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哌甲酯对注意力缺陷多动障碍儿童的副作用:一项系统性、安慰剂对照评估

Side effects of methylphenidate in children with attention deficit hyperactivity disorder: a systemic, placebo-controlled evaluation.

作者信息

Barkley R A, McMurray M B, Edelbrock C S, Robbins K

机构信息

Dept of Psychiatry, University of Massachusetts Medical Center, Worcester 01655.

出版信息

Pediatrics. 1990 Aug;86(2):184-92.

PMID:2196520
Abstract

The frequency and severity of 17 side effects presumably associated with stimulant medication were assessed during a rigorous, triple-blind, placebo-controlled, crossover evaluation of methylphenidate, 0.3 and 0.5 mg/kg twice a day, in 83 children with attention deficit hyperactivity disorder. Side effects were rated by parents and teachers at the end of each weekly drug condition. Three children (3.6%) had side effects that were sufficiently serious to warrant immediate discontinuation of medication. Parent ratings indicated that only the side effects of decreased appetite, insomnia, stomachaches, and headaches increased significantly in frequency and severity during the two active medication doses as compared with the placebo condition. Fewer than half of the children experienced these side effects and among those who did, ratings of mean severity remained in the mild range. Teacher ratings showed little change over drug conditions, except on ratings of staring, sadness, and anxiety, which declined with increasing dose of medication. Parent ratings indicated that only the side effects of decreased appetite, insomnia, stomachaches, and headaches increased significantly in frequency and severity during the two active medication doses as compared with the placebo condition. Fewer than half of the children experienced these side effects and among those who did, ratings of mean severity remained in the mild range. Teacher ratings showed little change over drug conditions, except on ratings of staring, sadness, and anxiety, which declined with increasing dose of medication. Surprisingly, a high frequency of these behavior side effects were reported during the placebo condition. Stimulant medication within this therapeutic range, therefore, results in few, generally mild side effects.(ABSTRACT TRUNCATED AT 250 WORDS)

摘要

在一项针对83名患有注意力缺陷多动障碍儿童的严格、三盲、安慰剂对照、交叉评估中,对17种可能与兴奋剂药物相关的副作用的频率和严重程度进行了评估。该评估使用了哌醋甲酯,剂量为每天两次,每次0.3毫克/千克和0.5毫克/千克。在每种每周用药情况结束时,由家长和教师对副作用进行评级。三名儿童(3.6%)出现了严重到足以立即停药的副作用。家长评级表明,与安慰剂情况相比,在两种有效药物剂量期间,只有食欲下降、失眠、胃痛和头痛的副作用在频率和严重程度上显著增加。不到一半的儿童经历了这些副作用,而在经历这些副作用的儿童中,平均严重程度评级仍处于轻度范围。教师评级显示,除了凝视、悲伤和焦虑的评级随着药物剂量增加而下降外,在不同药物情况下变化不大。家长评级表明,与安慰剂情况相比,在两种有效药物剂量期间,只有食欲下降、失眠、胃痛和头痛的副作用在频率和严重程度上显著增加。不到一半的儿童经历了这些副作用,而在经历这些副作用的儿童中,平均严重程度评级仍处于轻度范围。教师评级显示,除了凝视、悲伤和焦虑的评级随着药物剂量增加而下降外,在不同药物情况下变化不大。令人惊讶的是,在安慰剂情况下报告了这些行为副作用的高频率。因此,在此治疗范围内的兴奋剂药物只会导致很少的、通常为轻度的副作用。(摘要截选至250字)

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