ABSTRACT
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.
ABSTRACT
The modernization research on Fangji is not only an important approach to the improvement on the clinical effects of Chinese medicine, but also a representative field on the inheritance and innovation of Chinese medicine in this new historical period. For the rule of the combintions in Fangji, we proposed a hypothesis of "the holistic harmonious pharmacological effect", which is defined as the different efficacies of different combinations in Fangji deriving from the harmoniousness on the diversity of pharmacological effects like antagonism, complementarity, regulation, etc. In our paper, by analyzing the different pharmacological mechanisms in the differential genes and pathways for the additive effect on the combinations of gardenoside and baicalin as well as the synergy effect on the combinations of gardenoside and cholic acid, we introduced a developed analytical technique for the principle of comprehensive pharmacological effects, pointed out the encountered dilemma in the researches on the combinations in Fangji and at last proposed three transformations to the further researches in this fields.