Ho Che-Sheng, Chiu Nan-Chang, Tseng Chih-Fan, Huang Yuan-Ling
Department of Pediatrics, Mackay Memorial Hospital, Taipei, Taiwan; Mackay Medicine, Nursing and Management College, Taipei, Taiwan.
Department of Pediatrics, Mackay Memorial Hospital, Taipei, Taiwan.
Pediatr Neonatol. 2014 Feb;55(1):48-52. doi: 10.1016/j.pedneo.2013.05.009. Epub 2013 Aug 3.
BACKGROUND/PURPOSE: The purpose of this study was to evaluate the effectiveness and tolerability of aripiprazole in short-term treatment of children and adolescents with tic disorder (TD).
This was a 14-week, prospective, open-label flexible dose trial of aripiprazole. We enrolled patients with TD aged between 4 years and 18 years. They received aripiprazole (dose: 2.5 mg/day) initially, which was then adjusted according to clinical response. The severity was assessed by the Yale Global Tic Severity Score (YGTSS) at 0, 2, 6, 10, and 14 weeks. The linear mixed models were used for evaluation of the YGTSSs at each follow-up, which were compared with baseline scores.
Eighty-one patients were enrolled in this study. Nine patients withdrew from the study with complaints of adverse side effects. Of the remaining 72 patients, 15 patients discontinued medications prematurely due to being free of symptoms for over 2 weeks. Two patients discontinued medications due to no significant improvement. The mean scores had significantly decreased since the 2nd week (p < 0.01). The mean reduction was 51.0% in the motor tic scores, 67.1% in the vocal tic scores, and 70.0% in the total YGTSSs. The common adverse effects were sedation (32.1%) and increased appetite (22.2%). A slight increase in average body weight was noted, from 32.7 to 33.7 kg (+1.0 kg, p < 0.05).
Aripiprazole is effective for short-term treatment of TD, especially vocal tics, in children and adolescents with mild adverse effects. However, further double-blind trials against placebo or other medications are needed to verify the efficacy of aripiprazole in the pharmacotherapy of TD.
背景/目的：本研究旨在评估阿立哌唑在短期治疗儿童和青少年抽动障碍（TD）中的有效性和耐受性。
这是一项为期14周的阿立哌唑前瞻性、开放标签、灵活剂量试验。我们纳入了年龄在4岁至18岁之间的TD患者。他们最初接受阿立哌唑治疗（剂量：2.5毫克/天），然后根据临床反应进行调整。在第0、2、6、10和14周时，通过耶鲁全球抽动严重程度评分（YGTSS）评估严重程度。使用线性混合模型评估每次随访时的YGTSS，并与基线评分进行比较。
本研究共纳入81例患者。9例患者因不良反应投诉退出研究。在其余72例患者中，15例患者因症状消失超过2周而提前停药。2例患者因无明显改善而停药。自第2周起，平均评分显著下降（p < 0.01）。运动抽动评分平均降低51.0%，发声抽动评分平均降低67.1%，YGTSS总分平均降低70.0%。常见的不良反应为镇静（32.1%）和食欲增加（22.2%）。平均体重略有增加，从32.7千克增至33.7千克（增加1.0千克，p < 0.05）。
阿立哌唑对儿童和青少年TD的短期治疗有效，尤其是对发声抽动，且不良反应较轻。然而，需要进一步针对安慰剂或其他药物的双盲试验来验证阿立哌唑在TD药物治疗中的疗效。
