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一项关于胍法辛治疗广泛性发育障碍儿童的前瞻性开放性试验。

A prospective open trial of guanfacine in children with pervasive developmental disorders.

作者信息

Scahill Lawrence, Aman Michael G, McDougle Christopher J, McCracken James T, Tierney Elaine, Dziura James, Arnold L Eugene, Posey David, Young Christopher, Shah Bhavik, Ghuman Jaswinder, Ritz Louise, Vitiello Benedetto

机构信息

Yale Child Study Center, P.O. Box 207900, New Haven, CT 06520, USA.

出版信息

J Child Adolesc Psychopharmacol. 2006 Oct;16(5):589-98. doi: 10.1089/cap.2006.16.589.

DOI:10.1089/cap.2006.16.589
PMID:17069547
Abstract

OBJECTIVE

A common complaint for children with pervasive developmental disorder (PDD) is hyperactivity. The purpose of this pilot study was to gather preliminary information on the efficacy of guanfacine in children with PDD and hyperactivity.

METHODS

Children with PDD accompanied by hyperactivity entered the open-label trial if there was a recent history of failed treatment with methylphenidate or the child did not improve on methylphenidate in a multisite, placebo-controlled trial.

RESULTS

Children (23 boys and 2 girls) with a mean age of 9.03 (+/-3.14) years entered the open-label trial. After 8 weeks of treatment, the parent-rated Hyperactivity subscale of the Aberrant Behavior Checklist (ABC) went from a mean of 31.3 (+/-8.89) at baseline to 18.9 (+/-10.37) (effect size = 1.4; p < 0.001). The teacher-rated Hyperactivity subscale decreased from a mean of 29.9 (+/-9.12) at baseline to 22.3 (+/-9.44) (effect size = 0.83; p < 0.01). Twelve children (48%) were rated as Much Improved or Very Much Improved on the Clinical Global Impressions- Improvement. Doses ranged from 1.0 to 3.0 mg/day in two or three divided doses. Common adverse effects included irritability, sedation, sleep disturbance (insomnia or midsleep awakening), and constipation. Irritability led to discontinuation in 3 subjects. There were no significant changes in pulse, blood pressure, or electrocardiogram.

CONCLUSIONS

Guanfacine may be useful for the treatment of hyperactivity in children with PDD. Placebo-controlled studies are needed to guide clinical practice.

摘要

目的

广泛性发育障碍(PDD)患儿常见的主诉是多动。本初步研究的目的是收集有关胍法辛治疗PDD伴多动患儿疗效的初步信息。

方法

伴有多动的PDD患儿若近期有使用哌甲酯治疗失败史,或在多中心、安慰剂对照试验中对哌甲酯无反应,则进入开放标签试验。

结果

平均年龄为9.03(±3.14)岁的患儿(23名男孩和2名女孩)进入开放标签试验。治疗8周后,异常行为检查表(ABC)中家长评定的多动分量表从基线时的平均31.3(±8.89)降至18.9(±10.37)(效应量=1.4;p<0.001)。教师评定的多动分量表从基线时的平均29.9(±9.12)降至22.3(±9.44)(效应量=0.83;p<0.01)。12名患儿(48%)在临床总体印象改善评定中被评为明显改善或非常明显改善。剂量为1.0至3.0mg/天,分两或三次服用。常见不良反应包括易怒、镇静、睡眠障碍(失眠或睡眠中觉醒)和便秘。易怒导致3名受试者停药。脉搏、血压或心电图无显著变化。

结论

胍法辛可能对治疗PDD患儿的多动有效。需要进行安慰剂对照研究以指导临床实践。

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