参麦注射液联合西药治疗肺源性心脏病疗效与安全性的Meta分析

Meta-analysis of Efficacy and Safety of Shen Mai Injection Combined with Western Medicine in the Treatment of Pulmonary Heart Disease

目的系统评价参麦注射液联合西药治疗肺源性心脏病的临床疗效与安全性。方法检索中国知网(CNKI)、维普中文期刊(VIP)、万方全方数据库(Wanfang)、中国生物医学文献服务系统(SinoMed)、Pubmed、Embase、the Cochrane Library等7个数据库建库起至2020年7月有关参麦注射液联合西药治疗肺源性心脏病的随机对照研究。根据纳入、排除标准进行文献筛选和资料提取,采用GRADE profiler 3.2和RevMan 5.3软件对结局指标进行证据质量分级和Meta分析。结果共纳入19项研究,患者1469例,其中治疗组743例,对照组726例。Meta分析结果显示,治疗组能够提高患者心功能疗效[RR=1.23,95%CI(1.16,1.30),P<0.00001]、心输出量[MD=0.65,95%CI(0.20,1.10),P=0.005]、动脉氧分压[MD=8.72,95%CI(8.32,9.13),P<0.00001],降低二氧化碳分压[MD=-8.86,95%CI(-10.32,-7.41),P<0.00001]、红细胞比积[MD=-0.03,95%CI(-0.06,-0.01),P<0.00001],各项结局指标均优于对照组。参麦注射液联合西药治疗肺源性心脏病无明显不良反应,各项结局指标的GRADE分级为低、中级。结论参麦注射液联合西药能提高肺源性心脏病的临床疗效,无严重不良反应。但由于文献质量不高,结论仍需更多设计严谨、实施规范的多中心、大样本的研究来支持。

Objective To systematically evaluate the efficacy and safety of Shen Mai injection combined with Western medicine in the treatment of pulmonary heart disease.Methods A randomized controlled study of Shen Mai injection combined with western medicine in the treatment of pulmonary heart disease was retrieved from 7 databases including CNKI,VIP,Wanfang,SinoMed,Pubmed,Embase,and the Cochrane Library until July 2020.Literatures were screened and data extracted according to inclusion and exclusion criteria.The GRADE profiler 3.2 and RevMan 5.3 software were used for evidence quality grading and Meta-analysis of outcome indicators.Results A total of 19 studies were included with 1469 patients,including 743 in the treatment group and 726 in the control group.Meta-analysis results showed that patients in the treatment group could improve the efficacy of cardiac function[RR=1.23,95%CI(1.16,1.30),P<0.00001],cardiac output[MD=0.65,95%CI(0.20,1.10),P=0.005],arterial oxygen partial pressure[MD=8.72,95%CI(8.32,9.13),P<0.00001]and reduce partial pressure of carbon dioxide[MD=-8.86,95%CI(-10.32,-7.41),P<0.00001],red blood cell specific volume[MD=-0.03,95%CI(-0.06,-0.01),P<0.00001].All outcome indicators were better than those of the control group.There were no obvious adverse reactions in the treatment of pulmonary heart disease by Shen Mai injection combined with western medicine,and the GRADE grading of all outcome indexes were low and intermediate.Conclusion Shen Mai injection combined with western medicine can improve the clinical efficacy of pulmonary heart disease without serious adverse reactions.However,due to the poor quality of the literatures,more multi-center and large-sample studies with rigorous design and standard implementation are still needed to support the current conclusion.