State University of New York, USA.
J Atten Disord. 2011 Jan;15(1):28-35. doi: 10.1177/1087054709359163. Epub 2010 May 3.
To test the efficacy and tolerability of the methylphenidate transdermal formulation (MTS) against immediate-release methylphenidate (IR MPH) and placebo in a 12-hr analog classroom setting.
A total of nine boys ages 6 to 9 years, medicated with MPH for ADHD, complete a within-subject, double-blind study. For the purpose of the study, the boys are administered a dose of 20 cm(2) MTS, a matched dose of IR MPH 10 mg TID, and placebo. ADHD symptoms and frequency counts of classroom rule violations and the number of math problems completed are assessed hourly, during three consecutive analog classroom sessions.
Findings show that, across measures and throughout the day, both treatments significantly differentiated from placebo (p < .05) but not from each other. It is also observed that the MTS produced more consistent results across the day but had a delayed onset versus IR MPH. Both medications are well tolerated with only mild reductions in sleep onset.
The MTS demonstrates comparable efficacy and tolerability to TID IR MPH.
在 12 小时模拟课堂环境中，测试哌醋甲酯透皮贴剂（MTS）相对于速释哌醋甲酯（IR MPH）和安慰剂的疗效和耐受性。
共有 9 名年龄在 6 至 9 岁的男孩，因注意力缺陷多动障碍（ADHD）而接受 MPH 治疗，完成了一项自身对照、双盲研究。在研究中，男孩们接受 20cm²MTS、10mg TID 的 IR MPH 匹配剂量和安慰剂。在三个连续的模拟课堂期间，每小时评估 ADHD 症状和课堂规则违规的频率计数以及完成的数学问题数量。
研究结果表明，在各项测量指标和全天内，两种治疗方法均与安慰剂显著区分（p<.05），但彼此之间无显著差异。还观察到，MTS 在全天内产生了更一致的结果，但与 IR MPH 相比，起效时间延迟。两种药物均具有良好的耐受性，仅轻度延迟入睡。
MTS 显示出与 TID IR MPH 相当的疗效和耐受性。
