NEURODEVELOPMENT EFFECTS OF ANTIEPILEPTIC DRUGS

描述（申请人摘要）：拟议的研究涉及 妇女及其子女重要保健问题。使用 抗癫痫药物（AEDs）在育龄妇女癫痫和 其它指示（例如，疼痛和精神疾病）是常见的，但 医生需要额外的数据，这对于充分建议和 直接治疗这些妇女。动物研究已经清楚地表明， 通常使用的AED损害行为神经发育。的潜在 人类这种认知和行为缺陷的后果是严重的， 个人和社会成本。然而，争议存在于 这一建议将解决以下问题。做最常用的 抗癫痫药物对暴露儿童神经行为结果的影响不同 在子宫里？本研究的主要目的是区分相对 三种主要AED治疗女性癫痫的风险/获益 他们的孩子在子宫内暴露后的神经行为发育方面。 研究目的将通过前瞻性、平行组、队列研究来解决 设计，多中心调查，纳入三组孕妇， AED单药治疗（卡马西平、苯巴比妥和苯妥英）。主 结果变量是儿童的智商分数和其他测量指标， 神经行为发育研究结果将影响临床 管理接受这些药物的妇女，并改善妇女的健康。 子女

DESCRIPTION (Applicant's Abstract): The proposed investigation addresses an important health care issue for women and their children. The use of antiepileptic drugs (AEDs) in women of childbearing age for epilepsy and for other indications (e.g., pain and psychiatric disorders) is common, but physicians need additional data, which are critical to adequately advise and direct treatment in these women. Animal studies have clearly demonstrated that commonly employed AEDs impair behavioral neurodevelopment. The potential consequences of such cognitive and behavioral deficits in humans are severe in terms of both personal and societal costs. However, controversy exists on the following issue to be addressed by this proposal. Do the most commonly used AEDs have differential effects on neurobehavioral outcomes in children exposed in utero? The primary objective of this study is to differentiate the relative risks/benefits of three major AEDs in the treatment of women with epilepsy in terms of their children's neurobehavioral development after in utero exposure. The study objectives will be addressed by a prospective, parallel-group, cohort design, multi-center investigation enrolling three groups of pregnant women on AED monotherapy (carbamazepine, phenobarbital, and phenytoin). The primary outcome variables are IQ scores of the children and other measures of neurobehavioral development. The results of the study will impact the clinical management of women receiving these medications, and improve the health of their children.