目的 剖析中医药治疗儿童哮喘的随机对照试验（RCT）结局指标，为中医药治疗该病临床试验的核心指标集构建提供初步依据。方法 检索中国知网（CNKI）、万方（WanFang）、维普网（VIP）、中国生物医学文献数据库（SinoMed）、PubMed、Cochrane Library、EmBase、Web of Science。时间跨度为建库至2024年7月1日。此次检索全面覆盖了中医药疗法治疗儿童哮喘的临床随机对照研究，由两名研究者根据纳排标准独立完成文献筛选和资料提取，提取文献基本特征和结局指标。结果 初步检索出2 449篇文献，最终纳入165个RCT，包括205个结局指标，分为症状/体征、中医症状/证候、理化检查、生活质量评价、远期预后、安全性指标六域。结论 中医药治疗儿童哮喘尚存在中医证候诊断和疗效标准不完善、主要和次要结局指标界限不清等问题，应当构建统一规范且广为认可的核心指标集，以促进儿童哮喘核心指标集的完善。
Objective To analyze the outcome indicators of randomised controlled trials（RCTs）of traditional Chinese medicine（TCM）for the treatment of childhood asthma，and to provide a preliminary basis for the construction of a core set of indicators for clinical trials of TCM for the treatment of this disease．Methods A database search was conducted on China Knowledge Network（CNKI），WanFang，VIP，SinoMed，PubMed，Cochrane Library，EmBase，and Web of Science，covering the period from the establishment of the database to 1 July 2024．The search comprehensively covered clinical randomised controlled studies of TCM therapies in the treatment of childhood asthma，and was completed independently by two investigators who screened the literature and extracted information according to the criteria，and extracted the basic characteristics of the literature and outcome indicators．Results Initially，2 449 literatures were retrieved，and 165 RCTs were finally included，including 205 outcome indicators，which were classified into six domains：symptoms/signs，TCM symptoms/evidence，physical and chemical examination，quality of life evaluation，long-term prognosis，and safety indicators．Conclusions Currently，there are problems such as imperfect diagnostic and efficacy criteria for TCM evidence，and unclear boundaries between primary and secondary outcome indicators in the treatment of childhood asthma with TCM．A unified，standardised and widely recognised core indicator set should be constructed to promote the improvement of the core indicator set for childhood asthma．
目的 系统评价心脉通治疗冠心病的临床疗效及其安全性。方法 2名研究者独立系统地检索心脉通治疗冠心病的文献,其中包括维普中文科技期刊全文数据库(VIP)、PubMed 电子期刊全文数据库、中国学术期刊全文数据库(CNKI)、The Cochrane Library 数据库、万方数据库等6个数据库。同时运用Review Manager 5.4 软件进行本研究的数据处理。结果 最终共纳入8篇文献,共计985名心脉通治疗冠心病患者。治疗前后的临床疗效、发作频率、血脂水平的Meta分析结果显示心脉通组优于常规治疗组。有3项纳入试验报告不良反应。结论 心脉通治疗冠心病的临床疗效优于常规治疗。心脉通不仅可以降低冠心病发作频率,缩短其发作持续时间,还能调节血脂水平,在治疗冠心病方面疗效确切,值得临床参考应用。
Objective To systematically evaluate the clinical efficacy and safety of Xinmaitong in the treatment of coronary heart disease (CHD). Methods Two researchers searched the literatures of Xinmaitong in the treatment of coronary heart disease independently and systematically, including VIP Chinese Sci-tech Journal full-text Database (VIP), PubMed Electronic Journal full-text Database, Chinese Academic Journal full-text Database (CNKI), The Cochrane Library Database and Wanfang Database. At the same time, Review Manager 5.4 software was used to process the data of this study. Results A total of 8 articles were included, and a total of 985 patients with coronary heart disease were treated with Xinmaitong. The results of Meta analysis of clinical efficacy, attack frequency and blood lipids level before and after treatment showed that Xinmaitong group was better than routine treatment group. Three items were included in the report of adverse reactions. Conclusions The clinical effect of Xinmaitong in the treatment of coronary heart disease was better than that of routine treatment. Xinmaitong can not only reduce the frequency and duration of coronary heart disease attack, but also regulate blood lipids level. Xinmaitong was effective in the treatment of coronary heart disease and is worthy of clinical reference.
