Atomoxetine for the treatment of attention-deficit/hyperactivity disorder and oppositional defiant disorder

Atomoxetine for the treatment of attention-deficit/hyperactivity disorder and oppositional defiant disorder
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DOI:
10.1542/peds.2006-1880
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发表时间:
2008-02-01
期刊:
影响因子:
8
通讯作者:
Levine, Louise
Levine, Louise
中科院分区:
医学2区
文献类型:
--
作者:
Bangs, Mark E.;Hazell, Philip;Levine, Louise

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OBJECTIVE.在这项研究中,我们检查了托莫西汀治疗合并注意缺陷多动障碍的对立违抗性障碍的有效性。患者年龄为6 - 12岁,符合精神障碍诊断和统计手册第四版注意力缺陷/多动障碍的诊断标准,Swanson、Nolan和Pelham评定量表-修订的注意力缺陷/多动障碍子量表评分高于年龄和性别标准;临床总体印象-严重程度量表评分>= 4; Swanson、Nolan和Pelham评定量表-修订的对立违抗性障碍子量表得分>= 15。患者以2:1的比例随机分配接受1.2 mg/kg/天托莫西汀(n = 156)或安慰剂(n = 70)治疗8周。通过使用Swanson、Nolan和Pelham评定量表修订版量表评估对立违抗性障碍和注意力缺陷/多动障碍症状的治疗效果。重复测量分析表明,在Swanson、Nolan和Pelham评定量表-修订的对立违抗性障碍总分降低方面,托莫西汀优于安慰剂的统计学显著性差异。在基线后第2周和第5周存在显著的成对治疗差异,但在第8周不存在。末次观察结转分析显示,托莫西汀组和安慰剂组终点时的Swanson、Nolan和Pelham评定量表修订评分在注意力缺陷/多动障碍症状方面存在显着差异,但在对立违抗性障碍症状方面则无显着差异。托莫西汀在临床疗效总评量表-改善和临床疗效总评量表-严重程度评分的末次观察值结转分析中上级安慰剂。本研究证实了先前的研究结果,即注意力缺陷/多动障碍和共病对立违抗性障碍患者在接受托莫西汀治疗时,注意力缺陷/多动障碍症状和总体临床功能显示出统计学和临床显著性改善。然而,托莫西汀是否对对立违抗性障碍症状产生特异性和持久性影响仍不确定。
OBJECTIVE. In this study we examined the effectiveness of atomoxetine for the treatment of oppositional defiant disorder comorbid with attention-deficit/hyperactivity disorder.METHODS. Patients were aged 6 to 12 years and met Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, diagnostic criteria for attention-deficit/hyperactivity disorder with a Swanson, Nolan, and Pelham Rating Scale-Revised attention-deficit/hyperactivity disorder subscale score above age and gender norms; Clinical Global Impressions-Severity Scale score of >= 4; and Swanson, Nolan, and Pelham Rating Scale-Revised oppositional defiant disorder subscale score of >= 15. Patients were randomly assigned in a 2: 1 ratio to receive 1.2 mg/kg per day of atomoxetine (n = 156) or placebo (n = 70) for 8 weeks. Treatment effect on oppositional defiant disorder and attention-deficit/hyperactivity disorder symptoms was measured by using the investigator-rated Swanson, Nolan, and Pelham Rating Scale-Revised.RESULTS. Repeated-measures analysis demonstrated a statistically significant difference favoring atomoxetine over placebo in the reduction of Swanson, Nolan, and Pelham Rating Scale-Revised oppositional defiant disorder total scores. There were significant pairwise treatment differences at weeks 2 and 5 but not at week 8 postbaseline. A last-observation-carried-forward analysis showed Swanson, Nolan, and Pelham Rating Scale-Revised scores at endpoint for the atomoxetine and placebo groups were significantly different for attention-deficit/hyperactivity disorder symptoms but not for oppositional defiant disorder symptoms. Atomoxetine was superior to placebo in a last-observation-carried-forward analysis of Clinical Global Impression-Improvement and Clinical Global Impression-Severity scores.CONCLUSIONS. This study confirms previous findings that patients with attention-deficit/hyperactivity disorder and comorbid oppositional defiant disorder show statistically and clinically significant improvement in attention-deficit/hyperactivity disorder symptoms and global clinical functioning when treated with atomoxetine. It remains uncertain, however, whether atomoxetine exerts a specific and enduring effect on oppositional defiant disorder symptoms.