| 中药新药治疗小儿厌食临床研究设计技术要点 |
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| 引用本文： | 王卉,胡思源.中药新药治疗小儿厌食临床研究设计技术要点[J].中国临床药理学与治疗学,2012,17(10):1191-1195. |
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| 作者姓名： | 王卉 胡思源 |
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| 作者单位： | 天津中医药大学第一附属医院药试机构办公室,天津300193 |
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| 基金项目： | 国家科技重大专项十二五“重大新药创制”课题“儿科中药新药临床评价研究技术平台规范化建设”（2011ZX09302-006-03） |
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| 摘 要： | 本文立足国内研究进展和实践经验,对中药新药治疗小儿厌食临床研究方案设计过程中的关键问题,从试验目的与总体设计、诊断标准、中医辨证标准、受试者的选择、对照药的选择、导入期、疗程及随访、有效性评价、安全性评价、合并用药、质量控制等各个方面,阐述了作者的认识,为中药新药治疗小儿厌食的临床研究设计提出了具体的思路,也为中药新药的临床研究设计与评价方法提供了借鉴。
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| 关 键 词： | 小儿厌食 中药新药 临床研究 技术要点 |
Clinical research design technical points on child anorexia treated by new TCM drugs |
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| WANG Hui,HU Si-yuan.Clinical research design technical points on child anorexia treated by new TCM drugs[J].Chinese Journal of Clinical Pharmacology and Therapeutics,2012,17(10):1191-1195. |
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| Authors: | WANG Hui HU Si-yuan |
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| Institution: | The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine,Tianjin 300193,China |
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| Abstract: | Through literature and practice search,the author puts forward ideas on new TCM drugs in the treatment of child anorexia clinical research,including test purpose and design,diagnosis and the standard of TCM syndromes,the choice of subjects,exit criteria,choice of control drugs,test process,effectiveness evaluation,safety indicators,combination therapy and quality control of test.New ideas of design and evaluation method on child anorexia clinical research,as well as new TCM drugs clinical research are provided for reference. |
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| Keywords: | Child anorexia New TCM drugs Clinical research Design technical points |
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