Sinzig Judith K, Döpfner Manfred, Plück Julia, Banaschewski Tobias, Stephani Ulrich, Lehmkuhl Gerd, Rothenberger Aribert
Klinik für Psychiatrie und Psychotherapie des Kindes- und Jugendalters am Klinikum der Universität Köln.
Z Kinder Jugendpsychiatr Psychother. 2004 Nov;32(4):225-33. doi: 10.1024/1422-4917.32.4.225.
In order to treat children with Attention-deficit/Hyperactivity Disorder (ADHD) with a once-a-day stimulant several galenic approaches have been tried. The long acting methylphenidate (MPH, Medikinet-Retard) is a preparation with a two-step dynamic to release MPH (step one: acute; step two: prolonged). The efficacy of Medikinet-Retard, a new long-acting methylphenidate preparation, is analyzed based on the assessment of parents in the afternoon.
In a multicenter drug treatment study (placebo controlled, randomized, double-blind) 85 children (normal intelligence, age 6 to 16 years, diagnosis of ADHD according to DSM-IV) were investigated over 4 weeks with weekly visits. Forty-three children received Medikinet-Retard and forty-two children placebo. The weekly dose titration depending on body weight and symptomatology allowed a final maximum of 60 mg. The effects on ADHD as perveived by the parents were assessed weekly with a German symptom checklist for ADHD according to DSM-IV and ICD-10 (FBB-HKS). The differences between baseline and last week of treatment were compared statistically between groups.
There was a large and statistically significant positive drug effect on ADHD symptomatology. The effect size of these differences was d = 1.2 (total score). Effects were found on inattention, hyperactivity and impulsity on the respective subscales. The efficacy of Medikinet-Retard was evaluated by the parents on an average as good. The rate of responders was four-times higher in the verum-group. The correlations of the changed scores in the parent ratings with the respective change scores in the teacher ratings were in the medium range.
This is the first study with a German long-acting methylphenidate preparation (Medikinet-Retard). According to data based on parents' assessments, the drug showed very good clinical efficacy and safety in children with ADHD. Its two step galenic release of methylphenidate seems to be appropriate for a once-a-day (morning) stimulant in schoolchildren.
为了用每日一次的兴奋剂治疗患有注意力缺陷/多动障碍（ADHD）的儿童，人们尝试了几种药剂学方法。长效哌甲酯（MPH，美达力长效片）是一种具有两步动态释放MPH的制剂（第一步：急性释放；第二步：持续释放）。基于下午家长的评估分析了一种新型长效哌甲酯制剂美达力长效片的疗效。
在一项多中心药物治疗研究（安慰剂对照、随机、双盲）中，对85名儿童（智力正常，年龄6至16岁，根据《精神疾病诊断与统计手册》第四版诊断为ADHD）进行了为期4周的研究，每周进行一次访视。43名儿童服用美达力长效片，42名儿童服用安慰剂。根据体重和症状每周进行剂量滴定，最终最大剂量为60毫克。每周使用根据《精神疾病诊断与统计手册》第四版和《国际疾病分类》第十版（FBB - HKS）制定的德国ADHD症状清单评估家长所感知到的药物对ADHD的影响。对两组治疗基线和治疗最后一周之间的差异进行统计学比较。
药物对ADHD症状有显著且具有统计学意义的积极作用。这些差异的效应大小为d = 1.2（总分）。在各个子量表上均发现了对注意力不集中、多动和冲动的影响。家长对美达力长效片疗效的总体评价为良好。试验组的有效率是对照组的四倍。家长评分变化分数与教师评分相应变化分数之间的相关性处于中等范围。
这是第一项关于德国长效哌甲酯制剂（美达力长效片）的研究。根据家长评估数据，该药物在患有ADHD的儿童中显示出非常好的临床疗效和安全性。其哌甲酯的两步药剂学释放似乎适合作为学童每日一次（早晨）的兴奋剂。
