Risperidone in the treatment of disruptive behavioral symptoms in children with autistic and other pervasive developmental disorders
Risperidone in the treatment of disruptive behavioral symptoms in children with autistic and other pervasive developmental disorders
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DOI：
10.1542/peds.2003-0264-f
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发表时间：
2004-11-01
期刊：
影响因子：
8
通讯作者：
Dunbar, F
中科院分区：
文献类型：
--
作者：
Shea, S;Turgay, A;Dunbar, F
目标。探讨利培酮治疗孤独症及其他广泛性发育障碍（PDD）患儿破坏性行为症状的疗效和安全性。在这项为期8周的随机、双盲、安慰剂对照试验中，对79名5至12岁患有PDD的儿童给予利培酮/安慰剂溶液（0.01-0.06 mg/kg/天）。行为症状采用异常行为检查表（ABC）、尼松格儿童行为评定表和临床总体印象改变量表进行评估。安全性评估包括生命体征、心电图、锥体外系症状、不良事件和实验室检查。与服用安慰剂的受试者相比，服用利培酮（平均剂量：0.04 mg/kg/天；1.17 mg/天）的受试者在ABC的易怒亚量表（主要终点）上的平均下降幅度显著更大。到研究终点，利培酮治疗的受试者在烦躁评分方面比基线改善了64%，几乎是安慰剂治疗受试者（31%）的两倍。接受利培酮治疗的受试者在ABC的其他4个分量表上也表现出更显著的下降；《尼松格儿童行为评分表》（家长版）行为问题、不安全/焦虑、过度活跃、过度敏感量表；在最麻烦症状的视觉模拟量表上。与安慰剂组（40%）相比，更多利培酮治疗的受试者（87%）的整体病情得到改善。嗜睡是最常见的不良事件，72.5%和7.7%的受试者（利培酮vs安慰剂）注意到嗜睡，并且似乎可以通过剂量/剂量计划调整来控制。接受利培酮治疗的受试者在体重（2.7 vs 1.0 kg）、脉搏率和收缩压方面均有统计学意义上的显著增加。两组间锥体外系症状评分具有可比性。利培酮在治疗儿童PDD相关行为症状方面具有良好的耐受性和有效性。
Objective. To investigate the efficacy and safety of risperidone for the treatment of disruptive behavioral symptoms in children with autism and other pervasive developmental disorders (PDD).Methods. In this 8-week, randomized, double-blind, placebo-controlled trial, risperidone/placebo solution (0.01-0.06 mg/kg/day) was administered to 79 children who were aged 5 to 12 years and had PDD. Behavioral symptoms were assessed using the Aberrant Behavior Checklist (ABC), Nisonger Child Behavior Rating Form, and Clinical Global Impression-Change. Safety assessments included vital signs, electrocardiogram, extrapyramidal symptoms, adverse events, and laboratory tests.Results. Subjects who were taking risperidone ( mean dosage: 0.04 mg/kg/day; 1.17 mg/day) experienced a significantly greater mean decrease on the irritability subscale of the ABC (primary endpoint) compared with those who were taking placebo. By study endpoint, risperidone-treated subjects exhibited a 64% improvement over baseline in the irritability score almost double that of placebo-treated subjects (31%). Risperidone-treated subjects also exhibited significantly greater decreases on the other 4 subscales of the ABC; on the conduct problem, insecure/anxious, hyperactive, and overly sensitive subscales of the Nisonger Child Behavior Rating Form ( parent version); and on the Visual Analog Scale of the most troublesome symptom. More risperidone-treated subjects (87%) showed global improvement in their condition compared with the placebo group (40%). Somnolence, the most frequently reported adverse event, was noted in 72.5% versus 7.7% of subjects (risperidone vs placebo) and seemed manageable with dose/dose-schedule modification. Risperidone-treated subjects experienced statistically significantly greater increases in weight (2.7 vs 1.0 kg), pulse rate, and systolic blood pressure. Extrapyramidal symptoms scores were comparable between groups.Conclusions. Risperidone was well tolerated and efficacious in treating behavioral symptoms associated with PDD in children.