经络病机与证候新药评价

Channel pathogenesis and syndrome new drug evaluation

经络病机以经络学说为依据,横向参合脏腑、气血津液等理论,反映疾病发生发展及变化转归的机制,能更好体现证候的时空转化轨迹。证候新药是以证候为基点纵向贯穿多种疾病的一类新药,其常用评价方式存在评价指标量化的问题,不能反映证候动态演进等,制约其进一步发展。笔者在完善证候新药评价模式的探索中发现,经络病机契合证候新药评价发展的内在要求,但前人未予以重视,淡化其临床地位。发展基于经络病机的证候新药评价,并结合现代临床科研方法学,有利于构建综合多维的评价体系,有利于形成互为印证的评价模式,有利于证候新药研发与技术审评体系的建设。

The channel pathogenesis is based on the meridian theory,lateral involvement in syndrome differentiation of zang-fu viscera,qi-blood fluid theory,and so on.The theory not only reflect the mechanism of disease occurrence and development,but also can reflect the temporal and spatial transformation trajectory of syndromes.Syndrome new drugs are a new class of drugs that run through a variety of diseases in a longitudinal direction.The common evaluation methods have many problems in the evaluation of quantitative indicators,that cannot reflect the dynamic evolution of syndromes,which restricts their further development.In the exploration of perfecting the new drug evaluation model,it is found that the channel pathogenesis fits the inherent requirements of the development of the syndrome new drug evaluation,but the predecessors did not pay attention to it and disregarded its clinical status.The development of the syndrome new drug evaluation based on channel pathogenesis,that combine with modern clinical research methodology,which is conducive to the construction of a comprehensive multidimensional evaluation system,the formation of mutually validated evaluation model,and the development of syndrome new drugs and the construction of technical review system.