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TechnicalInventionandMechanismofActionofTraditionalChineseMedicineQiangfuPlasterforTreatingAscitesinLiverCirrhosis

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Registration number:G20251386

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Subject classification:

Key words: Anti-flatulence plaster technical invention external use

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Publisher:管理人员

Release time:2025-08-09 09:20:56.0

  • Essential information
Name of achievement: TechnicalInventionandMechanismofActionofTraditionalChineseMedicineQiangfuPlasterforTreatingAscitesinLiverCirrhosis
Result registration number: G20251386 Subject classification:
Green classification: Item keywords: Anti-flatulence plaster   technical invention   external use    
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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 integrated traditional Chinese and Western medicine clinical medicine. The main content: Ascites is the most common clinical manifestation in decompensated cirrhosis, with a wide range of incidence, serious harm, and difficult treatment. It falls under the category of 'distension' among the 'four major difficult diseases' in traditional Chinese medicine. This project is based on the theoretical experience of traditional Chinese medicine for abdominal application in treating ascites due to liver cirrhosis, inventing an herbal plaster preparation called 'promoting qi circulation, removing blood stasis, dredging meridians, and expelling water' for abdominal application in treating ascites due to liver cirrhosis. It systematically evaluates the efficacy through clinical trials, develops new drugs, investigates the mechanism of action, and promotes its clinical application. Firstly, on the basis of general diuretic therapy, multi-center randomized controlled observations were conducted to evaluate the efficacy of the Shizhangfang (Real Distention Formula) and Xuzhangfang (Empty Distention Formula) plasters on 242 patients with ascites due to liver cirrhosis. The results showed that both preparations reduced ascites and abdominal distension, with the Shizhangfang being more effective than the Xuzhangfang (Rhubarb, processed Euphorbia, radish seeds, Artificial musk and other substances have shown good effects. Subsequently, the focus shifted to the real swelling formula, optimizing the process and renaming it 'Effervescent Stomachache Patch'. A multicenter randomized controlled trial was conducted again to observe the treatment of 100 patients with cirrhosis-related ascites. The results showed that the comprehensive efficacy rate for ascites resolution in the Effervescent Stomachache Patch group at levels I/II was 63.3%, significantly higher than the 38% in the control group, with no significant adverse reactions. Following this, a preclinical study on the application of Effervescent Stomachache Patch to treat cirrhosis-related ascites was carried out. The study confirmed that Effervescent Stomachache Patch significantly alleviated experimental cirrhosis-related ascites, with a stable formulation process and controllable quality; no significant toxic side effects were observed. Further research found that the components of Effervescent Stomachache Patch, such as borneol and rhein, can be absorbed through the skin, and their mechanism of action is related to improving the permeability of abdominal blood vessels and increasing gastrointestinal motility. As a characteristic technology of Shanghai University of Traditional Chinese Medicine, it has been promoted and applied. Innovation points: Invention of 'Qi-promoting Blood Stasis Dispelling'. The traditional Chinese medicine preparation 'Tongluo Zhushui' - Xiaozhang Plaster provides a new method for the treatment of ascites in liver cirrhosis from an internal disease treated externally. The effectiveness, safety, quality control standards, and preparation process of Xiaozhang Plaster for the treatment of ascites in liver cirrhosis were established, and a new drug clinical research approval was obtained. The main transdermal absorption components of Xiaozhang Plaster for the treatment of ascites in liver cirrhosis were identified, as well as its mechanisms of action in regulating gastrointestinal motility and peritoneal vascular permeability. Application and promotion: Xiaozhang Plaster is not only widely used in the Affiliated Shuguang Hospital of Shanghai University of Traditional Chinese Medicine but also applied in 8 hospitals including the Shenyang Infectious Disease Hospital and Nanjing Second Hospital. It is used not only for ascites in liver cirrhosis but also for postoperative recovery of intestinal motility function, etc. The project has been authorized with two national invention patents (ZL2008 1018 2153.7, ZL2005 1002 8971.8). One new drug clinical research approval, one achievement transfer, and one formation of traditional Chinese medicine-specific diagnosis and treatment technology. Published 10 papers (including 1 SCI paper), with 73 citations, referenced in 4 industry guidelines and monographs, and trained 5 graduate students. Improved the comprehensive treatment efficacy for ascites due to liver cirrhosis and promoted the modernization development of traditional Chinese medicine therapy.
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