益气养阴类中成药治疗早期糖尿病肾病的网状Meta分析

Network Meta-analysis of Qi-supplementing and Yin-nourishing Chinese patent medicines in treatment of early diabetic nephropathy

运用网状Meta分析对益气养阴类中成药干预早期糖尿病肾病的疗效进行评价,以期探究疗效较优的中成药,为防止糖尿病及肾脏恶化、延缓早期糖尿病肾病进展提供参考。计算机检索中国知网(CNKI)、万方(Wanfang)、维普(VIP)、中国生物医学文献服务系统(SinoMed)、PubMed、EMbase、Cochrane Library、Web of Science数据库中益气养阴类中成药治疗早期糖尿病肾病的临床随机对照试验(RCT)。筛选符合纳入标准的文献,运用Cochrane风险偏倚评价工具进行质量评价,运用R 4.2.1的BUGSnet程序包进行网状Meta分析。共纳入文献72篇,样本量6344例,涉及8种中成药和7个结局指标。网状Meta分析结果显示,(1)改善尿白蛋白排泄率(UAER)方面,各中成药联合常规治疗均显著优于常规治疗,芪药消渴胶囊+常规治疗疗效相对较优;(2)降低血肌酐(Scr)方面,百令胶囊+常规治疗疗效相对较优;(3)降低24 h尿蛋白定量(24hUTP)方面,肾炎康复片+常规治疗与金水宝胶囊+常规治疗疗效相当,以肾炎康复片+常规治疗略优;(4)改善空腹血糖(FBG)方面,肾炎康复片+常规治疗疗效相对较优;(5)改善总胆固醇(TC)方面,芪药消渴胶囊+常规治疗疗效相对较优;(6)降低甘油三酯(TG)方面,百令胶囊+常规治疗疗效相对较优;(7)安全性方面,7种干预措施均报道了不良反应,但由于临床异质性较大,无法进行定量分析。总体而言,益气养阴类中成药联合常规治疗早期糖尿病肾病效果显著优于单纯常规治疗。结果表明,益气养阴类中成药联合常规治疗具有较好的临床疗效,在显著降低UAER、Scr、24hUTP等肾功能指标的同时,发挥降血糖、降血脂的作用,可为早期治疗提供循证医学证据。但因纳入文献的数量和质量存在差异,后期仍需大样本、多中心、高质量的RCT进一步验证。

This study aimed to evaluate the efficacy of Qi-supplementing and Yin-nourishing Chinese patent medicine in the treatment of early diabetic nephropathy(DN)by network Meta-analysis to explore the Chinese patent medicine with optimal efficacy and provide references for preventing renal deterioration and delaying the progression of early DN.Eight databases,including CNKI,Wanfang,VIP,SinoMed,PubMed,EMbase,Cochrane Library,and Web of Science,were searched for clinical randomized controlled trial(RCT)of Qi-supplementing and Yin-nourishing Chinese patent medicines in the treatment of early DN.After the literature mee-ting the inclusion criteria was screened,the quality of the literature was evaluated using the Cochrane risk-of-bias tool,and network Meta-analysis was performed using the BUGSnet package in R 4.2.1.Seventy-two research articles with a sample size of 6344 cases were included,involving eight Chinese patent medicines and seven outcome indicators.The results of the network Meta-analysis showed that(1)in terms of improving urinary albumin excretion rate(UAER),Chinese patent medicines combined with conventional treatment were superior to conventional treatment,and Qiyao Xiaoke Capsules+conventional treatment was optimal.(2)In terms of reducing serum crea-tinine(Scr),Bailing Capsules+conventional treatment had superior efficacy.(3)In terms of reducing 24-hour urine total protein(24hUTP),Shenyan Kangfu Tablets+conventional treatment and Jinshuibao Capsules+conventional treatment had equivalent efficacy,and Shenyan Kangfu Tablets+conventional treatment was superior.(4)In terms of improving fasting blood glucose(FBG),Shenyan Kangfu Tablets+conventional treatment had superior efficacy.(5)In terms of improving total cholesterol(TC),Qiyao Xiaoke Capsules+conventional treatment had superior efficacy.(6)In terms of reducing triglyceride(TG),Bailing Capsules+conventional treatment had superior efficacy.(7)In terms of safety,the occurrence of adverse reactions was reported in seven interventions,but due to the large clinical heterogeneity,the quantitative analysis could not be performed.Overall,Qi-supplementing and Yin-nourishing Chinese patent medicines combined with conventional treatment were superior to conventional treatment alone in the treatment of early DN.The results showed that Qi-supplementing and Yin-nourishing Chinese patent medicines combined with conventional treatment had good clinical efficacy,and they could significantly reduce renal function indicators such as UAER,Scr,and 24hUTP,and reduce blood sugar and blood lipid,which can provide evidence-based support for the treatment of early DN.However,due to the differences in the quantity and quality of the included research articles,large-sample,multi-center,high-quality studies are still needed for further verification.