Abstract
As a unique model for the development of new traditional Chinese medicine(TCM)drugs,syndrome TCM new drugs adhere to the principle of consistency in"theory,method,prescription,and medicine,"making them the category of TCM compound preparations that best reflect TCM thinking and clinical value.However,since syndrome new drug research is still in its exploratory stage,the lack of authoritative syndrome diagnostic standards and the singularity of efficacy evaluation methods limit its credibility in clinical research.This makes it difficult to provide strong evidence for new drug approval.This article reviews the development history of syndrome new drug research,analyzes the bottlenecks and challenges faced in its market transformation,and proposes preliminary ideas and suggestions for constructing clinical evaluation approaches for syndrome new drugs.(1)Classification of TCM registration and the development of syndrome new drugs.The material basis was previously the criterion for classifying TCM registration categories.However,since 2020,the new classification has shifted the focus of new drug development towards clinical value.Since the category of syndrome TCM new drugs was first proposed in 2007,relevant policy documents have continuously enriched this category.They suggest that the clinical research of syndrome TCM new drugs can adopt various models,including purely TCM syndrome research model,TCM disease-syndrome combined research model,or TCM syndrome integrated with Western disease research model.(2)Bottlenecks in the transformation of syndrome new drugs.The disease-syndrome combined research model emphasizes modern medical"paradigm"indicators,often neglecting or even sacrificing the TCM academic characteristics intrinsic.While the purely syndrome research model firmly grasps the core concept of syndrome in TCM theory,its semi-quantitative research methods still fail to completely address the fundamental issue of propensity bias.The key to the clinical evaluation of syndrome new drugs lies in how to transform subjective qualitative assessments into objective quantitative measures.(3)Construction and practice of clinical evaluation approaches for syndrome new drugs.First,it is necessary to establish evaluation standards and quantitative indicators that can reflect the diagnostic and therapeutic characteristics of syndrome new drugs.Second,it is essential to obtain real and reliable data through objective quantitative detection tools or methods.We suggest identifying clinical biomarkers of syndromes through retrospective analysis,screening for syndrome biomarkers using systems biology,and developing objective measurement tools targeting the main symptoms of syndromes.(4)Prospects and considerations for the development of syndrome new drugs.It is crucial to establish a clinical evaluation system that aligns with the characteristics and development principles of TCM.We propose focusing on four key aspects:the scientific nature of decision-making standards,the innovation of evaluation tools,the gradual improvement of research methods,and the personalization of experimental design.Additionally,special considerations should be given to the registration classification of TCM,such as distinguishing between traditional TCM and modern TCM.
维普
万方数据