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缓释右苯丙胺和混合苯丙胺盐的剂量效应及相对疗效

Dose effects and comparative effectiveness of extended release dexmethylphenidate and mixed amphetamine salts.

作者信息

Stein Mark A, Waldman Irwin D, Charney Elizabeth, Aryal Subhash, Sable Craig, Gruber Reut, Newcorn Jeffrey H

机构信息

Institute for Juvenile Research, University of Illinois, Chicago, Illinois 60608, USA.

出版信息

J Child Adolesc Psychopharmacol. 2011 Dec;21(6):581-8. doi: 10.1089/cap.2011.0018. Epub 2011 Dec 2.

Abstract

OBJECTIVE

To compare the dose effects of long-acting extended-release dexmethylphenidate (ER d-MPH) and ER mixed amphetamine salts (ER MAS) on attention-deficit/hyperactivity disorder (ADHD) symptom dimensions, global and specific impairments, and common adverse events associated with stimulants.

METHODS

Fifty-six children and adolescents with ADHD participated in an 8-week, double-blind, crossover study comparing ER d-MPH (10, 20, 25-30 mg) and ER MAS (10, 20, 25-30) with a week of randomized placebo within each drug period. Efficacy was assessed with the ADHD Rating Scale-IV (ADHD-RS-IV), whereas global and specific domains of impairment were assessed with the Clinical Global Impressions Severity and Improvement Scales and the parent-completed Weiss Functional Impairment Scale, respectively. Insomnia and decreased appetite, common stimulant-related adverse events, were measured with the parent-completed Stimulant Side Effects Rating Scale.

RESULTS

Both ER d-MPH and ER MAS were associated with significant reductions in ADHD symptoms. Improvement in Total ADHD and Hyperactivity/Impulsivity symptoms were strongly associated with increasing dose, whereas improvements in Inattentive symptoms were only moderately associated with dose. About 80% demonstrated reliable change on ADHD-RS-IV at the highest dose level of ER MAS compared with 79% when receiving ER d-MPH. Decreased appetite and insomnia were more common at higher dose levels for both stimulants. Approximately 43% of the responders were preferential responders to only one of the stimulant formulations.

CONCLUSIONS

Dose level, rather than stimulant class, was strongly related to medication response.

摘要

目的

比较长效缓释右苯丙胺(ER d-MPH)和长效缓释混合苯丙胺盐(ER MAS)对注意力缺陷多动障碍(ADHD)症状维度、整体和特定功能损害以及与兴奋剂相关的常见不良事件的剂量效应。

方法

56名患有ADHD的儿童和青少年参与了一项为期8周的双盲交叉研究,比较ER d-MPH(10、20、25 - 30毫克)和ER MAS(10、20、25 - 30毫克),每个药物治疗期内有一周随机服用安慰剂。使用ADHD评定量表第四版(ADHD-RS-IV)评估疗效,而分别使用临床总体印象严重程度和改善量表以及家长完成的韦斯功能损害量表评估整体和特定功能损害领域。使用家长完成的兴奋剂副作用评定量表测量失眠和食欲减退这两种与兴奋剂相关的常见不良事件。

结果

ER d-MPH和ER MAS均与ADHD症状的显著减轻相关。ADHD总分以及多动/冲动症状的改善与剂量增加密切相关,而注意力不集中症状的改善仅与剂量呈中度相关。与接受ER d-MPH时的79%相比,约80%的患者在ER MAS最高剂量水平时在ADHD-RS-IV上显示出可靠的变化。两种兴奋剂在较高剂量水平时食欲减退和失眠更为常见。约43%的反应者仅对其中一种兴奋剂制剂有优先反应。

结论

剂量水平而非兴奋剂类别与药物反应密切相关。

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