基于方剂靶点谱效关系的中成药临床精准定位模式探索——以芪蛭通络胶囊为例  

Precise Clinical Positioning of Chinese Patent Medicine in Paradigm of"Target Spectral Effect of Prescription":A Case Study of Qizhi Tongluo Capsules

作　　者：于亚南[1] 李兵[2] 刘骏[1] 王忠[1] YU Yanan;LI Bing;LIU Jun;WANG Zhong(Institute of Basic Research in Clinical Medicine,Chinese Academy of Chinese Medical Sciences,Beijing 100700,China;Institute of Chinese Materia Medica,Chinese Academy of Chinese Medical Sciences,Beijing 100700,China)

机构地区：[1]中国中医科学院中医临床基础医学研究所,北京100700 [2]中国中医科学院中药研究所,北京100700

出　　处：《中国实验方剂学杂志》2024年第3期98-104,共7页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：中国中医科学院科技创新工程项目(CI2021A04707);国家自然科学基金项目(82105052);国家食品药品监督管理总局课题(G20150I)。

摘　　要：中成药临床价值是中药产业发展的核心方向。“精准化”的临床定位决定了从哪个角度证明药物的价值,是凸显临床价值的关键环节。该文以中成药“芪蛭通络胶囊”临床定位研究为例,展示“方剂靶点谱效比较-方剂核心价值发现-临床定位试验确证”的中成药临床精准定位关键技术框架。该技术框架靶向临床精准定位需要解决的系列问题,在临床试验开展前,基于方剂多组分、多靶点及临床适应证多表型数据的多组学网络分析技术,发现中药品种的核心价值,预测其可能的临床优势,继而再针对其预测的临床优势选择合理的疗效指标,结合动态灵活的创新性临床试验判断及验证其临床疗效,提高临床定位的成功率。该研究模式将“组学技术”与“循证”相结合,定位“精准循证”的理念,旨在为建立具有中医药特色的中成药上市后精准用药与定位提供一种新的策略与方法,也为中医学走向精准医学提供更多技术层面的思考。The clinical value of Chinese patent medicine is the core direction of the development of the traditional Chinese medicine industry.The precise clinical positioning determines the way to prove the value of the drug,and is a key link to highlight the clinical value.This paper presented a case study of clinical positioning for Chinese patent medicine,namely Qizhi Tongluo capsules,and the key technical framework of precise clinical positioning of Chinese patent medicine,which was manifested as a comparison of prescription target spectral effect,discovery of core value of prescription,and confirmation of clinical positioning trial.The technical framework was designed to address a range of issues in the realm of precise clinical positioning.Before the clinical positioning trial,based on the multi-component,multi-target,and multi-phenotype data of prescription and clinical indication,the multi-omics network analysis technology was used to identify the core value of the traditional Chinese medicine varieties and predict the potential clinical advantages.Then,based on the predicted clinical advantages,reasonable efficacy indicators were selected,and the clinical efficacy was judged and verified by dynamic and flexible innovative clinical trials to improve the success rate of clinical positioning.This research paradigm integrates"omics technology"with"evidence-based"principles and follows the"precise evidence-based"concept.This research aims to provide a new strategy and method for the precise medication and positioning of Chinese patent medicine with traditional Chinese medicine characteristics after being put into the market and provide more technical thinking for traditional Chinese medicine to move towards precise medicine.

关 键 词：方剂组学 临床定位 靶点谱效 精准循证 芪蛭通络胶囊 

分 类 号：R2-0[医药卫生—中医学] R22R285.5R2-031R289.5