Wu Wen-Jun, Zhang Chi-Dao, Sun Yang, Li Xue, Li Xing-Yuan, Zhu Ming-Jun
Department of Cardiovascular Diseases, the First Affiliated Hospital of Henan University of Chinese Medicine Zhengzhou 450000, China Henan University of Chinese Medicine Zhengzhou 450000, China.
Department of Cardiovascular Diseases, the First Affiliated Hospital of Henan University of Chinese Medicine Zhengzhou 450000, China.
Zhongguo Zhong Yao Za Zhi. 2024 Oct;49(19):5354-5364. doi: 10.19540/j.cnki.cjcmm.20240611.501.
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 research 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, SinoMed, 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 literature, particular attention was given to CPHD caused by chronic obstructive pulmonary disease, and a total of 42 Chinese patent medicines 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 function 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 resulted 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 systematic 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.
中成药在慢性肺源性心脏病（CPHD）的治疗中发挥着关键作用。目前，该领域临床研究证据仍缺乏全面把控。本研究旨在采用证据图谱总结中成药治疗CPHD的临床研究，以了解该领域证据的现状和不足。通过在包括中国知网、万方、维普、中国生物医学文献数据库、PubMed、EMbase、Web of Science和Cochrane图书馆等多个数据库中进行系统检索，查找关于中成药治疗CPHD的临床研究。以数值和图表形式呈现证据的分布特征。最终，本分析纳入了397项随机对照试验（RCT）、1项观察性研究、14项系统评价/Meta分析、1项网状Meta分析以及3项指南/专家共识。在过去十年中，与该主题相关的已发表文献数量有所下降。在所纳入的文献中，特别关注了慢性阻塞性肺疾病所致的CPHD，共涉及42种中成药，其中丹红注射液、丹参川芎嗪注射液和参麦注射液最为常用。典型疗程为2 - 4周。结局指标更关注总有效率、心功能指标和血气分析，而对经济指标、预后/终点指标、生活质量指标、临床症状/体征以及中医指标关注较少。RCT和系统评价/Meta分析的总体质量普遍较低，指南/专家共识制定过程缺乏标准化，导致证据质量等级较低。研究结果表明，尽管中成药治疗慢性肺源性心脏病的临床研究在数量上具有优势，但证据的总体质量普遍较低。未来仍有必要开展大样本、多中心、长周期的临床研究，规范系统评价/Meta分析、指南/专家共识制定过程，并积极构建中医治疗肺心病的核心指标集，以促进中医临床研究的高质量发展。
