中医脾胃病临床研究设计及评价关键技术的研究现状与思考OA

Clinical trials represent a pivotal stage in the development of pharmaceutical drugs.Nevertheless,given the unique characteristics of traditional Chinese medicine(TCM)and the diagnostic and treatment principle of syndrome differentiation and treatment in TCM,the clinical evaluation techniques and methods that can comprehen-sively reflect the characteristics of TCM and are tailored to its specificities are still in need of refinement and innova-tion.This paper systematically summarizes the key techniques and methods for designing and evaluating the clinical research on the treatment of the spleen and stomach diseases with TCM from three aspects including clinical research design,evaluation,and platform construction,compares domestic and international research landscapes,and proposes for future directions.It is suggested that a multidimensional evaluation system integrating modern medicine and TCM theory should be established,and further innovation is needed in TCM research design and methodologies,leveraging intelligent devices and technologies powered by next-generation information technology to transform clinical data into high-quality TCM evidence.Moreover,standardized and shared platforms for TCM clinical data should be accelerated,so as to provide references for the design,implementation,and evaluation of future clinical research on the treatment of the spleen and stomach diseases with TCM.