Integrative evaluation of the clinical evidence and value of <italic style="font-style: italic">Tianma Xingnao Capsules</italic> for the treatment of liver and kidney deficiency syndrome (neurological headache and vascular dementia) based on a multi-criteria decision analysis model

FENG Wenye; WEI Zhongyi; WANG Yaxing; XIE Yanming

doi:10.16025/j.1674-1307.2026.01.008

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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

更新时间：2026-04-01

- 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
- Beijing Journal of Traditional Chinese Medicine Vol. 45, Issue 1, Pages: 42-50(2026)
- 作者机构：
  
  中国中医科学院中医临床基础医学研究所，北京 100700
- 作者简介：
- 基金信息：
- DOI：10.16025/j.1674-1307.2026.01.008
  CLC：
- Received：09 December 2024，
  
  Published：25 January 2026
- 稿件说明：
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冯文烨，魏仲义，王雅星，等.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.

FENG Wenye,WEI Zhongyi,WANG Yaxing,et al.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[J]. Beijing Journal of Traditional Chinese Medicine,2026,45(01):42-50.
冯文烨，魏仲义，王雅星，等.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. DOI： 10.16025/j.1674-1307.2026.01.008.

FENG Wenye,WEI Zhongyi,WANG Yaxing,et al.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[J]. Beijing Journal of Traditional Chinese Medicine,2026,45(01):42-50. DOI： 10.16025/j.1674-1307.2026.01.008.

摘要

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。

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

Keywords

references

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Related Institution

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⁰

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

DOI：10.16025/j.1674-1307.2026.01.008

摘要

Abstract

关键词

Keywords

references