摘要
临床疗效是中医学发展的基础,中医药临床疗效评价一直是人们关注的焦点,评价过程中的技术和方法难题往往制约高级别证据的产生,故如何应用科学的研究方法评价中医药的疗效优势,尚需要深化方法学研究并开展创新性实践。经过十余年的发展,中医药临床疗效评价在最初开展的经典安慰剂随机对照试验的基础上,又相继在单病例随机对照试验、队列研究、病例-对照研究、横断面研究、真实世界研究、叙事医学研究、系统评价等方面进行了一系列有意义的尝试探索,为中医药从“经验”向“证据”的转化奠定了基础。该文围绕中医药临床疗效评价,总结了疗效评价指标、标准及方法的主要内涵与发展现状,并针对研究过程中出现的指标选择问题、标准制定问题、方法学优化问题提出相应对策及建议,明确科学、客观地评价中医药疗效是目前亟须解决的问题。
Clinical efficacy is the basis for the development of traditional Chinese medicine(TCM),and the evaluation of clinical efficacy of TCM has always been the focus of attention.The technical and methodological difficulties in the evaluation process often restrict the generation of high-level evidence.Therefore,methodological research should be deepened and innovative practice should be carried out to study the application of scientific research methods in the evaluation of the advantages of TCM.After more than ten years of development,the clinical efficacy evaluation of TCM,on the basis of the initially classic placebo randomized controlled trials,has successively carried out a series of meaningful attempts and explorations in N-of-1 trials,cohort studies,case-control studies,crosssectional studies,real world studies,narrative medicine studies,systematic evaluation,and other aspects,laying the foundation for the transformation of TCM from"experience"to"evidence".This paper focused on the clinical efficacy evaluation of TCM,summarized the main connotation and development status of efficacy evaluation indicators,standards,and methods,and put forward corresponding countermeasures and suggestions for the problems of indicator selection,standard formulation,and methodology optimization in the research process.It is clear that scientific and objective evaluation of the efficacy of TCM is an urgent problem to be solved at present.
作者
庄铭
安佳丽
钟梦媛
王春洋
杜雪晨
翟佳妮
郑文科
ZHUANG Ming;AN Jia-li;ZHONG Meng-yuan;WANG Chun-yang;DU Xue-chen;ZHAI Jia-ni;ZHENG Wen-ke(Center for Evidence-based Medicine,Tianjin University of Traditional Chinese Medicine,Tianjin 301617,China)
出处
《中国中药杂志》
CAS
CSCD
北大核心
2023年第12期3263-3268,共6页
China Journal of Chinese Materia Medica
基金
天津市医学重点学科建设项目(2021001)。
关键词
中医药
疗效评价
临床研究
方法学
trtaditional Chinese medicine
evaluation of efficacy
clinical research
methodology
