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从阿托莫西汀转换为奥洛他定(®)哌甲酯对 ADHD 儿童和青少年有效。

Transitioning to OROS(®) methylphenidate from atomoxetine is effective in children and adolescents with ADHD.

机构信息

Janssen-Cilag GmbH, Raiffeisenstrasse 8, D-41470 Neuss, Germany.

出版信息

Expert Rev Neurother. 2011 Apr;11(4):499-508. doi: 10.1586/ern.11.18.

Abstract

OBJECTIVE

To explore the clinical outcomes of children/adolescents with attention-deficit/hyperactivity disorder (ADHD) who required a therapy switch from atomoxetine to OROS(®) methylphenidate (MPH).

METHODS

This prospective, noninterventional study involved patients aged 6-18 years with a confirmed diagnosis of ADHD who experienced insufficient clinical response and/or poor tolerability during atomoxetine treatment. Patients were transitioned to OROS MPH and followed for 12 weeks. ADHD symptoms, functional outcomes, health-related quality of life (HRQoL) and tolerability were assessed throughout the study.

RESULTS

42 patients (intention-to-treat) transitioned from atomoxetine 43.2 plus 14.7 mg onto OROS MPH 33.0 plus 17.7 mg (mean daily starting dose), increasing to 38.6 plus 17.6 mg at the final visit. Median treatment duration was 85 days (range: 3-155). Compared with baseline, symptoms, functional outcome and HRQoL improved after transitioning to OROS MPH as assessed by the Conners' Parent Rating Scale (mean change from baseline: -10.1 ± 11.6; p < 0.0001), Children's Global Assessment Scale (8.7 ± 16.2; p = 0.0015) and ILC-LQ0-28 scores (parents' rating from 14.9 ± 3.6 [baseline] to 17.5 ± 4.8 [study end]; p = 0.0002; patients' rating from 16.9 ± 3.9 [baseline] to 19.3 ± 4.4 [study end]; p = 0.0003). Social interactions and late afternoon tasks (playing with other children, household chores, school homework and behavior towards visitors/at visits) improved (p < 0.001). Approximately 62% expressed satisfaction ('very good' or `good') with OROS MPH therapy compared with prior atomoxetine with respect to symptom control in the late afternoon. The most common treatment-emergent adverse events after switching were involuntary muscle contractions (tics; 16.7%), insomnia (14.3%), abdominal pain (9.5%) and headache (9.5%). No clinically relevant changes in body weight or vital signs were observed.

CONCLUSION

In this naturalistic setting, transitioning from atomoxetine to OROS MPH was associated with improved ADHD symptoms and impacted positively on patients' and parents' HRQoL and disease burden in ADHD children who demonstrated an insufficient response and/or poor tolerability to atomoxetine.

摘要

目的

探讨从盐酸托莫西汀转换为奥洛他定控释片(OROS(®) 哌甲酯)治疗儿童/青少年注意缺陷多动障碍(ADHD)的临床疗效。

方法

这是一项前瞻性、非干预性研究,纳入了年龄在 6-18 岁之间、经确诊患有 ADHD 且在接受盐酸托莫西汀治疗时临床疗效欠佳和/或耐受性较差的患者。患者转为接受 OROS MPH 治疗,并随访 12 周。在整个研究过程中,评估 ADHD 症状、功能结局、健康相关生活质量(HRQoL)和耐受性。

结果

42 例患者(意向治疗人群)从盐酸托莫西汀 43.2mg+14.7mg 转换为 OROS MPH 33.0mg+17.7mg(平均起始日剂量),最终剂量增至 38.6mg+17.6mg。中位治疗持续时间为 85 天(范围:3-155 天)。与基线相比,在转为接受 OROS MPH 治疗后,Conners 父母评定量表(从基线的平均变化:-10.1±11.6;p<0.0001)、儿童总体评估量表(8.7±16.2;p=0.0015)和 ILC-LQ0-28 评分(父母评分从 14.9±3.6[基线]变为 17.5±4.8[研究结束];p=0.0002;患者评分从 16.9±3.9[基线]变为 19.3±4.4[研究结束];p=0.0003)均有显著改善,提示 ADHD 症状得到改善。社交互动和下午晚些时候的任务(与其他孩子玩耍、做家务、学校作业和对访客/在访问时的行为)也有所改善(p<0.001)。与先前使用盐酸托莫西汀相比,大约 62%的患者对下午晚些时候的症状控制表示满意(“非常好”或“好”)。转换治疗后最常见的治疗相关不良事件是不自主肌肉收缩(抽动)(16.7%)、失眠(14.3%)、腹痛(9.5%)和头痛(9.5%)。未观察到体重或生命体征有临床相关变化。

结论

在这种自然环境下,从盐酸托莫西汀转换为 OROS MPH 治疗可改善 ADHD 症状,并积极影响对盐酸托莫西汀反应不足和/或耐受性较差的 ADHD 儿童患者的生活质量和疾病负担。

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