Atomoxetine for hyperactivity in autism spectrum disorders: Placebo-controlled crossover pilot trial
Atomoxetine for hyperactivity in autism spectrum disorders: Placebo-controlled crossover pilot trial
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DOI：
10.1097/01.chi.0000231976.28719.2a
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发表时间：
2006-10-01
影响因子：
13.3
通讯作者：
Ramadan, Yaser
中科院分区：
文献类型：
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作者：
Arnold, L. Eugene;Aman, Michael G.;Ramadan, Yaser
目的：探讨托莫西汀(ATX)对孤独症谱系障碍(ASD)儿童注意缺陷多动障碍(ADHD)症状的安慰剂对照疗效和安全性。方法：5至15岁患有自闭症并有明显ADHD症状的儿童被随机分配到临床滴定的ATX和安慰剂的交叉试验中，每组6周，用1周的冲洗法分开。每种情况下的斜率比较采用配对t检验。结果：在2004-2005年间，12名男孩和4名女孩(7名自闭症患者，1名阿斯伯格综合症患者，8名普及性发育障碍患者)均至少完成了每种疾病的3周。在主要结果，异常行为检查表的多动子量表上，ATX优于安慰剂(p=.043，效应大小d=0.90)。在DSM-IV的9个ADHD多动/冲动症状的0到3分上，它也优于DSM-IV(p=.005，d=1.27)，但在9个注意力不集中的症状上(p=.053，d=0.89)没有显著意义。9名受试者对ATX有反应，4名受试者接受安慰剂治疗(多动子量表改善25%，加上临床总体印象-改善1-2。其中一人因ATX上反复发生的暴力事件而再次住院。不良事件在其他方面是可以容忍的，没有刻板印象的倾向。结论：ATX治疗部分自闭症谱系障碍儿童多动症安全有效。在同一人群中，这种效果与多点哌醋酸甲酯试验的效果一样大，而无法忍受的副作用更少。对自闭症谱系障碍的进一步研究提出了建议。
Objective: To explore placebo-controlled efficacy and safety of atomoxetine (ATX) for attention-deficit/hyper-activity disorder (ADHD) symptoms in children with autism spectrum disorders (ASD). Method: Children ages 5 to 15 with ASD and prominent ADHD symptoms were randomly assigned to order in a crossover of clinically titrated ATX and placebo, 6 weeks each, separated by 1-week washout. Slopes for each condition were compared by paired t test. Results: In 2004-2005, 12 boys and 4 girls (7 with autistic disorder, 1 Asperger's, 8 pervasive developmental disorder not otherwise specified) all completed at least 3 weeks of each condition. On the primary outcome, the Hyperactivity subscale of the Aberrant Behavior Checklist, ATX was superior to placebo (p=.043, effect size d=0.90). It was also superior on a 0 to 3 rating of nine DSM-IV ADHD hyperactive/impulsive symptoms (p = .005, d = 1.27), but missed significance on nine inattentive symptoms (p = .053, d = 0.89). Nine subjects responded to ATX, four to placebo (25% improvement on the Hyperactivity subscale plus Clinical Global Impressions-improvement of 1-2. One Was rehospitalized for recurrent violence on ATX. Adverse events were otherwise tolerable, with no tendency to stereotypy. Conclusions: ATX appears safe and effective for treating hyperactivity in some children with autism spectrum disorders. The effect appears as large as in a multisite methylphenidate trial in the same population, with fewer intolerable side effects. Further study in autism spectrum disorders is indicated.