Psychiatry, Johnson & Johnson Pharmaceutical Research & Development L.L.C, Titusville, New Jersey 08560, USA.
Pediatr Neurol. 2010 Mar;42(3):187-95. doi: 10.1016/j.pediatrneurol.2009.10.001.
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.
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。