Neurodevelopmental Effects of Antiepileptic Drugs II

抗癫痫药物对神经发育的影响 II

• 批准号: 7495646
• 负责人: KIMFORD J MEADOR
• 金额: $ 84.68万
• 依托单位: EMORY UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-09-30 至 2010-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7495646
• 关键词: 6 year old; Address; Adult; Affect; Age; Animals; Antiepileptic Agents; Behavioral; Carbamazepine; Child; Child Development; Child health care; Clinical Management; Cognitive; Data; Development; Drug Exposure; Enrollment; Epilepsy; Exposure to; Female of child bearing age; Frequencies; Future; Grant; Health; Healthcare; Human; Investigation; Measures; Mental disorders; Mothers; Neurodevelopmental Impairment; Nutritional status; Outcome; Outcome Measure; Pain; Pattern; Performance; Perinatal Exposure; Pharmaceutical Preparations; Pharmacogenetics; Pharmacogenomics; Pharmacotherapy; Phenytoin; Physicians; Pregnancy; Pregnant Women; Relative (related person); Relative Risks; Sampling; Schools; Seizures; Severities; Socioeconomic Status; Time; Woman; animal data; base; child bearing; cohort; cost; design; improved; in utero; lamotrigine; neurobehavioral; neurodevelopment; postnatal; prenatal; primary outcome; prospective; valproate

The proposed investigation is a continuation of the ongoing NEAD study, which 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 the four most commonly used AEDs in the treatment of women with epilepsy in terms of their children's neurobehavioral development after in utero exposure to AED monotherapy (carbamazepine, lamotrigine, phenytoin, or valproate). The NEAD study is a prospective, parallel-group, cohort design, multicenter investigation. The major strength of the NEAD study is that it has enrolled a large and unique cohort of 323 mother/child pairs during pregnancy and collected prospective data on factors, which could affect neurobehavioral outcome. The primary outcome variables are IQ scores of the children and other measures of neurobehavioral development at 6 years/old. This grant extension is designed to follow the children to 6 years/old at which time neurobehavioral measures predict school performance and ultimate adult IQ. Samples have and will be collected for future pharmacogenetic investigations. The NEAD study has an invaluable cohort, and the results of this continuation proposal will impact the clinical management of women receiving these medications, and improve the health of their children.

拟议的调查是正在进行的NEAD研究的继续，该研究解决了妇女及其子女的一个重要卫生保健问题。在患有癫痫和其他适应症(如疼痛和精神障碍)的育龄妇女中，使用抗癫痫药物(AEDs)是很常见的，但医生需要额外的数据，这些数据对于充分建议和指导这些妇女的治疗至关重要。动物研究清楚地表明，常用的抗癫痫药物会损害行为神经发育。人类这种认知和行为缺陷的潜在后果在个人和社会成本方面都是严重的。然而，这项提案要解决的以下问题存在争议。最常用的抗癫痫药对宫内暴露的儿童的神经行为结果是否有不同的影响？这项研究的主要目的是区分四种最常用的抗癫痫药物在妇女癫痫治疗中的相对风险/收益，根据她们的孩子在宫内暴露于AED单一疗法(卡马西平、拉莫三嗪、苯妥英或丙戊酸盐)后的神经行为发育。NEAD研究是一项前瞻性、平行组、队列设计、多中心调查。NEAD研究的主要优势在于，它招募了一大批独特的323对孕期母婴，并收集了可能影响神经行为结果的因素的前瞻性数据。主要的结果变量是6岁/岁时儿童的智商分数和其他神经行为发育指标。这项助学金延期旨在跟踪儿童到6岁/岁，届时神经行为测量可以预测学校表现和最终的成人智商。样本已经并将被收集，用于未来的药物遗传学研究。NEAD研究有一个非常宝贵的队列，这项延续建议的结果将影响接受这些药物的妇女的临床管理，并改善她们孩子的健康。