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Clinical Application and Mechanism Research of the Intervention Method for Sanjiao in Chronic Kidney Disease

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登记号:G20251410

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关键词: Mediating the Sanjiao meridians clinical and applied basic research chronic kidney disease

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成果名称: Clinical Application and Mechanism Research of the Intervention Method for Sanjiao in Chronic Kidney Disease
成果登记号: G20251410 学科分类:
绿色分类: 项目关键词: Mediating the Sanjiao meridians   clinical and applied basic research   chronic kidney disease    
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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: Utility model patent
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This project belongs to the nephrology specialty of traditional Chinese medicine internal medicine. There are about 120 million patients with chronic kidney disease (CKD) in China, which has become a heavy burden on public health resources. Our team has long adhered to the clinical and basic research on the prevention and treatment of membranous nephropathy (MN), IgA nephropathy (IgAN), and diabetic nephropathy (DN) using traditional Chinese medicine, integrating the theory of differentiation and treatment based on the Sanjiao concept into clinical practice, solving clinical difficulties, forming innovative achievements, and gaining international recognition. 1. We pioneered the theoretical system of 'manipulating the Sanjiao' for the diagnosis and treatment of CKD, guiding the formation of a series of proprietary formulas and medicines. Based on the fundamental pathological changes of water-fire imbalance, abnormal qi transformation, and stagnation of qi mechanism in the Sanjiao and its associated organs during the course of CKD, we pioneered the method of 'manipulating the Sanjiao' for differentiation and treatment, resulting in the development of specialized formulas such as Shenqi Membrane Nephropathy Formula for MN, Renping Formula for IgAN, and Astragalus and Arctium Lappa Series Formula for DN, greatly improving the clinical efficacy of refractory CKD. 2. Took the lead in constructing a comprehensive TCM scheme for MN, completed large-sample RCT clinical research, and achieved international recognition of the results. Through multicenter (7 centers), 190 randomized controlled clinical studies confirmed that the traditional Chinese medicine Shenqi Membrane Kidney Granules combined with hormone and cyclophosphamide regimens are effective in reducing urinary protein excretion, increasing plasma albumin levels, and improving lipid metabolism; compared with Western medicine regimens, this traditional Chinese medicine significantly improved patient kidney function (P<0.05), and no serious adverse events possibly related to the medication occurred, while there were 9 cases (3 deaths) in the control group. This achievement is the first clinical research report on a traditional Chinese medicine compound published in an international authoritative nephrology journal (AJKD, 2013, IF5.756), making a significant contribution to the international recognition of TCM treatment for refractory CKD. 3. Pioneered 'cicada flower kidney treatment', developed artificial substitutes, Promote industrialization and make outstanding contributions to enriching the treatment methods for CKD. This study is a pioneering research on the clinical new uses of natural medicine (cicada flowers) and the development of its artificial substitute (cicada flower fungal powder). Over a period of more than 30 years, systematic clinical and basic research has confirmed that cicada flowers improve kidney function and slow down the progression of renal fibrosis, with effects comparable to Cordyceps sinensis; a series of application basic research on cicada flower fungal powder has also been carried out. The industrialization process of cicada flower fungal powder development has been promoted, with cumulative sales reaching about 50 million yuan in the past two years. 4. Pioneered the concept of staged treatment for DN and laid a solid foundation for the development of new drugs. Over a period of more than 40 years, through a series of clinical studies, a total of 249 patients with stage III to V DN were observed, confirming that the Astragalus membranaceus and Arctium lappa series of prescriptions can effectively protect patients' kidney function and delay the progression of uremia. Through a series of experimental studies, its mechanisms of action have been elucidated, and the rules of its compatibility have been revealed. The article argues the concept of staged treatment for DN, which suggests that in the early stage with excessive internal heat due to yin deficiency, it is appropriate to clear heat and nourish yin; in the late stage when both spleen and kidney yang qi are deficient, warming and tonifying should be the main approach. The academic value lies in creating a combined diagnosis and treatment view for complex diseases between traditional Chinese medicine (TCM) and Western medicine, closely integrating TCM syndrome changes with Western medical disease progression, and serving as an exemplary role in the research on the combination of TCM and Western medicine for complex diseases. 5. The first to create the '斡旋三焦' method for the treatment of moderate to severe IgAN, significantly improving clinical efficacy. Through multiple clinical studies, a total of 858 cases of IgAN patients were observed, confirming that a series of proprietary formulas combined with steroids can delay the progression of renal failure in moderate to severe IgAN patients, and their effect is superior to that of steroids alone. Received funding from 28 national and provincial-level projects, including the National Eleventh Five-Year Plan. Published 179 papers (with 2637 citations in Chinese, 9 papers included in SCI with a total impact factor of 33.88, and 65 citations). Hosted 2 international conferences on the integration of traditional Chinese and Western medicine, participated in 10 international academic exchanges. Transferred 2 new drug research achievements; published 4 books; trained 2 postdoctoral fellows, as well as 67 doctoral and master's students. Became the leading unit for the collaborative group of key special diseases during the Eleventh Five-Year Plan "Edema Disease," with research findings being widely applied and promoted by multiple units, greatly advancing the development of the discipline.
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