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两项儿童托莫西汀安慰剂对照研究中家长与教师对注意力缺陷/多动障碍症状报告的比较。

Comparison of parent and teacher reports of attention-deficit/hyperactivity disorder symptoms from two placebo-controlled studies of atomoxetine in children.

作者信息

Biederman Joseph, Gao Haitao, Rogers Ann K, Spencer Thomas J

机构信息

Scientific Communications, Lilly Research Laboratories, Indianapolis, Indiana, USA.

出版信息

Biol Psychiatry. 2006 Nov 15;60(10):1106-10. doi: 10.1016/j.biopsych.2006.03.036. Epub 2006 Jun 27.

DOI:10.1016/j.biopsych.2006.03.036
PMID:16806096
Abstract

BACKGROUND

The validity of parent reports regarding children's attention-deficit/hyperactivity disorder (ADHD) symptoms has been questioned. This study assessed whether parent reports were as sensitive as teacher reports to document change in ADHD symptoms during clinical trials with atomoxetine.

METHODS

Data were compared from two randomized, double-blind, placebo-controlled clinical trials of atomoxetine using different versions (parent or teacher) of the same rating scale (Attention-Deficit/Hyperactivity Disorder Rating Scale-IV [parent or teacher] Version: Investigator Administered and Scored - ADHD RS). Exclusion criteria included history of bipolar disorder, psychosis, seizures, alcohol abuse, or positive drug screen. Patients (6-16 years old) were treated with atomoxetine (titrated to a maximum dose of 1.8 mg/kg/day) administered once daily for up to 7 weeks. Parent and teacher ratings were compared using an analysis of covariance (ANCOVA) model.

RESULTS

The analysis (n = 318) showed that treatment effects (mean change, baseline to endpoint) were similar between parent and teacher ratings (total, p = .762; inattention, p = .519; hyperactive/impulsive, p = .955). Effect sizes also were similar based on total scores (parent ratings = .69; teacher ratings = .63).

CONCLUSIONS

Parent reports are as sensitive as teacher reports in assessing the efficacy of long-acting pharmacologic treatment for ADHD in children during clinical trials using the nonstimulant atomoxetine.

摘要

背景

关于儿童注意力缺陷多动障碍(ADHD)症状的家长报告的有效性受到质疑。本研究评估了在使用托莫西汀的临床试验中,家长报告与教师报告记录ADHD症状变化的敏感性是否相同。

方法

比较了两项使用相同评分量表(注意力缺陷/多动障碍评定量表-IV[家长或教师版]:研究者施测与计分-ADHD RS)不同版本(家长或教师)的托莫西汀随机、双盲、安慰剂对照临床试验的数据。排除标准包括双相情感障碍、精神病、癫痫、酒精滥用史或药物筛查阳性。患者(6-16岁)接受托莫西汀治疗(滴定至最大剂量1.8mg/kg/天),每日一次,最长7周。使用协方差分析(ANCOVA)模型比较家长和教师的评分。

结果

分析(n = 318)显示,家长和教师评分的治疗效果(从基线到终点的平均变化)相似(总分,p = 0.762;注意力不集中,p = 0.519;多动/冲动,p = 0.955)。基于总分的效应量也相似(家长评分为0.69;教师评分为0.63)。

结论

在使用非兴奋剂托莫西汀的临床试验中,家长报告在评估儿童ADHD长效药物治疗疗效方面与教师报告一样敏感。

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