中成药治疗慢性肺源性心脏病临床研究证据图分析

Analysis of evidence map of clinical research on Chinese patent medicines in treatment of chronic pulmonary heart disease

中成药是治疗慢性肺源性心脏病的重要中医手段,但目前尚缺乏对该领域临床研究证据的总体把控。运用证据图对中成药治疗慢性肺源性心脏病的临床研究总结,以期了解该领域的证据现状与不足。计算机系统检索中国知网(CNKI)、万方(Wanfang)、维普(VIP)、中国生物医学文献服务系统(SinoMed)、PubMed、EMbase、Web of Science、Cochrane Library等数据库收录的有关中成药治疗慢性肺源性心脏病的临床研究。以图表结合的形式展示证据分布特征。最终纳入397篇随机对照试验(RCTs),1篇观察性研究,14篇系统评价/Meta分析,1篇网状Meta分析,3篇指南/专家共识。近10年来发文量整体呈下降趋势;纳入文献对慢性阻塞性肺疾病引起的慢性肺源性心脏病关注度较高;共涉及42种中成药,以丹红注射液、丹参川芎嗪注射液和参麦注射液占比最多;疗程以2~4周为主。结局指标对总有效率、心功能指标和血气分析关注度较高,对经济学指标、预后/终点指标、生活质量指标、临床症状/体征和中医指标等关注较少。RCT、系统评价/Meta分析的文献质量普遍不高,指南/专家共识制订流程规范性不足,导致证据质量等级偏低。结果表明,中成药治疗慢性肺源性心脏病的临床研究虽有数量优势,但证据质量普遍较低。未来仍需开展更多大样本、多中心、长疗程的临床研究,规范系统评价/Meta分析、指南/专家共识制订流程,积极构建中医药治疗慢性肺源性心脏病的核心指标集,以期推进中医药临床研究的高质量发展。

Chinese patent medicines play a crucial role in the treatment of chronic pulmonary heart disease(CPHD).Nowadays,there is still a lack of comprehensive control over clinical research evidence in this field.This study aims to summarize the clinical re-search on the treatment of CPHD with Chinese patent medicines using an evidence map,in order to understand the current status and deficiencies of evidence in this area.Systematic searches were conducted across various databases including CNKI,Wanfang,VIP,Si-noMed,PubMed,EMbase,Web of Science and Cochrane Library for clinical studies on Chinese patent medicines in treatment of CPHD.The distribution characteristics of evidence are presented numerically and graphically.Finally,397 RCTs,1 observational study,14 systematic reviews/Meta-analysis,1 network Meta-analysis and 3 guidelines/expert consensus were included in this analysis.Over the past decade,there has been a decline in the number of published documents related to this topic.Amongst the included litera-ture,particular attention was given to CPHD caused by chronic obstructive pulmonary disease,and a total of 42 Chinese patent medi-cines were involved,with Danhong Injection,Danshen Chuanxiongqin Injection and Shenmai Injection being most commonly used.The typical course of treatment ranged from 2-4 weeks.The outcome measures paid more attention to the total effective rate,cardiac func-tion indicators and blood gas analysis,while paid less attention to the economic indicators,prognosis/endpoint indicators,quality of life indicators,clinical symptoms/signs and traditional Chinese medicine(TCM)indicators.The overall quality of RCT and systematic review/Meta-analysis was generally low,and the process of formulating guidelines/expert consensus lacked standardization,which re-sulted in a low evidence quality grade.The findings indicated that despite the quantitative advantages observed in clinical studies on the treatment of chronic pulmonary heart disease with proprietary Chinese medicine,the overall quality of evidence was generally low.In the future,it is still necessary to carry out large-sample,multi-center and long-period clinical studies,standardize the process of sys-tematic review/Meta-analysis,guidelines/expert consensus formulation,and actively construct the core indicator set of TCM treatment of pulmonary heart disease,so as to promote the high-quality development of TCM clinical research.