世界中医药

目的：课题以研究胃溃疡活动期的中医“毒热”病因理论为突破口，以建立中医病因学研究方法为途径，以阐明中医药治疗胃癌前状态性疾病的疗效机制为特色，丰富和发展中医病因学理论和实践。方法：通过中医胃脘病“毒热”病因理论研究、中医“毒热”实验病因学研究、“毒热”病因要素的临床流行病学调查、“毒热”病因的中药干预验证性临床试验，进行系统研究。结果：通过病例对照设计，581例胃溃疡活动期83.3%为毒热证；266例浅表性胃炎13.3%为毒热证，从而确证胃溃疡活动期“毒热”为多发、常见病因，通过多因素Logistic回归分析，辨证求因要点包括幽门螺杆菌(Hp)感染、胆汁反流、炎症因子增高、胃肠激素分泌异常等。经300例随机双盲双模拟多中心对照临床试验，试验组证候积分愈显率86.62%，胃镜愈显率80.29%。改良胃溃疡活动期胃毒热证的实验动物模型及其评价方法，验证清热解毒、消痈生肌治法中药复方疗效确切，并阐明其生物学机制。结论：“毒热”为胃溃疡活动期的主要病因，“以痈论治”胃溃疡活动期的新治法为清热解毒、消痈生肌，疗效显著。

English Summary:

To enrich and develop the theory and practice of TCM etiology， taking “toxin-heat” etiological study of gastric ulcer in active state (GUIAS) as a breakthrough， to establish the research methods of TCM etiology and elucidated the therapeutic mechanism of GUIAS TCM therapy.Methods： By theoretical analyses， experiments， clinical epidemiological investigations， clinical trials of Chinese medicine， we systematically analyzed the role of “toxin-heat” etiological factor in gastric ulcer in active state. Results： Case-control studies revealed that 83.3% out of 581 patients with GUIAS presented a “toxin-heat” syndrome which was only diagnosed in 13.3% of 266 patients with superficial gastritis. Multiple logistic regression analysis further confirmed that “toxin-heat” could lead to helicobacter pylori infection， bile reflux， increase of inflammatory factors and abnormal secretion of gastrointestinal hormone， etc. In a 300-patient-involved clinical trial， syndrome analyses and gastroscopy showed that the effective rate of the treatments was as high as 86.62% and 80.29%， respectively. Besides， this project modified the animal model and its evaluation method， and verified the efficacy of TCM extract and elucidated the underlying biological mechanism. Conclusion： “Toxin-heat” is a common and frequent cause of GUIAS. Treating GUIAS as carbuncle is a new and effective way for GUIAS therapy， which is capable of clearing heat， detoxifying， and eliminating carbuncle while growing muscle.

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