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[抗血管生成药物治疗糖尿病性黄斑水肿的间接比较]

[Indirect comparison of anti-angiogenic agents in the treatment of diabetic macular edema].

作者信息

Klabukova D L, Krysanov I S, Krysanova V S, Ermakova V Yu

机构信息

Russian University of Medicine, Moscow, Russia.

Medical Institute of Continuing Education of the Russian Biotechnological University, Moscow, Russia.

出版信息

Vestn Oftalmol. 2024;140(6):69-79. doi: 10.17116/oftalma202414006169.

Abstract

UNLABELLED

Diabetic macular edema (DME) is a leading cause of visual impairment and blindness among diabetic patients, its prevalence is continuing to increase worldwide. Faricimab, a bispecific antibody, represents a new generation of treatments for DME.

PURPOSE

This study presents an indirect comparison of the effectiveness and safety of faricimab versus other treatment options for DME.

MATERIAL AND METHODS

This systematic review of the effectiveness and safety of intravitreal injections (IVIs) of anti-angiogenic agents was conducted using the PRISMA methodology. Randomized clinical trials (RCTs) with outcomes at 12 months of DME treatment were included for network meta-analysis (NMA). Six endpoints were evaluated: the change in best-corrected visual acuity (BCVA), central retinal thickness (CRT); number of IVIs; proportion of patients with improved/deteriorated vision (per ETDRS); incidence of ophthalmic adverse events; and probability of treatment discontinuation. Evidence network diagrams and forest plots for faricimab 6.0 mg in a personalized treatment interval (PTI) regimen (up to one injection every 16 weeks) compared to aflibercept 2 mg and ranibizumab 0.5 mg were generated using RStudio.

RESULTS

Of 2845 initial publications, 38 studies were reviewed, and 20 RCTs were included in the base NMA. A random-effects model was applied for the NMA of injection frequency due to high heterogeneity, while fixed-effect models were used for other endpoints. Faricimab 6 mg in the PTI regimen demonstrated superior or comparable functional (BCVA improvement) and anatomical (CRT reduction) outcomes over 12 months with fewer injections than aflibercept 2 mg or ranibizumab 0.5 mg. Safety outcomes were similar across all anti-angiogenic agents.

CONCLUSIONS

The clinical efficacy and safety of faricimab, aflibercept and ranibizumab are comparable in adult patients with DME with a fewer number of faricimab IVIs vs comparators.

摘要

未标注

糖尿病性黄斑水肿(DME)是糖尿病患者视力损害和失明的主要原因,其在全球的患病率持续上升。法西单抗,一种双特异性抗体,代表了新一代治疗DME的药物。

目的

本研究对法西单抗与其他治疗DME的方案的有效性和安全性进行间接比较。

材料与方法

采用PRISMA方法对玻璃体内注射抗血管生成药物的有效性和安全性进行系统评价。纳入DME治疗12个月时有结局的随机临床试验(RCT)进行网状Meta分析(NMA)。评估了六个终点:最佳矫正视力(BCVA)、中心视网膜厚度(CRT)的变化;玻璃体内注射次数;视力改善/恶化患者的比例(根据ETDRS);眼科不良事件的发生率;以及治疗中断的概率。使用RStudio生成了法西单抗6.0mg在个性化治疗间隔(PTI)方案(每16周最多注射一次)与阿柏西普2mg和雷珠单抗0.5mg相比的证据网络图和森林图。

结果

在2845篇初始出版物中,审查了38项研究,基础NMA纳入了20项RCT。由于异质性高,对注射频率的NMA应用随机效应模型,而对其他终点使用固定效应模型。在PTI方案中,6mg法西单抗在12个月内显示出优于或相当于阿柏西普2mg或雷珠单抗0.5mg的功能(BCVA改善)和解剖学(CRT降低)结局,且注射次数更少。所有抗血管生成药物的安全性结局相似。

结论

在患有DME的成年患者中,法西单抗、阿柏西普和雷珠单抗的临床疗效和安全性相当,与对照药物相比,法西单抗的玻璃体内注射次数更少。

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