a Child Neurology and Psychiatry Unit, Systems Medicine Department , Tor Vergata University of Rome , Rome , Italy.
b Child Neurology Unit, Neuroscience and Neurorehabilitation Department , "Bambino Gesù", Children's Hospital, IRCCS , Rome , Italy.
Expert Opin Drug Saf. 2018 Oct;17(10):1015-1028. doi: 10.1080/14740338.2018.1518427. Epub 2018 Sep 17.
Treatment of pediatric epilepsy requires a careful evaluation of the safety and tolerability profile of antiepileptic drugs (AEDs) to avoid or minimize as much as possible adverse events (AEs) on various organs, hematological parameters, and growth, pubertal, motor, cognitive and behavioral development.
Treatment-emergent AEs (TEAEs) reported in the literature 2000-2018 regarding second- and third-generation AEDs used in the pediatric age, with exclusion of the neonatal period that exhibits specific peculiarities, have been described on the basis of their frequency, severity/tolerability, and particular association with a given AED.
Somnolence/sedation and behavioral changes, like irritability and nervousness, are among the most commonly observed TEAEs associated with almost all AEDs. Lamotrigine, Gabapentin, Oxcarbazepine, and Levetiracetam appear to be the best-tolerated AEDs with a ≤2% withdrawal rate, while Tiagabine and Everolimus are discontinued in up to >20% of the patients because of intolerable TEAEs. For some AEDs, literature data are scanty to draw a high-level evidence on their safety and tolerability profile. The reasons are: insufficient population size, short duration of treatments, or lack of controlled trials. A future goal is that of identifying clearer, easier, and more homogeneous methodological strategies to facilitate AED testing in pediatric populations.
治疗儿科癫痫需要仔细评估抗癫痫药物（AEDs）的安全性和耐受性特征，以尽可能避免或最小化各种器官、血液参数以及生长、青春期、运动、认知和行为发育方面的不良事件（AEs）。
本文描述了 2000 年至 2018 年文献中报道的与儿科使用的第二代和第三代 AED 相关的治疗中出现的不良事件（TEAEs），排除了具有特定特征的新生儿期，其基于频率、严重程度/耐受性以及与特定 AED 的特定关联进行描述。
镇静和行为改变（如烦躁不安和神经质）是与几乎所有 AED 相关的最常见的 TEAEs 之一。拉莫三嗪、加巴喷丁、奥卡西平、和左乙拉西坦似乎是耐受性最好的 AEDs，停药率≤2%，而噻加宾和依维莫司因难以耐受的 TEAEs，停药率高达 20%以上。对于某些 AEDs，文献数据很少，难以得出其安全性和耐受性特征的高级别证据。原因是：人群规模不足、治疗持续时间短或缺乏对照试验。未来的目标是确定更清晰、更容易和更统一的方法学策略，以促进儿科人群中的 AED 测试。
