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2006年 l ft第4卷第1期 Journal of Chinese Integrative Medicine，January 2006·Vo1．4，No．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—05 [文献标识码] A [文章编号] 1672—1977(2006)01—0001—06 Meth0d010gicaI quality assessment of clinical trials in traditional 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，Beijing University of Chinese Medicine，Beijing 100029，China) ABSTRACT The quality of clinical trials in traditional Chinese medicine(TCM)was analyzed with respect to their methodology and outcome assessment according to the concepts of evidence—based medicine(EBM)．It was suggested that the essential methOdOlOgical principles of EBM should be applied in clinical trials of TCM， including randomization，control and blindness．The sample size estimation，optimal parameter selection for outcome assessment，compliance and intention—to-treat analysis are all important aspects of randomized controlled trials．TO bring the benefits of EBM into clinical trials wilI improve the quality of research in TCM and also promote international CO—operation and communications．It is necessary to establ ish an assessment system of clinical outcome for TCM on the basis of EBM in order to evaluate the efficacy and safety of TCM objectively and scientifically． KEY WoRDS medicine，traditionaI Chinese；evidence—based medicine；CIinicaI trials；methodology Zhong Xi Yi Jie He Xue Bao／J Chin Integr Med，2006，4(1)：1—6 WWW．jcimjourna1．com 学活性和作用靶点等科学实验证据；(2)中医辨证论 1 中医药的临床评价 治强调治疗的个