参芪地黄汤治疗早期糖尿病肾病13项随机对照试验的Meta分析

Shenqi Dihuang Decoction Treats Early Diabetic Nephropathy:A Meta-Analysis of 13 Randomized Controlled Trials

目的通过荟萃分析系统评价参芪地黄汤(SQDHD)治疗早期糖尿病肾病的疗效和安全性。方法通过Mogensen分期法,选择诊断为糖尿病肾病Ⅲ期的患者,在互联网上检索中国知网(CNKI)、万方数据库、维普数据库(VIP)、中国生物医学文献数据库(CBM)、Cochrane图书馆、Embase、Web of science以及Pubmed等8个电子数据库,查找截至2020年11月1日发布的随机对照试验。实验组和对照组均采用常规方法治疗(如控制饮食、适当运动、降脂等);对照组采用降糖、ACEI或ARB药物治疗;实验组在对照组的基础上加用参芪地黄汤或加味参芪地黄汤治疗。根据Cochrane回顾手册评估文献质量。采用随机或固定效应模型,使用Revman 5.3软件进行分析,主要观察指标包括临床疗效、尿微量白蛋白尿排泄率(Urinary albumin excretion rates,UAER);次要转归指标包括肌酐(Creatinine,Cr)、血尿素氮(Blood urea nitrogen,BUN)、糖化血红蛋白(Glycated hemoglobin/glycosylated hemoglobin,HbA1c)、空腹血糖(Fasting plasma glucose,FPG)、餐后血糖(2-hour postprandial blood glucose,2 h PG)、胱抑素C(Cystatin C,Cys-C)指标。结果纳入13项随机对照试验,涉及876例DN患者。SQDHD可显著提高临床总有效率,降低UAER、Cr和BUN。FPG、2 h PG和Cys-C水平均有效降低。其中两项研究明确表明无不良事件发生;两项研究报道,对照组的主要不良事件为咳嗽、低血糖和胃肠道反应,未发生严重不良事件。结论SQDHD治疗DN有效。由于纳入研究的质量较低,疗效的可靠性受到影响,需要在未来通过高质量的RCT进行确认。

Objective To evaluate the efficacy and safety of ShenqiDihuang Decoction(SQDHD)in the treatment of early diabetic nephropathy by Meta-analysis.Methods The patients withstage III DN according to Mogensen classificationwereselected as the research subjects in this study.Eight electronic databases,including CNKI,Wanfang Data,VIP,CBM,Cochrane,Embase,Webof Science,and PubMed,were searched for randomized controlled trials(RCTs)from database inception to November 1,2020.The experimental group and the control group were treated with conventional methods(such as diet control,appropriate exercise,and lipid reduction).The control group was treated with hypoglycemic agents,ACEI or ARB.The experimental group was additionally treated with SQDHD or modified SQDHD on the basis of the control group.The quality of the research articles was assessed according to the Cochrane Review Manual.The random or fixed effect model was used and Revman 5.3 was used for analysis.The main outcome indicators included clinical efficacy and urinary albuminuria excretion rate(UAER).The secondary outcome indicators included creatinine(Cr),blood urea nitrogen(BUN),glycosylated hemoglobin(HbA1 c),fasting plasma glucose(FPG),2-hour postprandial glucose(2 h PG),and cystatin C(Cys-C).Results Thirteen RCTs were included,with 876 patients with DN involved.SQDHD could significantly improve the clinical total effective rate and reduce UAER,Cr,and BUN.Furthermore,the levels of FPG,2 h PG,and Cys-C declined effectively.Two RCTs indicated that no adverse events occurred.Two RCTs reported that the main adverse events in the control group were cough,hypoglycemia,and gastrointestinal reactions,and no severe adverse events occurred.Conclusion SQDHD is effective in the treatment of DN.Due to the low quality of the included RCTs,the reliability of the efficacy is affected,and it needs to be confirmed by high-quality RCTs in the future.