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)

Chinese experts consensus for the intravitreal injection of aflibercept treating diabetic macular edema(2021)

糖尿病性黄斑水肿(DME)是糖尿病视网膜病变(DR)常见的严重并发症之一。2017年中国糖尿病患者人数已居全球首位,约有33.62%的DR患者同时患有DME,及时有效地治疗DME对改善患者的视觉质量和生活质量具有重要意义。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内注射为DME的治疗开辟了新的途径。VEGF和胎盘生长因子(PGF)在DR/DME的发生和发展过程中具有协同作用,而抗VEGF药物阿柏西普可同时抑制2种细胞因子。研究表明,阿柏西普是一种人源化的VEGF受体融合蛋白,能够与所有类型的VEGF-A及PGF结合。相比单克隆抗体,阿柏西普的亲和力更强,对眼内VEGF的抑制时间更长,可有效改善视力,具有长期疗效,且总体安全性和耐受性良好。阿柏西普已由国家药品监督管理局批准上市,但其在应用过程中临床实践方案的制定仍存在一定困难。针对DME的发病机制以及阿柏西普的药理作用、治疗方案、剂量和安全性问题等,我国眼底病学家充分复习相关文献,对相关内容进行认真评估和分析讨论,并结合临床经验形成阿柏西普玻璃体内注射治疗DME中国专家共识和用药指导意见,为阿柏西普在中国DME治疗中的合理和规范使用提供参考。

Diabetic macular edema(DME)is one of the most common complications of diabetic retinopathy(DR).There was the largest number of diabetic patients in the world in China since 2017,and about 33.62%of Chinese DR patients suffer from DME.Therefore,it is very necessary to give effective management for DME as early as possible.In recent years,intravitreal injection of anti-vascular endothelial growth factor(VEGF)drugs and glucocorticoids has provided a novel treatment approach for DME patients.The inhibition of 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)play a synergistic effect in the pathogenesis of DR/DME,and aflibercept can simultaneously inhibit these two factors after intravitreal injections.Aflibercept is a humanized fusion protein of VEGF receptor,and it can bind to all types of VEGF-A and PGF.The affinity of aflibercept is proved to be stronger,and the acting duration of aflibercept is confirmed to be longer following intravitreal injection in comparison with monoclonal antibody drugs.Clinical practices show that aflibercept can improve visual acuity for a long term and is well tolerated in DME patients.This drug has been approved to apply in ophthalmology in China,but there is still a great challenge in standardization of procedure in clinical practices.An expert proposal of intravitreal injections of aflibercept for DME is put forward and recommended based on the pathogenesis of DME,the pharmacological effects,regimes,dosage and safety of aflibercept,analysis and discussion of literature,and the clinical experience of leading experts in ophthalmology,which will provide a guidance for the reasonable application of aflibercept in the management of Chinese DME patients.