口服中药治疗支气管扩张症随机对照试验的文献特征及结局指标研究

Literature characteristics and outcome lndicators of randomized controlled trials of oral traditional Chinese medicine in treatment of bronchiectasis

关键词:  口服中药  支气管扩张症  随机对照试验  研究设计  结局指标

Key words:  oral Chinese medicine  bronchiectasis  randomized controlled trial  study design  outcome indicator

摘要:

[目的] 系统梳理口服中药治疗支气管扩张症（简称“支扩”）随机对照试验（RCT）的文献特征及结局指标现状，为提高临床研究质量及构建核心指标集提供参考。[方法] 计算机检索PubMed、Embase、Cochrane Library、Web of Science、中国知网（CNKI）、万方数据知识服务平台（Wangfang Database）、维普网（VIP）及中国生物医学文献服务系统（SinoMed）数据库中口服中药治疗支扩RCT相关文献，检索时间为2019年1月1日—2024年7月31日，提取基本信息、文献特征、结局指标等进行统计分析。[结果] 共纳入117篇文献、9 733例患者。1项为多中心研究，汤剂为最常用剂型，干预疗程多集中于8 d~2周，15篇文献提及随访，94篇文献报告患者中医证型。共得到106种结局指标，可归为9个指标域，总报告频次为889次，报告率前10位的指标依次是：有效率、不良反应、第1秒用力呼气容积（FEV1）、中医证候积分、C反应蛋白（CRP）、白细胞计数、用力肺活量（FVC）、FEV1/FVC、降钙素原（PCT）、中医症状积分。[结论] 近5年口服中药治疗支扩RCT在研究方案设计及结局指标报告方面存在病例代表性差、疗程短、随访率低、辨证参考标准不一、结局指标应用不规范等诸多问题，未来仍需更多高质量RCT，同时需构建中医药治疗支扩核心指标集，以提高中医药循证证据质量。

Abstract:

[Objective] To systematically review the literature characteristics and outcome indicators of randomized controlled trial（RCT） of oral traditional Chinese medicine（TCM） in the treatment of bronchiectasis，so as to provide a reference for improving the quality of clinical research and constructing the core index set. [Methods] PubMed，Embase，Cochrane Library，Web of Science，CNKI，Wanfang Database，VIP and SinoMed were searched for RCTs of TCM in the treatment of bronchiectasis，and the retrieval time between January 1st 2019 and July 31st 2024，then extract the basic information，literature characteristics，outcome indicators and so on to analyse. [Results] A total of 117 studies involving 9 733 patients were included. 1 study is multicenter，potion is the most commonly dosage form，course of treatment focused on eight days to two weeks，15 studies refer to follow-up，94 studies report patients’ TCM syndrome. In the risk of bias assessment，randomized sequence generation，outcome data integrity，and selective reporting were mostly rated as “low risk”，and the rest were “unclear”. A total of 106 outcome indicators were obtained，which could be classified into 9 indicator domains. The total frequency of reporting was 889 times，and the top 10 indicators were：effective rate，adverse reactions，forced expiratory volume in the first second（FEV1），TCM syndrome score，C-reactive protein（CRP），white blood cell count，forced vital capacity（FVC），FEV1/FVC，procalcitonin（PCT），TCM symptom score. [Conclusion] Nearly five years of RCTs of oral TCM in the treatment of bronchiectasis have mang problems such as cases of typical difference，short course of treatment and low follow-up rate，different reference standards，nonstandard application outcome indicators in study design and outcome indicators report. The future still needs more high-quality RCTs，at the same time to build the core indicators set，in order to improve the quality of evidence-based evidence of TCM.