[1]吕健,王志飞,谢雁鸣,等.祖师麻膏药治疗骨关节炎的风寒湿痹证临床综合评价[J].西部中医药,2025,38(04):70-78.[doi:10.12174/j.issn.2096-9600.2025.04.14]
　LYU Jian,WANG Zhifei,XIE Yanming,et al.Clinical Comprehensive Evaluation of Zushima Plaster for Osteoarthritis (Wind-cold-dampness Arthralgia Syndrome)[J].Western Journal of Traditional Chinese Medicine,2025,38(04):70-78.[doi:10.12174/j.issn.2096-9600.2025.04.14]
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祖师麻膏药治疗骨关节炎的风寒湿痹证临床综合评价()
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《西部中医药》[ISSN:2096-9600/CN:62-1204/R]

卷:
38
期数:
2025年04期
页码:
70-78
栏目:
二次研究
出版日期:
2025-04-15

文章信息/Info

Title:
Clinical Comprehensive Evaluation of Zushima Plaster for Osteoarthritis (Wind-cold-dampness Arthralgia Syndrome)
作者:
吕健1,2, 王志飞1, 谢雁鸣1, 成冯镜茗1, 张强1, 崔鑫1
1.中国中医科学院中医临床基础医学研究所，北京 100700
2.中国中医科学院西苑医院，北京 100091
Author(s):
LYU Jian1,2, WANG Zhifei1, XIE Yanming1, CHENG Fengjingming1, ZHANG Qiang1, CUI Xin1
1.Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China
2.Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China
关键词:
祖师麻膏药; 骨关节炎; 风寒湿痹证; 临床综合评价
Keywords:
plaster; osteoarthritis; wind-cold-dampness arthralgia syndrome; clinical comprehensive evaluation
分类号:
R684.3
DOI:
10.12174/j.issn.2096-9600.2025.04.14
文献标志码:
A
摘要:
目的通过安全性、有效性、经济性、创新性、适宜性、可及性和中医药特色“6+1”维度，进行临床证据和价值评价，体现祖师麻膏药治疗骨关节炎（风寒湿痹证）的优势和特点。 方法研究采用定性与定量相结合的评价方法，基于循证医学、流行病学、临床医学、循证药学、药物经济学、数理统计学、卫生技术评价等方法学，通过专家对准则层、指标层赋予权重，采用多准则决策分析（MCDA）模型及CSC V2.0软件进行计算，综合评价祖师麻膏药治疗骨关节炎（风寒湿痹证）的临床价值。评价结果由高到低依次分为A、B、C、D共4个等级。 结果该药品不良反应主要为皮肤瘙痒、发红、轻微肿胀，均为一般不良反应，停药后逐渐缓解直至消失，未观察到严重不良反应，安全性好，风险可控，评价为A级。Meta分析结果显示祖师麻膏药治疗骨关节炎（风寒湿痹证）在降低视觉模拟疼痛评分（visual analog scale，VAS）评分方面等效于单用吲哚美辛巴布膏，在西安大略麦克马斯特大学骨关节炎功能评分（the Western Ontario and McMaster University Osteoar-thritis，WOMAC），疼痛评分降低30%应答率方面优于单用吲哚美辛巴布膏，有效性好，临床意义大，评价为A级。药物经济性评价显示，基于2020年人均可支配收入作为患者意愿支付阈值的假设，骨关节炎患者使用祖师麻膏药治疗比吲哚美辛巴布膏更具有经济性，证据报告比较充分、结果较明确，评价为B级。该药品采用现代水提取技术，使有效成分药物含量更稳定，具备较好的创新性，服务体系与产业创新较突出，评价为B级。对临床医生、护士、药师以及使用本药品的患者具有较好的适宜性，可基本满足临床用药需求，评价为B级。药材资源不存在短缺及供应限制，覆盖全国4025家医院，年产能可达3000万张，可满足供应需求，可及性评价为A级。祖师麻膏药的主要成分祖师麻与其基质“武威膏药”均为民族药，属于传统医药经典名方，中医药特色较突出，评价为B级。 结论临床综合评价结果显示，祖师麻膏药治疗骨关节炎（风寒湿痹证）临床价值综合评价为A类，依据国家卫生健康委发布的《药品临床综合评价管理指南（2021年版试行）》，建议按程序转化为基本临床用药管理的相关政策结果。
Abstract:
ObjectiveTo assess clinical evidence and value from the aspects of safety, effectiveness, economy, innovation, suitability, accessibility and "6+1" dimensions of TCM characteristics, so as to reflect the characteris-tics and features of Zushima plaster in the treatment of osteoarthritis (wind-cold-dampness arthralgia syndrome). MethodsThe study, adopting a combination of qualitative and quantitative evaluation methods, based on evidence-based medicine, epidemiology, clinical medicine, evidence-based pharmacy, pharmacoeconomics, mathematical statistics, health technology assessment (HTA) and others, conducts the calculation using the multicriteria decision analysis model (MCDA) and CSC V2.0 software through expert assigning the weights to criteria and indicator levels, in order to comprehensively assess clinical values of Zushima plaster in the treatment of osteoarthritis (wind-cold-dampness arthralgia syndrome). The evaluation results are categorized into four grades, A, B, C and D. ResultsThe adverse reactions of the drug are mainly itching, redness and slight swelling of the skin, all of which are general adverse reactions, gradually relieved until disappeared after the withdrawal. No severe adverse reaction was observed with good safety and controlled risks, rated as grade A. Meta analysis showed that Zushima plaster in the treatment of osteoarthritis (wind-cold-dampness arthralgia syndrome) was better than single use of indomethacin cataplasm in reducing VAS scores, superior to single use of indomethacin cataplasm in WOMAC and in terms of pain scores reducing the response rate by 30%, with good validity and clinical significance, evaluated as level A. Drug economy evaluation found that, assuming that the threshold for patient willingness to pay is based on per capita disposable income in 2020, treatment of osteoarthritis patients with Zushima plaster was more economic than indomethacin cataplasm with sufficient evidence reports and clear results, and rated as grade B. Zushima plaster adopts modern water extraction technology to make the content of effective component drugs more stable, showing good innovation, with more outstanding service system and industrial innovation, and it is rated as grade B. It has good suitability for clinicians, nurses, pharmacists and patients, which can basically meet the needs of clinical uses of the drugs, rated as grade B. There are no shortages and supply constraints in herbal resources, covering 4,025 hospitals across the country, with an annual capacity of 30 million units, which can meet the supply demand, accessibility is assessed as grade A. The main component of Zushima plaster and its matrix "Wuwei plaster" are folk medicine, belonging to the classic prescription of traditional medicine, with prominent characteristics of traditional Chinese medicine, evaluated as grade B. ConclusionThe comprehensive evaluation results of drugs show that the clinical value of Zushima plaster in the treatment of osteoarthritis (Wind-cold-dampness arthralgia syndrome) belongs to category A, according to the Guidelines for Comprehensive Clinical Evaluation of Drugs (2021) issued by the National Health Commission, it is suggested to be transformed into the relevant policy results of basic clinical medication management according to the procedures

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备注/Memo

备注/Memo:
吕健（1991—），男，博士学位，助理研究员。研究方向：中医药临床评价与循证研究。国家重点研发计划项目（2018YFC1707400）；甘肃省科技计划项目（18ZD2FH020）；中国中医科学院科技创新工程重大攻关项目（CI2021A00702）。
更新日期/Last Update: 2025-04-15