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Evidence-basedResearchandTranslationoftheShi'sOrthopedicsSeriesTherapyforKneeOsteoarthritis

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Registration number:G20251390

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Key words: Therapy Shi's Wound Science Osteoarthritis

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Publisher:管理人员

Release time:2025-08-09 09:21:02.0

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Name of achievement: Evidence-basedResearchandTranslationoftheShi'sOrthopedicsSeriesTherapyforKneeOsteoarthritis
Result registration number: G20251390 Subject classification:
Green classification: Item keywords: Therapy   Shi's Wound Science  Osteoarthritis    
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Shanghai University of Traditional Chinese Medicine Affiliated Shuguang Hospital

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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 traditional Chinese medicine. Osteoarthritis is a degenerative disease, most commonly affecting the knee joints, and is a common condition worldwide. It is one of the main causes of functional disability and decreased quality of life in the elderly population. Current Western medical treatments mainly include acetaminophen and non-steroidal anti-inflammatory drugs (NSAIDs), which can alleviate arthritis symptoms but have significant side effects. The recently introduced joint protectants, such as glucosamine sulfate, still do not have recognized cartilage protective effects and are not significantly effective in improving symptoms. In the past, traditional Chinese medicine (TCM) treatments for this disease often started with 'kidney' and 'bone', but based on the TCM theory of bone injury that 'the liver governs tendons' and 'both bone and tendon are equally important', combined with the over a hundred years of experience in treating joint diseases by Shi's orthopedics clinic and modern research progress, The theory of treatment 'treating from tendons' was proposed, with the principle of 'equal emphasis on bones and tendons, with a focus on tendons', and the main therapeutic method is 'soothing the liver and nourishing tendons'. Under the guidance of this theory, several technological innovation achievements have been obtained. (1) The development of a series of traditional Chinese medicine preparations for soothing the liver and nourishing tendons (Peony Tendon Relaxing Tablets, Huai Zhen Liver Nourishing Capsules, active ingredient HBP-A), which are comparable in efficacy to existing drugs, but with significantly reduced dosage and no obvious adverse side effects. Randomized controlled clinical trials confirmed that both drugs can significantly alleviate symptoms of knee osteoarthritis; compared with the marketed traditional Chinese medicine anti-osteophyte capsules, they can reduce the dosage by 40% and 62%, respectively; especially after discontinuation of medication, the follow-up trend of efficacy for Huai Zhen Liver Nourishing Capsules was more robust than that of anti-osteophyte capsules and the Western medicine Vigor. Obtained 1 national new drug clinical research approval, 2 Shanghai hospital preparation clinical use approvals, and 2 national invention patent authorizations. (2) Developed an individualized traditional Chinese medicine treatment plan for knee osteoarthritis, which has better efficacy than the Western drugs acetaminophen and celecoxib, and can significantly reduce the economic cost of comprehensive treatment. A multicenter randomized controlled clinical trial nationwide confirmed that applying this plan resulted in a WOMAC total score improvement of over 30% in 93.7% of cases within 4 weeks. The research paper, as a high-evaluation Biomed article, attracted international attention. It has been verified by 33 hospitals from the National Knee Osteoarthritis Collaborative Group and has become recognized as the 'Traditional Chinese Medicine Clinical Pathway for Knee Osteoarthritis' (recognized by the Medical Administration Department of the State Administration of Traditional Chinese Medicine in 2011). (3) Experimental research revealed that the method of soothing the liver and nourishing the tendons improves cartilage metabolism. The mechanism of action in maintaining the level of skeletal muscle myosin. Based on in vitro experiments, Shaoyao Shujin tablets and HBP-A medicated serum can promote the synthesis of cartilage extracellular matrix collagen and proteoglycan, and inhibit the matrix degradation enzyme MMP-13. Observations from different types of animal models of osteoarthritis (stress-induced and spontaneous degeneration models) have shown that Huai Zhen Yanggan capsules can delay cartilage degeneration and promote the expression of cartilage Aggrecan, significantly downregulating ADAMTS-5 expression levels; at the same time, they can upregulate the expression levels of α-actin and MHC in model animals' skeletal muscles. Application and promotion status: The comprehensive level of the above research has reached a leading position domestically, with mature technology. The core technology has been widely applied nationwide, and according to data from some application units, the number of benefiting patients has exceeded 12,000 cases. Related research reports have been published in international academic journals and received high evaluations. It reflects the international influence and advancement of achievements, with a total of 24 main papers published, including 6 SCI-indexed articles. The papers have been cited 162 times, with 16 citations from SCI journals. It has trained 683 participants in national continuing education classes (5 batches). R&D formulation has become one of the most sold formulations within the hospital, and 'Peony Muscle Relaxing Tablets' won the Excellent Exhibition Award at the 2011 China International Industrial Expo and was granted a new drug clinical research approval by the state. As the leading unit of the National Administration of Traditional Chinese Medicine (NATCSM) for knee osteoarthritis collaboration, it has taken the lead in guiding the treatment standards of 33 hospitals across the country with the theory of 'treating from muscles'. The 'Traditional Chinese Medicine Treatment Plan for Knee Osteoarthritis' has been practically applied by national collaborative units, contributing to the key books of the 'Eleventh Five-Year Plan', such as 'Today's Traditional Chinese Medicine Orthopedics'. The 'Clinical Pathways for 22 Specialties and 95 Diseases in Traditional Chinese Medicine' adopted by the project group serves as the leading unit for the national 'Eleventh Five-Year' Science and Technology Support Plan's research on 'Optimization of TCM Treatment for Knee Osteoarthritis'. The concept of 'Treatment from Tendons' is reflected in the national plan.
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