肾康注射液联合前列地尔对比单用前列地尔治疗慢性肾衰竭的Meta分析

Meta-analysis of Efficacy of Shenkang Injection with Alprostadil Versus Alprostadil Alone on Chronic Renal Failure

目的:系统评价肾康注射液联合前列地尔(试验组)对比单用前列地尔(对照组)治疗慢性肾衰竭(CRF)的临床疗效及安全性,为临床治疗提供参考。方法:采用Cochrane协作组提供的Revman5.4软件对纳入的RCT文献进行风险评估与Meta分析。结果:共纳入9项RCT研究,共计691例患者。Meta分析结果显示,试验组在提高优化总有效率(RR=1.24,95%CI[1.16,1.33],P<0.00001),BUN(MD=-4.28,95%CI[-6.10,-2.46],P<0.00001),Scr(MD=-51.91,95%CI[-68.11,-35.70],P<0.00001),Ccr(MD=5.78,95%CI[2.15,9.41],P=0.002),24 h Upro(MD=-0.56,95%CI[-0.66,-0.46],P<0.00001)方面明显优于对照组,不良反应发生率差异无统计学意义,无严重不良反应。结论:肾康注射液联合前列地尔对比单用前列地尔疗效更佳,值得临床推广使用。但由于证据质量不高,还需要更多严格的、多中心的、随机双盲、大样本的RCT试验进一步探讨。

Objective:To systematically evaluate the clinical effect and safety of Shenkang Injection with Alprostadil(experimental group)versus Alprostadil alone(control group)on chronic renal failure(CRF),and to provide reference for clinical use.Methods:RevMan 5.4 provided by the Cochran collaboration was applied to risk assessment and meta-analysis of the included RCTs.Results:A total of 9 studies involving 691 patients were included.Meta analysis indicated that the experimental group had advantages in total clinical effective rate(RR=1.24,95%CI[1.16,1.33],P<0.00001),BUN(MD=-4.28,95%CI[-6.10,-2.46],P<0.00001),Scr(MD=-51.91,95%CI[-68.11,-35.70],P<0.00001),Ccr(MD=5.78,95%CI[2.15,9.41],P=0.002),24 h Upro(MD=-0.56,95%CI[-0.66,-0.46],P<0.00001)compared with the control group.But there were no significant difference in incidence of adverse reactions between two groups.Serious adverse reactions were not found.Conclusion:Compared with Alprostadil alone,Shenkang Injection with Alprostadil has better efficiancy,and deserved to be promoted for clinical use.However,due to the low quality of evidence,more rigorous,multicenter,randomized double-blind,large sample randomized controlled trials are needed for further exploration.