基于Meta分析研究芪明颗粒治疗糖尿病视网膜病变效果

Study on the Effect of Qi-Ming Granule on the Treatment of Diabetic Retinopathy Based on Meta-analysis

用Meta分析方法比较中药复方芪明颗粒与羟苯磺酸钙两种药物治疗糖尿病视网膜病变的临床疗效和安全性。本研究利用中国期刊全文数据库(CNKI)、万方数据库、维普网、PubMed及Embase数据库检索芪明颗粒与羟苯磺酸钙治疗糖尿病视网膜病变的相关文献,检索时限均为建库至2016年5月31日,同时查阅该文献的参考文献。制定检索策略以及纳入和排除文献的标准,根据标准确定最终纳入的随机对照试验(RCT)文献。采用RevMan 5.2进行Meta分析,用固定效应模型进行数据合并。研究结果表明,共纳入文献8篇,均为RCT,涉及患者1 261名。纳入的研究方法学质量评价结果部分偏低。Meta分析结果显示:总有效率8项研究的同质性结果为卡方Ch^i2=5.98,自由度是7 (p=0.54),8项研究统计量均为二分类变量,故采取Z检验;M-H=1.96,95%可信区间为(1.52, 2.54),合并效应检验Z=5.13,p<0.001,表明芪明颗粒治疗组的总有效率大于对照组,两组比较差异具有统计学意义。不良反应发生率分析4项研究的同质性结果为卡方Ch^i2=0.41,自由度是3 (p=0.94),同属二分类变量,采取Z检验,M-H=0.15,95%可信区间为(0.05, 0.39),合并效应检验Z=3.82,p<0.001,表明芪明颗粒治疗组的不良反应发生率小于对照组,两组比较差异具有统计学意义。Meta分析初步表明,芪明颗粒治疗糖尿病视网膜病变疗效显著,安全性好。因不良反应原始研究的质量偏低,样本量小,尚需更多高质量、大样本的随机对照试验进一步观察研究。

This study was to comp are the clinical efficacy and safety of traditional Chinese medicine Qi-Ming granule and calcium dobesilate in the treatment of diabetic retinopathy based on Meta-analysis. We searched the related literature of Qi-Ming granule and calcium dobesilate in the treatment of diabetic retinopathy by using CNKI, Wanfang Database, VIP, PubMed and Embase Database. They were searched from database building to May31, 2016, and the literature references were searched at the same time. Retrieval strategies, including and excluding literature criteria were made, with which to determine the final inclusion of the randomized controlled trial(RCT)literature. Meta-analysis was carried out by RevMan5.2, and the data was combined with the fixed effect model.The research results showed that a total of 8 literatures were included, all of which were RCT, involving 1261 patients. The quality evaluation results of the included studies were partly low. The results of Meta-analysis showed that the total effective rate of the 8 studies on the homogeneity of results was Chi^2=5.98, and the degree of freedom was 7(p=0.54). The 8 study statistics were binary classification variables, thus, Z test was taken. M-H =1.96, 95%CIwas(1.52, 2.54), the combined effect test of Z=5.13, p<0.001. The result showed that the total effective rate of the treatment group with Qi-Ming granule was significantly higher than that of the control group, and there was statistical significance in the differences between two groups. The incidence of adverse drug reactions of the 4 studies on the homogeneity of results was Chi^2=0.41, and the degree of freedom was 3(p=0.94). Four study statistics were binary classification variables, thus, Z test was taken. M-H=0.15, 95% CI was(0.05, 0.39), the combined effect test of Z=3.82, p<0.001. The result showed that the incidence of adverse drug reactions in the treatment group with Qi-Ming granule was lower than that in the control group. There was statistical significance in the differences between two groups. Meta-analysis preliminarily indicated that the therapeutic effect of Qi-Ming Granule on diabetic retinopathy was obvious with good safety. Due to low quality of the original study on adverse reaction and small sample size,more high-quality and large sample RCT were needed for further observation and study.