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藤黄健骨片治疗膝骨关节炎的临床综合评价OA

Clinical comprehensive evaluation of Tenghuang Jiangu Tablets in the treatment of knee osteoarthritis

中文摘要英文摘要

目的 综合评价藤黄健骨片治疗膝骨关节炎(KOA)的优势和特点,明确其临床定位.方法 采用循证医学、临床流行病学、临床医学、循证药学、药物经济学、数理统计学、卫生技术评估等方法,基于多准则层决策分析模型和中成药临床证据和价值评估软件,综合整理藤黄健骨片治疗KOA的"6+1"维度的证据,评价其临床价值.结果 藤黄健骨片不良反应主要涉及胃肠系统,安全性证据较充分,结论较明确;藤黄健骨片治疗KOA在降低西安大略湖麦克马斯特大学骨关节炎指数(WOMAC)总分及恢复功能、改善僵直、缓解疼痛、提高临床疗效方面有效,有效性证据充足,结果确定;以WOMAC评分为评价终点,KOA患者使用藤黄健骨片治疗方案比单用常规治疗方案更具有经济性,经济性证据充足,结果确定;藤黄健骨片的创新性、适宜性、可及性均证据充足,结果确定.藤黄健骨片在KOA的治疗中应用广泛,以中医学"治骨先治肾"的理论为基础,具有一定中医理论特色,证据较充分,结论明确.结论 藤黄健骨片临床价值较高,建议根据目前安全性研究,针对严重不良反应,开展安全性机制研究;开展高级别、高质量有效性研究,同时基于此进行经济性评价;开展以临床价值为导向的精准用药机制研究.

Objective To comprehensively evaluate the advantages and characteristics of Tenghuang Jiangu Tablets in the treatment of knee osteoarthritis(KOA)and clarify their clinical positioning.Methods Methods from evidence-based medicine,clinical epidemiology,clinical medicine,evidence-based pharmacy,pharmacoeconomics,mathematical statistics,and health technology assessment were applied.Based on a multi-criteria decision-making analysis model and clinical evidence and value evaluation software for Chinese patent medicines,the"6+1"dimensional evidence of Tenghuang Jiangu Tablets in treating KOA was comprehensively collated and its clinical value evaluated.Results The adverse reactions of Tenghuang Jiangu Tablets mainly involve the gastrointestinal system.Safety evidence is relatively sufficient,and conclusions are clear.Tenghuang Jiangu tablets are effective in reducing the Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC)total score,restoring function,improving stiffness,relieving pain,and enhancing clinical efficacy in KOA,with sufficient efficacy evidence and confirmed results.Based on WOMAC scores,using Tenghuang Jiangu Tablets in KOA patients is more cost-effective than conventional treatment alone,with sufficient economic evidence and confirmed results.Evidence on the innovation,suitability,and accessibility of Tenghuang Jiangu Tablets is sufficient,with clear results.Tenghuang Jiangu Tablets are widely used in the treatment of KOA.Based on the TCM theory of"treating bone by first treating the kidney",they have distinctive TCM characteristics,with sufficient evidence and clear conclusions.Conclusion Tenghuang Jiangu Tablets have high clinical value.It is recommended to conduct safety mechanism studies for serious adverse reactions,carry out high-level,high-quality efficacy studies along with economic evaluations,and explore precision medication mechanisms guided by clinical value.

杜莹;谢雁鸣;路振凯

中国中医科学院中医临床基础医学研究所,北京 100700中国中医科学院中医临床基础医学研究所,北京 100700中国中医科学院中医临床基础医学研究所,北京 100700

藤黄健骨片膝骨关节炎临床综合评价"6+1"维度

Tenghuang Jiangu Tabletsknee osteoarthritisclinical comprehensive clinical evaluation"6+1"dimensions

《北京中医药》 2026 (1)

59-65,7

全国名老中医药专家传承工作室建设项目(国中医药人教函[2022]75号)国家中医药管理局2021年岐黄学者支持项目(国中医药人教函[2022]6号)

10.16025/j.1674-1307.2026.01.010

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