Klinik für Psychiatrie und Psychotherapie, Lübeck, Germany.
Postgrad Med. 2011 Sep;123(5):27-38. doi: 10.3810/pgm.2011.09.2457.
To explore the clinical and health-related quality of life (HRQoL) outcomes in children/adolescents with attention-deficit/hyperactivity disorder (ADHD) who required a therapy switch from immediate-release (IR) methylphenidate (MPH) and were initiated on Osmotic Release Oral System (OROS(®)) MPH.
Prospective, noninterventional study including patients (aged 6-18 years) with a confirmed diagnosis of ADHD who transitioned from IR MPH to OROS(®) MPH based on medical needs. Patients were transitioned to OROS(®) MPH and were followed for 12 weeks. Attention-deficit/hyperactivity disorder symptoms, functional outcomes, HRQoL, and tolerability were assessed throughout the study.
598 patients entered the intention-to-treat analysis. The mean OROS(®) MPH starting dose was 29.5 ± 12.0 mg/day, increasing slightly to 33.5 ± 13.2 mg/day at final visit. Compared with baseline, there were significant (all P < 0.0001) symptomatic, functional, and HRQoL improvements after transitioning from IR MPH to OROS(®) MPH as assessed by the Conners' Parent Rating Scale (from 29.0 ± 10.5 to 19.5 ± 11.1), Children's Global Assessment Scale (by 11.0 ± 13.3), and Inventory for Assessing Quality of Life (ILC) LQ0-28 scores (parents' rating from 17.2 ± 3.9 to 19.4 ± 4.0; patients' rating from 18.7 ± 4.0 to 20.5 ± 3.9). Overall, no significant changes in quality of sleep or appetite were observed. More than 70% of parents and physicians rated the effectiveness of OROS(®) MPH as at least "good" and were at least "satisfied" with OROS(®) MPH. The most common treatment-emergent adverse events were insomnia and anorexia. No clinically relevant changes in body weight or vital signs were observed.
In this naturalistic setting, transitioning from IR MPH to OROS(®) MPH, in patients who showed previously insufficient response and/or poor tolerability, was successful. Patients' and parents' HRQoL as well as burden of disease showed a clinically relevant improvement. OROS(®) MPH was generally safe and well tolerated.
探讨需要从速释型哌甲酯（MPH）转换治疗且开始使用渗透控释型 OROS（®）MPH 的注意缺陷多动障碍（ADHD）儿童/青少年的临床和健康相关生活质量（HRQoL）结局。
本前瞻性、非干预性研究纳入了年龄在 6-18 岁之间、确诊为 ADHD 的患者，这些患者基于医疗需求从速释型 MPH 转换为 OROS（®）MPH。患者转为使用 OROS（®）MPH，并接受了 12 周的随访。整个研究过程中，评估了 ADHD 症状、功能结局、HRQoL 和耐受性。
598 例患者进入意向治疗分析。起始 OROS（®）MPH 平均剂量为 29.5 ± 12.0 mg/天，最终随访时略有增加至 33.5 ± 13.2 mg/天。与基线相比，从速释型 MPH 转换为 OROS（®）MPH 后，Conners 父母评定量表（从 29.0 ± 10.5 降至 19.5 ± 11.1）、儿童总体评估量表（下降 11.0 ± 13.3）和生活质量评估量表（ILC）LQ0-28 评分（父母评分从 17.2 ± 3.9 升至 19.4 ± 4.0；患者评分从 18.7 ± 4.0 升至 20.5 ± 3.9）均显示出显著（均 P < 0.0001）的症状、功能和 HRQoL 改善。总体而言，睡眠质量或食欲无明显变化。超过 70%的父母和医生认为 OROS（®）MPH 的有效性至少为“良好”，并且对 OROS（®）MPH 至少为“满意”。最常见的治疗中出现的不良事件是失眠和厌食。未观察到体重或生命体征的临床相关变化。
在这种自然环境下，对于先前反应不足和/或耐受性差的患者，从速释型 MPH 转换为 OROS（®）MPH 是成功的。患者和家长的 HRQoL 以及疾病负担均有明显改善。OROS（®）MPH 通常是安全且耐受良好的。
