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阿立哌唑治疗儿童和青少年抽动障碍的疗效及耐受性开放性研究。

An open-label study of the efficacy and tolerability of aripiprazole for children and adolescents with tic disorders.

作者信息

Yoo Hanik K, Choi Soon-Ho, Park Subin, Wang Hee-Ryung, Hong Jin-Pyo, Kim Chang-Yoon

机构信息

Department of Psychiatry, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.

出版信息

J Clin Psychiatry. 2007 Jul;68(7):1088-93.

Abstract

OBJECTIVES

This study aimed to investigate the efficacy and tolerability of aripiprazole, an atypical antipsychotic with dual agonist and antagonist actions toward dopaminergic imbalance and partial serotonin-2A receptor antagonism, for treating children and adolescents with tic disorders.

METHOD

Twenty-four outpatients aged 7 to 18 years with DSM-IV-diagnosed tic disorders were treated with aripiprazole using an open-label, flexible dosing schedule for 8 weeks from January 2005 to August 2006. The Korean versions of the Yale Global Tic Severity Scale (YGTSS), the Clinical Global Impressions-Improvement scale (CGI-I), and the CGI-Severity of Illness scale (CGI-S) scores were used to measure the drug efficacy. Side effects were assessed using an adverse effect checklist, the Extrapyramidal Symptom Rating Scale, height and weight measurements, laboratory tests, and electrocardiograms.

RESULTS

Aripiprazole was prematurely discontinued in 6 (25%) of the 24 subjects due to intolerable adverse effects. After a mean of 9.8 +/- 4.8 mg/day of aripiprazole for 8 weeks, there was a 52.8% reduction in the mean YGTSS Total Tic scores (from 26.7 +/- 5.5 to 12.6 +/- 7.6, p < .001). Nineteen patients (79.2%) showed either much improved or very much improved status according to the CGI-I. The CGI-S score was also reduced (from 5.5 +/- 0.5 to 3.0 +/- 1.4, p < .001). The initial dose of 5 mg/day aripiprazole for 2 weeks was also found to reduce tic symptoms significantly (Total Tic scores decreased from 26.7 +/- 5.5 to 17.9 +/- 8.7, p < .001). Fourteen subjects (58.3%) experienced unwanted side effects, the most common being hypersomnia (37.5%), nausea (20.8%), and headache (16.6%).

CONCLUSION

This open-label study suggests that aripiprazole is an efficacious and safe treatment for children and adolescents with tic disorders.

摘要

目的

本研究旨在探讨阿立哌唑(一种对多巴胺能失衡具有双重激动剂和拮抗剂作用且对5-羟色胺-2A受体有部分拮抗作用的非典型抗精神病药物)治疗患有抽动障碍的儿童和青少年的疗效及耐受性。

方法

2005年1月至2006年8月,对24名年龄在7至18岁、经DSM-IV诊断为抽动障碍的门诊患者采用开放标签、灵活给药方案,使用阿立哌唑治疗8周。采用韩国版耶鲁综合抽动严重程度量表(YGTSS)、临床总体印象改善量表(CGI-I)和临床总体印象疾病严重程度量表(CGI-S)评分来衡量药物疗效。使用不良反应清单、锥体外系症状评定量表、身高和体重测量、实验室检查及心电图来评估副作用。

结果

24名受试者中有6名(25%)因无法耐受的不良反应而提前停药。在平均每日9.8±4.8毫克阿立哌唑治疗8周后,YGTSS总抽动评分平均降低了52.8%(从26.7±5.5降至12.6±7.6,p<.001)。根据CGI-I,19名患者(79.2%)显示有很大改善或非常大的改善。CGI-S评分也有所降低(从5.5±0.5降至3.0±1.4,p<.001)。还发现阿立哌唑初始剂量5毫克/天,持续2周也能显著减轻抽动症状(总抽动评分从26.7±5.5降至17.9±8.7,p<.001)。14名受试者(58.3%)出现了不良副作用,最常见的是嗜睡(37.5%)、恶心(20.8%)和头痛(16.6%)。

结论

这项开放标签研究表明,阿立哌唑对患有抽动障碍的儿童和青少年是一种有效且安全的治疗方法。

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