疏血通注射液治疗慢性肺源性心脏病急性加重期疗效和安全性的系统评价

Efficacy and safety of Shuxuetong Injection for acute exacerbation of chronic cardiopulmonary disease:a systematic review

关键词:  疏血通注射液  慢性肺源性心脏病  肺心病  系统评价  Meta分析

Key words:  Shuxuetong Injection  chronic pulmonary heart disease  pulmonary heart disease  systematic review  Meta-analysis

摘要:

[目的] 系统评价疏血通注射液治疗慢性肺源性心脏病急性加重期的疗效和安全性。[方法] 检索中国全文期刊数据库、万方数据库（WanFang Data）、中国生物医学文献数据库（Donta SinoMed）、维普数据库（VIP）、PubMed、Cochrane library和EMbase数据库，全面收集疏血通注射液治疗慢性肺源性心脏病急性加重期的临床随机对照试验（RCT），检索时限为建库至2019年3月6日。由2名系统评价员按照纳入与排除标准独立进行文献筛选、资料提取和质量评价，文献方法学质量评价采用Cochrane handbook偏倚风险评估工具，采用Revman5.3软件进行Meta分析并用证据质量分级系统GRADE评价结局指标证据质量。[结果] 共纳入9个RCT，Meta分析结果显示：与单用常规西药相比，在常规西药治疗基础上加用疏血通注射液，可以进一步提高临床治疗效果（RR=1.29，95% CI[1.19，1.38]，P<0.000 01）。氧分压（MD=10.15，95% CI[9.16，11.14]，P<0.000 01），二氧化碳分压（MD=-6.63，95% CI[-7.31，-5.96]，P<0.000 01）及血黏度等指标组间差异有统计学意义。GRADE证据分级结果显示：总有效率、血液流变学指标证据等级为低级，血气分析指标证据等级为极低级。试验组仅有1例不良事件报告。[结论] 在应用常规西药治疗慢性肺源性心脏病急性加重期的基础上加用疏血通注射液，能够提高临床疗效，改善血气指标和血黏度指标。但纳入研究存在较多方法学质量问题，影响文献结果的可靠性，因此还需开展大样本随机对照试验进一步证实。

Abstract:

[Objective] To evaluate the efficacy and safety of Shuxuetong Injection in the treatment of acute exacerbation of chronic pulmonary heart disease.[Methods] CNKI,WanFang,SinoMed,VIP,PubMed,Cochrane library and EMbase databases were searched by computer,and the clinical randomized controlled trial(RCT) of Shuxuetong Injection for the treatment of acute exacerbation of chronic pulmonary heart disease was comprehensively collected. The retrieval time was from the building database to March 6,2019. Literature screening,data extraction and quality evaluation were conducted independently by 2 system evaluators according to inclusion and exclusion criteria. Literature methodology quality evaluation was conducted using the Cochrane handbook bias risk assessment tool. Meta-analysis using Revman 5.3 software and evaluation of outcome quality of outcome indicators with GRADE.[Results] A total of 9 RCTs were included. The results of the Meta-analysis showed that compared with the conventional Western medicine alone,the application of Shuxuetong Injection on the basis of conventional Western medicine treatment can further improve the clinical treatment effect (RR=1.29,95%CI[1.19,1.38],P<0.000 01). There were statistically significant differences in partial pressure of oxygen (MD=10.15,95%CI[9.16,11.14],P<0.000 01),partial pressure of Carbon Dioxide (MD=-6.63,95%CI[-7.31,-5.96],P<0.000 01) and blood viscosity. The GRADE evidence grading results show that the total effective rate,blood viscosity index evidence level is low,and the blood gas analysis index evidence level is extremely low. There was only one adverse event report in the trial group.[Conclusion] On the basis of the application of conventional Western medicine in the treatment of acute exacerbation of chronic pulmonary heart disease,Shuxuetong Injection can Improve the clinical efficacy,blood gas index and blood viscosity index. However,there are many methodological quality problems in the included studies,which will affect the reliability of the results of the literature. It needs to be further confirmed by large sample randomized controlled trials.