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A series of research and application on the prevention and treatment of cholelithiasis based on the combination of disease syndrome

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登记号:G20251412

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关键词: cholelithiasis Insulin resistance and liver-based treatment for bile diseases

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成果名称: A series of research and application on the prevention and treatment of cholelithiasis based on the combination of disease syndrome
成果登记号: G20251412 学科分类:
绿色分类: 项目关键词: cholelithiasis  Insulin resistance   and liver-based treatment for bile diseases    
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Shanghai University of Traditional Chinese Medicine Affiliated Longhua Hospital

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国家/地区: Shanghai 知识产权: Invention patent, others
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This project falls within the scope of basic and applied research in traditional Chinese medicine (TCM) surgery. Since the 1980s, Professor Gu Bohua, a renowned TCM expert, has systematically summarized his clinical experience on gallstone disease, identifying two major syndromes: liver qi stagnation and insufficient liver yin. He was the first to advocate the academic theory of 'treating gallbladder diseases from the perspective of the liver.' With the support of four national natural science foundation research projects, he successfully developed three Chinese herbal medicines for soothing the liver and promoting bile flow—Dan Ning tablets, Sheng Qing capsules, and Shao Qi granules, which have been granted national new drug certificates and production approval numbers—and explored a path to modernization of TCM that is guided by syndrome differentiation and treatment, with coordinated development in industry, academia, and research. Since 1986, a series of clinical studies have been conducted, using liver-soothing and bile-promoting Chinese herbal medicines to treat 274 patients with gallstone disease, achieving an overall effective rate of 85.4%. At Longhua Hospital, Ruijin Hospital, A multicenter, randomized, double-blind, controlled prospective clinical study involving more than 10 units including Renji Hospital showed that the treatment efficacy rate of liver-soothing and gallbladder-relieving traditional Chinese medicine for cholelithiasis was 95.83%. In a double-blind, randomized, controlled prospective study conducted on 360 patients with cholelithiasis using a combination of No.1 formula with liver-soothing and gallbladder-relieving effects and No.2 formula with liver nourishing and softening effects, the total effective rate of liver-soothing and gallbladder-relieving traditional Chinese medicine was 92.11%, and the total effective rate of liver nourishing and gallbladder-relieving traditional Chinese medicine was 90.11%. The insulin levels in patients with cholesterol stones were significantly higher than those of normal individuals, with an elevated insulin resistance index and reduced insulin sensitivity. After treatment with liver nourishing and gallbladder-relieving granules, there was a significant decrease in insulin levels, an improvement in insulin resistance index, and an increase in insulin sensitivity, indicating that liver nourishing and gallbladder-relieving formulas significantly improve insulin resistance. The method of nourishing and softening the liver can also reduce MCB and UCB in T-tube bile of patients with pigment gallstones, increase the content of total bile acids, and decrease their lithogenicity. Animal experiments have shown that traditional Chinese medicines for soothing the liver and promoting bile flow can upregulate the expression of B-UGT mRNA and cholesterol CYP7A1 mRNA in the livers of animals with pigment gallstones, reduce the expression of NF-κB protein induced by lipopolysaccharide stimulation, maintain the relative stability of bilirubin and cholesterol, and decrease their lithogenicity, which may be one of the mechanisms by which they prevent and treat gallstone formation and biliary inflammation; traditional Chinese medicines for soothing the liver and promoting bile flow can increase plasma CCK levels in animals with cholesterol gallstones and the concentrations of IP3, [Ca2+]i in gallbladder tissue cells, significantly upregulate the expression levels of Gs protein and its mRNA in gallbladder tissue cells, as well as the mRNA and protein expression of aromatase in adipose tissue and estrogen receptor α, reduce Gi, The expression levels of Cap protein and its mRNA, the multi-target and multi-link correction of bile duct dynamics and fatty tissue aromatization signal transduction pathway disorders by traditional Chinese medicines for liver protection and gallbladder regulation, and the alleviation of bile stasis are important mechanisms for effectively preventing and treating gallstone disease; it was the first to reveal the pathogenesis of gallstone disease from insulin resistance; traditional Chinese medicines for liver nourishment and softening significantly improve insulin resistance in cholesterol stone animal models, downregulate IRS-2 expression levels, upregulate the expression of InsR, IRS-1, p85, PKB, IKK-β proteins and their mRNA in liver tissue, improve insulin resistance, regulate lipid metabolism disorders, and are important mechanisms for preventing and treating the occurrence of gallstone disease. This achievement has obtained 3 national new drug certificates and 1 patent, and the experience of traditional Chinese medicine in the syndrome differentiation and treatment of gallstone disease was included in the 'Guidelines for Clinical Research on New Traditional Chinese Medicine' by the National Food and Drug Administration in 2002. Train 2 postdoctoral fellows, 10 doctoral candidates, and 16 master's degree students. Publish three academic monographs such as 'Gallbladder Diseases Treated from the Liver', and publish more than 200 papers, with over 184 citations. The research results have been promoted and applied in more than 20 provinces and cities across China, improving the level of traditional Chinese medicine treatment for gallstone diseases in our country.
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