Lyon Gholson J, Samar Stephanie, Jummani Rahil, Hirsch Scott, Spirgel Arie, Goldman Rachel, Coffey Barbara J
New York University Child Study Center, New York, New York 10016, USA.
J Child Adolesc Psychopharmacol. 2009 Dec;19(6):623-33. doi: 10.1089/cap.2009.0035.
The aim of this study was to conduct a prospective safety and tolerability study of aripiprazole for the treatment of tics in children and adolescents with Tourette's disorder (TD).
Eleven subjects (10 males) with TD (age 9-19 years, mean 13.36, standard deviation [SD] 3.33) who did not respond or were unable to tolerate previous tic medication were treated with aripiprazole in an open-label, flexible-dosing study over 10 weeks. Tic severity was rated using the Yale Global Tic Severity Scale (YGTSS) and the Clinical Global Impressions Scale for tics (CGI-Tics) at baseline and at follow-up.
The mean (+/-SD) daily dose for aripiprazole was 4.5 +/- 3.0 mg. Mean (+/-SD) YGTSS Global Severity scores reduced from 61.82 +/- 13.49 at baseline to 33.73 +/- 15.18 at end point; mean YGTSS total tic scores reduced from 28.18 +/- 7.74 at baseline to 16.73 +/- 7.54 at end point. Mean (+/-SD) CGI-Tic severity scores reduced from 4.45 +/- 0.52 (moderate-marked) at baseline to 3.18 +/- 0.60 (mild) at end point. On the CGI-Tic improvement scale, 10 (91%) subjects achieved 1 ("very much improved") or 2 ("much improved") at end point. Most common adverse effects included appetite increase and weight gain in 5 subjects, mild extrapyramidal effects in 7 subjects, and headaches and tiredness/fatigue in 7 subjects; 1 subject experienced akathisia and muscle cramps.
Aripiprazole appears to be a safe and tolerable treatment in children and adolescents with TD that appears to reduce tics; it should be further investigated as a treatment option in controlled trials.
本研究旨在对阿立哌唑治疗抽动秽语综合征（TD）儿童及青少年的抽动症状进行前瞻性安全性和耐受性研究。
11名TD患者（10名男性），年龄9 - 19岁，平均13.36岁，标准差（SD）3.33，对既往抽动症状治疗无反应或无法耐受，在一项为期10周的开放标签、灵活剂量研究中接受阿立哌唑治疗。在基线和随访时使用耶鲁全球抽动严重程度量表（YGTSS）和抽动症状临床总体印象量表（CGI - Tics）对抽动严重程度进行评分。
阿立哌唑的平均（±SD）日剂量为4.5±3.0毫克。YGTSS总体严重程度评分均值（±SD）从基线时的61.82±13.49降至终点时的33.73±15.18；YGTSS抽动总分均值从基线时的28.18±7.74降至终点时的16.73±7.54。CGI - Tic严重程度评分均值（±SD）从基线时的4.45±0.52（中度 - 明显）降至终点时的3.18±0.60（轻度）。在CGI - Tic改善量表上，10名（91%）受试者在终点时达到1级（“非常显著改善”）或2级（“显著改善”）。最常见的不良反应包括5名受试者食欲增加和体重增加、7名受试者出现轻度锥体外系反应、7名受试者出现头痛和疲倦/疲劳；1名受试者出现静坐不能和肌肉痉挛。
阿立哌唑对于TD儿童及青少年似乎是一种安全且耐受性良好的治疗方法，似乎能减轻抽动症状；应在对照试验中作为一种治疗选择进行进一步研究。
