肾康注射液治疗Ⅲ期糖尿病肾病的Meta分析

Meta analysis on efficacy of Shenkang Injection in treating stage Ⅲ diabetic nephropathy

目的:评价肾康注射液治疗Ⅲ期糖尿病肾病(DN)的疗效。方法:计算机检索Cochrane Library、Pubmed、Embase、中国知网(CNKI)、维普(VIP)、中国生物医学文献数据库(CBM)及万方数据库,纳入有关肾康注射液治疗Ⅲ期DN的随机对照试验,根据Cochrane手册及Jadad评分标准评价纳入研究方法学质量,并应用Rev Man 5.2软件统计分析。结果:纳入11个随机对照试验,共746例受试者。Meta分析显示与常规西药治疗相比,加用肾康注射液静滴对Ⅲ期DN患者尿白蛋白排泄率(UAER)的影响具有统计学差异(MD=-45.14,P<0.00001);对24h-UP、Scr、BUN、Cys C等肾功能指标的影响具有统计学意义;对TG、TC、HDL-C、LDL-C等脂代谢指标的影响具有统计学意义;但对FBS等糖代谢指标的影响无统计学意义。本研究纳入的11篇文献,均未报告与肾康注射液有关的严重不良反应。结论:西医常规治疗基础上加用肾康注射液可提高Ⅲ期DN的治疗效果,但受研究质量限制,其疗效及安全性需要更多高质量临床试验加以验证。

Objective：To evaluate the effects of Shenkang Injection for treating patient with stage Ⅲ diabetic nephropathy（DN）.Methods：The randomized controlled trials（RCTs） about treating stage Ⅲ diabetic nephropathy（DN） with Shenkang Injection included in Cochrane library,Pubmed,Embase,CNKI,VIP,CBM and Wanfang datasases were searched by computer.The methodological quality of included studies was evaluated according to the Cochrane Handbook and the Jadad criteria,and the results were analyzed by using RevMan 5.2 software.Results：A total of 11 RCTs involving 746 participants were included.Results of Meta-analysis showed that the difference in the influence of Shenkang Injection on urinary albumin excretion rate（UREA）,was statistically significant compared to conventional treatment（MD=- 45.14,P〈0.00001）,renal function indexes as24h-UP,Scr and BUN,and CysC lipid metabolism indexes as TG,TC,HDL-C and LDL-C of patient with stage Ⅲ DN,however,the difference in the influence of Shenkang Injection on glucose metabolism index as FBS and so on was not significant.There was no serious adverse reaction reported in the 11 included RCTs.Conclusion：Shenkang Injection could improve the curative effect of stage Ⅲ DN based on the western medicine routine treatment,but the effectiveness and safety needs to be verified by more high quality RCTs because of the limitation in the quality of these included RCTs.