目的 制定《兒童中成藥研發(fā)目錄建議清單》，為促進兒童中藥創(chuàng)新研發(fā)提供參考依據(jù)。方法 以兒科領(lǐng)域臨床優(yōu)勢病種為切入點，以兒童中成藥“未滿足的臨床需求”為導(dǎo)向，通過文獻計量法、專家問卷調(diào)查法和專家論證會等循證醫(yī)學(xué)方法，立足國家中藥研發(fā)制度，系統(tǒng)梳理兒童中成藥應(yīng)用現(xiàn)狀，兒科臨床疾病診療需求及現(xiàn)有人用經(jīng)驗等，形成清單證據(jù)體。結(jié)果 制定了涉及10個系統(tǒng)包含22個優(yōu)勢病種的《兒童中成藥研發(fā)目錄建議清單》。整體上明確了兒童中成藥新藥的兩大研發(fā)思路：一是老藥新用，增加完善兒童用法用量；二是進行新藥研發(fā)。結(jié)論 《兒童中成藥研發(fā)目錄建議清單》的制定為兒童用藥不足的關(guān)鍵問題提出方向性的解決策略，有力地推動兒童中成藥新藥的研發(fā)上市。

Objective To formulate "Development Catalogue Suggested List of Chinese Patent Drug for Children", in order to provide a reference for promoting innovative research and development of traditional Chinese medicines (TCM) for children. Methods Taking clinical advantage diseases in the field of pediatrics as the starting point, guided by the "unmet clinical needs" of children's Chinese patent drug, through evidence-based medicine methods such as literature measurement method, expert questionnaire survey method and expert demonstration meeting, based on the national TCM research and development system, systematically sorted out the application status of children's Chinese patent drug, clinical disease diagnosis and treatment needs of pediatrics and existing human use experience, and formed a list of evidence. Results "Development Catalogue Suggested List of Chinese Patent Drug for Children" involving 22 advantageous diseases in 10 systems was developed. On the whole, it is clear that the first is the new use of old drugs, increase and improve the usage and dosage of children, and the second is the two major research and development ideas of new Chinese patent drugs for children. Conclusion The formulation of "Development Catalogue Suggested List of Chinese Patent Drug for Children" puts forward directional solutions to the key problems of insufficient medicines for children, and effectively promotes the research and development of new medicines for children.

中華中醫(yī)藥學(xué)會求實項目（兒科專項）資助項目（2022-QSEKZX-01）；第五批全國中醫(yī)臨床優(yōu)秀人才研修項目（國中醫(yī)藥辦人教函［2021］271號）；中醫(yī)藥傳承與創(chuàng)新“百千萬”人才工程（岐黃工程）岐黃學(xué)者（國中醫(yī)藥人教發(fā)［2018］12號）