[关键词]
[摘要]
国家大力推进中药现代化所取得的重要成就已为中药学人所共识,然而临床医生和广大老百姓对中药现代化成果的感受仍较为滞后。重视临床、结合临床,大力开展中药转化医学研究,是推动中药现代化走进临床的重要出路和举措。中药转化医学研究路径可概括为:源于临床-证于实验-回归临床的循环往复过程;其研究内容可概括为:面向临床的中药标准化研究和源于临床的创新中药研制。面向临床的中药标准化研究的核心是以临床需求为导向,建立以功效为基础的中药品质与性效评价方法和标准,推动中药“品-质-性-效-用”一体化,使中药标准在临床上能让医生看得懂、用得上;源于临床的创新中药研制,包括基于临床经验和循证医学证据的特色复方中药研制、基于临床标本和组学方法的现代组分中药研制,加快中药新药研究与开发进程,为中医临床提供“源于传统、优于传统”的安全高效药物。建议国家有关主管部门从科研立项、人才培养、新药审评及配套的相关政策法规和组织机构等方面,支持中医药转化医学研究工作。
[Key word]
[Abstract]
The vigorous advance on modernization of Chinese materia medica (CMM) has achieved great successes, which is the consensus of scholars. However, the physicians and populace have few awareness of the CMM modernization achievements. It is in great need to promote the modernization of CMM into clinic by translational medicine. The research pathway of CMM translational medicine could be summarized as a repeated cycle of bedside to bench to bedside. And, its main research might include two missions, one is the clinic-oriented standardization of CMM and the other is the clinic-derived discovery of CMM new drugs. The clinic-oriented standardization of CMM is focusing on the development of the effect-based evaluating methods and standards on CMM quality and drug property and promoting CMM integration of “species-quality-property-effect-usage”, which aims at making doctors be able to comprehend and emply the CMM standards. The clinic-derived discovery of CMM new drugs diverges into two pathways: one is the development of traditional compound formula drugs based on the physicians’ experiences and evidence-based medicine; the other is the innovation of modern multi-component CMM drugs based on the clinical specimens and -omic techniques. The clinic-derived drug discovery provides an efficient approach to develop novel CMM drugs with superior efficacy and safety to traditional ones. Thus, it is reasonable to suggest that the related administrations of state should strongly support the translational research of CMM by granting scientific research projects, training specialists of translational medicine, and reforming the regularities of new drug evaluation and relative policies.
[中图分类号]
[基金项目]
国家杰出青年科学基金项目(30625042);国家“重大新药创制”科技重大专项课题(2009ZX09502-022)