关联临床疗效的中药复方质量评价思路探讨

Quality evaluation of compound Chinese medicines as related to clinical efficacy

中药复方质量评价是中药研究领域的热点与难点,囿于与临床疗效的相关性而备受争议。开展关联临床疗效的中药复方质量评价方法学,是让中药质量研究回归初衷,确保其临床有效性、安全性的重要举措。为此,本文立足"源于临床-证于试验-归于临床"研究策略,以模式药消渴方为例,从临床切入发掘代谢组、蛋白质组、微生物组的特征信息,融入人工智能发现关联临床疗效的整合标志物;以整合标志物为联通临床与基础的纽带和指征,阐释关联临床疗效的消渴方主要药效物质和关键作用靶点;回归临床样本验证,建立基于主要药效物质和关键作用靶点的消渴方质量化学评价和生物评价方法及关键技术,最后形成包括疗效应答指标(关联临床)、主要药效物质(化学评价)、关键作用靶点(生物评价)三要素在内的中药复方质量评价方法学,以期为提升中药复方质量评价能力提供新思路、新方法。

The quality evaluation of compound Chinese medicines is an important but challenging issue in this research field,which has been paid much controversial due to the constrained association with clinical efficacy.Developing a methodology for quality evaluation of compound Chinese medicines related to clinical efficacy is an important measure in research on Chinese material medica quality to ensure clinical effectiveness and safety.Therefore,based on the research concept that"originating from clinic-testing in experiment-returning to clinic",and taking Xiaoke prescription as an example,the characteristic information of metabolome,proteome and microbiome are discussed from the clinical aspect,and the integrated markers associated with clinical efficacy constructed with artificial intelligence technology.Taking the integrated markers as the link and indication are connecting the clinical and basic,the main pharmacodynamic substances and key targets of Xiaoke prescription that are related to clinical efficacy are explained.Clinical samples are used for validation.Based on the main pharmacodynamic substances and key targets,methods and key technologies for chemical and biological evaluation of the quality of Xiaoke prescription are established,providing a methodology for quality evaluation of compound Chinese medicines,including clinical efficacy response indicators(related to clinic),main pharmacodynamic substances(chemical evaluation),and key targets(biological evaluation),to provide new ideas and methods for improving the quality evaluation of compound Chinese medicines.