NEURODEVELOPMENT EFFECTS OF ANTIEPILEPTIC DRUGS

描述（申请人的摘要）：拟议的调查涉及一个 妇女及其子女的重要保健问题。使用 育龄妇女用于治疗癫痫和治疗癫痫的抗癫痫药物 (AED) 其他适应症（例如疼痛和精神疾病）很常见，但是 医生需要额外的数据，这对于充分提供建议和 对这些妇女进行直接治疗。动物研究清楚地表明 常用的 AED 会损害行为神经发育。潜力 人类的这种认知和行为缺陷的后果是严重的 个人和社会成本。但对此存在争议 本提案要解决以下问题。做最常用的 AED 对接触 AED 的儿童的神经行为结果有不同的影响 在子宫内？本研究的主要目的是区分相对 三种主要 AED 治疗女性癫痫患者的风险/益处 孩子在子宫内暴露后的神经行为发育。 研究目标将由前瞻性平行组队列来实现 设计、招募三组孕妇的多中心调查 AED 单一疗法（卡马西平、苯巴比妥和苯妥英）。初级 结果变量是儿童的智商分数和其他衡量标准 神经行为发育。研究结果将影响临床 对接受这些药物的妇女进行管理，并改善她们的健康 他们的孩子。

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.