[Efficacy and safety of Breviscapine Injection in treatment of diabetic nephropathy: systematic review and Meta-analysis of randomized controlled trials].

This study aimed to systematically evaluate the efficacy and safety of Breviscapine Injection in the treatment of diabetic nephropathy( DN). Eight electronic databases and Clinical Trials.gov were searched to collect randomized controlled trials on Breviscapine Injection in the treatment of DN. According to the Cochrane Handbook 5. 1,two independent reviewers screened out the literatures,extracted data and assessed the quality of the studies included. Rev Man5. 3 software was used for the data analysis. A total of 29 studies containing 37 trials were included,involving 2 097 patients,1 054 cases in test groups and 1 043 cases in control groups. The clinical studies included had a low overall quality. According to Meta-analysis: ①Conventional therapy plus breviscapine injection was superior to conventional therapy in total efficiency rate,24 h UTP,SCR,BUN,UEAR,ALB and m ALB during DN stage Ⅲ( RRtotal effective rate=1. 60,95%CI [1. 32,1. 93],P<0. 000 01; SMD24 h UTP=-1. 21,95%CI[-1. 56,-0. 87],P<0. 000 01; MDSCR=-6. 33,95%CI[-9. 20,-3. 46],P<0. 000 1; MDBUN=-6. 6,95%CI[-1. 10,-0. 22],P = 0. 003; MDUEAR=-20. 30,95%CI [-28. 14,-12. 46],P<0. 000 01; MDALB= 0. 47,95%CI[0. 42,0. 52],P<0. 000 01; MDmALB=-10. 03,95%CI[-10. 62,-9. 46],P<0. 000 01). ②Conventional therapy plus Breviscapine Injection was better than conventional therapy in total efficiency rate( only 1 study),24 h UTP,SCR and BUN during DN stage Ⅳ( RRtotal effective rate= 1. 57,95% CI[1. 10,2. 25],P = 0. 01; SMD24 h UTP=-0. 52,95% CI [-0. 71,-0. 33],P<0. 000 01; MDSCR=-35. 38,95%CI[-48. 57,-22. 19],P<0. 000 01; MDBUN=-1. 89,95%CI [-3. 01,-0. 77],P<0. 000 01). ③Conventional therapy plus Breviscapine Injection was better than conventional therapy in SCR( MD =-26. 35,95% CI[-47. 45,-5. 24],P= 0. 01),but with no significant difference in 24 h UTP,BUN and ALB during DN stageⅤ. ④It was impossible to obtain the specific judgment information on the adverse reactions of Breviscapine Injection in the treatment of the disease from the existing evidences. The current evidences suggest that the combination of Breviscapine Injection and conventional therapy had a certain curative effect in the treatment of DN,especially in stages Ⅲ and Ⅳ. The safety of Breviscapine Injection needs to be further explored.Because the low quality of the study impacted the accuracy of the result,more rigorous,high-quality,multi-center,randomized doubleblind controlled trials are required to increase the support of the evidences in the future.