| 变应性鼻炎中药新药临床研究方案设计探讨 |
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| 引用本文： | 姚贺之,李睿,曹唯仪,杨巧宁,高蕊. 变应性鼻炎中药新药临床研究方案设计探讨[J]. 中国新药杂志, 2020, 0(5): 520-524 |
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| 作者姓名： | 姚贺之 李睿 曹唯仪 杨巧宁 高蕊 |
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| 作者单位： | 中国中医科学院研究生院;中国中医科学院西苑医院 |
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| 基金项目： | 国家“重大新药创制”科技重大专项资助项目(2017ZX09304003);国家自然科学基金(81603505);中医药国际合作专项(GZYYGJ2017010) |
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| 摘 要： | 本文参照2018年9月FDA发布的《变应性鼻炎医药产品行业研发指南》(allergic rhinitis:developing drug products for treatment guidance for industry)相关内容,以我国药物临床试验登记与信息公示平台中定位于变应性鼻炎的Ⅱ,Ⅲ期中药/天然药物临床试验方案为分析案例,结合中医药自身特点,尝试对变应性鼻炎中药新药临床研究方案设计中的总体思路、适应证定位、试验周期、有效性及安全性评价等关键问题进行探讨。以期提高相关中药临床研究方案设计水平和证据质量,为变应性鼻炎治疗中药的研发提供支持和参考。
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| 关 键 词： | 变应性鼻炎 中药新药 临床研究 方案 |
Clinical protocol design and analysis of new Chinese medicine drug for allergic rhinitis |
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| YAO He-zhi,LI Rui,CAO Wei-yi,YANG Qiao-ning,GAO Rui. Clinical protocol design and analysis of new Chinese medicine drug for allergic rhinitis[J]. Chinese Journal of New Drugs, 2020, 0(5): 520-524 |
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| Authors: | YAO He-zhi LI Rui CAO Wei-yi YANG Qiao-ning GAO Rui |
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| Affiliation: | (Graduate School of China Academy of Chinese Medical Sciences,Beijing 100700,China;Institute of Clinical Pharmacology of Xiyuan Hospital,China Academy of Chinese Medical Sciences,Beijing 100091,China) |
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| Abstract: | Referring to related contents of allergic rhinitis: Developing Drug Products for Treatment Guidance for Industry issued by the FDA of the United States in September 2018,the paper attempts to discuss the key issues about general consideration,potential indication,trial cycle,effectiveness and safety evaluation using the phases Ⅱ and Ⅲ Chinese medicine/natural medicine clinical trial protocols in the drug clinical trial registration and information publicity platform as examples associating with the characteristics of traditional Chinese medicine.The paper is aimed to improve the design of relevant Chinese medicine clinical research so as to provide highquality evidence for the treatment of allergic rhinitis with Chinese medicine preparations,as well as supporting technical reference for development of TCM. |
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| Keywords: | allergic rhinitis Chinese medicine new drug clinical research protocol |
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