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Technical Innovation and Promotion Application of Combined Traditional Chinese Medicine and Western Medicine Treatment Plan for Drug-Resistant Tuberculosis

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登记号:G20251397

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学科分类:

关键词: Qingbu Dan Tablets Multidrug-Resistant Tuberculosis Anti-Tuberculosis Formula No. 1

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  • 基本信息
成果名称: Technical Innovation and Promotion Application of Combined Traditional Chinese Medicine and Western Medicine Treatment Plan for Drug-Resistant Tuberculosis
成果登记号: G20251397 学科分类:
绿色分类: 项目关键词: Qingbu Dan Tablets   Multidrug-Resistant Tuberculosis   Anti-Tuberculosis Formula No. 1    
推荐单位:

Shanghai University of Traditional Chinese Medicine Affiliated Longhua Hospital

成果所处阶段:
合作方式: JointVentureandCooperation 成果所属行业:
国家/地区: China 知识产权: Invention patent, others
简介: 点击查看
This achievement belongs to the research field of traditional Chinese medicine in the prevention and treatment of tuberculosis. With the support of national 'Eleventh Five-Year' and 'Twelfth Five-Year' infectious disease science and technology major special projects, major new drug creation, etc., interdisciplinary teams from both traditional Chinese medicine and Western medicine across the country have collaboratively innovated to improve the prevention and treatment level of drug-resistant tuberculosis, achieving 4 scientific and technological innovations. 1. Sixty years ago, the team first proposed that 'yin deficiency and stasis heat' is the basic pathological element of tuberculosis, and 'nourishing yin to reduce fire, promoting blood circulation to expel parasites' is the basic treatment principle. In the past 10 years, a multicenter, large-sample clinical epidemiological survey has been completed across the country, further deeply revealing the distribution patterns and pathological basis of TCM syndromes in multidrug-resistant tuberculosis: A multicenter study across the country involving 1,113 cases of MDR-TB revealed that the TCM syndromes in patients with MDR-TB are often complex, characterized by a mix of deficiency and excess, and involve multiple organ lesions. There is a clear correlation between these syndromes and the extent of lung lesions, cavities, etc. Second, for the first time in China, a high-quality clinical research was jointly completed by traditional Chinese medicine (TCM) units in collaboration with major Western medical tuberculosis units nationwide. This integrated optimization led to the formation of an effective combined TCM and Western medicine treatment plan for drug-resistant pulmonary tuberculosis, which has been proven to significantly improve the clinical cure rate of multidrug-resistant tuberculosis. It also possesses multi-target composite advantages and has been widely promoted and applied nationwide, effectively driving the development of the TCM discipline in tuberculosis: A clinical study on the treatment of refractory/drug-resistant pulmonary tuberculosis with TCM over a period of 10 years was conducted at 25 tertiary-level designated hospitals for tuberculosis in 17 provinces and cities. More than 1,500 cases of multidrug-resistant tuberculosis were treated for a full course of 12-24 months. Over 500 cases of fibrocavitary pulmonary tuberculosis and more than 300 cases of retreatment pulmonary tuberculosis have been treated with a multidrug-resistant tuberculosis international standard anti-tuberculosis regimen loaded with the traditional Chinese medicine compound 'No. 2 Anti-Tuberculosis'. The cure rate has increased by 15.87%, reaching an international advanced level, while also possessing multiple advantages such as improving patient quality of life and reducing the incidence of secondary diseases. Thirdly, for the first time, a research platform for new traditional Chinese medicine drugs for pulmonary tuberculosis was jointly constructed, integrating industry, academia, and research to carry out innovative research on new traditional Chinese medicine drugs for pulmonary tuberculosis: in accordance with the requirements for innovative traditional Chinese medicines, integrated modern methods of extraction and purification of traditional Chinese medicines were used to enrich the target components in the medicinal materials, improve the formulation process and quality control standards of Qinbu Dan tablets, establish a TLC identification method for tuberculinum stoloniferum, isolate pure tuberculinum stoloniferum alkaloids with a purity greater than 98%, obtain clinical research approval documents for the new traditional Chinese medicine drug Qinbu Dan tablets and related patents, receive national major innovation new drug projects, Carry out a national center RCT study on the treatment of retreatment pulmonary tuberculosis with Qinbu Dan tablets. 4. Promote the construction of an experimental research platform for the mechanism of action of traditional Chinese medicine compound preparations, and jointly carry out innovative research on the immune microbial composite regulatory mechanisms of anti-tuberculosis TCM compound preparations: (1) Conduct immunological microbial mechanism research on a series of TCM compound preparations such as Qinbu Dan, Anti-Tuberculosis No.1, and Anti-Tuberculosis No.2, finding that they have strong in vivo and in vitro inhibitory/killing effects on Mycobacterium tuberculosis and can alleviate pulmonary inflammatory damage; (2) Confirm that the core monomer components of Anti-Tuberculosis No.2 compound preparation and baicalin can regulate innate immunity to clear Mycobacterium tuberculosis by modulating the expression of TLR2 and the PI3K/Akt/NF-κB pathway. This effectively promotes the development of traditional Chinese medicine in the field of tuberculosis, gradually changing the extremely weak academic status and professional recognition of TCM for tuberculosis in China. The project team has published 42 papers related to traditional Chinese medicine (TCM) tuberculosis, authored 7 monographs, obtained 1 patent, developed 1 new drug, transformed 1 project, and established 2 national standards. It has also led the promotion of TCM in tuberculosis treatment among 25 tuberculosis hospitals nationwide, driving the establishment of TCM departments for tuberculosis at 5 hospitals. The team took the lead in founding the 'Chinese Medical Association Tuberculosis Branch Traditional Chinese Medicine Group'. In 2017, Chen Chuanhong, Director of the Major Project Office of the Ministry of Science and Technology, Academician Ba De Nian, Academician Li Song, Academician Chen Kaixian, and others came to the hospital for field research, setting new requirements and expectations for the project team's research in the field of TCM.
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