阿柏西普玻璃体内注射治疗糖尿病性黄斑水肿中国专家共识(2021)

标题: 阿柏西普玻璃体内注射治疗糖尿病性黄斑水肿中国专家共识(2021)
title: Intravitreal Aflibercept Injection in the Treatment of Diabetic Macular Edema: Chinese expert consensus (2021)
版本: 原创版
version: Original
分类: 专家共识
classification: Experts consensus
领域: 治疗
field: Treatment
国家和地区: 中国
Country and region: China
指南使用者:
Guide users:
证据分级方法:
Evidence grading method: Not available
制定单位: 中国医学科学院北京协和医院
Formulating unit: Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
注册时间: 2021-01-07
Registration time:
注册编号: IPGRP-2021CN004
Registration number:
指南制订的目的: 糖尿病性黄斑水肿(DME)是糖尿病视网膜病变(DR)最常见的并发症之一。2017年中国糖尿病患者数已达全球首位,约有33.62% 的DR患者同时患有DME,因此及时、有效干预DME十分重要。近年来抗血管内皮生长因子(VEGF)药物和糖皮质激素的玻璃体注射为DME的治疗开辟了新的途径。VEGF和胎盘生长因子(PGF)在DR/DME发病机理中具有协同作用,而抗VEGF玻璃体注射剂阿柏西普可同时抑制此两种因子。研究表明阿柏西普的亲和力和眼内VEGF抑制时间分别约为单克隆抗体的100倍和2倍,可有效改善视力,具有长期疗效,且总体安全耐受性良好。该药已在中国获批,但其临床实践的方案制定仍存在困难。本文为眼底病诊疗专家组针对DME的发病机理以及阿柏西普的药理作用、治疗方案、剂量和安全性问题等多个方面,进行文献评估和分析讨论,并结合临床经验所形成的专家共识和用药指导,以期能为促进阿柏西普在中国DME患者中的科学使用提供参考。
Purpose of the guideline: ] Diabetic macular edema (DME) is one of the most common complications of diabetic retinopathy (DR). Since 2017, China has had the largest number of diabetic patients in the world. About 33.62% of Chinese DR patients also suffer from DME, that is why the intervention of DME should be early and effective. Recently, intravitreal injection of anti-VEGF drugs and glucocorticoids has opened up a novel treatment approach for DME patients. The inhibition of vascular endothelial growth factor (VEGF) for treating DME has been widely tested in pivotal and comparative randomized controlled clinical trials. As far as we know, VEGF and placental growth factor (PGF) have a synergistic effect in the pathogenesis of DR/DME, while aflibercept, a kind of anti-VEGF intravitreal injections, can simultaneously inhibit these two factors. The affinity of aflibercept and its inhibition time of intraocular VEGF have been proved about 100 times and twice than that of monoclonal antibodies, respectively. Aflibercept resulted in improvement in visual acuity with a long-term effects, and were well tolerated in DME patients. It has been approved in China, but there are still challenges for application in clinical practice. This expert consensus shall give an overview on the pathogenesis of DME, the pharmacological effects, regimes, dosage and safety of aflibercept, etc. The following guidance for the medication of aflibercept has been formed by analysis and discussion of literature, and the clinical experience of leading experts in ophthalmology, which may provide a helpful reference for the scientific application of aflibercept in Chinese DME patients.