【作者】 郑文科； 陈静； 张莉； 商洪才；

【Author】 ZHENG Wen-ke;CHEN Jing;ZHANG Li;SHANG Hong-cai;Tianjin University of Traditional Chinese Medicine;Tianjin Institute of Clinical Evaluation of Traditional Chinese Medicine;

【机构】 天津中医药大学； 天津中医药临床评价研究所；

【摘要】 辨证论治是中医在诊疗疾病过程中的核心思想,是区别于西医治疗疾病理念的最大特色。但是近年来的中医临床试验顶层设计不能彰显中医辨证论治的优势,试验结果难以体现中医药的科学性。为了在临床试验中科学、客观地证明中医药的优势特色,文章根据既往中医药临床试验设计与实施中积累的经验及遇到的具体问题,同时查阅相关文献,针对中医特色,遵循循证医学理念,汇总涉及到临床试验各个环节的建议,并提出在中医药临床试验设计中的要点,以供研究者参考。更多还原

【Abstract】 Syndrome differentiation and treatment is the core idea of traditional Chinese medicine(TCM) in diagnosis and treatment,is the most significant different from the western medicine.In clinical practice,the majority doctors of TCM have recognized the advantages of syndrome differentiation and treatment With the improvement of modern medical research method,the data,which based on clinical trials,has become important evidence to guide clinical practice.But,recently,there are some problems such as ignore the characteristics of TCM lead to the advantage of TCM are covered.In order to take evidence to prove the advantage of TCM,there need be integrated the syndrome differentiation and treatment in Chinese medicine when design the clinical trials of TCM.This paper introduce several points should be considered in the design of clinical trials.更多还原