Meta-analysis on the randomized controlled trials of Fufang-Danshen injection in the treatment of unstable angina pectoris / 国际中医中药杂志

ABSTRACT

Objective To systematically evaluate the clinical efficacy and safety of Fufang-Danshen Injection (FD) in the treatment of unstable angina pectoris(UAP). Methods Randomized controlled trials (RCTs) and quasi-RCTs regarding FD in the treatment of UAP were collected through comprehensive searches of China National Knowledge Infrastructure(CNKI), Chinese Scientific Journals Database(VIP), Wan fang Database, Chinese Biomedical Literature Database(CBM), PubMed, Embase and Cochrane Library from January 1979 to December 2013. Two reviewers independently assessed the quality of the included studies by the Cochrane risk of bias, and extracted the information from the included studies. Meta-analysis was conducted with the software Review Manager 5.2. Results A total of 13 studies with 1156 participants were included. In the meta-analysis, ①the total effective rate of UAP:in term of FD+conventional therapy with western medicine(WM)vsWM, the difference between two groups was statistically significant [RR=1.32, 95%CI(1.21, 1.43), P<0.01]; FD+low molecular weight heparin+WM vs WM, difference between two groups was also statistically significant [RR=1.29, 95% CI(1.17, 1.42), P<0.01], which indicated that the efficacy of experimental group was higher than the control group. Other interventions, such as FD+WM vs low molecular weight heparin+WM and FD vs WM, there was no significant difference between two groups. ②the total effective rate of ECG:in term of FD+WM vs WM, the difference between two groups was statistically significant [RR=1.34, 95%CI (1.14, 1.57), P<0.01]; in term of FD vs WM, difference between two groups was statistically significant [RR=1.49, 95%CI(1.13, 1.96), P<0.01], which indicated that experimental group can effectively improve the total effective rate of ECG. ③ frequency of angina attacks:in term of FD+WM vs WM, the difference between two groups was statistically significant [MD=1.07, 95%CI(0.48, 1.66), P<0.01]. No differences between groups existed in other analysis. ④ adverse drug reactions(ADRs):4 articles cleared that there was no ADRs in the studies, 4 studies reported ADRs, which represented headache, nausea, flushing and so on. There were 9 cases in the experimental group, and 9 in control group. Conclusion Based on the meta-analysis, FD was effective and relatively safe for the treatment of UAP in clinical. However, since the articles enrolled in the study were not in high quality, more qualified studies should be conducted for the further assessment of efficacy and safety of FD for UAP.