RESUMEN
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.
RESUMEN
The clinical value is the core factor for determining the products of Chinese patent medicines on the market. It is clear that defining the clinical positioning of Chinese patent medicines and maximizing their clinical efficacy and value are of great practical significance for each Chinese patent medicine. Precise clinical positioning not only requires systematic analysis and summarization of existing literature and clinical practice data, but also requires verification and proof from detailed experimental data, thus to provide scientific support for basic research. In this research, a three-dimensional integration strategy of " traditional Chinese medicine (TCM) theory-clinical practice-basic research" was proposed to play a vital role in clinical positioning and evaluation of Chinese patent medicines. Yixinshu capsule was taken as an example to discuss clinical positioning of Chinese patent medicines under the guidance of TCM theory. Based on the interpretation of the evolution of the pathogenesis of coronary heart disease (thoracic obstruction), combined with the core efficacy of the drug composition, the effect of Yixinshu capsule in benefiting Zongqi, calming midnd, improving blood circulation and eliminating blood stasis was identified, which was suitable for treatment for the recurrent episodes of angina pectoris, and emergency of symptoms of chronic heart failure. At the level of TCM theory, the clinical positioning of Yixinshu capsule was further defined, and the key points of in-depth research were proposed to provide reference for the mechanism research and clinical application of Yixinshu capsule. Based on the prescription and its score functions, precise analysis of clinical positioning of large varieties of TCM under the guidance of TCM theory, on the one hand will give full play to the value of TCM original knowledge and guide the basic research of Chinese patent medicines, on the other hand the research results will enrich, benefit and sublimate the TCM theory, and finally provide a critical paradigmatic for the clinical positioning of large varieties of TCM under the guidance of TCM theory.