Western Psychiatric Institute and Clinic, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.
Child Adolesc Psychiatry Ment Health. 2009 Dec 10;3(1):39. doi: 10.1186/1753-2000-3-39.
To evaluate health-related quality of life (HRQL) and medication satisfaction after switching from a stable dose of oral extended-release methylphenidate (ER-MPH) to methylphenidate transdermal system (MTS) via a dose-transition schedule in children with attention-deficit/hyperactivity disorder (ADHD).
In a 4-week, multisite, open-label study, 171 children (164 in the intent-to-treat [ITT] population) aged 6-12 years diagnosed with ADHD abruptly switched from a stable dose of oral ER-MPH to MTS nominal dosages of 10, 15, 20, and 30 mg using a predefined dose-transition schedule. Subjects remained on the scheduled dose for the first week, after which the dose was then titrated to an optimal effect. The ADHD Impact Module-Children (AIM-C), a disease-specific validated HRQL survey instrument measuring child and family impact, was used to assess the impact of ADHD symptoms on the lives of children and their families at baseline and study endpoint. Satisfaction with MTS use was assessed via a Medication Satisfaction Survey (MSS) at study endpoint. Both the AIM-C and MSS were completed by a caregiver (parent/legally authorized representative). Tolerability was monitored by spontaneous adverse event (AE) reporting.
AIM-C child and family HRQL mean scores were above the median possible score at baseline and were further improved at endpoint across all MTS doses. Similar improvements were noted for behavior, missed doses, worry, and economic impact AIM-C item scores. Overall, 93.8% of caregivers indicated a high level of satisfaction with their child's use of the study medication. The majority of treatment-emergent AEs (> 98%) were mild to moderate in intensity, and the most commonly reported AEs included headache, decreased appetite, insomnia, and abdominal pain. Seven subjects discontinued the study due to intolerable AEs (n = 3) and application site reactions (n = 4).
This study demonstrates that MTS, when carefully titrated to optimal dose, may further improve child and family HRQL, as well as behavioral, medication worry, and economic impact item scores, as measured by the AIM-C in subjects switching to MTS from a stable dose of routinely prescribed oral ER-MPH after a short treatment period. Furthermore, following the abrupt conversion from oral ER-MPH to MTS, the majority of caregivers reported being highly satisfied with MTS as a treatment option for their children with ADHD.
NCT00151983.
评估患有注意缺陷多动障碍（ADHD）的儿童在经过剂量转换方案从稳定剂量的口服缓释哌甲酯（ER-MPH）转换为哌甲酯透皮系统（MTS）后的健康相关生活质量（HRQL）和药物满意度。
在一项为期 4 周的多中心、开放性研究中，171 名年龄在 6-12 岁的 ADHD 儿童（意向治疗[ITT]人群中的 164 名）通过预定义的剂量转换方案从稳定剂量的口服 ER-MPH 突然转换为 MTS 的标称剂量 10、15、20 和 30mg。受试者在第一周内维持预定剂量，之后根据需要滴定至最佳效果。使用 ADHD 影响模块-儿童（AIM-C），一种专门用于衡量儿童和家庭影响的疾病特异性验证 HRQL 调查工具，评估 ADHD 症状对儿童及其家庭生活的影响，在基线和研究终点进行评估。通过研究终点的药物满意度调查（MSS）评估对 MTS 使用的满意度。AIM-C 由照顾者（父母/法定授权代表）完成。通过自发不良事件（AE）报告监测耐受性。
AIM-C 儿童和家庭 HRQL 的平均得分在基线时高于中位数可能得分，并且在所有 MTS 剂量下，在终点时都进一步提高。在行为、漏服、担忧和经济影响 AIM-C 项目评分方面，也注意到类似的改善。总体而言，93.8%的照顾者表示对其孩子使用研究药物非常满意。大多数治疗出现的 AE（>98%）为轻度至中度，最常见的 AE 包括头痛、食欲下降、失眠和腹痛。由于无法耐受的 AE（n=3）和应用部位反应（n=4），7 名受试者退出了研究。
这项研究表明，在经过短暂治疗后，MTS 在仔细滴定至最佳剂量时，可能会进一步改善儿童和家庭的 HRQL，以及行为、药物担忧和经济影响项目评分，这是通过切换至 MTS 的受试者的 AIM-C 测量的从常规处方口服 ER-MPH 的稳定剂量。此外，在从口服 ER-MPH 突然转换为 MTS 后，大多数照顾者报告说，他们对 MTS 作为治疗 ADHD 儿童的选择非常满意。
NCT00151983。
