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TheEfficacyandMaterialBasisofTraditionalChineseMedicineCompoundinPreventingandTreatingEsophagealVaricealBleedingandGastricVaricealBleeding

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Registration number:G20251391

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Key words: Cirrhosis portal hypertension hepatic microcirculation disorder

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Publisher:管理人员

Release time:2025-08-09 09:21:04.0

  • Essential information
Name of achievement: TheEfficacyandMaterialBasisofTraditionalChineseMedicineCompoundinPreventingandTreatingEsophagealVaricealBleedingandGastricVaricealBleeding
Result registration number: G20251391 Subject classification:
Green classification: Item keywords: Cirrhosis   portal hypertension   hepatic microcirculation disorder    
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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 falls within the fields of traditional Chinese medicine and clinical medicine. Esophageal varices rupture bleeding is one of the main causes of death in patients with cirrhosis and portal hypertension. Reducing portal hypertension, preventing upper gastrointestinal bleeding and rebleeding, is of great significance for reducing the risk of bleeding in cirrhosis patients, improving survival rates, and enhancing prognosis. Currently, there are no internationally recognized effective treatment regimens for mild esophageal and gastric varices in cirrhosis to prevent bleeding. For moderate to severe esophageal varices, β-blockers such as propranolol are mainly used to prevent bleeding. However, some patients often cannot tolerate treatment due to the side effects and contraindications of these drugs, and propranolol does not have a therapeutic effect on the fundamental cause of portal hypertension, which is the contraction and activation of hepatic stellate cells leading to liver fibrosis, thus it can only treat the symptoms. This project aims to prevent and treat bleeding in patients with liver cirrhosis using traditional Chinese medicine compound formulas as a breakthrough, conducting evidence-based clinical and basic research, and achieving several important innovative results. Innovative content of this project: 1. Clearly proposed the academic viewpoint that blood-activating and stasis-dissolving traditional Chinese medicines can prevent esophageal variceal rupture and bleeding by treating liver cirrhosis and improving hepatic circulation. Propranolol reduces portal venous blood flow to lower portal hypertension, which belongs to the 'restriction' method. This project adopts the 'dispelling' method, using Fuzheng Huayu Capsules to treat hepatitis B cirrhosis for 2 years. The results show that the cumulative probability of no bleeding in patients with mild esophageal varices treated with Fuzheng Huayu Capsules was 96.3%, significantly higher than the 77.01% of the placebo group; The cumulative probability of no bleeding in patients with moderate to severe varicose veins treated with Fuzheng Huayu Capsules is 76.13%, and when used in combination with propranolol, it rises to 87.55%, significantly higher than the 56.99% for propranolol alone. The combined use of the two drugs prevents rebleeding in patients who have previously bled, with a cumulative probability of no bleeding at 44.87%. The median time without bleeding in the Fuzheng Huayu Capsules group is 22±1.38 months, compared to the median time of 8±2.56 months in the propranolol group, showing a significant difference. The advantage of Fuzheng Huayu Capsules lies in that it does not reduce cardiac output but rather treats the root cause by anti-fibrosis and improving liver microcirculation, thereby increasing the outflow of blood from the liver, accelerating its flow, and thus reducing portal hypertension. The combination of traditional Chinese and Western medicine shows even better therapeutic effects. 2. Reveal the mechanism of action and clarify the role of Shuzheng Huayu Capsules and the main ingredient Salvia Miltiorrhiza B Salt (SA-B) in reducing portal hypertension. Since among thousands of Chinese herbal compound formulas, only a portion of the constituent components or chemical substances can be absorbed through the intestines into the bloodstream to exert pharmacological effects, it is not appropriate to directly apply crude extracts of traditional Chinese medicine compound decoctions for in vitro experimental research on drug mechanisms. At present, the scientific level allows extraction of representative effective components or ingredients from traditional Chinese medicine compounds to replace the formula for in vitro studies. Research has confirmed that both Shuzheng Huayu Compound and SA-B can reduce liver fibrosis while lowering portal pressure in rats with cirrhosis models. SA-B can inhibit the Ca2+-MLCK pathway and Rho-ROCK signaling pathway, thereby suppressing the activation and contraction of hepatic stellate cells induced by endothelin. 3. The application of the first-ever rat and mouse portal hypertension models induced by endothelin confirmed that SA-B can significantly inhibit the increase in rat portal pressure caused by endothelin and improve liver microcirculation disorders in mice caused by endothelin. The characteristics of this project are to use traditional Chinese medicine methods such as 'activating blood circulation' and 'unblocking blood vessels' to reduce portal hypertension, establishing a treatment approach for actively preventing esophageal variceal bleeding due to cirrhosis, elucidating the mechanisms and pathways of action of traditional Chinese medicine and its effective components. This project has published 46 related papers, including 4 SCI-indexed articles with an overall impact factor of 15.1, with a total of 595 citations (including 246 from SCI). The main achievements have been included in one foreign monograph, which has been downloaded 2477 times; presented at international conferences 6 times; Obtained 1 patent and applied for 2; Fuzheng Huayu Capsules have been promoted in 1903 hospitals across 30 provinces, cities, and regions in China, as well as Hong Kong and Macau.
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