中医药辨证治疗慢性阻塞性肺疾病稳定期随机对照试验的疗效评价指标系统评价

目的:在系统评价中医药辨证治疗慢性阻塞性肺疾病(COPD)随机对照试验临床疗效基础上评述其疗效评价指标的选择和使用。方法:计算机检索CBM、CNKI、VIP、万方数据库、Cochrane图书馆、PubMed和Embase数据库,收集公开发表的中医药辨证治疗COPD随机对照试验的临床研究,由两位研究者按照纳入标准独立筛选文献、提取资料后,应用RevMan5.1软件进行Meta分析。结果:共纳入40篇随机对照试验(RCT),Meta分析结果显示中医辨证治疗能够改善患者肺功能,提高生存质量,提高临床疗效和中医证候疗效,减少急性加重次数,改善临床症状体征;疗效评价指标使用较多的有肺功能、生存质量、临床综合疗效、急性加重次数、临床症状体征、证候疗效、中医证候积分,其余如6分钟步行距离、BODE指数、卫生经济学评价则选用相对较少。结论:中医药辨证治疗COPD具有较好的临床疗效,但由于纳入研究的质量不高,仍需开展大样本、多中心、方法科学的高质量临床试验;临床疗效评价指标的选用仍不规范,疗效指标的选择应根据临床研究的目的不同而有所侧重,另外还应体现中医药的临床特点。

Therapeutic Effect Assessment Indexes of Randomized Controlled Trials on Traditional Chinese Medicine Syndrome Differentiation and Treatment of Chronic Obstructive Pulmonary Disease: A Systematic Review

This study was aimed to review of the selection and use of the therapeutic effect assessment indexes of randomized controlled trials (RCTs) on traditional Chinese medicine (TCM) syndrome differentiation and treatment of chronic obstructive pulmonary disease (COPD) based on clinical efficacy. Published studies were searched in the CBM, CNKI, VIP, Wanfang database, Cochrane Library, PubMed and Embase to identity all RCTS on TCM treatment of COPD. Two researchers selected studies and extracted data independently using a designed extraction form. The Cochrane collaboration software RevMan 5.1 was used for meta-analysis. The results showed that a total of 40 RCTs were included. Meta-analyses showed that TCM syndrome differentiation and treatment of COPD can improve the pulmonary function and life quality, improve the clinical effect and TCM syndrome effect, reduce the number of acute exacerbation of COPD and improve clinical symptoms. Some therapeutic effect assessment indexes, such as pulmonary function, life quality, clinical comprehensive effect,the number of acute exacerbation of COPD, clinical symptoms and signs, syndrome effect and the integral of syndrome were used more frequent. Other indexes such as 6-min walk distance, BODE Index and health economic evaluation were used less frequently. It was concluded that TCM syndrome differentiation and treatment of COPD had certain therapeutic efficacy. A large number of strictly-designed, multicenter, high-quality RCTs are required because of the low quality of the included studies. The selection of therapeutic effect assessment indexes is still not standardized. The therapeutic effect assessment indexes should be selected based on different purposes of clinical studies with the clinical characteristics of TCM.