It is clinically common to see different therapeutic effects of the same kind of therapy on different individuals with the same disease, and that is why traditional Chinese medicine emphasizes that the different therapies shall be given to different patients with the same diseases .Studies in the past showed that the therapeutic effect of Fuzheng Huyu formula treating liver fibrosis was 52%, and why did nearly half of the patients have no positive fibrosis improvement?In order to answer the question , a hypothesis of “liver fibrosis pa-tients responding differently to Fuzheng Huyu formula may have differences on endogenous biology and exogenous drug metabonomics ”was established and might be the theoretical foundation to treat differently on the patients with the same disease .First an animal test was conducted to learn the effect of Fuzheng Huayu formula on metalolome of the model annimals as well as the metabolism changes of the drug.Then it was used to treat liver fibrosis patients to evaluate the effect through pathological tissue fibrosis observation .Patients who showed therapeutic effect and no therapeutic effect were given tests on biological and drug metabolism as well as metabolism network a -nalysis to prove the hypothesis .It verifies the mechanism of different therapeutic effects of Fuzheng Huayu formula on different individu -als with liver fibrosis , and identifies the drug action principles and best indications which promotes the scientific explanation of Chinese theory of “different therapies shall be given to different patients with the same diseases ”.%同一疾病相同治疗却出现不同疗效，这是临床常见现象与中医学强调“同病异治”的原因所在。既往研究证实，中药新药扶正化瘀方抗乙肝肝纤维化的有效率为52％，为何另约一半患者未出现肝组织纤维化逆转？从这一问题出发，结合中医据病分证、疾病遗传背景差异等认识发展，基于代谢组学整体反应的特点，提出“对扶正化瘀方有效与无效的乙肝肝纤维化患者群存在内源性生物与外源性药物代谢组学的差异特征，且相互影响，构成该药物对乙肝肝纤维化同病同治而差异疗效的内在基础”的科学假说。首先动物实验，了解扶正化瘀方对肝纤维化模型生物代谢组的影响与药物代谢变化特点，继之以扶正化瘀方治疗乙肝肝纤维化患者，以组织纤维化病理评价疗效，将患者分为显效与无效2组，进行给药前后的生物与药物代谢组学检测、代谢网络分析，验证以上科学假说，阐明扶正化瘀方抗乙肝肝纤维化差异疗效的内在机制，明确该药物作用原理与最佳适应证，促进中医学“同病异治”的科学诠释。
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