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| 中药治疗儿童急性咽炎和扁桃体炎临床试验设计的新认识 |
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许雅倩1,2, 胡思源1,2, 李梅芳1,2, 郦涵1,2
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1.天津中医药大学第一附属医院, 天津 300381;2.国家中医针灸临床医学研究中心, 天津 300381
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| 摘要: |
| 在前期发表的《中药新药治疗小儿急性咽炎、扁桃体炎临床研究技术要点》基础上，依据国内外相关研究进展，结合实践经验，从临床定位、试验总体设计、诊断标准、受试人群和入选标准、治疗方案、有效性评价6个方面，对中药治疗儿童急性咽炎和扁桃体炎临床试验设计要点提出新认识。 |
| 关键词: 儿童 急性咽炎 急性扁桃体炎 临床试验 设计 |
| DOI：10.11656/j.issn.1673-9043.2023.01.07 |
| 分类号:R272 |
| 基金项目:“十三五”国家科技重大专项——重大新药创制项目（2020ZX09201-008）；中华中医药学会标准化项目。 |
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| New insights into the design of clinical trials for the treatment of acute pharyngitis and tonsillitis in children with Chinese medicine |
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XU Yaqian1,2, HU Siyuan1,2, LI Meifang1,2, LI Han1,2
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1.First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China;2.National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin 300381, China
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| Abstract: |
| In this paper,on the basis of the clinical important technical points of traditional Chinese medicine and new medicine in treating acute pharyngitis-tonsillitis,summarize the progress of clinical trial design methods for pediatric acute pharyngitis and tonsillitis at home and abroad,and combine our team's practical experience to propose new understanding in six aspects,including clinical positioning,overall trial design,diagnostic criteria,subject population and enrollment criteria,treatment plan,and effectiveness evaluation in order to enrich the clinical trial design and evaluation of Chinese medicine for pediatric acute pharyngitis and tonsillitis. |
| Key words: child acute pharyngitis acute tonsillitis clinical trial design |
