凯时注射液治疗糖尿病肾病的系统评价

目的对公开发表的凯时注射液治疗糖尿病肾病的文献进行Meta分析,评价凯时注射液治疗糖尿病肾病的疗效与安全性。方法计算机检索PubMed（1995～2010）、FMJS外文全文数据库（EMCC,1995～2010）、中国生物医学文献数据库（CBM,1995～2010）、中国期刊全文数据库（CNKI,1995～2010）、中文科技期刊全文数据库（VIP,1989～2010）,收集凯时注射液治疗糖尿病肾病的随机对照试验。由两名研究者独立选择试验、提取资料并交叉核对,而后评价纳入研究的质量和提取有效数据,应用RevMan 4.2.8软件进行Meta分析。评价指标包括：尿蛋白排泄率、血肌酐、尿素氨、24h尿蛋白定量。结果共纳入19篇RCT,合计1 153例患者,其中试验组594例,对照组559例。各研究基线资料具有可比性,均报道有随机方法但未提及盲法和分配隐藏,仅有1篇明确提到按随机数列表随机分组。Meta分析结果显示：凯时注射液在降低尿蛋白排泄率WMD= -77.86,95%CI（-85.64,-70.08）]、血肌酐WMD= -3.14,95%CI（-5.30,-0.98）]、尿素氨WMD= -0.71,95%CI（-1.13,-0.29）]、24h尿蛋白定量方面WMD= -0.56,95%CI（-0.79,-0.33）]均优于常规治疗组。结论凯时注射液治疗糖尿病肾病疗效明显优于常规治疗。但由于纳入的高质量文献很少,样本量有限,仍需进一步深入研究。

Kaishi Injection for Diabetic Nephropathy: A Systematic Review

Objective To carry out Meta analyses about the published literature that concerns Kaishi injection curing diabetic nephropathy,and to evaluate the efficacy and safety of Kaishi injection for diabetic nephropathy.Methods We searched the following databases：PubMed（1995 to 2010）,EMCC（1995 to 2010）,CBM（1995 to 2010）,CNKI（1995 to 2010）,and VIP（1989 to 2010） to collect randomized controlled trials（RCTs） of Kaishi injection curing diabetic nephropathy.The selection of studies,assessment of methodological quality and data extraction were performed independently by two reviewers.According to prede ned inclusion and exclusion criteria Cochrane systematic review methods,the methodological quality assessment was undertaken,and meta-analyses were performed by using the Cochrane Collaboration＇s RevMan 4.2.8 so ware.Evolution index were included：UAER,Scr,BUN,and 24 hours urinary protein.Results The literature included 19 RCTs with a total of 1 153 cases.Among them,594 cases belonged to the treatment group and the control group included 559 ones.The studies of baseline data were comparable,and all reported that there were random methods but did not mention blinding and allocation concealment.Only one mentioned references to a list of random numbers by random grouping.The results of meta-analyses indicated that Kaishi injection was superior to routine treatment in decreasing UAER WMD=-77.86,95%CI（-85.64,-70.08）],Scr WMD=-3.14,95%CI（-5.30,-0.98）],BUN WMD=-0.71,95%CI（-1.13,-0.29）],and 24 hours urinary protein WMD=-0.56,95%CI（-0.79,-0.33）].Conclusion The treatment of the diabetic nephropathy of Kaishi injection is superior to the conventional therapy.However,because of few high quality literature and limited sample size,further study is needed.