中医药治疗慢性阻塞性肺疾病临床试验结局指标文献研究

Literature study on outcome indicators of clinical trials of traditional Chinese medicine in the treatment of chronic obstructive pulmonary disease

关键词:  慢性阻塞性肺疾病  中医药  核心指标集

Key words:  chronic obstructive pulmonary disease  traditional Chinese medicine  core indicators

摘要:

[目的] 通过分析慢性阻塞性肺疾病（COPD）随机对照试验研究中的结局指标，为未来在临床分期的基础上构建COPD核心指标集提供参考依据。[方法] 计算机检索中文期刊全文数据库（CNKI）、中文科技期刊全文数据库（VIP）、万方数据库（WanFang Data）、中国生物医学文摘数据库（SinoMed）、PubMed、Embase、Cochrane Library和Web of Science 8个数据库，检索时间为建库至2020年11月。由2名参与人员严格按照预先设定的纳入排除标准独立筛选文献并进行信息提取。[结果] 纳入了536个急性加重期随机对照试验（RCT）研究，共纳入47 379例患者，涉及159种结局指标，单个研究指标数量最少为1个，最多有16个；纳入了457个稳定期RCT研究，共纳入38 879例患者，样本量大小为30～331例，平均每项RCT研究样本量为85例，涉及结局指标135种，单个研究指标数量最少为1个，最多有14个。发现结局指标存在不规范、不统一、种类繁杂等亟待解决的问题。[结论] 中医药治疗COPD临床随机对照试验评价结局指标的选择普遍存在指标差异大等问题，需要在临床分期的基础上开展COPD核心指标集研究，规范中医药治疗COPD临床疗效评价指标，为评价中医药治疗COPD疗效如何选择结局指标时提供参考。

Abstract:

[Objective] By analyzing the outcome indicators in the randomized controlled trials of chronic obstructive pulmonary disease(COPD), we can provide a reference for the future construction of the core indicator set of COPD on the basis of clinical staging. [Methods] Eight databases including Chinese Journal Full Text Database(CNKI), Chinese Science and Technology Journal Full Text Database(VIP), Wanfang Data, China Biomedical Abstracts Database(SinoMed), PubMed, Embase, Cochrane Library and Web of Science were searched by computer, and the search time was from November 2020. Two participants independently screened the literature and extracted the information in strict accordance with the preset inclusion and exclusion criteria. Methods eight databases including Chinese Journal Full-text Database (CNKI), Chinese Sci-tech Journal Full-text Database (VIP), Wanfang Data, sinomed, PubMed, EMBASE, Cochrane Library and web of science were searched by computer from the establishment of the database to November 2020. Two participants independently screened the literature and extracted the information in strict accordance with the preset inclusion and exclusion criteria. [Results] The 536 RCT studies in acute exacerbation were included, including 47 379 patients, involving 159 outcome indicators. The number of single study indicators was at least 1 and at most 16.457 stable RCT studies were included. A total of 38 879 patients were included. The sample size ranged from 30 to 331 cases. The average sample size of each RCT study was 85 cases, involving 135 outcome indicators. The number of single study indicators was at least 1 and at most 14. It is found that there are some urgent problems to be solved, such as non-standard, non-uniform and complex types of outcome indicators.[Conclusion] The selection of evaluation outcome indicators in clinical randomized controlled trials of traditional Chinese medicine for COPD generally has such problems as large differences in indicators. It is necessary to carry out research on the core indicator set of COPD on the basis of clinical stages, standardize the evaluation indicators of clinical efficacy of traditional Chinese medicine for COPD, and provide a reference for evaluating the efficacy of traditional Chinese medicine for COPD when selecting outcome indicators.