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目的:系统评价参麦注射液辅助治疗冠心病心绞痛的疗效和安全性,为临床提供循证参考。方法:计算机检索中国期刊全文数据库、万方数据库、中文科技期刊数据库、PubMed,收集参麦注射液联合常规方案(试验组)对比单用常规方案(对照组)治疗冠心病心绞痛的随机对照试验(RCT),提取资料并根据Cochrane系统评价员手册5.1.0评价质量,采用Rev Man 5.3统计软件进行 Meta分析。结果: 共纳入25项RCT,合计2 093例患者。Meta 分析结果显示,试验组患者临床总有效率[RR=1.31,95%CI(1.25,1.37), P<0.001]和心电图总有效率[RR=1.42 ,95%CI(1.31,1.54),P<0.001]均显著高于对照组,差异均有统计学意义。亚组分析结果显示,在高剂量(>40 mL/d)和低剂量(≤40 mL/d)亚组中,试验组患者临床总有效率[高剂量:RR=1.26,95%CI(1.19,1.34),P<0.001;低剂量:RR=1.36,95%CI(1.27,1.45),P<0.001]和心电图总有效率[高剂量:RR=1.39,95%CI(1.22,1.60),P<0.001; 低剂量:RR=1.43,95%CI(1.30,1.58),P<0.001]均显著高于对照组,差异均有统计学意义。两组患者不良反应发生率比较,差异无统计学意义[RR=0.66 ,95%CI(0.32,1.40),P=0.28]。结论:参麦注射液辅助治疗冠心病心绞痛疗效与安全性均较好,建议临床从低剂量开始使用。
OBJECTIVE: To evaluate the therapeutic efficacy and safety of Shenmai injection in adjuvant therapy of angina pectoris, and to provide evidence-based reference in clinic. METHODS: Retrieved from CJFD, Wanfang database, VIP and PubMed, randomized control trials (RCTs) about Shenmai injection combined with routine plan (trial group) vs. routine plan sole (control group) in the treatment of angina pectoris were collected. Meta-analysis was conducted by using Rev Man 5.3 statistical software after data extraction and quality evaluation with Cochrane systematic evaluator manual 5.1.0. RESULTS: A total of 25 studies were included, involving 2 093 patients. Meta-analysis showed that clinical efficacy rate [RR=1.31,95%CI(1.25,1.37),P<0.001] and ECG total response rate [RR=1.42,95%CI(1.31,1.54),P<0.001] of trial group were significantly higher than those of control group, with statistical significance. Results of subgroup analysis showed that among high-dose subgroup(>40 mL/d) and low-dose subgroup(≤40 mL /d), clinical efficacy rate [high dose: RR=1.26,95%CI(1.19,1.34),P<0.001; low dose: RR=1.36,95%CI(1.27,1.45),P<0.001] and ECG total response rate [high dose: RR=1.39,95%CI(1.22,1.60),P<0.001; low dose: RR=1.43,95%CI(1.30,1.58),P<0.001] of trial group were significantly higher than those of control group, with statistical significance. There was no statistical significance in the incidence of ADR between 2 groups [RR=0.66,95%CI(0.32,1.40),P=0.28]. CONCLUSIONS: Shenmai injection in adjuvant therapy of angina pectoris shows good therapeutic efficacy and safety in the treatment of angina pectoris. It is suggested to its clinical application start from the low dose.
参麦注射液冠心病心绞痛疗效安全性Meta 分析
Shenmai injectionAngina pectorisTherapeutic efficacySafetyMeta-analysis
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