| Aim:Apply the translational medicine principles and methods, based on "ignore the nature of a drug and to emphasize on drug usage" thought, accordance to "Blood vessel midget mass" conception propose softening hardness and dissipating mass, esolving accumulation and eliminating pus and necrotic tissues, cooling blood to remove apthogenic heat method and use Chinese medicine prescription contain Ferula asafoetida L as a principal drug for treatment hyperlipoidemia, also applied clinical-mimetic research and clinical research to evaluation the Chinese medicine efficacy and safety on treating on hyperlipoidemia. 1)Theory innovation is is crucial to promote the Chinese medicine curative effect.2) Prove translational medicine model has prevalent meaning of guidance to Chinese medicine development. Method:1) The pathogeny, pathogenesis and differentiation of symptoms and signs for classification of syndrome on hyperlipoidemia of the traditional Chinese medicine dynasties literature were systematically evaluated.2) Establish diseases animal model conduct the clinical-mimetic research.3) A Multi-center, Randomized, Double-blind, Placebo-controlled, Clinical Trial was adopted to evaluation the efficacy and safety of Ruanjiansanjie (softening hardness and dissipating mass) therapy method treating for hyperlipoidemia. Results:1) 6054 cases of hyperlipoidemia were selected for this study, the results showed that: Intermingled Phlegm and Blood Stasis, Resistance within the sputum wet muddy, Spleen Dysfunction due to Dampness is main syndrome, account for 57.46%. the clinical trial results showed that the total efficacy of Chinese medicine treatment for hyperlipoi-demia was 76.86%Decrease the TG average 0.83±0.49mmol/L。did not found adverse effect to main organ such as liver and kidney.2) a fingerprinting map of Ferula asafoetida L was also made, Ferula asafoetida L can decrease the normal rat and hyperlipoidemia animal model TC TG、LDLC, increase HDLC (P<0.05), and prevent high fat diet cause abnormity of plasma lipid. Administrate for six month period the high dosage group has hypersplenia, RBC、HGB、HCTdecresing, but recover after discontinuation of medicine。cytotoxicity test results showed that the medicice induce cell proliferation.3) clinical trial results showed that the average efficacy was 74.50%, the Chinese syndrome effecay was 79.19%O there was significantly different between those in the pre-and post-treatment TC、TG、HDL-C、LDL-C (P<0.05 or P<0.01) in chinese medicine treatment group, TG was decreased at 0.8503±1.803mmol/L. Conclusion:1) Based on "ignore the nature of a drug and to emphasize on drug usage" thought, "Blood vessel midget mass" theory san support the softening hardness and dissipating mass, esolving accumulation and eliminating pus and necrotic tissues, cooling blood to remove apthogenic heat method for hyperlipoidemia and open a new road for Chinese treatment for hyperlipoidemia. Additionally the new Chinese medicine "Awei capsule " was developed according the theory for treatment hyperlipoidemia, the medicine has safety, effecay, quality controllable. This results can explain theory innovation is core of Chinese medicine development.2) clinical-mimetic research and clinical research results showed that "Awei capsule" has lipid regulation effection, among them remarkedly decerease TG.3) based on Chinese medicine theory innovation and innovation theory guide to Chinese prescription, also apply modern techniques and method to research and evaluate Chinese prescription, can develop safety, effective, quality controllable modern Chinese medicine. The study is not only of important theory value, but also translational medicine positive reality meaning to improve the Chinese medicine,... |
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