| 摘要: |
| 在收集国内外资料的基础上，结合自身的临床科研实践，在试验目的与设计、诊断标准选择、受试者的入选与退出、有效性评价、安全性评价、合并用药及质量控制等方面，总结了中药新药防治小儿手足口病临床研究技术要点，提出了作者自己的观点，以期为本病的中药新药临床试验设计提供借鉴。 |
| 关键词: 中药新药 小儿手足口病 技术要点 |
| DOI：10.11656/j.issn.1672-1519.2014.03.05 |
| 分类号: |
| 基金项目:国家科技重大专项十二五“重大新药创制”课题（2011ZX09302）. |
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| Key technical elements in clinical research of new Chinese medicine for children with hand-foot-mouth disease |
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ZHAO Jing1, HU Si-yuan2
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1.Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China;2.The First Affiliated Hospital of Tianjin University of Traditaional Chinese Medicine, Tianjin 300193, China
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| Abstract: |
| Through literature search,the author has put forward some ideas on the clinical research of new traditional Chinese medicine in the treatment for children with hand-foot-mouth disease, including the test purpose and design, diagnosis and differentiation of TCM, the choice and exclusion of subjects, choice of control drugs, test process, effectiveness evaluation, safety indicators, combined therapy and quality control of test. |
| Key words: new traditional Chinese medicine children with hand-foot-mouth disease skill element |
