与aflibercept和faricimab相关的眼部不良事件:基于人群的药监测研究
Sara Kamali Zonouzi1, Michael Balas2, Parnian Arjmand3
1School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.
概括
在市场营销后的报告中,法里西马布的眼部不良事件比阿弗利塞普特少. 由于FAERS数据库中的潜在报告偏差,建议继续进行安全监测.
科学领域:
- 眼科医生 眼科 眼科
- 药物监督 药物监督 药物监督
- 药品安全 药品安全
背景情况:
- 内抗VEGF疗法对于治疗视网膜疾病至关重要.
- 营销后监测对于评估这些治疗方法的实际安全性至关重要.
- 阿弗利伯塞普和法里西马布是常用的静脉内抗VEGF药物.
研究的目的:
- 为了比较与aflibercept (2 mg和 8 mg) 和faricimab (6 mg) 相关的营销后眼部不良事件 (AEs).
- 为了确定这些内抗VEGF疗法不成比例地报告的眼部副作用.
主要方法:
- 对FAERS数据库的回顾性药监分析 (2023年第四季度 - 2025年第一季度).
- 使用了描述性统计数据和报告几率比率 (ROR) 分析.
- 在2毫克阿弗利伯塞普,8毫克阿弗利伯塞普和法里西马布之间对AEs的比较.
主要成果:
- 总共有462份关于2毫克aflibercept的报告,151份关于8毫克aflibercept的报告和2,427份关于法利西马布的报告被确定.
- 常见的过度报告的眼部副作用包括注射并发症,眼内压力升高,眼内膜炎,视力减弱和炎症.
- 与两种aflibercept剂量相比,法里西马布显示眼部AEs的ROR点估计值较低.
结论:
- 在这项分析中,法里西马布与阿弗利塞普特相比,一般显示出有利的眼部安全概况.
- 对法里西马布的更广泛的置信区间强调了持续安全监测的必要性.
- 局限性包括FAERS数据库偏差和缺乏详细的患者/剂量信息,需要持续监测.
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