丹参川芎嗪注射液辅助治疗肺源性心脏病疗效与安全性的系统评价

目的:系统评价丹参川芎嗪注射液辅助治疗肺源性心脏病疗效与安全性,为临床安全、有效用药提供循症医学参考。方法:系统检索中国期刊全文数据库、万方数据库、中国生物医学文献数据库(SinoMed)、Cochrane Library和Embase,PubMed数据库,收集丹参川芎嗪注射液治疗肺源性心脏病的临床随机对照试验(RCTs),检索时限均为建库至2018年1月,采用Cochrane风险评价表评价其研究质量,提取资料后通过RevMan 5.3软件和State13.0软件进行数据分析。结果:共纳入21篇RCTs文献,累计2005例患者。Meta分析显示:常规治疗的基础上,辅助丹参川芎嗪注射液比对照组仅用常规治疗,在治疗肺源性心脏病方面具有较好的疗效,可显著提高患者总有效率RR=1.28,95%CI=(1.21,1.35),P<0.000 01]和改善患者1s用力呼气容积(FEV1)、FEV1/FVC值和肺动脉压(PAP)等肺功能指标,左心射血分数(LVEF)、心率和脑钠肽(BNP)等心功能指标,全血高切黏度、全血低切黏度和血浆黏度等血液流变学指标以及PaO2、PaCO2等血气指标。结论:结果揭示在常规治疗的基础上辅助使用丹参川芎嗪注射液治疗可以显著提高其临床疗效且安全性好,目前仍缺乏大型多中心临床随机试验对治疗结果的高质量证据支持。

Efficacy and safety of Salviae miltiorrhiza and ligustrazine hydrochloride injection for treatment of pulmonary heart disease: A systematic review of 21 randomized controlled trials

OBJECTIVE To evaluate therapeutic efficacy and safety of Salviae miltiorrhiza and ligustrazine hydrochloride injection for treatment of pulmonary heart disease and to provide the reference of evidence-based medicine.METHODS Databases including CNKI, Wanfang Data, SinoMed, the Cochrane Library, Embase and PubMed were searched from inception to January 2018 to identify the randomized controlled trials(RCTs) on Salviae miltiorrhiza and ligustrazine hydrochloride injection for the treatment of pulmonary heart disease. All included studies were critically appraised by two independent reviewers followed the cochrane systematic review method and using Revman 5.3 software and State13.0 for meta-analysis.RESULTS There were 21 RCTs and 2005 patients with pulmonary heart disease were eligible for the inclusion criteria. Meta-analysis showed that compared with control group of conventional medicine alone, Salviae miltiorrhiza and ligustrazine hydrochloride injection combined with conventional medicine achieved the better effect of total effective rateRR=1.28, 95%CI=(1.21, 1.35), P<0.000 01]. Furthermore, the result showed that Salviae miltiorrhiza and ligustrazine hydrochloride injection in the treatment of pulmonary heart disease significantly improved lung function index of forced expiratory volume in one second(FEV₁), FEV1/FVC and pulmonary artery pressure(PAP), the cardiac function of left ventricular ejection fraction(LVEF), heart rate and brain natriuretic peptide(BNP) and hemorheology of the high blood viscosity, low blood viscosity, plasma viscosity and the blood gas index of PaO₂ and PaCO₂.CONCLUSION This meta-analysis demonstrates that Salviae miltiorrhiza and ligustrazine hydrochloride injection for the treatment of pulmonary heart disease is safe and effective, but lacks the large multicenter clinical randomized trials to support treatment outcome.