儿科中成药的临床有效性探索主要在新药的Ⅱ期临床试验中执行.由于历史原因,目前已经上市的儿科中成药品种大多未进行过临床试验,其上市后临床再评价一般也可将有效性探索作为研究目的.阐述了儿科中成药有效性探索的内容,尤其是量效关系探索的设计与统计方法,同时总结了儿科中成药有效性探索的特点并提出可行性建议.

The study on the clinical efficacy of Chinese patent medicine (CPM) used in children is usually carried out in Phase Ⅱ clinical trials. For historical reasons, the majority of the marketed products used in children has not been tested in clinical trials, then re-evaluation of the effectiveness of the products also aims at the clinical efficacy study. This article proposes the content of the clinical efficacy study of CPM used in children, especially the design and statistical methods of the study on dosage and function association. The author summarizes the characteristics of the clinical efficacy study of CPM used in children and makes some suggestions.

国家科技重大专项十二五"重大新药创制"课题(2011ZX09302-006-03)