Risperidone in children with autism and serious behavioral problems
Risperidone in children with autism and serious behavioral problems
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DOI：
10.1056/nejmoa013171
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发表时间：
2002-08-01
影响因子：
158.5
通讯作者：
McMahon, D
中科院分区：
文献类型：
--
作者：
McCracken, JT;McGough, J;McMahon, D
背景：非典型抗精神病药物，阻断突触后多巴胺和5-羟色胺受体，在治疗成人精神分裂症方面优于传统抗精神病药物，对有严重行为障碍的自闭症儿童可能有益。然而，非典型抗精神病药物在儿童中的安全性和有效性的数据是limited.Methods我们进行了一项多中心，随机，双盲试验利培酮与安慰剂相比，用于治疗伴有严重发脾气，侵略，或自伤行为的儿童5至17岁的自闭症障碍。主要结果指标为第8周时异常行为检查表中的易怒子量表评分和临床总体免疫改善（CGI-I）量表评分。（82名男孩和19名女孩;平均[+/-SD]年龄为8.8 ± 2.7岁）被随机分配接受利培酮（49名儿童）或安慰剂（52名儿童）。利培酮治疗8周（剂量范围，每天0.5至3.5毫克）导致易怒评分下降56.9%，而安慰剂组下降14.1%（P < 0.001）。利培酮组的阳性反应率为69%（49名儿童中有34名有阳性反应），安慰剂组为12%（52名儿童中有6名，P < 0.001）。利培酮治疗组平均体重增加2.7 ± 2.9 kg，而安慰剂组平均体重增加0.8 ± 2.2 kg（P < 0.001）。食欲增加、疲劳、嗜睡、头晕和流口水在利培酮组比安慰剂组更常见（每次比较P < 0.05）。在三分之二的儿童与积极响应利培酮在8周（23 34），利益是保持在6 months.Conclusions利培酮是有效的，耐受性良好的治疗发脾气，侵略，或自伤行为的自闭症儿童。这项试验的时间很短，限制了对迟发性运动障碍等不良反应的推断。
Background Atypical antipsychotic agents, which block postsynaptic dopamine and serotonin receptors, have advantages over traditional antipsychotic medications in the treatment of adults with schizophrenia and may be beneficial in children with autistic disorder who have serious behavioral disturbances. However, data on the safety and efficacy of atypical antipsychotic agents in children are limited.Methods We conducted a multisite, randomized, double-blind trial of risperidone as compared with placebo for the treatment of autistic disorder accompanied by severe tantrums, aggression, or self-injurious behavior in children 5 to 17 years old. The primary outcome measures were the score on the Irritability subscale of the Aberrant Behavior Checklist and the rating on the Clinical Global Impressions - Improvement (CGI-I) scale at eight weeks.Results A total of 101 children (82 boys and 19 girls; mean [+/-SD] age, 8.8 +/- 2.7 years) were randomly assigned to receive risperidone (49 children) or placebo (52). Treatment with risperidone for eight weeks (dose range, 0.5 to 3.5 mg per day) resulted in a 56.9 percent reduction in the Irritability score, as compared with a 14.1 percent decrease in the placebo group (P < 0.001). The rate of a positive response, defined as at least a 25 percent decrease in the Irritability score and a rating of much improved or very much improved on the CGI-I scale, was 69 percent in the risperidone group (34 of 49 children had a positive response) and 12 percent in the placebo group (6 of 52, P < 0.001). Risperidone therapy was associated with an average weight gain of 2.7 +/- 2.9 kg, as compared with 0.8 +/- 2.2 kg with placebo (P < 0.001). Increased appetite, fatigue, drowsiness, dizziness, and drooling were more common in the risperidone group than in the placebo group (P < 0.05 for each comparison). In two thirds of the children with a positive response to risperidone at eight weeks (23 of 34), the benefit was maintained at six months.Conclusions Risperidone was effective and well tolerated for the treatment of tantrums, aggression, or self-injurious behavior in children with autistic disorder. The short period of this trial limits inferences about adverse effects such as tardive dyskinesia.