NEURODEVELOPMENT EFFECTS OF ANTIEPILEPTIC DRUGS

描述(申请人摘要)：拟议的调查涉及 对妇女及其子女来说，这是一个重要的保健问题。对.的使用 抗癫痫药物(AEDs)在育龄妇女中的应用 其他指征(如疼痛和精神障碍)也很常见，但 医生需要更多的数据，这些数据对于充分建议和 对这些妇女进行直接治疗。动物研究清楚地表明， 常见的抗癫痫药物会损害行为神经发育。潜力 人类这种认知和行为缺陷的后果是严重的 包括个人成本和社会成本。然而，在这方面存在争议。 以下是本提案要解决的问题。做最常用的 抗癫痫药物对暴露儿童的神经行为结果有不同的影响 在子宫里？这项研究的主要目的是区分 三种主要抗癫痫药物治疗女性癫痫的风险/益处 他们的孩子在宫内暴露后神经行为发育的条件。 研究目标将由一个预期的、平行分组的队列来解决 设计，多中心调查，招募三组孕妇参加 AED单一治疗(卡马西平、苯巴比妥和苯妥英)。初级阶段 结果变量是儿童的智商分数和其他测量 神经行为发育。这项研究的结果将影响临床 管理接受这些药物的妇女，并改善妇女的健康 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.