| 中药复方保健产品人体试验评价体系构建的要点探讨 |
| 投稿时间：2023-02-26 点此下载全文
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| 引用本文：寇秋爱,万盈盈,孙文婷,林明雄.中药复方保健产品人体试验评价体系构建的要点探讨[J].中国现代中药,2023,25(9):2008-2012 |
| DOI：10.13313/j.issn.1673-4890.20230226002 |
| 摘要点击次数: 299 |
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| 作者中文名 | 作者英文名 | 单位中文名 | 单位英文名 | E-Mail |
| 寇秋爱 |
KOU Qiu-ai |
中国中医科学院 西苑医院，北京 100091 |
Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China |
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| 万盈盈 |
WAN Ying-ying |
中国中医科学院 西苑医院，北京 100091 |
Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China |
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| 孙文婷 |
SUN Wen-ting |
中国中医科学院 西苑医院，北京 100091 |
Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China |
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| 林明雄* |
LIN Ming-xiong |
中国人民解放军总医院 第二医学中心 中医（针灸）科，北京 100853 |
Department of Traditional Chinese Medicine (Acupuncture), Second Medical Center, PLA General Hospital, Beijing 100853, China |
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| 基金项目:国家重点研发计划项目（2018YFC1706805） |
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| 中文摘要:中药复方保健产品种类众多，但缺乏人体试验指导原则与技术规范。现有的评价技术规范不能体现中医药的优势和特色。基于中药复方保健产品的特点与优势、人体试食试验实施的总结与思考，对中药复方保健产品人体试验的试验设计、伦理审查、受试人群、对照设置、样本量规定、功能及安全性等评价要点进行探讨，为建立中药复方保健产品人体评价体系提供参考。 |
| 中文关键词:中药复方保健产品 辨证保健 评价体系 试验设计 |
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| Key Points of the Human Trial Evaluation System of Chinese Medicinal Compound Health Care Products |
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| Abstract:There is a wide variety of Chinese medicinal compound health products, but there is a lack of guidance principles and technical standards for human trials. Existing evaluation technical standards do not adequately reflect the advantages and characteristics of traditional Chinese medicine. Based on the characteristics and advantages of Chinese medicinal compound health care products, as well as a summary and reflection on the implementation of human taste trials, this paper discussed key evaluation points for human trials of Chinese medicinal compound health care products, including trial design, ethical review, participant selection, control group setup, sample size determination, functional efficacy assessment, and safety evaluation, aiming to provide guidance for the establishment of a human evaluation system for Chinese medicinal compound health care products. |
| keywords:Chinese medicinal compound health care products health care based on syndrome differentiation evaluation system experiment design |
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