• Ying-Jie Zhi, Jun Zhao, Hui Zhao, and Dan-Dan Yu.
• Institute of Basic Research Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China.
• Zhongguo Zhong Yao Za Zhi. 2018 Oct 1; 43 (19): 3940-3955.

AbstractTo systematically evaluate the efficacy and safety of breviscapine injection in the treatment of unstable angina pectoris (UAP). Eight electronic databases and clinical trials registries were searched to collect randomized controlled trials on breviscapine injection in the treatment of UAP. According to the evaluation standards in Cochrane Handbook 5.1, two independent reviewers screened out the literature, extracted data and assessed the quality of the studies included. RevMan 5.3 software was used for Meta quantitative analysis and corresponding description analysis. A total of 36 studies involving 3 058 patients were included, 1 552 cases in the trial group, 1 506 cases in the control group, 1 846 males and 1 212 females. All the clinical studies showed a low quality. Meta-analysis results showed that the combination of breviscapine injection and conventional therapy was superior to conventional therapy in angina pectoris efficacy (RRangina pectoris efficacy=1.29, 95%CI[1.23,1.35],P<0.000 01；RRECG1=1.25,95%CI[1.12,1.38],P<0.000 1；RRECG2=1.38,95%CI[1.27,1.49],P<0.000 01); descriptive analysis of a single study showed that the efficacy of combination of breviscapine injection and conventional therapy was superior to that of conventional therapy alone. In respect of hemorheology, the combination of breviscapine injection and conventional therapy was better than conventional therapy in lowering LBV and EAI (MDLBV=-1.27,95%CI[-1.55,-0.99],P<0.000 01；MDEAI=-0.38,95%CI[-0.60,-0.16],P=0.000 6), as well as in lowering WBV and HCT in the descriptive analysis of single study. In respect of blood lipid, the combination of breviscapine injection and conventional therapy was better than conventional therapy in lowering TC, TG and LDL-C (MDTC=-0.30,95%CI[-0.51,-0.10],P=0.003；MDTG=-0.32,95%CI[-0.77,0.13],P=0.16；MDLDL-C=-0.45,95%CI[-0.76,-0.14],P=0.004). In reducing the frequency of angina attacks, heart rate, high sensitive C-reactive protein and improving exercise tolerance, the combination of breviscapine injection and conventional therapy was also superior to the conventional therapy alone (MDFAP=-3.30,95%CI[-4.06,-2.54],P< 0.000 01；MDHR=-9.38,95%CI[-12.78,-5.98],P=0.000 2；MDhs-CRP=-0.56,95%CI[-0.85,-0.27],P=0.000 2；MDET=0.88,95%CI[0.41,1.35],P=0.000 2). The main adverse reactions in the two groups included headache, dizziness, palpitations, nausea, abdominal distension, skin pruritus, flushes and allergic reactions in the study. The safety of breviscapine injection needs to be further studied and clarified because of the combination of drugs and the incomplete information reported in the original study. The current evidence suggested that the combination of breviscapine injection and conventional therapy had certain advantages in curative effect for the treatment of UAP. Due to the low quality of the study and its own shortcomings, it is necessary to design more rigorous, high-quality, multi-center randomized double-blind controlled trials to increase the strength of the evidence.Copyright© by the Chinese Pharmaceutical Association.

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