北京中医药2026,Vol.45Issue(1):42-50,9.DOI:10.16025/j.1674-1307.2026.01.008
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
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
摘要
Abstract
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.关键词
天麻醒脑胶囊/临床综合评价/肝肾不足证/血管性痴呆/头痛Key words
Tianma Xingnao Capsules/comprehensive clinical evaluation/liver-kidney deficiency syndrome/vascular dementia/headache引用本文复制引用
冯文烨,魏仲义,王雅星,谢雁鸣..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[J].北京中医药,2026,45(1):42-50,9.基金项目
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) (国中医药人教函[2022]6号)