Gilbert Donald L, Batterson J Robert, Sethuraman Gopalan, Sallee Floyd R
Department of Neurology, Cincinnati Children's Hospital Medical Center, Division of Developmental and Behavioral Sciences. Children's Mercy Hospital, Kansas City, KS, USA.
J Am Acad Child Adolesc Psychiatry. 2004 Feb;43(2):206-14. doi: 10.1097/00004583-200402000-00017.
To compare the tic suppression, electrocardiogram (ECG) changes, weight gain, and side effect profiles of pimozide versus risperidone in children and adolescents with tic disorders.
This was a randomized, double-blind, crossover (evaluable patient analysis) study. Nineteen children aged 7 to 17 years with Tourette's or chronic motor tic disorder were randomized to 4 weeks of treatment with pimozide or risperidone, followed by the alternate treatment after a 2-week placebo washout. The primary efficacy outcome measure was change in tic severity assessed by the Yale Global Tic Severity Scale (YGTSS). ECG results, weight gain, and side effects were also compared.
Compared to pimozide treatment, risperidone treatment was associated with significantly lower tic severity scores (YGTSS: baseline 43.3 +/- 17.5, pimozide 34.2 +/- 14.2, risperidone 25.2 +/- 13.6; p =.05). Weight gain during the 4-week treatment periods was greater for risperidone (mean 1.9 kg) than pimozide (1.0 kg). No patient suffered a serious adverse event, but 6 of 19 subjects failed to complete the protocol. Neither medication was associated with ECG changes.
In this study, risperidone appeared superior to pimozide for tic suppression but was associated with greater weight gain.
比较匹莫齐特与利培酮对抽动障碍儿童和青少年的抽动抑制、心电图(ECG)变化、体重增加及副作用情况。
这是一项随机、双盲、交叉(可评估患者分析)研究。19名7至17岁患有图雷特氏症或慢性运动性抽动障碍的儿童被随机分为两组,分别接受4周的匹莫齐特或利培酮治疗,在经过2周的安慰剂洗脱期后换用另一种治疗。主要疗效指标是通过耶鲁综合抽动严重程度量表(YGTSS)评估的抽动严重程度变化。同时比较心电图结果、体重增加及副作用情况。
与匹莫齐特治疗相比,利培酮治疗使抽动严重程度评分显著降低(YGTSS:基线43.3±17.5,匹莫齐特34.2±14.2,利培酮25.2±13.6;p = 0.05)。在4周治疗期间,利培酮组(平均增加1.9千克)的体重增加幅度大于匹莫齐特组(1.0千克)。没有患者发生严重不良事件,但19名受试者中有6人未完成研究方案。两种药物均未引起心电图变化。
在本研究中,利培酮在抽动抑制方面似乎优于匹莫齐特,但与更大幅度的体重增加有关。