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治疗和延长与替代抗血管内皮生长因子方案治疗 nAMD 的疗效、安全性和治疗负担:系统评价和荟萃分析。

Efficacy, safety, and treatment burden of treat-and-extend versus alternative anti-VEGF regimens for nAMD: a systematic review and meta-analysis.

机构信息

Michael G. DeGroote School of Medicine, McMaster University, Hamilton, ON, L8P 1H6, Canada.

St. Joseph's Healthcare Hamilton and McMaster University, Hamilton, ON, L8G 5E4, Canada.

出版信息

Eye (Lond). 2023 Jan;37(1):6-16. doi: 10.1038/s41433-022-02020-7. Epub 2022 Apr 8.

Abstract

This study aimed to compare efficacy and treatment burden of treat-and-extend (T&E) anti-VEGF against fixed and pro re nata (PRN) regimens for neovascular age-related macular degeneration (nAMD). MEDLINE, CENTRAL, and EMBASE were searched. Randomized-controlled trials and observational studies comparing T&E to PRN or fixed dosing for treatment-naïve AMD patients were included. Mean difference (MD) for visual acuity (VA) and number of injections are presented. Risk of bias was assessed according to Cochrane guidelines. Methodology was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). VA improvement was similar with T&E and fixed dosing at one (MD -0.08 letters, p = 0.95) and two years (MD 0.58 letters, p = 0.62). In contrast, VA improvements were significantly greater for T&E when compared against a PRN regimen at one (MD 3.95 letters, p < 0.0001) and two years (MD 4.08 letters, p < 0.001). Significantly fewer ranibizumab injections were administered in the T&E arm at one (MD -2.42 injections, p < 0.0001) and two years (MD -6.06 injections, p < 0.00001) relative to fixed dosing. Fewer aflibercept injections were likewise administered to patients on a T&E regimen versus fixed dosing at one year (MD -0.78 injections, p < 0.0001). Low-certainty evidence from the present synthesis implies that T&E preserves VA similar to fixed schedules with significantly fewer injections at one and two years. Also, patients with T&E dosing achieved better VA outcomes than those on PRN regimen but T&E dosing was associated with more injections.

摘要

本研究旨在比较治疗-延长(T&E)抗血管内皮生长因子与固定和按需(PRN)方案治疗新生血管性年龄相关性黄斑变性(nAMD)的疗效和治疗负担。检索了 MEDLINE、CENTRAL 和 EMBASE。纳入了比较 T&E 与 PRN 或固定剂量治疗初治 AMD 患者的随机对照试验和观察性研究。给出了视力(VA)和注射次数的均数差(MD)。根据 Cochrane 指南评估了偏倚风险。方法的实施符合系统评价和荟萃分析的首选报告项目(PRISMA)。在一年(MD-0.08 个字母,p=0.95)和两年(MD0.58 个字母,p=0.62)时,T&E 与固定剂量的 VA 改善相似。相比之下,T&E 与 PRN 方案相比,VA 改善在一年(MD3.95 个字母,p<0.0001)和两年(MD4.08 个字母,p<0.001)时显著更大。在第一年(MD-2.42 次注射,p<0.0001)和第二年(MD-6.06 次注射,p<0.00001)时,T&E 组接受的雷珠单抗注射次数明显减少。同样,与固定剂量相比,接受 T&E 方案的患者第一年(MD-0.78 次注射,p<0.0001)接受的阿柏西普注射次数也更少。本综合研究中低确定性证据表明,T&E 与固定方案相比可保持相似的 VA,并且在一年和两年时注射次数明显减少。此外,接受 T&E 剂量的患者比接受 PRN 方案的患者获得更好的 VA 结局,但 T&E 剂量与更多的注射次数相关。

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