性化治疗策略.
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