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The therapeutic mechanism and application promotion of kidney-tonifying and essence-benefiting method in the prevention and treatment of primary osteoporosis

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登记号:G20251404

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关键词: Mechanism Efficacy Patent

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成果名称: The therapeutic mechanism and application promotion of kidney-tonifying and essence-benefiting method in the prevention and treatment of primary osteoporosis
成果登记号: G20251404 学科分类:
绿色分类: 项目关键词: Mechanism   Efficacy   Patent    
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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, invention patent, new drug certificate
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Osteoporosis and the fractures it causes have a high incidence rate and significant harm, posing a serious threat to the health and life of middle-aged and elderly people. In 1986, our research group was among the first to propose 'Treatment of Osteoporosis with Kidney Tonifying and Essence Benefiting Method,' and after 28 years of continuous efforts, we have formed five scientific innovations: 1. Completed surveys in Shanghai, Beijing, Fujian, and other regions on the high-risk population for primary osteoporosis (POP) (6,447 cases), proving that kidney yang deficiency and kidney yin deficiency are the main symptoms of POP (83%). We constructed an early risk assessment model for POP based on 'syndrome-disease combination,' laying the foundation for screening and early prevention and treatment of high-risk populations. 2. Completed a randomized double-blind, placebo-controlled, multicenter clinical trial study on the treatment of POP with kidney tonifying and essence benefiting method (200 cases). The study found that warm kidney yang granules significantly relieved pain and reduced symptoms of kidney yang deficiency. Improve the quality of life; Zishenyin Granules significantly increase lumbar bone density. A clinical standardized scheme for treating POP from the perspective of kidney yin and kidney yang, evaluation technical methods, and evaluation system have been established. 3. It has been discovered that Wnt/β-Catenin, BMP2/4/7, Notch signaling pathways are upregulated to promote bone formation; RANKL and other signaling pathways are downregulated to inhibit bone resorption. The regulatory mechanisms of the signal transduction network in bone metabolism and the gene network regulatory model of 'Kidney Bone System' have been revealed, as well as the material basis and variation patterns of the internal connection between the theory of 'Kidney Governing Bone'. 4. A database of effective components of kidney tonifying Chinese medicine and an in vitro and in vivo screening system for treating POP have been established. It has been proven that MiGu Pian, QiangGu Capsule, and effective components such as icariin, psoralen, total flavonoids of Dendrobium officinale, osthole, Oleanolic acid and other compounds promote bone formation by upregulating the Wnt/β-catenin, BMP2/4/7, Notch signaling pathways, and inhibit bone resorption by downregulating the RANKL signaling pathway. The targets and mechanisms of action of traditional Chinese medicines for kidney tonification and their active components in regulating bone metabolism have been elucidated. 5. From field surveys of high-risk populations, clinical trial studies, gene discovery, and drug action research, the network mechanisms of comprehensive regulation of bone metabolism by warming kidney yang and nourishing kidney yin traditional Chinese medicines have been elucidated, revealing the law of 'seeking yang within yin and seeking yin within yang' in the prevention and treatment of osteoporosis (POP), forming an overall view of 'regulating kidney yin and kidney yang' in the prevention and treatment of POP, and enriching and developing the theory that 'the kidney governs bone'. It has successively received national '973' plan projects, Supported by 59 key national and departmental-level projects including the National 'Ninth Five-Year' Science and Technology Tackling Project, the National Outstanding Youth Science Fund, and the Key Projects of the National Natural Science Foundation of China. Organized 9 international symposia on bone biology, participated in 82 domestic and international academic exchanges, with 56 papers included in ISTP; published 362 papers, including 86 SCI-indexed papers with a total impact factor of 369 (the highest individual paper being 15.287), with 2671 citations (including 378 citations from journals with an IF greater than 10 such as Science and Nat Med), served as the chief editor of 11 textbooks, monographs, and curricula for the 'Twelfth Five-Year' Plan of the Ministry of Health and for national higher education institutions in traditional Chinese medicine; obtained 9 authorized national patents and 3 international invention patents (in the United States, South Korea, and Singapore). Developed a new traditional Chinese medicine (TCM) drug, Qianggu Capsule. Guoyifang Certificate No. Z20030007) and the total flavonoids of Dendrobium officinale (Guoyifang Certificate No. Z20020009) have been promoted and used in more than 1,520 medical institutions and over 580 community health centers nationwide. The 'Guidelines for Evidence-Based Clinical Practice in Primary Osteoporosis' compiled by them have been widely used in national traditional Chinese medicine hospitals and integrated Chinese and Western medicine hospitals, and have guided the development of new drugs and the establishment of clinical pathways for this type of disease. They have trained 33 postdoctoral fellows, 186 doctoral and master's students, won 17 international outstanding young academic awards (such as ASBMR Young Investigator Award), and received the National Top 100 Excellent Doctoral Dissertation Award. They have established the 'Innovative Team for the Prevention and Treatment of Osteoporosis with Traditional Chinese Medicine,' which has become an innovative team of the Ministry of Education. They have completed the national TCM clinical research base, National key disciplines, national clinical key specialties, and joint construction of key laboratories by provincial departments under the Ministry of Education have been established. The method of kidney-tonifying and essence-benefiting has been included in the unified textbooks for undergraduate and graduate students at traditional Chinese medicine colleges nationwide; a scientific research collaboration network has been formed both domestically and internationally, and standardized clinical and experimental protocols have been promoted and applied in more than 300 hospitals and research institutes.
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