RESUMO
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.
RESUMO
OBJECTIVE： To study the protective effects of Qizhi tongluo capsules and their 9 ingredients decomposed recipes for promoting blood circulation and removing blood stasis （PBCRBS） on cerebral ischemia-reperfusion injury model rats， and to lay a foundation for studying the active components of Qizhi tongluo capsules through decomposed recipes. METHODS： Totally 60 SD rats were randomly divided into sham operation group （0.5％ CMC-Na）， model group （0.5％ CMC-Na）， Qizhi tongluo capsules without the ingredients for PBCRBS group [0.389 g/（kg·d）]， the ingredients of Qizhi tongluo capsules for PBCRBS group [0.253 g/（kg·d）] and Qizhi tongluo capsules group [0.500 g/（kg·d）]， with 12 rats in each group. The rats were given relevant medicine intragastrically， once a day， for consecutive 14 d. 2 h after last medication， except for sham operation group， cerebral ischemia- reperfusion injury model was induced by suture method in each group. The neurological function score was measured according to Bederson score 2 h after ischemia and 24 h after reperfusion. The area of cerebral infarction was calculated by TTC staining. The contents of NO， MDA， LDH and SOD in cerebral tissue of rats were measured by biochemical method. The contents of IL-1β and TNF-α in cerebral tissue of rats were detected by ELISA. RESULTS： Compared with sham operation group， the neurological function score， the infarct area and the contents of NO， MDA， LDH， IL-1β and TNF-α in cerebral tissue were significantly increased in model group （P＜0.05）. The content of SOD in cerebral tissue were decreased significantly （P＜0.05）. Compared with model group， the neurological function score of rats was decreased significantly in each administration group （P＜0.05）； the area of cerebral infarction， the contents of NO， MDA， LDH， IL-1β and TNF-α in cerebral tissue were decreased significantly （P＜0.05）， while the content of SOD in cerebral tissue was increased significantly （P＜0.05）. Compared with Qizhi tongluo capsules group， the area of cerebral infarction， the contents of NO， MDA， LDH， IL-1β and TNF-α in cerebral tissue were increased in the ingredients of Qizhi tongluo capsules for PBCRBS group and Qizhi tongluo capsules without the ingredients for PBCRBS group （P＜0.05）， the content of SOD was decreased significantly （P＜0.05）. CONCLUSIONS： The formulation of Qizhi tongluo capsules and their 9 ingredients decomposed recipes for PBCRBS （without 9 ingredients for PBCRBS） have protective effects on cerebral ischemia-reperfusion injury in rats. Although the protective effects of decomposed recipes for PBCRBS is not as good as that of the whole prescription， the protective effects of whole formulation were decreased significantly. It shows that the drugs for PBCRBS play an important role in protecting the function of cerebral ischemia reperfusion injury. It is of certain significance to separate the ingredients for PBCRBS to clarify the effect of Qizhi tongluo capsules.