CAJ | 학술논문

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。
목적：재계통평개중의약변증치료만성조새성폐질병（COPD）수궤대조시험림상료효기출상평술기료효평개지표적선택화사용。방법：계산궤검색CBM、CNKI、VIP、만방수거고、Cochrane도서관、PubMed화Embase수거고，수집공개발표적중의약변증치료COPD수궤대조시험적림상연구，유량위연구자안조납입표준독립사선문헌、제취자료후，응용 RevMan5.1연건진행Meta분석。결과：공납입40편수궤대조시험（RCT），Meta분석결과현시중의변증치료능구개선환자폐공능，제고생존질량，제고림상료효화중의증후료효，감소급성가중차수，개선림상증상체정；료효평개지표사용교다적유폐공능、생존질량、림상종합료효、급성가중차수、림상증상체정、증후료효、중의증후적분，기여여6분종보행거리、BODE지수、위생경제학평개칙선용상대교소。결론：중의약변증치료COPD구유교호적림상료효，단유우납입연구적질량불고，잉수개전대양본、다중심、방법과학적고질량림상시험；림상료효평개지표적선용잉불규범，료효지표적선택응근거림상연구적목적불동이유소측중，령외환응체현중의약적림상특점。
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 re-sults 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 eco-nomic 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 differ-ent purposes of clinical studies with the clinical characteristics of TCM .