芪明颗粒治疗糖尿病性黄斑水肿Meta分析

Meta-analysis on Qiming Granules for Treatment of Diabetic Macular Edema

目的:评价芪明颗粒治疗糖尿病性黄斑水肿(diabetic macular edema,DME)的临床疗效及安全性。方法:在中国期刊全文数据库、中国生物医学文献数据库、万方医学数据库、中文科技期刊数据库、Pubmed数据库中,检索从建库至2018年以芪明颗粒为干预措施治疗DME随机对照(randomized controlled trial,RCT)的研究文献,由两名研究人员独立地对这些研究的基本特征和方法学质量进行评价,采用RevMan5.3软件对临床疗效(有效率、视力、黄斑厚度改善情况、黄斑水肿复发情况)进行Meta分析。结果:共纳入13篇文献,共991例患者(1783只眼)。Meta分析结果显示,治疗组有效率显著优于对照组,差异具有统计学意义[OR=4.08,95%CI(2.84,5.86),Z=7.61,(P<0.00001)]。治疗组视力提高显著优于对照组,差异有统计学意义[MD=0.15,95%CI(0.12,0.19),Z=8.50,(P<0.00001)]。治疗组黄斑中心凹厚度改善情况显著优于对照组,差异有统计学意义[SMD=-0.84,95%CI(-1.29,-0.39),Z=3.64,(P=0.0003)]。治疗组黄斑水肿复率显著低于较对照组[OR=0.25,95%CI(0.12,0.55),Z=3.49,(P=0.0005)]。1篇文献提及3～10个月后进行随访,个别患者服用芪明颗粒后出现胃脘不适等症状。3篇文献在3个月后进行随访,并未发现服用芪明颗粒明确引起的不良反应。结论:芪明颗粒对治疗DME有一定疗效,且具有一定安全性,但还需更多高质量的RCT进行分析才能对其疗效及安全性得出更为肯定性结论。

Objective:To assess the efficacy and safety of Qiming Granules on diabetic retinopathy. Methods:Retrieved CNKI,WanFang Data,VIP,CBM,PubMed,etc.,and selected clinical trialsconforming with the enrolled criteria from building library to 2018. There were two researchers independently doing a data extrion of valid data. To evaluate the quality of the literature,use the Cochrane collaboration RevMan5.3 software for Meta-analysis. Results:A total number of 13 papers involving 991 patients were concluded. Fixed effect model was used to undergo Meta-analysis and the results showed that the total effective rate of Qiming Granules on diabetic retinopathy against other drugs was statistically difference between the treatment groups(OR=4.08,95%CI(2.84,5.86),Z=7.61,(P<0.00001))The visual acuity of the treatment group was significantly better than that of the control group(MD=0.15,95%CI(0.12,0.19),Z=8.50,(P<0.00001))The difference was statistically significant. The macular foveal thickness in the treatment group was significantly better than that in the control group(SMD=-0.84,95%CI(-1.29,-0.39),Z=3.64,(P=0.0003))The difference was statistically significant. The recovery of macular edema was significantly lower in the treatment group than in the control group(OR=0.25,95%CI(0.12,0.55),Z=3.49,(P=0.0005))One article mentioned follow-up after 3-10 months,individual patients had epigastric discomfort after taking Qiming Granules. After three months of follow-up of the three documents,no adverse drug reactions caused by the Qiming Granules were found. Conclusion:Qiming Granules have a certain effect on the treatment of DME,and have a certain degree of safety,but more high-quality RCTs are needed for analysis to reach a positive conclusion on its efficacy and safety.