中药治疗慢性肺源性心脏病临床试验结局指标文献研究

目的]通过整理中药治疗慢性肺源性心脏病临床随机对照试验的结局指标,为制定慢性肺源性心脏病的核心指标集提供基础数据。方法]计算机检索中国知网(CNKI)、万方(WanFang)、维普(VIP)、中国生物医学文献服务系统(SinoMed)、PubMed、Cochrane Library和Embase数据库,收集中药干预治疗慢性肺源性心脏病随机对照试验数据。论文发表时间限定为2018年。由两位作者严格按照纳入和排除标准独立筛选文献,提取资料,若有分歧,经商讨决定。结果]经筛选最终纳入68篇慢性肺源性心脏病随机对照试验,共采用49个结局指标。根据指标功能属性,分为中医症状/证候、症状体征、理化检查、生活质量、远期预后、经济学评估和安全性事件7个指标域。排前15位的结局指标依次为临床有效率、血气分析、超声心动图、不良反应、脑钠肽、肺功能指标、中医证候积分、血液流变学、肺动脉压、生活质量、6 min步行试验、心功能分级、血清学指标、症状缓解时间、C-反应蛋白。结论]中药治疗慢性肺源性心脏病的临床试验采用的结局指标存在差异性大、报告不规范等问题,需要开展核心指标集研究,提高临床研究的价值。

Literature study on outcome index of clinical trial of traditional Chinese medicine in treating chronic pulmonary heart disease

Objective] To provide basic data for the development of the core outcomes set of chronic pulmonary heart disease by sorting out the outcome indexes of the clinical randomized controlled trial of traditional Chinese medicine (TCM) in the treatment of chronic pulmonary heart disease.Methods] CNKI,WanFang,VIP,SinoMed,PubMed,Cochrane Library and Embase databases were searched by computer to collect the data of randomized controlled trials of traditional Chinese medicine intervention in the treatment of chronic pulmonary heart disease. The publication time of the paper is limited to 2018. The literature was screened independently according to the inclusion and exclusion criteria by two authors,and the data were extracted. If there were differences,it was decided through discussion.Results] After screening,68 randomized controlled trials of chronic pulmonary heart disease were included,with 49 outcome indicators. According to the functional attributes of indicators,it can be divided into seven indicator fields:symptoms/syndromes,symptoms and signs,physical and chemical examination,quality of life,long-term prognosis,economic evaluation and safety events. The top 15 outcome indicators are:clinical effective rate,blood gas analysis,echocardiography,adverse reactions,brain natriuretic peptide,lung function indicators,TCM syndrome integral,hemorheology,pulmonary artery pressure,quality of life,6-minute walking test,cardiac function classification,serological indicators,symptom relief time and C-reactive protein.Conclusion] There are some problems in clinical trials of treating chronic pulmonary heart disease with traditional Chinese medicine,such as great difference in outcome index and irregular reports. It is necessary to carry out research on core outcome set to improve the value of clinical research.