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 predefined 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 software. 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 listof 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.
