我国儿童人口数量多，儿童用药情况复杂，主要存在的问题有儿童专用药物品种与数量少，信息不全，给药途径不安全，药物不良反应发生率高、危害严重等。本文从儿童专用药物临床试验进展困难、儿童专用药物临床试验参与率低以及伦理委员会审核试验方案通过率低等方面分析原因，提出改善儿童专用药物困境的建议，即加大对儿童药物研发企业的扶持力度、建立儿童药物不良反应监测体系、完善儿童药物再评价工作机制等。%The number of children population is large in our country, and there are many problems in the pediatric medication, such as less type of pediatric medicines, the lack of drug instruction, the dangerous of delivery, the serious adverse reactions of pediatric medicines. In the view of these problems, the paper analyzes the reasons from the field of the difficult process of the clinical trials on pediatric medicines, the low participation rate of pediatric medicines, and the low pass review rate of ethics committee. And some suggestions are raised to prove the plight of pediatric medication, for example increase the support strength to pediatric pharmaceutical companies, build the monitoring system of adverse re⁃actions of pediatric medicines, and improve the mechanism of the work of medicine revaluation.
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