| 摘要: |
| 腹泻病是儿科临床常见的综合征，中医药治疗疗效显著。文章参考小儿腹泻病国内外诊疗指南、评价指南和临床试验新进展，结合多年的实践经验，从适应症定位、试验目的、试验总体设计、诊断与临床分类标准、辨证标准、受试者的选择、合并用药、有效性评价、安全性观察、试验流程、试验的质量控制等方面，对中药治疗小儿腹泻病临床试验设计、实施与评价的技术要点和特点进行了系统阐述，希望能丰富儿科疾病中药临床评价的方法学内容，提高小儿腹泻病中药临床试验设计水平。 |
| 关键词: 中药 小儿腹泻病 临床试验 设计与评价 |
| DOI：10.11656/j.issn.1672-1519.2018.08.02 |
| 分类号: |
| 基金项目:中华中医药学会团体标准立项项目（2017-6-7）。 |
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| Highlight of Clinical research design and evaluation of Chinese materia medica for the treatment of pediatric diarrhea |
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HU Siyuan1, LI Xiaoxuan2,3
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1.The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China;2.Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China;3.Tianjin Binhai New District Women and Children Care and Family Planning Service Center, Tianjin 300459, China
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| Abstract: |
| Diarrhoea is a common syndrome in pediatrics which can be treated effectively by Chinese materia medica. This paper mainly elaborates the key technical points and characteristics of clinical trial design,implementation and evaluation of Chinese materia medica for this disease. It included indication selection, objective, overall design, standards of diagnostic and clinical classification,standards of syndrome differentiation, subject selection, treatment regimen, efficacy and safety evaluation, quality control of the experiment, etc. All of these problems were analyzed in detail not only through referring to the newest diagnosis,treatment and drug evaluation guidelines but conducting a survey of the related clinical trail at home and abroad combined with the author's many years of practical experience. The main aim is to enrich the methodological contents of clinical evaluation and to improve the level of clinical trail design. |
| Key words: Chinese materia medica pediatric diarrhea clinical trial design and evaluation |
