补阳还五汤治疗早期糖尿病肾病的疗效及安全性的Meta分析

Efficacy and safety of Buyang Huanwu Decoction for early-stage diabetic nephropathy: a Meta-analysis

补阳还五汤具有补气活血通络功效,是益气活血法中的代表方,目前用于治疗早期糖尿病肾病,但其疗效和安全性有待验证。故该研究旨在系统评价补阳还五汤治疗早期糖尿病肾病的疗效及安全性。计算机检索PubMed,EMbase,the Cochrane Library,CBM,CNKI,VIP,Wan Fang数据库,搜索补阳还五汤治疗早期糖尿病肾病的随机对照试验(RCT),检索时限从建库至2018年9月16日。由2名研究者独立筛选文献、提取资料、评价偏倚风险后,运用Rev Man 5. 3软件进行Meta分析,最终纳入15篇RCT,共计1 402例患者。Meta分析结果显示,补阳还五汤联合常规治疗组(联合治疗组)在降低24 h尿白蛋白排泄率(MD=-40. 23,95%CI[-71. 25,-9. 21],P=0. 01)、总胆固醇(MD=-0. 75,95%CI[-1. 02,-0. 48],P<0. 000 01)方面均优于常规治疗组,血肌酐(MD=-1. 48,95%CI[-4. 48,1. 53],P=0. 34) 2组疗效相当;而在降低甘油三脂方面受疗程的影响,疗程≤8周(MD=-0. 33,95%CI[-0. 97,0. 31],P=0. 31) 2组疗效相当;疗程12周(MD=-0. 30,95%CI[-0. 58,-0. 22],P=0. 03)和疗程≥16周(MD=-0. 49,95%CI[-0. 9,-0. 08],P=0. 02)联合治疗组优于常规治疗组;不良反应发生率2组间差异无统计学意义(OR=1. 38,95%CI[0. 28,6. 8],P=0. 69)。结果表明补阳还五汤联合常规治疗可显著提高防治早期糖尿病肾病的临床疗效,但受纳入研究质量的限制,上述结论尚需开展更多高质量的RCT加以验证。

Buyang Huanwu Decoction(BHD)has the effect in benefiting Qi and activating blood circulation,and is the representative prescription for benefiting Qi and activating blood.At present,it is used for treatment of early diabetic nephropathy.However,its efficacy and safety remained to be verified.Therefore,this study aims to systematically evaluate the efficacy and safety of Buyang Huanwu Decoction for early-stage diabetic nephropathy.Data of randomized controlled trials(RCTs)of Buyang Huanwu Decoction for earlystage diabetic nephropathy were collected through the retrieval of electronic databases,including PubMed,EMbase,the Cochrane Library,CBM,CNKI,VIP and Wan Fang Data from inception to September 16,2018.Two reviewers independently screened out literatures,extracted data,and assessed the risk of bias.And then Meta-analysis was conducted by Rev Man 5.3 software.A total of 15 RCTs involving 1 402 patients were included.The results of Meta-analysis indicated that Buyang Huanwu Decoction and conventional treatment group(combination treatment group)were superior to conventional treatment group in reducing 24 h urinary albumin excretion rates(MD=-40.23,95%CI[-71.25,-9.21],P=0.01)and total cholesterol(MD=-0.75,95%CI[-1.02,-0.48],P<0.000 01).The effects of the two groups in reducing serum creatinine were similar(MD=-1.48,95%CI[-4.48,1.53],P=0.34).However,the reduction of triglyceride was affected by the course of treatment.The effects were similar in less than or equal to eight weeks(MD=-0.33,95%CI[-0.97,0.31],P=0.31),whereas the combination group was superior to the conventional treatment group in 12 weeks(MD=-0.30,95%CI[-0.58,-0.22],P=0.03)and more than or equal to 16 weeks(MD=-0.49,95%CI[-0.9,-0.08],P=0.02).There were no significant difference in adverse events between the two groups(OR=1.38,95%CI[0.28,6.8],P=0.69).The results showed that combination treatment group has a significantly higher efficacy on early diabetic nephropathy.The above conclusion shall be verified with more high-quality RCTs because of the low quality of the included studies.