1.中国中医科学院 中药研究所,北京 100700
2.南方医科大学 中西医结合医院,广州 510315
3.华中科技大学 同济医学院 附属同济医院,武汉 430030
4.北京中医药大学 中药学院, 北京 100102
5.成都中医药大学 药学院,成都 610075
林娜,博士,研究员,从事抗炎免疫中药药理学研究,E-mail:nlin@icmm.ac.cn
收稿:2024-10-08,
录用:2024-11-26,
网络出版:2024-11-29,
纸质出版:2025-03-20
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林娜,张彦琼,肖长虹等.类风湿关节炎寒湿痹阻证和湿热痹阻证动物模型建立规范[J].中国实验方剂学杂志,2025,31(06):47-54.
LIN Na,ZHANG Yanqiong,XIAO Changhong,et al.Guidelines for Establishing Animal Models of Rheumatoid Arthritis with Cold-dampness Obstruction Syndrome and Dampness-heat Obstruction Syndrome[J].Chinese Journal of Experimental Traditional Medical Formulae,2025,31(06):47-54.
林娜,张彦琼,肖长虹等.类风湿关节炎寒湿痹阻证和湿热痹阻证动物模型建立规范[J].中国实验方剂学杂志,2025,31(06):47-54. DOI: 10.13422/j.cnki.syfjx.20242137.
LIN Na,ZHANG Yanqiong,XIAO Changhong,et al.Guidelines for Establishing Animal Models of Rheumatoid Arthritis with Cold-dampness Obstruction Syndrome and Dampness-heat Obstruction Syndrome[J].Chinese Journal of Experimental Traditional Medical Formulae,2025,31(06):47-54. DOI: 10.13422/j.cnki.syfjx.20242137.
类风湿关节炎属于中医“痹症”范畴,寒湿痹阻证和湿热痹阻证是其核心证候和主要辨证分型,很多中医名家在长期的临床实践中,以“寒热为纲”辨证论治,取得了显著疗效。为适应临床辨病辨证相结合的实际,更好开展中西医结合基础研究及中药新药临床前研究,项目组联合国内中医药学、临床、动物学和循证医学等研究领域知名专家,共同编制了《类风湿关节炎寒湿痹阻证和湿热痹阻证动物模型建立规范》(简称《规范》),以供科学研究、教学和临床应用参考。《规范》在制作过程中,以病证结合理论为指导,遵循“证据为主、共识为辅、经验为鉴”的原则,在综合评价病证结合动物模型与人类疾病相比较的发病机制同源性、行为表型一致性和药物治疗预见性基础上,通过名义组法,对有证据支持的推荐建议形成“推荐意见”,对无证据支持的推荐建议形成“共识建议”,形成了类风湿关节炎寒湿痹阻证和湿热痹阻证动物模型建立过程中涉及动物类型、关节炎造模方法、外部刺激条件和成模评估指标等内容的规范,适用于类风湿关节炎病证研究、疗效机制探索和中药新药研发,也为其他类别的病证结合动物模型规范建立提供借鉴和帮助,从而进一步推动中医药现代化研究,促进与国际学术发展接轨。
Rheumatoid arthritis belongs to arthralgia syndrome in the theory of traditional Chinese medicine, and cold-dampness obstruction syndrome and dampness-heat obstruction syndrome are core syndromes and main syndrome differentiation types of this disease. Fine therapeutic effects have been obtained in the long-term clinical practice of many famous traditional Chinese medicine practitioners following the syndrome differentiation and treatment based on the guiding principles of cold and heat. To adapt to the clinical diagnosis practice of combining disease differentiation and syndrome differentiation, and to better carry out basic research on integrated Chinese and Western medicine and preclinical study on new traditional Chinese medicines, Guidelines for Establishing Animal Models of Rheumatoid Arthritis with Cold-Dampness Obstruction Syndrome and Dampness-Heat Obstruction Syndrome (hereinafter referred to as the Guidelines) were compiled by our research group, in cooperation with the renowned experts in research fields including traditional Chinese medicine, clinical medicine, zoology and evidence-based medicine, which provide a meaningful reference for scientific research, teaching and clinical applications. The compilation process of the Guidelines was guided by the theory of disease and syndrome integration and the principles of "evidence takes the main place, consensus plays an auxiliary role, and experience serves as the reference". Based on the comprehensive evaluation of pathogenesis homology, behavioral phenotypic consistency, and drug treatment predictability compared between animal models and human diseases, by the nominal group method, "recommendations" were formed for recommendations supported by evidence, and "consensus recommendations" were formed for recommendations not supported by evidence. Guidelines were formed involving content such as animal types, arthritis modeling methods, external stimulation conditions, and modeling assessment indicators during the establishment of the animal models of rheumatoid arthritis with cold-dampness obstruction syndrome and dampness-heat obstruction syndrome. The Guidelines are applicable for the disease and syndrome research on rheumatoid arthritis, investigation of therapeutic mechanisms, and development of new traditional Chinese medicine. The Guidelines also provide a reference for the establishment of guidelines on other types of diseases and syndromes combined with animal models to further promote the modernization of traditional Chinese medicine research and its integration with international academic development.
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