银杏达莫联合前列地尔治疗糖尿病肾病疗效和安全性的Meta分析

Clinical efficacy and safety of Ginkgo dipyridolum injection combined with alprostadil injection in the treatment of diabetic nephropathy:A meta-analysis of randomized controlled trials

目的系统评价银杏达莫联合前列地尔治疗糖尿病肾病的疗效和安全性。方法通过Pubmed、Cochane Library、Embase、CNKI、维普等数据库检索有关联合银杏达莫及前列地尔治疗糖尿病肾病的文献,采用改良Jadad量表进行质量评分,Rev Man 5.3.1软件进行统计分析。结果共纳入5篇随机对照试验,均为中文文献。Meta分析结果显示:银杏达莫联合前列地尔治疗糖尿病肾病在降低24 h尿蛋白定量(MD=-0.33;95%CI:-0.47~^-0.19,P<0.00001),降低血肌酐(SCr)(MD=-11.44,95%CI:-22.37~^-0.52,P=0.04),降低24 h尿蛋白排泄率(MD=-46.35,95%CI:-51.39~^-41.32,P<0.00001),升高脂联素(ADPN)水平(MD=1.70,95%CI:1.15~~2.25,P<0.00001)方面优于单用银杏达莫或前列地尔,而24h尿量、血尿素氮(BUN)、血糖、不良反应等指标两组比较差异无统计学意义(P>0.05)。结论银杏达莫联合前列地尔可明显保护肾功能、改善临床症状,但与血糖、不良反应等预后结局的关系尚不明确,且纳入文献质量不高,因此有必要开展此方面的高质量、大样本、多中心的随机对照试验。

Objective AIM To explore the clinical efficacy and safety of Ginkgo Dipyridolum Injection combined with Alprostadil Injection in the treatment of patients with diabetic nephropathy.Methods Randomized controlled trials（RCT）on the clinical efficacy and safety of Ginkgo Dipyridolum Injection combined with Alprostadil Injection for diabetic nephropathy were reviewed from Pubmed,Cochane Library,Embase,CNKI,CBM and VIP,from the earliest published articles to December 2016,all reviewed literatures were accessed by Modified Jadad quality scale.Statistic data was analysed by Rev Man5.3.1.Two researchers independently selected articles,extracted data,assessed quality,and cross checked the results.Risk of bias was assessed using Cochrane Handbook guidelines.Study outcomes were presented as risk ratios（RRs）for dichotomous data or mean differences（MDs）for continuous outcomes.The sensitivity analysis by different effect model and sample size was employed for the reliability of meta-analysis.ResultsThis review contains 5 RCT studies（all Chinese literatures）,including 352 Diabetic Nephropathy patients with the treatment of Ginkgo Dipyridolum Injection combined with Alprostadil Injection.The meta-analysis indicated that compared with conventional Ginkgodipyidamolum or Alprostadil therapies alone,Ginkgo dipyridolum injection combined with Alprostadil Injection could reduce quantitative test of 24h urinary protein（MD=-0.33,95%CI：-0.47~^-0.19,P0.00001）,reduce the serum creatinine（SCr）（MD=-11.44,95%CI：-22.37~^-0.52,P=0.04）,decrease the 24-hours urinary albumin excretion rate.（MD=-46.35,95%CI：-51.39~^-41.32,P0.00001）,enhance the Adiponectin（ADPN）（MD=1.70,95%CI：1.15~~2.25,P0.00001）more effectively.However,there were no significant statistical differences on the 24h urine output,blood urea nitrogen（BUN）,blood glucose and adverse reactions between the treatment groups and the control groups（P0.05）.ConclusionGinkgo Dipyridolum Injection combined with Alprostadil Injection appears to have satisfactory efficacy and safety in the treatment of patients with diabetic nephropathy,which is superior to any conventional treatment.However,a clinical recommendation is not warranted due to the small number of studies included and low methodology quality.Multi-center and high-quality RCTs with large sample sizes are needed to provide stronger evidence.