中药新药治疗小儿厌食临床研究设计技术要点

Clinical research design technical points on child anorexia treated by new TCM drugs

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。

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.