利培酮治疗品行障碍儿童和青少年：一项单中心、开放标签研究。
Risperidone in children and adolescents with conduct disorder: a single-center, open-label study.
作者信息
Ercan Eyüp Sabri, Kutlu Ayşe, Cıkoğlu Sibel, Veznedaroğlu Baybars, Erermiş Serpil, Varan Azmi
机构信息
Departments of Child and Adolescent Psychiatry, Ege University, School of Medicine, Bornova, İzmir, Turkey.
Department of Psychiatry, Ege University, School of Medicine, Bornova, İzmir, Turkey.
出版信息
Curr Ther Res Clin Exp. 2003 Jan;64(1):55-64. doi: 10.1016/S0011-393X(03)00006-7.
BACKGROUND
Risperidone is one of the most commonly used atypical antipsychotic drugs in the treatment of children and adolescents. However, the data about its use in children and adolescents with conduct disorder (CD) are limited.
OBJECTIVE
The aim of this study was to investigate the effectiveness and tolerability of risperidone in controlling major symptoms of CD in children and adolescents diagnosed with attention deficit hyperactivity disorder (ADHD), oppositional defiant disorder (ODD), and severe CD.
METHODS
Children and adolescents were eligible for this single-center, open-label study if they met the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnostic criteria for ADHD and ODD and also were diagnosed with severe CD. The patients were treated with risperidone in an open-label fashion for 8 weeks, starting at a daily dosage of 0.25 mg or 0.5 mg (depending on their body weight) in 2 divided doses.
RESULTS
The study population comprised 21 children and adolescents (17 boys, 4 girls) with a mean (SD) age of 10.8 (3.6) years. The mean (SD) dosage of risperidone at the end of 8 weeks of treatment was 1.27 (0.42) mg/d (range, 0.75-2.0 mg/d). On the basis of the global improvement subscale of the Clinical Global Impression scale, 16 of 20 patients (80%) were classified as responders. Significant improvements were observed after risperidone treatment in the inattention, hyperactivity/impulsivity, ODD, and CD subscales of the Turgay DSM-IV-Based Child and Adolescent Behavior Disorders Screening and Rating Scale (parent and teacher forms). No severe adverse events were reported.
CONCLUSIONS
The results of this study are consistent with previous findings and suggest that risperidone may be an effective and well-tolerated atypical antipsychotic drug for the treatment of children and adolescents with CD. However, further studies, particularly placebo-controlled and double-blinded, are needed to better define the clinical use of risperidone in children and adolescents with CD.
背景
利培酮是治疗儿童和青少年最常用的非典型抗精神病药物之一。然而，关于其在患有品行障碍（CD）的儿童和青少年中的使用数据有限。
目的
本研究旨在调查利培酮对诊断为注意力缺陷多动障碍（ADHD）、对立违抗障碍（ODD）和重度CD的儿童和青少年控制CD主要症状的有效性和耐受性。
方法
如果儿童和青少年符合《精神疾病诊断与统计手册》第四版（DSM-IV）中ADHD和ODD的诊断标准且也被诊断为重度CD，则有资格参加这项单中心、开放标签研究。患者以开放标签方式接受利培酮治疗8周，起始剂量为每日0.25mg或0.5mg（取决于体重），分2次服用。
结果
研究人群包括21名儿童和青少年（17名男孩，4名女孩），平均（标准差）年龄为10.8（3.6）岁。治疗8周结束时利培酮的平均（标准差）剂量为1.27（0.42）mg/d（范围为0.75 - 2.0mg/d）。根据临床总体印象量表的总体改善分量表，20名患者中有16名（80%）被归类为有反应者。在基于Turgay DSM-IV的儿童和青少年行为障碍筛查与评定量表（家长和教师版）的注意力不集中、多动/冲动、ODD和CD分量表中，利培酮治疗后观察到显著改善。未报告严重不良事件。
结论
本研究结果与先前研究结果一致，表明利培酮可能是治疗患有CD的儿童和青少年的一种有效且耐受性良好的非典型抗精神病药物。然而，需要进一步研究，特别是安慰剂对照和双盲研究，以更好地确定利培酮在患有CD的儿童和青少年中的临床应用。
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