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MechanismandApplicationofDampness-RemovingandBloodStasis-ResolvingFormulainthePreventionandTreatmentofNon-AlcoholicFattyLiverDisease

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Registration number:G20251383

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Key words: non-alcoholic fatty liver disease mechanism Application

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Publisher:管理人员

Release time:2025-08-09 09:20:52.0

  • Essential information
Name of achievement: MechanismandApplicationofDampness-RemovingandBloodStasis-ResolvingFormulainthePreventionandTreatmentofNon-AlcoholicFattyLiverDisease
Result registration number: G20251383 Subject classification:
Green classification: Item keywords: non-alcoholic fatty liver disease   mechanism  Application    
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Shanghai University of Traditional Chinese Medicine Affiliated Shuguang Hospital

The stage of achievement:
Mode of cooperation: Outcome Information:
Countries/regions: Shanghai Intellectual property rights: Invention patent, others
Introduction: Click to view
This project belongs to the field of basic research on the application of traditional Chinese medicine (TCM) in non-alcoholic fatty liver disease (NAFLD). The main technological innovation content: In China, due to changes in lifestyle and dietary structure, the prevalence of NAFLD has entered a rapid growth phase and has become the most common chronic liver disease. However, there are no ideal therapeutic drugs available clinically, and developing new treatment drugs is an important topic in the prevention and treatment of NAFLD. This achievement is based on leveraging the unique advantages of TCM, grounded in clinical practice, proposes that 'phlegm-dampness-blood stasis' is the basic pathogenesis of NAFLD, and has created a TCM compound prescription for removing dampness and transforming stasis that is significantly effective in treating NAFLD. Moreover, (1) it uses systems biology methods such as transcriptomics and metagenomics, as well as in vitro and in vivo pharmacological research methods, to elucidate the comprehensive pharmacological effects of this formula through multiple pathways. The mechanisms mainly include increasing adiponectin, Regulate AMPK activity, regulate intestinal flora, improve intestinal permeability, reduce FFA toxicity, and enhance lipid peroxidation; (2) Innovatively use the uniform design mathematical model to analyze the main effects of traditional Chinese medicine in different pathological links for the dampness-removing and blood stasis-dissolving formula; confirm that gardenoside, chlorogenic acid, etc., are the main material bases of the pharmacological action of the dampness-removing and blood stasis-dissolving formula; (3) Prospective randomized controlled clinical study (including 164 patients with non-alcoholic fatty liver disease and phlegm-stasis interconnection syndrome) confirms that the dampness-removing and blood stasis-dissolving formula can significantly improve steatosis, liver function, blood lipids, and traditional Chinese medicine symptoms in patients with non-alcoholic fatty liver disease, with effects superior to those of polyene phosphatidylcholine capsules, and the mechanism is related to improving insulin resistance in patients, reducing serum TNF-a and leptin levels, and increasing serum adiponectin levels. Project Characteristics: This work is original. The main innovations include: (1) Invention of 'A Traditional Chinese Medicine Compound Preparation for the Treatment of Fatty Liver and Its Preparation Method' (Qushi Huayu Formula, granted national invention patent); Invention of 'A Traditional Chinese Medicine Compound Drug for the Treatment of Fatty Liver Disease' (Compound of Main Active Components in Qushi Huayu Formula, granted national invention patent); Demonstrated the efficacy and safety of Qushi Huayu Formula in patients with non-alcoholic fatty liver disease characterized by phlegm and blood stasis; (2) Revealed the mechanism of action of Qushi Huayu Formula in preventing and treating experimental fatty liver from aspects such as AMPK, adiponectin signaling pathways, lipid peroxidation, especially intestinal microecology; (3) Revealed that gardenoside, chlorogenic acid, etc., are the main material bases for the pharmacological effects of Qushi Huayu Formula against non-alcoholic fatty liver. Application and Promotion: (1) This project has published 51 papers in influential academic journals within the domestic disciplines and fields, including 3 SCI-indexed articles and 11 Pubmed-indexed articles. The papers have been cited 491 times, with 371 citations being from other sources. It has participated in international conference keynote speeches and exchanges twice, and invited reports at domestic conferences seven times. Two patents have been authorized; (2) This project has trained 5 master's and 5 doctoral students; it has cultivated one outstanding academic leader of Shanghai, one leading talent of Shanghai, and one national candidate for the New Century Hundred-Thousand Talents Program; (3) Based on the work of this project, it has completed and published the 'Guidelines for Diagnosis and Treatment of Common Diseases in Internal Medicine - Hepatobiliary Diseases Volume' section edited by Academician Wang Yongyan, the 'Fatty Liver Disease' chapter edited by Professor Fan Jiangao, including the 'Traditional Chinese Medicine Treatment for Non-Alcoholic Fatty Liver'. Provide extensive guidance for clinical application. (4) The project has been promoted in Ningbo Second Hospital, Zhenhai District Traditional Chinese Medicine Hospital, and Jiangdong District Traditional Chinese Medicine Hospital of Ningbo City. The intervention using the dampness-removing and blood stasis-dissolving prescription on patients with non-alcoholic fatty liver disease characterized by phlegm and blood stasis interconnection has shown good therapeutic effects and safety. The traditional Chinese medicine compound studied in the project has good prospects for new drug development. The new academic viewpoints proposed and demonstrated will play an important role in promoting the academic and clinical research on the prevention and treatment of non-alcoholic fatty liver disease with traditional Chinese medicine.
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