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托吡酯对 12 至 17 岁偏头痛患者认知功能的影响。

Cognitive effects of topiramate in migraine patients aged 12 through 17 years.

机构信息

Psychiatry, Johnson & Johnson Pharmaceutical Research & Development L.L.C, Titusville, New Jersey 08560, USA.

出版信息

Pediatr Neurol. 2010 Mar;42(3):187-95. doi: 10.1016/j.pediatrneurol.2009.10.001.

Abstract

Neuropsychologic data are presented from a randomized, double-blind, placebo-controlled, multicenter study with placebo, topiramate 50 mg/day, and topiramate 100 mg/day. The Cambridge Neuropsychological Test Automated Battery (CANTAB) and cognitive adverse events were used to evaluate neurocognitive effects of topiramate. Topiramate 100 mg/day vs placebo was associated with slight statistically significant score increases, indicating slowing, from baseline vs placebo in three CANTAB measures: five-choice reaction time (P = 0.028), pattern recognition memory mean correct latency (P = 0.027), and rapid visual information processing mean latency (P = 0.040). No other patterns related to topiramate treatment were observed in measurements of learning, memory, and visual information processing, except for potential improvement with topiramate 100 mg/day vs placebo in spatial span total errors (accuracy test) (P = 0.040). The most common cognitive and neuropsychiatric adverse events with a higher incidence in the topiramate 50 and 100 mg/day groups vs placebo were anorexia (9% and 11% vs 3%), insomnia (9% and 3% vs 3%), fatigue (6% and 9% vs 6%), and dizziness (6% and 9% vs 0%). Thus, topiramate 100 mg/day was associated with modest increases in psychomotor reaction times. Learning, memory, and executive function were unchanged. The tolerability profile, including cognitive adverse events, appeared to be acceptable.

摘要

本文介绍了一项随机、双盲、安慰剂对照、多中心研究的神经心理学数据,研究药物分别为安慰剂、托吡酯 50mg/天和托吡酯 100mg/天。采用剑桥神经心理学测试自动电池(CANTAB)和认知不良事件评估托吡酯的神经认知效应。与安慰剂相比,托吡酯 100mg/天组与基线相比,在 CANTAB 的三个测量指标中,出现了轻微的、具有统计学意义的评分增加,表明速度减慢:5 选择反应时间(P=0.028)、模式识别记忆平均正确潜伏期(P=0.027)和快速视觉信息处理平均潜伏期(P=0.040)。除了托吡酯 100mg/天组在空间跨度总错误(准确性测试)方面可能优于安慰剂组(P=0.040)之外,在学习、记忆和视觉信息处理的测量中,没有观察到与托吡酯治疗相关的其他模式。托吡酯 50mg/天和 100mg/天组比安慰剂组更常见的认知和神经精神不良事件包括厌食(9%和 11%比 3%)、失眠(9%和 3%比 3%)、疲劳(6%和 9%比 6%)和头晕(6%和 9%比 0%)。因此,托吡酯 100mg/天与精神运动反应时间的适度增加有关。学习、记忆和执行功能没有变化。包括认知不良事件在内的耐受性特征似乎是可以接受的。

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