PDF(Pubmed)
Abstract：
Modern drugs have changed epilepsy, which affects people of all ages. However, for young people with epilepsy, the framework of drug development has stalled. In the wake of the thalidomide catastrophe, the misconception emerged that for people < 18 years of age drugs, including antiseizure medications (ASMs), need separate proof of efficacy and safety, overall called \"pediatric drug development\". For ASMs, this has changed to some degree. Authorities now accept that ASMs are effective in < 18 years as well, but they still require \"extrapolation of efficacy,\" as if minors were another species. As a result, some of the pediatric clinical epilepsy research over the past decades was unnecessary. Even more importantly, this has hampered research on meaningful research goals. We do not need to confirm that ASMs work before as they do after the 18th birthday. Instead, we need to learn how to prevent brain damage in young patients by preventing seizures and optimize ASMs\' uses. Herein we discuss how to proceed in this endeavor.
摘要：
现代药物已经改变了癫痫，影响所有年龄段的人。然而,对于患有癫痫的年轻人来说，药物开发的框架已经停滞。在沙利度胺灾难之后,这种误解出现了，对于年龄<18岁的人来说，包括抗癫痫药物（ASM），需要单独的有效性和安全性证明，总体上称为“儿科药物开发”。对于ASM，这在某种程度上已经改变了。当局现在承认ASM在18年内也有效，但它们仍然需要“功效外推”，“好像未成年人是另一个物种。因此,在过去的几十年中，一些儿科临床癫痫研究是不必要的。更重要的是,这阻碍了对有意义的研究目标的研究。我们不需要确认ASM在18岁生日之后的工作。相反，我们需要学习如何通过预防癫痫发作和优化ASM的使用来预防年轻患者的脑损伤。在这里，我们讨论如何进行这项工作。
