Croonenberghs Jan, Fegert Joerg M, Findling Robert L, De Smedt Goedele, Van Dongen Stefan
University Center of Child and Adolescent Psychiatry, University of Antwerp, Belgium.
J Am Acad Child Adolesc Psychiatry. 2005 Jan;44(1):64-72. doi: 10.1097/01.chi.0000145805.24274.09.
To determine the long-term safety and effectiveness of risperidone for severe disruptive behaviors in children.
A multisite, 1-year, open-label study of patients aged 5 to 14 years with disruptive behaviors and subaverage intelligence was conducted.
Seventy-three percent of the 504 patients enrolled completed the study. The mean +/- SE dose of risperidone was 1.6 +/- 0.0 mg/day. The most common adverse events were somnolence (30%), rhinitis (27%), and headache (22%). The incidence of movement disorders was low, and mean Extrapyramidal Symptom Rating Scale scores decreased during risperidone treatment. No clinically significant changes in mean laboratory values were noted, except for a transient increase in serum prolactin levels. Scores on the Nisonger Child Behavior Rating Form Conduct Problem Scale improved significantly as early as week 1, and improvement was maintained throughout the trial (p < .001 at each time point). Significant improvements were noted on positive social behavior and other Nisonger Child Behavior Rating Form subscales, Aberrant Behavior Checklist, Clinical Global Impressions scale, and tests of patients' cognitive function (each p < .001).
Risperidone was well tolerated and effective in the long-term treatment of disruptive behavior disorders in children with subaverage intelligence.
确定利培酮治疗儿童严重破坏性行为的长期安全性和有效性。
对504例年龄在5至14岁、有破坏性行为且智力低于平均水平的患者进行了一项为期1年的多中心开放标签研究。
入组的504例患者中有73%完成了研究。利培酮的平均±标准误剂量为1.6±0.0毫克/天。最常见的不良事件为嗜睡（30%）、鼻炎（27%）和头痛（22%）。运动障碍的发生率较低，且在利培酮治疗期间锥体外系症状评定量表的平均得分有所下降。除血清催乳素水平短暂升高外，未观察到平均实验室值有临床显著变化。尼森格儿童行为评定表品行问题量表得分早在第1周就有显著改善，且在整个试验过程中持续改善（各时间点p<0.001）。在积极社交行为和尼森格儿童行为评定表的其他子量表、异常行为清单、临床总体印象量表以及患者认知功能测试方面均有显著改善（各p<0.001）。
利培酮对智力低于平均水平的儿童破坏性行为障碍的长期治疗耐受性良好且有效。
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