| 摘要: |
| 临床试验设计与评价技术规范是指导中医药临床试验开展的重要参照。历时一年余，由数十名临床、中药学与方法学专家参与制定的中华中医药学会团体标准《中药治疗颈动脉粥样硬化临床随机对照试验设计与评价技术规范》于2021年3月16日正式发布。有鉴于此，笔者不揣浅陋，谨对研究团队制订的评价技术规范中有关临床定位、试验总体设计、诊断与辨证标准、给药方案等问题进行详细阐述。以期为相关人员开展中药治疗颈动脉粥样硬化的临床试验解答少许疑惑和提供参考。 |
| 关键词: 颈动脉粥样硬化 解读 随机对照试验 中药 |
| DOI：10.11656/j.issn.1672-1519.2022.04.07 |
| 分类号:R259 |
| 基金项目:重大新药创制科技重大专项-中药新药“病-证-症关联”临床评价技术平台（2017ZX0930419）。 |
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| Interpretation of the technical specification for clinical trial design and evaluation of traditional Chinese medicine in the treatment of carotid atherosclerosis(version 2021) |
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LI He1, JI Hanrui1, WU Shenxian2
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1.The Second Ward Department of Brain Disease, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, China;2.National Drug Clinical Trial Institution, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, China
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| Abstract: |
| The technical specification of clinical trial design and evaluation is an important reference to guide the development of clinical trials of traditional Chinese medicine. After more than one year,the group standard of the Chinese society of traditional Chinese medicine Technical Guidelines for Clinical Trial Design and Evaluation of Traditional Chinese Medicine in the Treatment of Carotid Atherosclerosis was officially released on March 16,2021. I would like to elaborate on the clinical positioning,overall trial design,diagnostic and syndrome differentiation standards,administration scheme and other issues in the evaluation technical specifications formulated by the research team,in order to answer some queries and provide reference for relevant personnel to carry out the clinical trial of traditional Chinese medicine in the treatment of carotid atherosclerosis. |
| Key words: carotid atherosclerosis interpretation randomized controlled trial Chinese medicine |
