Graae F, Milner J, Rizzotto L, Klein R G
New York State Psychiatric Institute, New York, NY 10032.
J Am Acad Child Adolesc Psychiatry. 1994 Mar-Apr;33(3):372-6. doi: 10.1097/00004583-199403000-00011.
There is evidence for the efficacy and safety of clonazepam (CZP) in adult anxiety disorders, but no formal studies to substantiate clinical reports of similar benefit in children with anxiety disorders.
In this double-blind pilot study, 15 children, aged 7 to 13 years, entered a randomly assigned, double-blind crossover trial of 4 weeks of CZP (up to 2 mg/day) and 4 weeks of placebo.
Twelve children completed the trial. All but 1 had a diagnosis of separation anxiety disorder, and all but 2 had comorbid diagnoses. Nine children appeared to have moderate to significant clinical improvement, but statistical comparisons on several ratings failed to confirm a trend in favor of CZP. Side effects of drowsiness, irritability, and/or oppositional behavior were notable in 10 children in the CZP phase compared with 5 in the placebo phase.
Clonazepam was believed to have clinical benefit for some children, but this was not confirmed statistically in this small sample. Problematic side effects of drowsiness and disinhibition were common and possibly were due to rapid titration.
有证据表明氯硝西泮（CZP）对成人焦虑症有效且安全，但尚无正式研究证实其对儿童焦虑症有类似益处的临床报告。
在这项双盲试点研究中，15名7至13岁的儿童进入了一项随机分配的双盲交叉试验，接受为期4周的氯硝西泮（剂量高达2毫克/天）和4周的安慰剂治疗。
12名儿童完成了试验。除1名外，所有儿童均被诊断为分离焦虑症，除2名外，所有儿童均有合并诊断。9名儿童似乎有中度至显著的临床改善，但几项评分的统计学比较未能证实有利于氯硝西泮的趋势。与安慰剂阶段的5名儿童相比，在氯硝西泮阶段有10名儿童出现嗜睡、易怒和/或对立行为等副作用。
氯硝西泮被认为对一些儿童有临床益处，但在这个小样本中未得到统计学证实。嗜睡和去抑制等有问题的副作用很常见，可能是由于快速滴定所致。
