对视网膜疾病的生物类似抗血管内皮生长因子的有效性和安全性:系统性审查和元分析
Bhadra U Pandya1, Andrew Mihalache1, Ryan S Huang1
1Temerty Faculty of Medicine, University of Toronto, Ontario, Canada.
Retina (Philadelphia, Pa.)
|February 18, 2026
概括
生物相似的抗血管内皮生长因子 (VEGF) 注射显示了与视网膜疾病的抗VEGF治疗相比的安全性和视觉结果. 为了在不同人群中进行长期评估,需要进一步的研究.
科学领域:
- 眼科医生 眼科 眼科
- 药理学 药理学是指药理学的学科.
- 生物技术是生物技术.
背景情况:
- 视网膜疾病如AMD,DME和RVO显著影响视力.
- 内抗血管内皮生长因子 (VEGF) 注射是标准的治疗方法.
- 生物相似的抗VEGF剂为参考产品提供了潜在的成本有效的替代品.
研究的目的:
- 进行系统审查和元分析,将生物类似抗VEGF药物的有效性和安全性与参考抗VEGF药物的比较.
- 为了评估接受这些治疗的患者的视觉敏度,视网膜厚度和不良事件发生率.
主要方法:
- 2015年1月至2024年9月期间发表的25项研究的系统综述和元分析.
- 在OVID MEDLINE,Embase和Cochrane图书馆进行的搜索.
- 随机效应模型用于元分析;乔安娜·布里格斯研究所 (JBI) 工具用于偏差风险 (ROB) 评估;证据确定性的GRADE标准.
主要成果:
- 在生物类似药和参考抗VEGF治疗之间,在最终视力敏度,视力敏度变化,最终视网膜厚度或视网膜厚度变化方面没有发现显著差异.
- 在12-63.6周的随访期间,两组的不良事件发生率也相似.
- 亚组分析 (RCT,观察研究,特定疾病和阿弗利塞普特和拉尼比祖马布等药物) 产生了一致的,非显著的发现,得到了中等到高确定性证据的支持.
结论:
- 生物相似的抗VEGF药物表现出与其用于治疗视网膜疾病的参考对应物相比,具有可比的安全性和视觉结果.
- 有证据表明,生物类似药是一种可行的治疗选择.
- 未来的研究应侧重于多样化的患者队列和延长的随访,以确认长期的安全性和有效性.
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