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目的系统评价马来酸桂哌齐特注射液对于椎基底动脉供血不足(VBI)的疗效和安全性。方法计算机检索CNKI、维普及万方数据库,收集马来酸桂哌齐特治疗VBI的随机对照试验(RCT)文献,按照Cochrane系统评价方法对RCT进行筛选、质量评价与提取资料,并运用RevMan 5.0软件进行Meta分析。结果共纳入7篇RCT,共596例患者,Meta分析结果显示马来酸桂哌齐特注射液与复方丹参注射液比较,痊愈率OR合并值2.25(95%CI为1.57～3.22),P<0.01,差异有统计学意义;有效率OR合并值4.05(95%CI为2.54～6.45),P<0.01,差异有统计学意义;不良反应(ADR)发生率OR合并值4.61(95%CI为1.45～14.62),P<0.05,差异也具有统计学意义。结论基于目前国内证据,马来酸桂哌齐特注射液治疗VBI疗效优于复方丹参注射液,而不良反应的发生率高于对照药物,但因研究质量及研究样本的局限性,尚需进行高质量、大样本的随RCT予以进一步证实。
Objective To systematically evaluate the efficacy and safety of Cinepazide maleate injection for vertebrobasilar insufficiency (VBI). METHODS: CNKI, VIP and Wanfang databases were searched by computer, RCTs of cinepazide maleate for the treatment of VBI were collected, RCT was screened, evaluated and extracted according to the Cochrane systematic review method, Meta-analysis software. Results A total of 7 RCTs were enrolled in this study. A total of 596 patients were enrolled in this study. Meta analysis showed that the cure rate was 2.25 (95% CI, 1.57-3.22), and the cure rate was significantly lower than that of compound Danshen injection (P < 0.01, the difference was statistically significant; effective OR combined 4.05 (95% CI 2.54 ~ 6.45), P <0.01, the difference was statistically significant; adverse reaction (ADR) OR combined 4.61 (95% CI 1.45 ~ 14.62), P <0.05, the difference was also statistically significant. Conclusions Based on the current domestic evidence, the efficacy of cinepazide maleate injection in the treatment of VBI is better than that of compound Salvia miltiorrhiza injection, and the incidence of adverse reactions is higher than that of the control drug. However, due to the quality of the study and the limitations of the study sample, High-quality, large samples were further confirmed with the RCT.