兒科中成藥的臨床有效性探索主要在新藥的Ⅱ期臨床試驗(yàn)中執(zhí)行.由于歷史原因,目前已經(jīng)上市的兒科中成藥品種大多未進(jìn)行過(guò)臨床試驗(yàn),其上市后臨床再評(píng)價(jià)一般也可將有效性探索作為研究目的.闡述了兒科中成藥有效性探索的內(nèi)容,尤其是量效關(guān)系探索的設(shè)計(jì)與統(tǒng)計(jì)方法,同時(shí)總結(jié)了兒科中成藥有效性探索的特點(diǎn)并提出可行性建議.

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.

國(guó)家科技重大專(zhuān)項(xiàng)十二五"重大新藥創(chuàng)制"課題(2011ZX09302-006-03)