Systematic review on efficacy and safety of Shenfu Injection in adjuvant treatment of dilated cardiomyopathy

JIA Qiu-lei; HU Yuan-hui; SONG Qing-qiao; DU Bai; LI Ke; LI Si-si

doi:10.3969/j.issn.1674-4055.2015.05.08

Abstract：Objective To review systematically the efficacy and safety of Shenfu Injection combining Western drugs for improving heart function and quality of life (QOL) in patients with dilated cardiomyopathy.Methods The databases of CNKI, WanFang Database, VIP Database, PubMed, EMbase, Clinicaltrails and CENTRAL were retrieved for collecting the randomized-controlled trails (RCT) about treatment of dilated cardiomyopathy with Shenfu Injection. All RCT were selected by 2 reviewers independently according to inclusion and exclusion criterions, and materials were extracted, checked crossly and given methodological quality evaluation. A Meta-analysis was conducted by using RevMan 5.3 software.Results There were totally 8 RCT included involving 536 subjects. The results of Meta-analysis showed that improvement rate of NYHA grading was better in treatment group than that in control group [RR=1.25, 95%CI: (1.15~1.35),P<0.00001], LVEF was higher in treatment group than that in control group [MD=6.28, 95%CI: (3.29~9.27),P<0.0001], LVEDd was lower in treatment group than that in control group [MD=-4.07, 95%CI: (-5.85, -2.28),P<0.00001], BNP was lower in treatment group than that in control group [MD=-132.38, 95%CI: (-205.66, -59.10),P=0.0004], 6MWD was higher in treatment group than that in control group [MD=35.86, 95%CI: (17.95, 53.77),P<0.0001] and heart rate was lower in treatment group than that in control group [MD=-4.91, 95%CI: (-7.27, -2.55),P<0.0001]. Among 8 RCT, adverse reactions were observed in 2 RCT and in 1 RCT report.Conclusion Shenfu Injection, based on routine therapy, can improve heart function indexes in patients with dilated cardiomyopathy. As most of studies did not observe the safety of Shenfu Injection, they have not given reliable analysis on the safety. The bias risk of this conclusion is increased because small sample and lower quality of the systematical review, and more high-quality trials are needed to confirm the curative effect and safety of Shenfu Injection.