Walsh James K, Zammit Gary, Schweitzer Paula K, Ondrasik John, Roth Thomas
St. John's Mercy/St. Luke's Hospitals, Sleep Medicine and Research Center, Chesterfield, MO 63017, and Department of Psychology, St. Louis University, St. Louis, MO 63130, USA.
Sleep Med. 2006 Mar;7(2):155-61. doi: 10.1016/j.sleep.2005.05.004. Epub 2005 Nov 2.
To evaluate the effect of tiagabine on sleep and next-morning alertness and performance in adult patients with primary insomnia.
Patients with primary insomnia, as defined by Diagnostic and Statistical Manual of Mental Disorders--Fourth Edition (DSM-IV), received tiagabine 4, 8, 12, 16 mg, and placebo in a randomized, double-blind, five-period, Latin square, crossover study. Efficacy was assessed using polysomnographic and self-report techniques; residual effects were evaluated using the Digit Symbol Substitution Test (DSST) and the Rey Auditory Verbal Learning Test (RAVLT).
Fifty-eight patients (40f, 18m; mean age 46.6+/-8.0 years) were randomized. Results showed a significant dose-dependent increase in slow wave sleep percentage with all tiagabine doses, a trend toward a dose-dependent increase in total sleep time, and no effect on latency to persistent sleep. Wake after sleep onset also decreased in a dose-dependent manner, with the 16-mg dose differing significantly from placebo. The tolerability profiles of tiagabine 4 and 8 mg were similar to placebo. The most common adverse events reported following tiagabine 12 and 16 mg were dizziness and nausea. Residual effects were only apparent at 12- and 16-mg doses.
Tiagabine increased slow wave sleep and reduced wake after sleep onset in a dose-dependent manner. Tiagabine dosages up to 8 mg did not compromise next-morning alertness and psychomotor performance in adult patients with primary insomnia. Further investigation of tiagabine doses up to 8 mg is warranted.
评估噻加宾对成年原发性失眠患者睡眠及次晨警觉性和表现的影响。
符合《精神疾病诊断与统计手册》第四版（DSM-IV）定义的原发性失眠患者，在一项随机、双盲、五周期、拉丁方、交叉研究中接受4、8、12、16毫克噻加宾及安慰剂治疗。使用多导睡眠图和自我报告技术评估疗效；使用数字符号替换测验（DSST）和雷伊听觉词语学习测验（RAVLT）评估残留效应。
58例患者（40例女性，18例男性；平均年龄46.6±8.0岁）被随机分组。结果显示，所有噻加宾剂量组的慢波睡眠百分比均有显著的剂量依赖性增加，总睡眠时间有剂量依赖性增加的趋势，对持续睡眠潜伏期无影响。睡眠开始后的觉醒也呈剂量依赖性降低，16毫克剂量组与安慰剂组有显著差异。4毫克和8毫克噻加宾的耐受性与安慰剂相似。12毫克和16毫克噻加宾治疗后报告的最常见不良事件为头晕和恶心。残留效应仅在12毫克和16毫克剂量时明显。
噻加宾以剂量依赖性方式增加慢波睡眠并减少睡眠开始后的觉醒。高达8毫克的噻加宾剂量不会损害成年原发性失眠患者次晨的警觉性和精神运动表现。有必要对高达8毫克的噻加宾剂量进行进一步研究。
