Döpfner Manfred, Gerber Wolff Dieter, Banaschewski Tobias, Breuer Dieter, Freisleder Franz Joseph, Gerber-von Müller Gabi, Günter Michael, Hässler Frank, Ose Claudia, Rothenberger Aribert, Schmeck Klaus, Sinzig Judith, Stadler Christina, Uebel Henrik, Lehmkuhl Gerd
Klinik und Poliklinik für Psychiatrie und Psychotherapie, des Kindes-- und Jugendalters am Klinikum der Universität zu Köln, Robert-Koch-Str. 10, 50931, Köln, Germany.
Eur Child Adolesc Psychiatry. 2004;13 Suppl 1:I93-101. doi: 10.1007/s00787-004-1009-3.
Given the dosing limitations of methylphenidate short-acting preparations in treating ADHD, galenics with longer release of the substance were developed mainly to avoid drug intake during school hours.
This investigation was conducted to assess the efficacy and the duration of action of a new extended-release formulation of methylphenidate (Medikinet retard) as a once-daily treatment for children with attention-deficit hyperactivity disorder (ADHD).
This was a randomized, double-blind, crossover multicentre study with three treatment conditions: once-daily extended-release methylphenidate, twice-daily immediate-release methylphenidate and placebo given to 79 children (8-14 years old) with ADHD. Daily assessments in an analogue classroom setting included blind ratings of attention and deportment and a performance measure (math test) obtained 5 times over an 8-hour period. Secondary measures included an ADHD rating scale, based on DSMIV/ ICD-10 separately rated for the morning and the afternoon.
Both active treatment conditions displayed significant time course effects and were superior to placebo in improving all efficacy measures. Once a day extended-release methylphenidate was not different from the same dose of twice daily immediate-release methylphenidate.
These data provide support for the benefit of this novel, once-daily methylphenidate preparation in the treatment of ADHD. The longer duration of action of Medikinet Retard has the potential to simplify psychostimulant treatment, thus reducing dose diversion and eliminating the need for in-school administration.
鉴于哌甲酯短效制剂在治疗注意力缺陷多动障碍（ADHD）时的给药限制，主要开发了药物释放时间更长的盖仑制剂，以避免在上学时间服药。
本研究旨在评估一种新型哌甲酯缓释制剂（美达力长效片）作为注意力缺陷多动障碍（ADHD）儿童每日一次治疗药物的疗效和作用持续时间。
这是一项随机、双盲、交叉多中心研究，有三种治疗方案：每日一次的哌甲酯缓释制剂、每日两次的哌甲酯速释制剂和安慰剂，给予79名8至14岁的ADHD儿童。在模拟课堂环境中进行的每日评估包括对注意力和行为举止的盲法评分，以及在8小时内5次获得的一项表现测量指标（数学测试）。次要测量指标包括一个基于《精神疾病诊断与统计手册》第四版/《国际疾病分类》第十版的ADHD评定量表，分别在上午和下午进行评分。
两种活性治疗方案均显示出显著的时程效应，且在改善所有疗效指标方面均优于安慰剂。每日一次的哌甲酯缓释制剂与相同剂量的每日两次哌甲酯速释制剂没有差异。
这些数据为这种新型每日一次的哌甲酯制剂在治疗ADHD方面的益处提供了支持。美达力长效片较长的作用持续时间有可能简化精神兴奋药治疗，从而减少剂量偏差，并消除在校给药的必要性。
