Short-term side effects of stimulant medication are increased in preschool children with attention-deficit/hyperactivity disorder: A double-blind placebo-controlled study

Short-term side effects of stimulant medication are increased in preschool children with attention-deficit/hyperactivity disorder: A double-blind placebo-controlled study
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DOI:
10.1089/cap.1998.8.13
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发表时间:
1998-01-01
影响因子:
1.9
通讯作者:
Bennett, S
Bennett, S
中科院分区:
医学3区
文献类型:
--
作者:
Firestone, P;Musten, LM;Bennett, S

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患有注意力缺陷/多动障碍 (ADHD) 的学龄前儿童(27 名男孩,5 名女孩,平均年龄 4 岁 10 个月)参加了一项双盲安慰剂对照交叉药物研究,以评估哌甲酯的副作用。儿童每天接受两次安慰剂、0.3 mg/kg 哌甲酯和 0.5 mg/kg 哌甲酯,每次至少 1 周。通过为药物研究设计的家长评分量表来监测副作用。总体而言,哌醋甲酯的耐受性相对较好,没有儿童因不良反应而停药。在 17 种通常与副作用相关的儿童行为中,有 8 种行为显示出显着变化,通常是在较高剂量的哌醋甲酯下。有趣的是,其中 3 种副作用与行为改善有关。副作用的数量似乎高于学龄儿童中通常报告的数量,但很少有家长报告这些副作用很严重。据报道,不到 10% 的样本出现严重副作用,安慰剂组严重副作用的报告数量与低剂量和高剂量药物的严重副作用报告数量大致相同。结果表明,哌醋甲酯对学龄前儿童(7-10天)的毒性相对较低,一些可能被视为哌醋甲酯副作用的行为变化实际上是学龄前儿童的正常行为或多动症行为(例如社交能力),这些“副作用”行为在学龄前儿童中比学龄儿童更常见,哌醋甲酯的一些“副作用”与行为改善有关,学龄前儿童和学龄儿童儿童可能会出现不同的哌醋甲酯副作用(例如情绪变化和焦虑)。
Preschool children with attention-deficit/hyperactivity disorder (ADHD) (27 boys, 5 girls, mean age 4 years 10 months) participated in a double-blind placebo-controlled crossover drug study to assess the side effects of methyphenidate. Children received twice daily, for at least 1 week each, placebo, 0.3 mg/kg methylphenidate, and 0.5 mg/kg methylphenidate. Side effects were monitored by a parent rating scale designed for medication studies. In general, methylphenidate was tolerated relatively well, with no children withdrawing because of adverse effects. Of 17 childhood behaviors usually associated with side effects, 8 behaviors showed significant changes, generally at the higher dose of methylphenidate. Interestingly, 3 of the side effects were associated with improved behavior. The number of side effects appeared higher than what is usually reported in a population of school-age children, but few parents reported them as being severe. Severe side effects were reported in less than 10% of the sample, with approximately as many reports of severe effects on placebo as on low and high doses of the medication. The results indicate that methylphenidate has a relatively low toxicity in preschool children lover the first 7-10 days), that some behavioral changes that might be viewed as side effects of methylphenidate are actually normal behaviors or ADHD behaviors in preschool children (e.g., sociability), that these "side-effect" behaviors are more common in preschool than school-age children, that some "side effects" of methylphenidate are associated with improvements in behavior, and that preschool and school-age children may have different side effects of methylphenidate (e.g., mood changes and anxiety).