转化医学路径之一——“源于实验-证于临床”的中药新药研究方法学

New Chinese Medicine Methodology of One Research Path——“from Experiment to Clinical Verification”on Key Technology of Translational Medicine

转化医学即通过双向转化通道,在基础研究与临床医学之间建立联系的桥梁,进而推动基础研究向临床医疗快速转化与应用。中医药转化医学模式,旨在梳理并建立多维的中医药转化医学模式,理性开展中医药转化医学研究。探讨基于临床试验的中医药转化医学研究的方法,确定了三种转化路径,即:源于文献-证于临床;源于临床-证于临床;源于实验-证于临床;本研究是探讨建立转化医学关键技术研究路径之一"源于实验-证于临床"的方法学,在前期工作的基础上以开展了治疗便秘的中药复方药物、治疗失眠中药复方药物、治疗感冒后咳嗽的复方药物为示范,进行临床转化医学研究,为候选药物的确定和向中药新药研究转化,提供临床试验资料的支撑。建立了转化医学关键技术研究路径之一"源于实验-证于临床"的方法学。

Translational medicine means that to establish a bridge between fundamental research and clinical medicine through bidirectional translation path in order to promote the translation and application from fundamental research to clinical medicine. The purpose of traditional Chinese medicine （TCM） translational model is to collate and build one multidimensional TCM translational model, rationality carry out the research on TCM translation. Three paths have been confirmed, where are from literature research to clinical verification, from clinical application to clinical verification, and from experiment to clinical verification. In this research, methodology of one path mentioned above could be established,which is the key technology of translational medicine. Take constipation, insomnia, and post-flu cough as target diseases to investigate the herbal compounds which could be qualified for clinical application based on preliminary work. This research not only provided clinical data to TCM translation, but also established one methodology of TCM translation path - ＂from experiment to clinical verification＂.