Sonuga-Barke Edmund J S, Coghill David, Wigal Timothy, DeBacker Marc, Swanson James
Institute for Disorders of Impulse and Attention, School of Psychology, University of Southampton, UK.
J Child Adolesc Psychopharmacol. 2009 Dec;19(6):683-90. doi: 10.1089/cap.2009.0024.
Methylphenidate (MPH)-related adverse events are well characterized. Their predictors and their relationship with therapeutic effects are less well understood. Here we examine these issues in relation to two long-acting formulations.
Comparison of Methylphenidates in the Analog Classroom Setting (COMACS) was made in a large (n = 184) placebo-controlled trial comparing Equasym XL/Metadate CD, Concerta, and placebo (PLA) using a Laboratory School protocol. Therapeutic effects were measured using direct observation, scores on a simple math productivity task and parent ratings. Parents also completed the Barkley Stimulant Side Effect Rating Scale (BSSERS).
The BSSERS had six factors: Emotionality, sleep/appetite, disengaged, dizzy, uninterested, and aches. Treatment effects were seen only for emotionality (which improved) and sleep and appetite (which worsened). Adverse events were not predictable from personal and clinical characteristics of patients. Sleep/appetite adverse events were not associated with therapeutic effects. Improvements in attention-deficit/hyperactivity disorder (ADHD) and emotionality were correlated.
The results support a narrow conceptualization of MPH adverse events with problems restricted to appetite and sleep. These effects were not predictable on the basis of available information and may be due to an underlying mechanism rather distinct from those determining therapeutic effects.
哌甲酯（MPH）相关的不良事件已得到充分描述。但其预测因素以及它们与治疗效果的关系尚不太清楚。在此，我们针对两种长效制剂研究这些问题。
在一项大型（n = 184）安慰剂对照试验中，采用实验室学校方案，比较了Equasym XL/Metadate CD、康纳达（Concerta）和安慰剂（PLA），即模拟课堂环境中哌甲酯的比较研究（COMACS）。使用直接观察、简单数学生产率任务得分和家长评分来衡量治疗效果。家长们还完成了巴克利兴奋剂副作用评定量表（BSSERS）。
BSSERS有六个因素：情绪、睡眠/食欲、注意力不集中、头晕、无兴趣和疼痛。仅在情绪（有所改善）以及睡眠和食欲（有所恶化）方面观察到治疗效果。不良事件无法根据患者的个人和临床特征预测。睡眠/食欲不良事件与治疗效果无关。注意力缺陷多动障碍（ADHD）的改善与情绪改善相关。
结果支持对MPH不良事件进行狭义的概念化，即问题仅限于食欲和睡眠。这些影响无法根据现有信息预测，可能是由于一种与决定治疗效果的机制截然不同的潜在机制。
