复方药物研发创新体系展望

本文通过分析创新药物研发的机遇和挑战，提出了复方药物的定义：即指为了实现整体最佳的疗效目标，综合多种治疗原则和多种作用机理导向下所开发的由多个化合物或化合物群配伍组成的治疗药物。复方药物既包括中药复方药物，也包括西药复方药物（化学药复方药物），甚至还可能开发中西药结合的复方药物。复方药物研发创新体系的主要特点在于：强调治疗的对象是生病（或亚健康状态）的人（而不只是病）；充分体现“医生参与、医药结合”的特色；研发途径应体现“临床-动物-临床”的特点；应具有独特的临床疗效综合评价体系；应具有体现其作用模式（机理）的药物综合筛选模式；应具有体现其化合物群的整体表征和局部特征的综合表达形式。当前创制中药复方药物的关键在于：亟待发展能体现其临床疗效的综合评价体系；亟待发展能体现其作用模式（机理）的复方药物综合筛选体系；亟须将中药复方药物综合表达形式规范化。作为中药复方药物的研究示范，作者领导的研究组采用所建立的整合化学物质组学的整体系统生物学方法，成功的实现了从清开灵复方开发出治疗缺血性脑中风的复方药物，从双龙方开发出治疗缺血性心脏病的复方药物。当前创制化学药复方新药的关键在于：亟须转变观念，确立化学药复方药物也是一种新的普适模式；亟须由临床医生从头开始参与新药研发，建立“临床-动物-临床”研发模式；加强中西药合用的复方药物的研究。

Prospect on the Composite Drugs Innovation System

With the analysis of opportunities and challenges for the drug innovation the authors proposed a definition of the composite drug, which means a therapeutical medication with a compatible combination of multiple compounds or multi-group compounds developed under the guiding of multiple therapeutic principles and mechanisms to achieve an optimal holistic efficacy. Composite drugs may consist of composite drugs of TCM, composite synthetic drugs and the combination of the both. The characteristics of composite drugs innovation system are： firstly, its object is the sick but not just the disease; secondly, it requires the collaboration of physicians and the combination of iatrology and pharmacology; thirdly, it requires an R＆D routine of ＇clinical trial-animal experiment-clinical trial＇; fourthly, it requires to develop a comprehensive assessment system for the clinical efficacy; fifthly, it requires to develop an integrative system for screening of composite drugs; Sixthly, it requires to develop an integrative system with the ability of both holistic characterization and specific characterization of the pharmaceutical components group.The current key issues for the innovation of composite drugs of TCM are to develop a comprehensive assessment system for the clinical efficacy of TCM, to develop an integrative system for screening of composite drugs according with the characteristics of TCM and to standardize the approaches for the integrative characterization of composite drugs. As some demostrative studies, our group have develop a new approach, Chemomics - integrated Global System Biology, based on which we have managed to develop a new composite drug for treatment of ischemic apoplexy from TCM Qingkailing, and a composite drug for treatment of ischemic cardiopathy from TCM Shuanglongfang. The current key issues for the innovation of composite synthetic drugs should be to innovate the notions so as to establish an acknowledged model for the innovation of composite synthetic drugs, to absorb physicians to