一项针对患有注意力缺陷多动障碍（ADHD）儿童的哌甲酯透皮系统的随机、双盲、安慰剂对照实验室课堂评估。
A randomized, double-blind, placebo-controlled, laboratory classroom assessment of methylphenidate transdermal system in children with ADHD.
作者信息
McGough James J, Wigal Sharon B, Abikoff Howard, Turnbow John M, Posner Kelly, Moon Eliot
机构信息
University of California, Los Angeles, Semel Institute for Neuroscience and Human Behavior, 90095, USA.
出版信息
J Atten Disord. 2006 Feb;9(3):476-85. doi: 10.1177/1087054705284089.
OBJECTIVE
This study evaluates the efficacy, duration of action, and tolerability of methylphenidate transdermal system (MTS) in children with ADHD.
METHOD
Participants were dose optimized over 5 weeks utilizing patch doses of 10, 16, 20, and 27 mg applied in the morning and worn for 9 hours. Following optimization, 80 participants were randomized to 1 week of MTS or placebo followed by 1 week of the opposite treatment. Laboratory classroom sessions conducted after each randomized week included blinded ratings of attention, behavior, and academic performance.
RESULTS
MTS was well tolerated and displayed significant improvement compared with placebo. Improvements were seen at the first postdose time point measured and continued through 12 hours.
CONCLUSIONS
Treatment with MTS resulted in statistically significant improvements on all efficacy measures. Time course and therapeutic effects of MTS suggest that this novel methylphenidate delivery system is an efficacious once-daily treatment for ADHD.
目的
本研究评估哌甲酯透皮系统（MTS）治疗注意缺陷多动障碍（ADHD）患儿的疗效、作用持续时间和耐受性。
方法
参与者在5周内进行剂量优化，早晨使用10、16、20和27毫克的贴片剂量，并佩戴9小时。优化后，80名参与者被随机分为接受1周的MTS或安慰剂治疗，随后接受1周的相反治疗。在每个随机分组周后进行的实验室课堂环节包括对注意力、行为和学业成绩的盲法评分。
结果
MTS耐受性良好，与安慰剂相比有显著改善。在首次给药后的测量时间点即出现改善，并持续至12小时。
结论
MTS治疗在所有疗效指标上均有统计学意义的改善。MTS的时间过程和治疗效果表明，这种新型的哌甲酯给药系统是一种有效的ADHD每日一次治疗方法。
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