参麦注射液辅助治疗慢性阻塞性肺疾病的疗效与安全性的Meta分析

Meta-analysis on Efficacy and Safety of Shenmai Injection as a Subsidiary Therapy for Chronic Obstructive Pulmonary Disease

目的:系统评价参麦注射液辅助治疗慢性阻塞性肺疾病(COPD)的疗效与安全性。方法:计算机检索Cochrane图书馆、PubMed、EMbase、中国生物医学文献数据库、中国期刊全文数据库、维普数据库和万方数字化期刊全文数据库中关于参麦注射液辅助治疗COPD的疗效和安全性的随机对照试验(RCT),按纳入与排除标准选择,提取资料后采用Rev Man 5.0统计软件进行Meta分析。结果:共纳入24项RCT,合计2 118例患者。Meta分析结果显示,试验组的有效率[OR=4.86,95%CI(3.53,6.68),P<0.01]和显效率[OR=2.55,95%C(I2.04,3.18),P<0.01]显著高于对照组,两组比较差异有统计学意义。试验组在升高动脉血氧分压[MD=9.03,95%CI(5.21,12.85),P<0.01]、降低动脉血二氧化碳分压[MD=5.22,95%CI(3.20,7.23),P<0.01]、提高一秒用力呼气容积占用力肺活量的百分比[MD=3.96,95%C(I3.03,4.90),P<0.01]以及增加淋巴细胞CD4与CD8的比值[MD=0.42,95%CI(0.30,0.54),P<0.01]方面均显著优于对照组,两组比较差异有统计学意义。两组的不良反应发生率比较,差异无统计学意义[OR=0.41,95%C(I0.14,1.24),P=0.11]。结论:参麦注射液辅助治疗COPD可以提高治疗的有效率和显效率,还能显著改善动脉血气和肺功能指标,增强机体免疫力,且安全性较好。但是,由于纳入研究样本量较小,文献质量不高,上述结论还需多中心、大样本、随机双盲对照的RCT加以证实。

OBJECTIVE：To evaluate therapeutic efficacy and safety of Shenmai injection as a subsidiary therapy for chronic obstructive pulmonary disease（COPD）.METHODS：RCTs about therapeutic efficacy of Shenmai injection as a subsidiary therapy for COPD were retrieved from Cochrane library,PubMed,EMbase,CBM,CNKI,VIP and Wanfang database by computer.Trial selection was performed according to including and excluding criteria.Meta-analysis was conducted using Rev Man 5.0 software after data extraction.RESULTS：A total of 24 RCT were included,involving 2 118 patients.Meta-analysis showed that effective rate [OR=4.86,95%CI（3.53,6.68）,P0.01] and marked effective rate [OR=2.55,95%CI（2.04,3.18）,P0.01] of trial group were higher than those of control group;there was statistical difference between 2 groups.And the trial group was better than the control group in the following ways：the increase of arterial pbt（O2）[MD=9.03,95%CI（5.21,12.85）,P0.01],the decrease of arterial pbt（CO2）[MD=5.22,95%CI（3.20,7.23）,P0.01],FEV1/FVC% [MD=3.96,95%CI（3.03,4.90）,P0.01] and the increase of CD4/CD8 [MD=0.42,95%CI（0.30,0.54）,P0.01];there was statistical difference between 2 groups.However,the incidence of ADR in 2 groups showed no significant difference [OR=0.41,95%CI（0.14,1.24）,P=0.11].CONCLUSIONS：Shenmai injection as a subsidiary therapy for COPD can improve the effective rate and marked effective rate,and also promotes the index of arterial blood gas and pulmonary function,enhances the immunity and shows sound safety.While the number and quality of included study were not satisfactory,the study result should be confirmed by multi-center and large-scale randomized double-blind controlled trials.