Sonuga-Barke Edmund J S, Coghill David, Markowitz John S, Swanson James M, Vandenberghe Mieke, Hatch Simon J
Dr. Sonuga-Barke is with the Developmental Brain-Behaviour Unit, University of Southampton, Southampton, UK; Mr. Coghill is with the Department of Psychiatry, The University of Dundee, Dundee, UK; Dr. Markowitz is with the Departments of Pharmaceutical Sciences and Psychiatry and Behavioral Medicine, Medical University of South Carolina, Charleston; Dr. Swanson is with the Child Development Center (UCI-CDC), University of California at Irvine; Dr. Vandenberghe is with UCB Pharma, Brussels, Belgium; and Mr. Hatch is with Simon Hatch Consulting Inc., Pittsford, NY.
Dr. Sonuga-Barke is with the Developmental Brain-Behaviour Unit, University of Southampton, Southampton, UK; Mr. Coghill is with the Department of Psychiatry, The University of Dundee, Dundee, UK; Dr. Markowitz is with the Departments of Pharmaceutical Sciences and Psychiatry and Behavioral Medicine, Medical University of South Carolina, Charleston; Dr. Swanson is with the Child Development Center (UCI-CDC), University of California at Irvine; Dr. Vandenberghe is with UCB Pharma, Brussels, Belgium; and Mr. Hatch is with Simon Hatch Consulting Inc., Pittsford, NY.
J Am Acad Child Adolesc Psychiatry. 2007 Jun;46(6):701-710. doi: 10.1097/chi.0b013e31804659f1.
Studies of sex differences in methylphenidate response by children with attention-deficit/hyperactivity disorder have lacked methodological rigor and statistical power. This paper reports an examination of sex differences based on further analysis of data from a comparison of two once-daily methylphenidate formulations (the COMACS study), which addresses these shortcomings.
Children (184: 48 females; mean [SD] age, 9.58 [1.83] years) entered a double-blind, crossover trial of Concerta, MetadateCD/Equasym XL, or placebo. Attention-deficit/hyperactivity disorder symptoms were recorded at seven time points across the school day on the seventh day of treatment, using a laboratory classroom setting.
More females had comorbid anxiety disorder. Males and females did not differ with regard to other characteristics. Observed sex differences in pharmacodynamic symptom profiles persisted after controlling for placebo and time 0 hours attention-deficit/hyperactivity disorder scores and the presence of an anxiety disorder. Females had a statistically superior response at 1.5 hours post-dosing and an inferior response at the 12-hour time point relative to their male counterparts, no matter which methylphenidate formulation was being assessed.
Dose titration of once-daily formulations of methylphenidate should ideally be based on systematic evidence of response at different periods across the day. The responses of female patients may require additional assessments later in the day to determine the optimal dose.
关于注意力缺陷多动障碍儿童对哌甲酯反应的性别差异研究缺乏方法的严谨性和统计效力。本文报告了一项基于对两种每日一次哌甲酯制剂比较的数据（COMACS研究）进行进一步分析的性别差异研究，该研究弥补了这些不足。
儿童（184名：48名女性；平均[标准差]年龄，9.58[1.83]岁）进入一项关于康纳达、美达西控释片/易倍申控释片或安慰剂的双盲交叉试验。在治疗第7天，使用实验室教室环境，在整个上学日的7个时间点记录注意力缺陷多动障碍症状。
更多女性患有共病焦虑症。男性和女性在其他特征方面无差异。在控制了安慰剂、0小时时的注意力缺陷多动障碍评分以及焦虑症的存在后，观察到的药效学症状特征方面的性别差异仍然存在。无论评估哪种哌甲酯制剂，女性在给药后1.5小时的反应在统计学上优于男性，而在12小时时间点的反应则不如男性。
每日一次哌甲酯制剂的剂量滴定理想情况下应基于一天中不同时间段反应的系统证据。女性患者的反应可能需要在当天晚些时候进行额外评估以确定最佳剂量。
