中医药临床试验的方法学问题与挑战循证医学的观点.pdfVIP

中西医 结合 学报 2 0 06 年 1 月 第 4 卷 第 1 期 Jou r n al o f C hi ne se In t egr a tiv e M edicin e , J a n uar y 2 0 06 , V o l .4 , N o .1 ·1 · ① 中医药 临床 试验 的方 法 学 问题 与挑 战 : 循证 医学 的观 点 刘建平 ( 北京中医药大学基础医学院循证中医药临床研究与评价中心, 北京 100029 ) [摘要] 运用循证医学观点分析 了中医药临床试验及其评价的现状, 论述 了随机、对照、盲法在 中医药临床 试验及其疗效评价研究中的应用条件, 并阐明了在 中医药临床疗效评价研究中如何估算样本量、选择结局评 价指标及临床试验依从性与意向性治疗分析。将循证医学应用于 中医药临床试验, 有助于提 高 中医药临床 诊疗与研究水平、促进 国际间的合作与交流。建立循证 的中医药 临床疗效评价体系, 有利于客观、科 学地评 价 中医药的有效性与安全性。 [ 关键词] 医学, 中国传统; 循证医学; 临床试验; 方法学 [ 中图分类号] R2-0 5 [ 文献标识码 ] A [ 文章编号] 1672- 1977 (2 006) 01-0001-06 Methodological qualit y assessment of clinical t r ials in t radit ional Chinese medicine : the principles of evidence-based medicine Jian-Ping LIU (Evidence-based Chinese Medicine Center for Clinical Research and Evaluation , School of Preclinical Medicine , Beij ing University of Chinese Medicine , Beij ing 10002 9 , China) ABSTRACT The quality of clinical t rials in tradit ional Chinese medic ine (TCM) was analyzed with respect to their methodology and outcome assessment according to the concepts of ev idence-based medic ine ( EBM) . It was suggested that the essential methodological princ iples of EBM should be applied in clinical t rials of TCM, including randomizat ion, cont rol and blindness . The sample size est imat ion, optimal parameter selection for outcome assessment , compliance and intention-to-t reat analysis are all important aspects of randomized controlled trials . To bring the benef its of EBM into clinical trials will improve the quality of research in TCM and also promote international co-operat ion and communications . It is necessary to establish an assessment system of clinical outcome for TCM on the basis of EBM in order to evaluate the eff icacy and safety of TCM obj ectively and sc ientif ically . KEY WORDS medic ine, t raditional Chinese ; ev idence-based medicine ; clini