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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)
阿柏西普玻璃体内注射治疗糖尿病性黄斑水肿中国共识专家组
作者及单位信息
·
DOI： 10.3760/cma.j.cn115989-20210202-00088
Chinese experts consensus for the intravitreal injection of aflibercept treating diabetic macular edema (2021)
Intravitreal Injection of Aflibercept for Diabetic Macular Edema Experts Consensus Group
Chen Youxin
Authors Info & Affiliations
Intravitreal Injection of Aflibercept for Diabetic Macular Edema Experts Consensus Group
Chen Youxin
·
DOI： 10.3760/cma.j.cn115989-20210202-00088
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摘要

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。

糖尿病/并发症;糖尿病性黄斑水肿;血管内皮生长因子;玻璃体内注射;疗效;安全性;专家共识;阿柏西普
ABSTRACT

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.

Diabetes mellitus/complication;Diabetic macular edema;Vascular endothelial growth factor;Intravitreal injection;Efficacy;Safety;Expert consensus;Aflibercept
Chen Youxin, Email: nc.defhcabmupxynehc
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引用本文

阿柏西普玻璃体内注射治疗糖尿病性黄斑水肿中国共识专家组. 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)[J]. 中华实验眼科杂志,2021,39(05)：369-375.

DOI:10.3760/cma.j.cn115989-20210202-00088

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糖尿病性黄斑水肿(diabetic macular edema，DME)是糖尿病常见的并发症之一，也是糖尿病患者盲的主要原因 [ 1 ]。世界糖尿病联盟(International Diabetes Federation，IDF)的资料显示，估计2017年全球糖尿病患者总数为4.25亿，到2045年将达到6.29亿，其中成人DME患病率约为7.6% [ 2 ]。2017年中国糖尿病患病人数达1.144亿，高居全球首位 [ 2 ]。一项北京眼病研究表明，糖尿病患者中并发糖尿病视网膜病变(diabetic retinopathy，DR)者占37.1%，伴DME者占5.2% [ 3 ]。这些资料表明，DME为全社会带来了沉重的卫生、经济负担，寻求有效的干预方法对可治性盲的防控具有重大的社会意义。
《我国糖尿病视网膜病变临床诊疗指南》推荐的DME治疗方法包括抗血管内皮生长因子(vascular endothelial growth factor，VEGF)药物玻璃体内注射、黄斑区激光光凝疗法、糖皮质激素局部应用和手术疗法 [ 4 ]。在过去30多年中，黄斑区激光光凝疗法是DME的主要治疗方法，但目前尚无明确证据表明黄斑区激光光凝疗法比抗VEGF药物玻璃体内注射疗法效果和安全性更好。既往两项大型临床试验提示，黄斑区激光光凝疗法可减缓视力的丢失，降低致盲风险，但实际上只有3%的患者视力得到明显改善 [ 5 , 6 ]。此外，研究还表明黄斑区视网膜激光光凝疗法可能带来视网膜下纤维化等潜在并发症 [ 7 ]。自2012年以来，抗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。抗VEGF药物玻璃体内注射可特异性地抑制局部组织中VEGF的表达，进而抑制新生血管的生成和进展，改善视网膜、脉络膜微血管的通透性 [ 8 , 9 ]，有效地治疗DME。目前国内外常应用的抗VEGF药物包括贝伐单抗(眼科疾病的非处方治疗药物)、雷珠单抗、康柏西普和阿柏西普。贝伐单抗是一种人源化重组VEGF单克隆抗体，雷珠单抗是一种人源化的VEGF重组VEGF单克隆抗体片段(Fab)，二者均可抑制人VEGF-A表达，但在临床应用中均需要关注其免疫原性所致的不良反应。康柏西普和阿柏西普为非抗体的重组人氨基酸序列蛋白，可最大程度地降低免疫原性 [ 10 ]。康柏西普是由人VEGF受体1中细胞外结合区域2及VEGF受体2中细胞外结合区域3和4与人免疫球蛋白Fc片段融合而成的重组融合蛋白，阿柏西普是人VEGF受体1和受体2胞外亲和力最高、充分且必要的结合位点与人IgG1的Fc片段重组而形成的可溶性融合蛋白 [ 10 ]。VIVID、VISTA和VIVID-EAST研究均证实，阿柏西普玻璃体内注射治疗DME后患眼视力和解剖学的恢复均优于黄斑区视网膜激光光凝法。基于美国DRCR.net Protocol T研究结果，阿柏西普治疗第1年和第2年时，在初始视力较差(ETDRS字母数<69，Snellen等效视力20/50或更差)的DME患者中视力获益优势更为显著。欧洲EURETINA指南将抗VEGF药物推荐为DME治疗的首选药物，而对于基线视力ETDRS字母数低于69的DME患者则首选推荐使用阿柏西普 [ 11 ]。
DME的治疗是不断复发又不断再治疗的过程，规范的治疗措施可以降低DME复发的风险，因此应遵循循证医学研究及临床实践指南的建议或推荐意见来选择合适的治疗方案 [ 12 , 13 ]。
本专家组于2019年3月31日在北京首次召开了阿柏西普玻璃体内注射治疗DME的中国专家共识制定会，会议召集来自北京、上海、温州、广州、郑州、天津、徐州等地的11位眼底病诊疗专家、1位内分泌疾病诊疗专家及1位药学专家，采用面对面讨论的方法制定了共识制定流程。全体专家对相关文献进行了检索和阅读，采纳的涉及阿柏西普玻璃体内注射治疗DME治疗方案和安全性的文献来自于国内外大型的随机对照临床试验及真实世界研究形成的循证医学证据；此外各位专家还总结了我国DME临床诊疗实践，采用现场会议进行面对面交流，并选定共识专家根据专家意见起草共识文件初稿，初稿多次经邮箱发放给各位专家背对背提出修改意见并经过2年的反复修订整理，最终达成共识意见。
本专家组对以下6个临床前及临床相关问题进行阐述和讨论：(1)从DME的发病机制阐述胎盘生长因子(placental growth factor，PGF)和VEGF之间的协同作用；(2)从药理学角度评估不同的抗VEGF药物作用机制和药理作用的不同；(3)阿柏西普是否可以考虑作为DME的一线治疗方案？(4)阿柏西普治疗DME中负荷期强化治疗的重要性；(5)负荷期后阿柏西普维持治疗的推荐方案和剂量；(6)阿柏西普治疗中的安全性问题。
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备注信息
A
陈有信，Email： nc.defhcabmupxynehc
B

国际实践指南注册平台(www.guidelines-registry.cn)，IPGRP-2021CN0049

C
感谢拜耳医药保健有限公司对本共识专家组首次讨论会期间提供的资金帮助
D
所有作者均声明不存在利益冲突
E
中国医学科学院中央级公益性科研院所基本科研业务费专项基金项目 (2018PT32029)
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