The holistic concept of traditional Chinese medicine(TCM)pays more attention to the"sick person",that is"patient-centered diagnosis and treatment strategies".The most recent iteration of the Measures for the Administration of Drug Registration points out that the therapeutic evaluation of TCM should select the indicators that align with the clinical principles and showcase its unique functional characteristics and advantages.At the same time,under the continuous promotion of modern evaluation systems,there has been a notable increase in innovative clinical trial methods of TCM.There is a growing trend towards utilizing more flexible and expedited clinical trial designs throughout the drug product lifecycle to enhance efficiency of the trials based on rational utilization.This paper took the clinical research of Di'ao Xinxuekang capsule in the treatment of chronic stable angina pectoris as an example,introducing the practical exploration of combining patient-centered clinical research approach with adaptive design,providing useful reference for the evaluation of TCM efficacy.
关键词
以患者为中心/适应性设计/中医药临床研究模式/地奥心血康胶囊/心绞痛
Key words
patient-centered/adaptive design/clinical research model of traditional Chinese medicine/Di'ao Xinxuekang capsule/angina pectoris
万方数据