McDougle C J, Holmes J P, Bronson M R, Anderson G M, Volkmar F R, Price L H, Cohen D J
Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.
J Am Acad Child Adolesc Psychiatry. 1997 May;36(5):685-93. doi: 10.1097/00004583-199705000-00020.
To investigate the short-term safety and efficacy of risperidone in the treatment of children and adolescents with pervasive developmental disorders.
This was a 12-week, prospective, systematic, open-label trial that included 18 subjects (15 boys and 3 girls) with a mean age of 10.2 +/- 3.7 years. The sample included 11 subjects with autistic disorder, 3 with Asperger's disorder, 1 with childhood disintegrative disorder, and 3 with pervasive developmental disorder not otherwise specified. Fourteen subjects had comorbid mental retardation. Behavioral ratings were obtained during two baseline visits and again after 12 weeks of risperidone treatment.
The optimal dose of risperidone for the 18 subjects was 1.8 +/- 1.0 mg/day. On the basis of the global improvement item of the Clinical Global Impression Scale, 12 of 18 subjects were considered responders. Significant improvement was seen in measures of interfering repetitive behavior, aggression and impulsivity, and some elements of impaired social relatedness. The most common side effect was weight gain (range 10 to 35 lb).
These preliminary results suggest that risperidone may be effective for improving interfering behavioral symptoms in some children and adolescents with pervasive developmental disorders. Double-blind, placebo-controlled studies are needed before definitive statements of safety and efficacy can be made.
探讨利培酮治疗广泛性发育障碍儿童和青少年的短期安全性和疗效。
这是一项为期12周的前瞻性、系统性、开放标签试验，纳入了18名受试者（15名男孩和3名女孩），平均年龄为10.2±3.7岁。样本包括11名自闭症谱系障碍患者、3名阿斯伯格综合征患者、1名儿童期崩解性障碍患者和3名未特定的广泛性发育障碍患者。14名受试者合并智力发育迟缓。在两次基线访视期间以及利培酮治疗12周后再次进行行为评分。
18名受试者的利培酮最佳剂量为1.8±1.0毫克/天。根据临床总体印象量表的整体改善项目，18名受试者中有12名被视为有反应者。在干扰性重复行为、攻击和冲动以及社交关系受损的一些方面的测量中出现了显著改善。最常见的副作用是体重增加（范围为10至35磅）。
这些初步结果表明，利培酮可能对改善一些广泛性发育障碍儿童和青少年的干扰性行为症状有效。在能够做出关于安全性和疗效的确定性陈述之前，需要进行双盲、安慰剂对照研究。
