真实世界视域下中医临床验方人用经验证据转化的评价方法构建探析OA

Human use experience represents the summation of traditional Chinese medicine(TCM)clinical practice and serves as a vital data source for the application of institutional preparations and the evaluation of efficacy and safety in the development of new TCM drugs.Standardizing the data collection and statistical analysis methods of human use experience in TCM,and establishing efficacy evaluation methods to transform human use experience data into evidence-based data,are essential for converting clinical practice data into research data.This paper attempts to summarize the characteristics of data collection of human use experience evidence in TCM clinical prescriptions and the analysis methods of real-world data.It also provides an overview of how to select clinical research methods that align with the characteristics of TCM clinical practice and how to manage bias risks and confounding factors in standardized data collection and statistical analysis.In response to the TCM-specific diagnostic and therapeutic approach of'formula variation according to syndrome differentiation',a'score-based efficacy evaluation method'is proposed to accurately reflect the therapeutic advantages of human use experience.This method offers a novel approach and perspective for the effectiveness evaluation of transforming human use experience evidence of TCM clinical prescriptions under the perspective of real world.