中医药干预PCI术后合并焦虑和（或）抑郁随机对照试验的结局指标现状分析

Analysis of the current status of outcome measures in randomized controlled trials of traditional Chinese medicine interventions for anxiety and/or depression after percutaneous coronary intervention

关键词:  中医药  经皮冠状动脉介入术  焦虑  抑郁  随机对照试验  结局指标

Key words:  traditional Chinese medicine  percutaneous coronary intervention  anxiety  depression  randomized controlled trial  outcome measures

摘要:

[目的] 系统评价中医药干预冠心病经皮冠状动脉介入治疗（PCI）术后合并焦虑和（或）抑郁的随机对照试验（RCT）的结局指标应用情况，为后续开展高质量研究提供参考。[方法] 检索中国知网（CNKI）、万方知识服务平台（Wanfang Database）、维普数据库（VIP）、中国生物医学文献服务系统（SinoMed）、PubMed、Embase、Web of Science、Cochrane Library数据库，纳入符合要求的RCT，运用Cochrane工具评估偏倚风险，采用描述性统计方法对纳入文献进行分析。[结果] 共纳入84篇文献，涉及91种结局指标，累计使用频次517次。将结局指标按照功能属性分为7个指标域，包括生活质量（31.9%）、安全性评价（24.6%）、理化检查（18.8%）、症状/体征/临床疗效（17.4%）、中医证候/症状（5.8%）、预后（1.2%）及其他（0.4%）。[结论] 现有研究结局指标的选择具有一定合理性与中西医结合特色，但仍有不足之处，亟需建立中医药核心指标集，提升试验科学性与临床指导价值。

Abstract:

[Objective] To systematically evaluate the outcome measures in randomized controlled trials（RCTs）of traditional Chinese medicine（TCM）interventions for coronary heart disease after percutaneous coronary intervention（PCI）with comorbid anxiety and/or depression. The aim is to provide recommendations for future high-quality research. [Methods] A systematic search was conducted across databases including CNKI，VIP，Wanfang Database，SinoMed，PubMed，Embase，Web of Science，and the Cochrane Library. Eligible RCTs were included，and the risk of bias was assessed using the Cochrane tool. Descriptive statistical methods were used to analyze the included literature. [Results] A total of 84 studies were included，involving 91 different outcome measures，with a cumulative usage frequency of 517. These outcome measures were classified into seven domains based on their functional attributes： quality of life（31.9%），safety evaluation（24.6%），physical and chemical examinations（18.8%），clinical symptoms/signs/effectiveness （17.4%），TCM syndromes/symptoms（5.8%），prognosis（1.2%），and others（0.4%）. [Conclusion] The selection of outcome measures in existing studies is generally reasonable and reflects the characteristics of the integration of traditional Chinese and Western medicine. However，limitations still exist，and the establishment of a core set of TCM outcome measures is urgently needed to improve the scientific quality and clinical guidance of future trials.