Tic reduction with risperidone versus pimozide in a randomized, double-blind, crossover trial
Tic reduction with risperidone versus pimozide in a randomized, double-blind, crossover trial
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DOI：
10.1097/00004583-200402000-00017
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发表时间：
2004-02-01
影响因子：
13.3
通讯作者：
Sallee, FR
中科院分区：
文献类型：
--
作者：
Gilbert, DL;Batterson, JR;Sallee, FR
目的：比较匹莫齐特与利培酮对儿童和青少年抽动障碍患者的抽动抑制、心电图改变、体重增加和副作用。方法：这是一项随机、双盲、交叉（可评估的患者分析）研究。19名患有图雷特病或慢性运动抽动障碍的7至17岁儿童随机接受4周的吡莫齐或利培酮治疗，然后在2周安慰剂洗脱期后进行替代治疗。主要疗效指标是通过耶鲁全球抽动严重程度量表（YGTSS）评估抽动严重程度的变化。还比较了心电图结果、体重增加和副作用。结果：与匹莫齐治疗相比，利培酮治疗与抽动严重程度评分显著降低相关（YGTSS：基线43.3 +/- 17.5，匹莫齐34.2 +/- 14.2，利培酮25.2 +/- 13.6;p = 0.05）。在4周的治疗期间，利培酮（平均1.9 kg）的体重增加大于匹莫齐特（1.0 kg）。没有患者发生严重不良事件，但19名受试者中有6名未能完成方案。两种药物均未引起心电图改变。结论：在这项研究中，利培酮在抑制抽动方面似乎优于匹莫齐，但与体重增加有关。
Objective: 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. Method: 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. Results: 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. Conclusions: In this study, risperidone appeared superior to pimozide for tic suppression but was associated with greater weight gain.