研究进展 情报发生 2026-10-31 · 发布于 2026-11-01

真实世界研究:渗出性黄斑病换用阿柏西普生物类似药的早期结局

来源:BMC Ophthalmol · PMID 42958502 · DOI 10.1186/s12886-026-05491-4 · 来源:IMA 知识库《文献层·文献监控卡片》2026-10-31 期 · 全文级(file_id dmlmcfQeUyzO,实际下载核验) · 全文已获取并通过归属校验

时间标签:数据日期 2026-10-31 · 生成时间 2026-11-01 05:30(Asia/Shanghai)| 检索窗口 PubMed edat 2026/10/28–2026/10/31 | 情报发生日期 2026-10-31

研究问题

Bevacizumab, although used off-label, remains widely used in clinical practice due to its cost-effectiveness and broad accessibility.;However, most available evidence concerns the reference molecule, and prospective real-world data evaluating the switch to aflibercept biosimilars remain limited.;Interchangeability is, however, a jurisdiction-specific regulatory concept.

方法

This prospective, single-center, single-arm interventional cohort study was conducted at a tertiary ophthalmology clinic.;The study protocol was approved by the Afyonkarahisar Health Sciences University Ethics Committee before patient enrollment (approval number: 26/3-221).;Written informed consent was obtained from all participants before enrollment and treatment initiation.;Switching eligibility was prospectively defined and applied uniformly to all participants.

核心结论

All MNV eyes were associated with neovascular age-related macular degeneration; no myopic, pachychoroid-related, or other secondary MNV etiologies were included.;All eyes in this subgroup had received three consecutive monthly bevacizumab injections before the preswitch baseline assessment, and none had previously received ranibizumab or aflibercept.;Previous focal or panretinal laser photocoagulation had been performed in 30 eyes (56.6%). ‖ 结论:In conclusion, administration of aflibercept-jbvf following three monthly bevacizumab injections was temporally associated with a statistically significant but modest very early reduction in CST at 4 weeks in eyes with DME, MNV, and RVO.

局限

Direct comparison with these studies should also be interpreted with caution because of differences in study populations, baseline disease severity, follow-up duration, treatment exposure, and outcome metrics.;The inclusion of DME, MNV, and RVO within the same cohort represents both a pragmatic strength and an important interpretative limitation.;Disease-specific findings may be more clinically informative, although all subgroup analyses were exploratory and underpowered.

对本项目的价值

★☆☆☆☆ 皮肤是唯一可直接局部给药、可活检、可影像量化的器官,最快可验证 senotherapeutic 概念。

全文来源

PMC JATS 全文(正文 35,262 字符,已过标题/DOI 逐字归属校验)

原文题录

  • 英文标题:Early outcomes of switching from bevacizumab to aflibercept-jbvf in exudative macular diseases: a real-world study.
  • 期刊与标识:BMC Ophthalmol · PMID 42958502 · DOI 10.1186/s12886-026-05491-4

A 级证据分级:A 级(同行评议人体研究)

本文属人体研究证据,但需注意:观察性或小样本干预的结论不等于已证实临床获益;效应量与长期安全性仍需更大规模、更长随访的试验验证。

关于本文的文献来源:本站依据 IMA 知识库「五刊监控·深度文献卡片」撰写,依据已获取的期刊全文(方法、样本量与结论已回到原文核对);未能获取全文的同批条目另行标注「摘要级」,全程未做任何数值推算补全。