基于多准则决策分析模型综合评价天麻醒脑胶囊治疗肝肾不足证(神经性头痛、血管性痴呆)的临床证据与价值OA
Integrative evaluation of the clinical evidence and value of Tianma Xingnao Capsules for the treatment of liver and kidney deficiency syndrome(neurological headache and vascular dementia)based on a multi-criteria decision analysis model
目的 系统评估天麻醒脑胶囊治疗肝肾不足证(头痛、轻中度血管性痴呆)的临床证据和综合价值.方法 按照《药品临床证据和价值评估管理指南》标准,采用多准则决策分析模型,结合多学科方法,从安全性、有效性、经济性、创新性、适宜性、可及性以及中医药特色等"6+1"维度进行临床价值评估.结果 安全性:综合分析药品说明书、自发呈报系统(SRS)、公开发表文献的证据认为天麻醒脑胶囊安全性风险可控、安全性好;有效性:基于证据质量评价和证据价值评价结果,认为天麻醒脑胶囊在治疗肝肾不足证(头痛、轻中度血管性痴呆)方面证据比较充分,结果明确,有效性较好,临床价值较大;经济性:与同类中成药价格相比,本品日均费用价格水平低,通过经济学质量和经济性价值评价,本品经济性结果好,证据报告充分、结果确定;创新性:本品在临床应用、企业服务体系完善、生产工艺方面创新性证据比较充分;适宜性:综合考虑调查问卷及中成药信息服务两方面,天麻醒脑胶囊适宜性较好;可及性:天麻醒脑胶囊与同类产品相比价格水平低,可负担性好,药材资源丰富,可获得性好;中医药特色:基于中医药理论和人用经验研究,该药中医药特色突出.综合"6+1"维度结果认为,天麻醒脑胶囊临床价值较高.结论 天麻醒脑胶囊治疗肝肾不足证(头痛、轻中度血管性痴呆)临床证据充足,临床价值较高,中医特色突出.
Objective To systematically evaluate the clinical evidence and comprehensive value of Tianma Xingnao Capsules in the treatment of liver-kidney deficiency syndrome(headache and mild to moderate vascular dementia).Methods In accordance with the Guidelines for the Management of Clinical Evidence and Value Evaluation of Drugs,a multi-criteria decision analysis(MCDA)model was adopted in combination with a multidisciplinary approach.Clinical value was evaluated across the"6+1"dimensions,including safety,effectiveness,economy,innovation,suitability,accessibility,and characteristics of traditional Chinese medicine(TCM).Results Safety:Comprehensive analysis of evidence from the drug instructions,spontaneous reporting system(SRS),and published literature indicates that the safety risk of Tianma Xingnao Capsules is controllable and that its safety profile is good.Effectiveness:Based on the results of evidence quality evaluation and evidence value assessment,the clinical evidence supporting Tianma Xingnao Capsules in the treatment of liver-kidney deficiency syndrome(headache and mild to moderate vascular dementia)is relatively sufficient,with clear results,good effectiveness,and high clinical value.Economy:Compared with similar Chinese patent medicines,the average daily cost of this product is low.Economic quality and economic value evaluations demonstrate favorable economic outcomes,with sufficient evidence and definitive results.Innovation:Sufficient evidence supports innovation in its clinical application,enterprise service system,and production process.Suitability:Considering both questionnaire surveys and Chinese patent medicine information services,Tianma Xingnao Capsules show good suitability.Accessibility:Compared with similar products,Tianma Xingnao Capsules have a lower price level,good affordability,abundant medicinal material resources,and good accessibility.Characteristics of TCM:Based on TCM theory and studies of human use experience,the product demonstrates prominent characteristics of TCM.Overall,evaluation across the"6+1"dimensions indicates that Tianma Xingnao Capsules have high clinical value.Conclusion Tianma Xingnao Capsules have sufficient clinical evidence for the treatment of liver-kidney deficiency syndrome(headache and mild to moderate vascular dementia),with high clinical value and prominent characteristics of TCM.
冯文烨;魏仲义;王雅星;谢雁鸣
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中国中医科学院中医临床基础医学研究所,北京 100700
天麻醒脑胶囊临床综合评价肝肾不足证血管性痴呆头痛
Tianma Xingnao Capsulescomprehensive clinical evaluationliver-kidney deficiency syndromevascular dementiaheadache
《北京中医药》 2026 (1)
42-50,9
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]175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)
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