Findling Robert L, Aman Michael G, Eerdekens Marielle, Derivan Albert, Lyons Ben
Department of Psychiatry, Case Western Reserve University, University Hospital of Cleveland, OH 44106, USA.
Am J Psychiatry. 2004 Apr;161(4):677-84. doi: 10.1176/appi.ajp.161.4.677.
This study determined the long-term safety and effectiveness of risperidone in treating severe disruptive behavior in children with subaverage intelligence.
This 48-week, open-label extension included 107 children ages 5-12 years with severe disruptive behavior disorders (according to DSM-IV criteria and a score of > or = 24 on the conduct problem subscale of the Nisonger Child Behavior Rating Form) and subaverage intelligence (IQ 36-84) who completed at least 2 weeks of a randomized, double-blind, placebo-controlled study of risperidone. All patients received 0.02-0.06 mg/kg/day of oral risperidone; the purpose was to accumulate long-term safety data. Scores on the Nisonger Child Behavior Rating Form were also obtained.
The mean risperidone dose was 1.5 mg/day. The most common adverse events reported were somnolence (33%), headache (33%), rhinitis (28%), and weight gain (21%). Somnolence was usually mild and transient. The mean weight increase was 5.5 kg; half was attributable to developmentally expected growth. Transient and asymptomatic increases in prolactin levels were observed. There were no significant changes in Extrapyramidal Symptom Rating Scale scores and no cases of tardive dyskinesia. No clinically relevant changes in ECGs or vital signs were noted. Risperidone was associated with rapid, significant improvement on the conduct problem subscale score of the Nisonger Child Behavior Rating Form in patients previously treated with placebo; improvement was maintained during long-term treatment and in patients previously given risperidone.
Long-term risperidone appears to be generally safe, well tolerated, and effective for treating severely disruptive behaviors in children with subaverage intelligence.
本研究确定利培酮治疗智力发育迟缓儿童严重破坏性行为的长期安全性和有效性。
这项为期48周的开放标签扩展研究纳入了107名5至12岁的儿童，这些儿童患有严重破坏性行为障碍（根据《精神疾病诊断与统计手册》第四版标准，在尼森格儿童行为评定量表的品行问题分量表上得分≥24）且智力发育迟缓（智商36 - 84），他们完成了至少2周的利培酮随机、双盲、安慰剂对照研究。所有患者接受0.02 - 0.06 mg/kg/天的口服利培酮；目的是积累长期安全性数据。还获取了尼森格儿童行为评定量表的得分。
利培酮的平均剂量为1.5 mg/天。报告的最常见不良事件为嗜睡（33%）、头痛（33%）、鼻炎（28%）和体重增加（21%）。嗜睡通常为轻度且短暂。平均体重增加5.5 kg；其中一半归因于发育预期的生长。观察到催乳素水平有短暂且无症状的升高。锥体外系症状评定量表得分无显著变化，也无迟发性运动障碍病例。未观察到心电图或生命体征有临床相关变化。在先前接受安慰剂治疗的患者中，利培酮与尼森格儿童行为评定量表品行问题分量表得分快速、显著改善相关；在长期治疗期间以及先前接受利培酮治疗的患者中，改善得以维持。
长期使用利培酮治疗智力发育迟缓儿童的严重破坏性行为似乎总体安全、耐受性良好且有效。
