中藥審評(píng)審批機(jī)制改革以來，在“三結(jié)合”中藥審評(píng)證據(jù)體系下，兒童用藥研發(fā)積極性日益增高，對(duì)于需要開展臨床試驗(yàn)者，年齡段的選擇是研發(fā)者容易忽視的問題。針對(duì)來源于人用經(jīng)驗(yàn)的中藥兒童用藥研發(fā)臨床試驗(yàn)中年齡段的選擇提出了相關(guān)思考和建議，如需關(guān)注中醫(yī)藥理論、人用經(jīng)驗(yàn)情況、目標(biāo)人群發(fā)病情況、劑型選擇適宜性、療效評(píng)價(jià)指標(biāo)和工具的適用性，以及對(duì)臨床試驗(yàn)實(shí)施的影響等，以期為中藥兒童用藥研發(fā)提供參考。

Since the reform of the review and approval mechanism of traditional Chinese medicine(TCM) new drugs development, under the "three combined" evaluation evidence system of traditional Chinese medicine, the enthusiasm of children's drug research and development has been increasing. For those who need to carry out clinical trials, the age of subjects in clinical trials tend to bed ignored. This paper puts forward some thoughts and suggestions on the issues that need to be paid attention to in the clinical trial of children's medication research and development of traditional Chinese medicine, such as the need to pay attention to TCM theory, human use experience, the incidence of the target population, the suitability of dosage form, the suitability of efficacy evaluation tools, etc. In order to provide reference for the research and development of children's medicine of TCM.

R275.5；R969.4