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缓释右哌甲酯30毫克/天与20毫克/天对比:对注意力缺陷多动障碍儿童注意力、行为及表现改善的持续时间

Extended-release dexmethylphenidate 30 mg/d versus 20 mg/d: duration of attention, behavior, and performance benefits in children with attention-deficit/hyperactivity disorder.

作者信息

Silva Raul R, Brams Matthew, McCague Kevin, Pestreich Linda, Muniz Rafael

机构信息

Academic Behavioral Center, New York, NY, USA.

出版信息

Clin Neuropharmacol. 2013 Jul-Aug;36(4):117-21. doi: 10.1097/WNF.0b013e31829aa92c.

Abstract

OBJECTIVE

This study aimed to compare the effects of dexmethylphenidate (D-MPH) extended-release (ER) 30 mg and D-MPH-ER 20 mg on attention, behavior, and performance in children with attention-deficit/hyperactivity disorder.

METHODS

In a randomized, double-blind, 3-period-by-3-treatment, crossover study, children aged 6 to 12 years with attention-deficit/hyperactivity disorder stabilized on methylphenidate (40-60 mg/d) or D-MPH (20-30 mg/d) received D-MPH-ER 20 mg/d, 30 mg/d, and placebo for 7 days each (final dose of each treatment period administered in a laboratory classroom). Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Combined (Attention and Deportment) rating scale and Permanent Product Measure of Performance (PERMP) math test assessments were conducted at baseline and 3, 6, 9, 10, 11, and 12 hours postdose.

RESULTS

A total of 165 children (94 boys; mean age, 9.6 years) were randomized (162 included in intent-to-treat analyses). Significant improvements were noted for D-MPH-ER 30 mg over D-MPH-ER 20 mg at various late time points on the SKAMP scales (Combined scores at 9, 10, 11, and 12 hours postdose; Attention scores at 10, 11, and 12 hours postdose; deportment scores at 9 and 12 hours postdose). The PERMP math test-attempted and -correct scores (change from predose) were significantly higher with D-MPH-ER 30 mg than with D-MPH-ER 20 mg at 10, 11, and 12 hours postdose. Both D-MPH-ER doses were superior to placebo at all time points.

CONCLUSIONS

D-MPH-ER 30 mg was superior to D-MPH-ER 20 mg at later time points in the day, suggesting that higher doses of D-MPH-ER may be more effective later in the day.

摘要

目的

本研究旨在比较30毫克缓释右哌甲酯(D-MPH)和20毫克缓释右哌甲酯对注意力缺陷多动障碍儿童的注意力、行为及学习表现的影响。

方法

在一项随机、双盲、三阶段三治疗的交叉研究中,6至12岁、已稳定服用哌甲酯(40 - 60毫克/天)或右哌甲酯(20 - 30毫克/天)的注意力缺陷多动障碍儿童,分别接受20毫克/天、30毫克/天的缓释右哌甲酯及安慰剂治疗,各为期7天(每个治疗阶段的最终剂量在实验室教室给药)。在基线以及给药后3、6、9、10、11和12小时进行斯旺森、科特金、阿格勒、M - 弗林和佩勒姆(SKAMP)综合(注意力和行为)评定量表以及学习表现永久产品测量(PERMP)数学测试评估。

结果

共有165名儿童(94名男孩;平均年龄9.6岁)被随机分组(162名纳入意向性分析)。在SKAMP量表的多个后期时间点,30毫克缓释右哌甲酯在改善程度上显著优于20毫克缓释右哌甲酯(给药后9、10、11和12小时的综合得分;给药后10、11和12小时的注意力得分;给药后9和12小时的行为得分)。在给药后10、11和12小时,30毫克缓释右哌甲酯的PERMP数学测试尝试得分和正确得分(相对于给药前的变化)显著高于20毫克缓释右哌甲酯。两个剂量的缓释右哌甲酯在所有时间点均优于安慰剂。

结论

在一天中的后期时间点,30毫克缓释右哌甲酯优于20毫克缓释右哌甲酯,这表明更高剂量的缓释右哌甲酯在一天中较晚时候可能更有效。

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