我国儿童中成药应用现状分析与发展策略

Development strategy and current situation of Chinese patent medicine for children in China

该研究以《中国药典》(2020年版一部)和《国家基本药物目录》(2018年版)中的儿童中成药为研究载体,较为系统地分析我国儿童中成药的应用现状及应用过程中存在的问题。针对目前我国儿童中成药存在的剂量不精准、安全性信息不完善、适宜品种、剂型规格匮乏等问题,提出未来儿童中成药发展的策略。建议开展系统化再评价研究,鼓励研发适宜儿童使用的中成药新品种或新剂型,并提倡持续推动儿童真实世界研究,利用真实世界证据扩展儿童中成药用药信息,为开展儿童中成药上市后再评价奠定基础,指导临床合理用药。以期构建儿童中成药供应保障的良好政策生态系统,推动儿童中成药高质量发展。

This study took the 2020 edition of Chinese Pharmacopoeia(ChP) and the 2018 edition of National Essential Drug List(NEDL) for children as research carriers to systematically analyze the current situation of and problems in the use of Chinese patent medicine for children(CPMC) in China. In view of the problems of imprecise dosage, incomplete safety information, and lack of sui-table varieties, dosage form and specification of CPMC in China, development strategy of CPMC in the future was proposed. It is reco-mmended to carry out systematic post-marketing revaluation studies of CPMC, encourage the development of new varieties or new dosa-ge forms suitable for children, advocate the continuous promotion of real-world studies on children, and expand the information on the use of CPMC with real-world data, so as to lay the foundation for post-marketing revaluation of CPMC and guide the rational use of clini-cal medicines. This study was expected to build a positive policy ecosystem to ensure the supply of CPMC, and promote the high-quality development of CPMC.