阿柏西普注射液治疗糖尿病性黄斑水肿的Meta分析

Meta-analysis of Aflibercept Injection in the Treatment of Diabetic Macular Edema

目的评价阿柏西普注射液治疗糖尿病性黄斑水肿(DME)的有效性及安全性。方法以“Eylea”“aflibercept”“Diabetic Macular Edema”“DME”“VEGF”为检索词,检索Medline、PubMed数据库中有关文献以及FDA、EMA检索申报材料,以“艾力雅”“阿柏西普注射液”“糖尿病性黄斑水肿”“VEGF”为检索词,检索Medline、PubMed、万方及中国知网中有关文献及FDA、EMA、PMDA官网检索申报材料,同时辅助网页等其他检索方式,收集关于阿柏西普注射液治疗DME的随机对照试验文献,检索时间截止至2020年4月,使用Stata16软件对提取数据进行分析。结果最终仅纳入2篇文献,其中1篇文献包括1个研究,2个试验,每个试验有2个剂量(2Q4、2Q8),按4项试验处理;另外1篇文献包括1个研究,1个试验,其中试验包括3个剂量组(0.5Q4、2Q4、2Q8),按3项试验处理。2个研究共纳入1039只眼,其中试验组708只眼,对照组331只眼。与对照组相比,试验组在8、20、52周能提高BCVA水平[8周:WMD=5.152(95%CI:4.300~6.005);20周:WMD=8.209(95%CI:7.234~9.185);52周:WMD=10.334(95%CI:9.13~11.54)];另外,52周时,试验组参考BCVA较基线改善大于15个字母的比例(OR=5.527,95%CI:4.087~7.473)、视网膜厚度较基线变化(WMD=-120.305,95%CI:-138.086~-102.523)优于对照组;试验组眼部严重不良事件发生率优于对照组(OR=0.240,95%CI:0.078~0.755)。结论阿柏西普治疗糖尿病性黄斑水肿的疗效优于激光,眼部严重不良事件发生率低于激光。

Objective To evaluate the effectiveness and safety of aflibercept injection in the treatment of diabetic macular edema(DME).Methods Using"Eylea","aflibercept","Diabetic Macular Edema","DME",and"VEGF"as the search terms,the relevant documents in the Medline and PubMed databases and the FDA and EMA search application materials were searched.Using"Aliya","Aflibercept Injection","Diabetic Macular Edema"and"VEGF"as the search terms,searching for relevant documents in Medline,PubMed,Wanfang and CNKI as well as the official websites of FDA,EMA,PMDA to retrieve application materials,and assist other search methods such as web pages to collect literature on randomized controlled trials of aflibercept injection in the treatment of DME,and search As of April 2020,use Stata16 software to analyze the extracted data.Results In the end,only 2 documents were included,one of which included 1 study,2 trials,and each trial had 2 doses(2Q4,2Q8).Treated as 4 trials;another document includes 1 study,1 trial,and the trial includes 3 dose groups(0.5Q4,2Q4,2Q8),dealing with 3 tests.A total of 1039 eyes were included in the two studies,including 708 eyes in the test group and 331 eyes in the control group.Compared with the control group,the test group can increase the BCVA level at 8,20,52 weeks[8 weeks:WMD=5.152(95%CI:4.300-6.005);20 weeks:WMD=8.209(95%CI:7.234-9.185);52 weeks:WMD=10.334(95%CI:9.13-11.54)];In addition,at 52 weeks,the test group's reference BCVA improved by more than 15 letters from the baseline(OR=5.527,95%CI:4.087-7.473),and the change in retinal thickness from the baseline(WMD=-120.305,95%CI:-138.086--102.523)better than the control group;The incidence of serious ocular adverse events in the experimental group was better than that in the control group(OR=0.240,95%CI:0.078-0.755).Conclusion The efficacy of aflibercept in the treatment of diabetic macular edema is better than that of the laser,and the incidence of serious ocular adverse events is lower than that of the laser.