中药复方剂量效应关系临床研究方法探讨

中药复方的剂量效应(量效)关系除具有一般药物的共有属性特点外,还受中药产地、炮制、配伍、化学组分、辨证论治应用等多种因素的影响,这使得临床研究面临很大的挑战.中药量效关系的研究内容包括对整方、方剂君药、中成药的量效关系研究,以及方剂中各个药物不同剂量水平配伍与疗效的关系研究.解释性随机对照试验、单病例随机对照试验和前瞻...

Clinical research methods for dose-effect relationship of TCM compound formulas

The dose-effect relationship of TCM compound formulas shares the common characteristics with other medications,and it is influenced by place of origin,processing,combination,chemical components,syndrome differentiation and treatment,and other multiple factors,which presents a huge challenge for clinical research.The study on the dose-effect relationship of TCM compound formulas consists of whole formula research,sovereign mediocinal study,dose-effect relationship of TCM patent medicine,and relationship study of effectiveness and different doses of individual medicinal.Explanatory randomized controlled trial,single-case randomized controlled trial and prospective cohort study can be employed in clinical research on whole formula,sovereign medicinal study,and dose-effect relationship of TCM patent medicine,however,the design of research plan has to be facilitated with characteristics of the dose-effect relationship of Chinese medicinal.It is difficult to conduct the researches on relationship of effectiveness and different doses of each medicinal in a compound formula from clinical perspective.According to the original characteristics of dose-effect relationship of traditional Chinese medicine and TCM compound formulas,it is encouraged to explore and improve methodology in clinical studies,and therefore to scientifically evaluate dose-effect relationship of TCM compound formulas.