Wilens Timothy E, Hammerness Paul, Utzinger Linsey, Schillinger Mary, Georgiopoulous Anna, Doyle Robert L, Martelon Marykate, Brodziak Kerry
Pediatric Psychopharmacology Unit, Massachusetts General Hospital and Harvard Medical School , Boston, Massachusetts, USA.
J Child Adolesc Psychopharmacol. 2009 Oct;19(5):485-92. doi: 10.1089/cap.2008.0125.
This study evaluated the effectiveness of adding OROS methylphenidate (MPH) to children who are partial responders to atomoxetine (ATMX) in the treatment of attention-deficit/hyperactivity disorder (ADHD).
This is a two-phase, 7-week, open study in children aged 6-17 years. Phase I initiated ATMX for a minimum of 4 weeks. Phase II entered partial responders to ATMX and added up to 54 mg of OROS MPH to their regimen. Subjects were assessed on multiple outcomes, including ADHD, executive functioning, and adverse effects. All analyses were intent to treat, with last observation carried forward.
Fifty subjects who were partial responders to ATMX were treated with the combination therapy, with 41 subjects completing the entire protocol. There was a 40% reduction in their ADHD Rating Scale from the start of phase II through the end of study (from 21.14 +/- 9.9 to 12.8 +/- 9.7, t = 6.5, p < 0.0001). In addition, there was a clinically significant reduction in the Clinical Global Index of ADHD severity from moderate to mild ADHD (start of phase II, 3.7; end of phase II, 2.7, 27%, t = 6.5, p < 0.0001), as well as improvements in executive functioning.
These results suggest that OROS MPH added to the regimen of partial responders to ATMX improves ADHD and executive functioning, necessitating further controlled trials.
本研究评估了在对托莫西汀（ATMX）部分反应的儿童中添加奥氮平控释片（OROS）哌甲酯（MPH）治疗注意力缺陷多动障碍（ADHD）的有效性。
这是一项针对6至17岁儿童的两阶段、为期7周的开放性研究。第一阶段开始使用ATMX至少4周。第二阶段纳入对ATMX部分反应的儿童，并在其治疗方案中添加高达54毫克的OROS MPH。对受试者进行了多项评估，包括ADHD、执行功能和不良反应。所有分析均采用意向性治疗，末次观察值结转。
50名对ATMX部分反应的受试者接受了联合治疗，41名受试者完成了整个方案。从第二阶段开始到研究结束，他们的ADHD评定量表得分降低了40%（从21.14±9.9降至12.8±9.7，t = 6.5，p < 0.0001）。此外，ADHD严重程度的临床总体印象从中度ADHD显著降低至轻度ADHD（第二阶段开始时为3.7；第二阶段结束时为2.7，降低27%，t = 6.5，p < 0.0001），执行功能也有所改善。
这些结果表明，在对ATMX部分反应的受试者治疗方案中添加OROS MPH可改善ADHD和执行功能，需要进一步进行对照试验。
