循证医学的临床实践  

Evidence-based Clinical Practice

作　　者：Christian Gluud 武燕萍[2] 高国福[2] 乔友林[2] 

机构地区：[1]丹麦哥本哈根大学国家医院临床干预研究中心 [2]中国医学科学院,中国协和医科大学,肿瘤研究所,北京,100021

出　　处：《中国医学科学院学报》2002年第6期541-547,共7页Acta Academiae Medicinae Sinicae

摘　　要：循证医学是在充分考虑患者意愿的条件下,将临床经验和最好的研究证据有机地进行结合。随机临床试验被认为是评价卫生保健措施最有效的研究设计。但也有试验研究表明,如果用不适当的分组和双盲方法,即便是随机临床试验,其干预效果也会被显著地高估(在一项研究中干预效果平均被夸大约50%)。此外,试验结果如果不采用“治疗意向”(Intention-To-Treat)分析方法,干预效果也会被显著高估。遗憾的是90%以上的随机临床试验随机分组不适当,缺乏双盲或者未用“治疗意向”方法分析。这些不规范可以用于解释为什么在地区内、国家内或医院内的临床实践会显著不同,因此,亟待改进这种状况。制定临床/研究试验规范、进行更多的多中心临床试验、大家取得共识和建立Cochrane协作网都可以帮助在临床实践中应用最好的研究证据。通过关注教育、应用研究和建立Cochrane协作网,循证医学会为临床实践奠定更强大的基础。Evidence-based medicine combines the patient' s preferences with clinical e xperience and the best research evidence.Randomized clinical trials are conside red the most valid research design for evaluating health-care interventions.How ever,empirical research shows that intervention effects may be significantly o verestimated(in one study on average by about 50per cent)in randomized clini cal trials with inadequate methods for generation of allocation sequence,alloca tion concealment,and double blinding.Further,intervention effects may be sign ificantly overestimated if trial results are not analysed by the intention-to-tr eat method.Unfortunately more than90per cent of the randomized clinical tria ls have inadequate randomization,lack double blinding,or do not use intention- to-treat analysis.These irregularities may explain the considerable variation o f clinical practice-within regions,single countries,and single clinics.Accord ingly,there is an urgent need to improve this situation.Guidelines for Good C linical(Research)Practice,conduct of more trials as multicentre trials,The C onsort Statement,and The Cochrane Collaboration may all help in the application of the best research evidence in clinical practice.By investments in educatio n,applied research,and The Cochrane Collaboration,evidence-based medicine may form a stronger basis for clinical practice.

关 键 词：循证医学 多中心临床试验 随机临床试验 质量评价指标 方法学 COCHRANE系统评价 

分 类 号：R4[医药卫生—临床医学]