中医药辨证治疗急性加重期慢性阻塞性肺疾病随机对照试验疗效评价指标的系统评价

Systematic Review of Therapeutic Effect Assessment Index of Randomized Controlled Trials onAcute Exacerbation of Chronic Obstructive Pulmonary Disease by Chinese Medicine Syndrome Differentiation and Treatment

目的:在系统评价中医药辨证治疗急性加重期慢性阻塞性肺疾病(AECOPD)随机对照试验临床疗效基础上探讨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,收集公开发表中医药辨证治疗AECOPD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73篇相关文献,Meta分析结果显示中医辨证治疗能提高AECOPD患者的临床疗效和中医证候疗效,改善临床症状、肺功能,提高氧分压,降低二氧化碳分压,降低白细胞计数和CRP水平;疗效评价指标使用较多的有临床疗效、证候疗效、肺功能、血气分析、血常规、C反应蛋白、临床症状体征、中医证候积分等,其余如生活质量、影像学评价、住院时间和6 min步行距离等则相对较少。结论:中医药辨证治疗AECOPD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。

Objective：To explore the selection and use of the therapeutic effect assessment index base on systematic review of randomized controlled trials on acute exacerbation of chronic obstructive pulmonary disease（AECOPD） by TCM syndrome differentiation and treatment.Methods：The published clinical studies of randomized controlled trials on AECOPD by TCM syndrome differentiation and treatment were collected through computer retrieval CBM,CNKI,VIP,WanFang database,Cochrane Library,PubMed and Embase database,after two researchers selection literature and extraction information independently according to inclusion criteria.Results：73 pieces of randomized controlled trials were included.Meta-analysis results showed that TCM syndrome differentiation and treatment can improve the clinical curative effect and TCM syndrome effect of patients with AECOPD,improve the clinical symptoms and pulmonary function,increase the partial pressure of oxygen and reduce carbon dioxide partial pressure,lower the leucocyte count and the level of C-reactive protein（CRP）.Some therapeutic effect assessment indexes,such as clinical effect,syndrome effect,pulmonary function,blood gas analysis,blood routine,CRP,clinical symptoms and signs and the integral of syndrome were used much more than the quality of life,imaging evaluation,hospitalization time and 6-min walk distance.Conclusion：Chinese medicine syndrome differentiation and treatment on AECOPD has good clinical effects,but because of the low quality of the included researches,so large sample,multicenter,scientific method and high quality clinical trails are still required to carry out.The selection and use of the therapeutic effect assessment indexes are not standard,and the indexes should be used with different emphasis according to the different aims of clinical researches,also should reflect the clinical characteristics of TCM.