浅析美国食品药品监督管理局批准的儿童抗癫痫药

Analysis of antiepileptic drugs approved by Food and Drug Administration for children

癫痫是最常见的神经系统疾病之一,影响着世界各地各年龄段约5000万人。其中在儿童中发病率极高,如果未在早期进行适当治疗,发生于儿童期的癫痫可能对认知发育产生重要影响。目前大约30%的患者因控制不佳仍然持续出现癫痫发作,对患病儿童的身心发展产生很大的负面影响,临床上仍存在未满足的需求。抗癫痫药品可及性也与有效的监管和批准程序等有关。本文通过分析近年来美国食品药品监督管理局所批可用于儿童的抗癫痫药临床研究,以期为我国的药品研发和监管提供借鉴。

Epilepsy is one of the most common nervous system diseases,affecting approximately 50 million people of all ages around the world.Among them,the incidence rate is extremely high in children.When improperly treated in the early stage,children with epilepsy that occurs in the childhood may have deficiency on cognitive development.At present,about 30%of patients still have seizures due to inappropriate treatment,which has a great negative impact on physical and mental development of children,and there are still unmet needs in the clinic.The availability of anti-epileptic drugs is also related to effective regulatory and approval procedures.This article analyzes the clinical research of antiepileptic drugs for children approved by the U.S.Food and Drug Administration in recent years,so as to provide insights for drug development and supervision in China.