符合中医药特色的综合疗效评价体系构建思路及方法

Construction ideas and methods of comprehensive evaluation system of curative effect in line with the characteristics of traditional Chinese medicine

2019年《药品管理法》中明确提出要建立和完善符合中医药特点的技术评价体系,国家“十四五”规划明确将健全中医药评价体系、完善临床疗效评价技术和方法作为重要工作方向。缺乏体现中医药特色、客观、规范的疗效评价方法是制约中医药发展的瓶颈问题。2023年《中药注册管理专门规定》中明确提出,中药新药研制应当注重中医药原创思维及整体观,支持研制对人体具有系统性调节干预功能的中药新药。如何科学阐释中医药多靶向综合受益是临床疗效评价亟待解决的核心问题。本研究探索性地提出符合中医药特色的综合疗效评价思路及方法,在以患者为中心的前提下,提出中医药综合疗效评价体系构建的“O-S-W-I-D”基本原则,“病-证-人”三维疗效评价指标体系的构建思路,基于主客观赋权、综合评价模型的多指标评价方法,实现多干预方案横向、多时点纵向、“方案-时间”横纵向动态可视化等多个场景应用,科学、客观、全面、动态地解读中医药整体观指导下的多靶点、系统调节、综合受益的临床疗效价值及特色。

In 2019,the"Drug Management Law"clearly stated that it is necessary to establish and improve the technical evaluation system in line with the characteristics of traditional Chinese medicine.The national"14th Five-Year Plan"clearly regards the improvement of the evaluation system of traditional Chinese medicine and the improvement of clinical efficacy evaluation techniques and methods as important work directions.The lack of objective and standardized efficacy evaluation methods that reflect the characteristics of traditional Chinese medicine is a bottleneck restricting the development of traditional Chinese medicine.In the special provisions on the registration and management of traditional Chinese medicine in 2023,it is clearly stated that the development of new traditional Chinese medicine should pay attention to the original thinking and holistic view of traditional Chinese medicine,support the development of new traditional Chinese medicine with systematic regulation and intervention function for human body.How to scientifically explain the multi-target comprehensive benefits of traditional Chinese medicine is a difficult problem to be solved in the industry.This study explores the construction of comprehensive efficacy evaluation ideas and methods in line with the characteristics of traditional Chinese medicine,puts forward the basic principles of'O-S-W-I-D'for the construction of the comprehensive efficacy evaluation system of traditional Chinese medicine,and the construction of the three-dimensional efficacy evaluation index system of'disease-syndrome-person'.Based on the multi-index evaluation method of subjective and objective weighting and comprehensive evaluation model,the multi-intervention scheme is applied horizontally,vertically at multiple time points,and dynamically visualized horizontally and vertically at multiple time points.To scientifically,objectively,comprehensively,and dynamically interpret the clinical efficacy value and characteristics of multi-target,systematic regulation,and comprehensive benefit under the guidance of the holistic view of traditional Chinese medicine.