阿立哌唑在发育障碍儿童和青少年中未按药品说明书用药的临床疗效及不良反应

Clinical effects and adverse reactions of off-label use of aripiprazole in children and adolescents with developmental disabilities.

作者信息

Valicenti-McDermott Maria R, Demb Howard

机构信息

Children's Evaluation and Rehabilitation Center, R.F. Kennedy Center of Excellence in Developmental Disabilities, Albert Einstein College of Medicine, Bronx, New York, USA.

出版信息

J Child Adolesc Psychopharmacol. 2006 Oct;16(5):549-60. doi: 10.1089/cap.2006.16.549.

Abstract

OBJECTIVE

The aim of this study was to report on the clinical efficacy and side effects of aripiprazole in treating behavioral symptoms of children with a developmental disability (DDs).

DESIGN/METHODS: A retrospective chart review of the first 32 children treated with aripiprazole at an urban clinic for children with DD was conducted.

RESULTS

Ages ranged from 5 to 19 years; 9 (28%) were female. Twenty four had diagnoses within the autistic spectrum and 18 had mental retardation (MR). Other disorders included: attention-deficit/hyperactivity disorder/disruptive behavior disorders (n = 13), mood disorders (n = 7), reactive attachment (n = 2), and sleep disorders (n = 2). Target symptoms included aggression, hyperactivity, impulsivity and, self-injurious behaviors. Twenty eight of the children were switched from another antipsychotic. The mean daily aripiprazole starting dose was 7.1 +/- 0.32 mg (0.17 mg/kg/day) and the mean daily maintenance dose was 10.55 +/- 6.9 mg (0.27 mg/kg/day). Aripiprazole had been used for a period between 6 and 15 months. Improvement in target symptoms was found in 56%. When treating a child with MR, the concomitant presence of an autistic spectrum diagnosis predicted a worse outcome. Side effects were reported in 16 (50%), with the most frequent being sleepiness (n = 6). Mean body mass index (BMI) rose from 22.5 to 24.1 (p = 0.003) over the follow up period, with changes in the BMI z scores. These changes were more pronounced in children younger than 12 years.

CONCLUSIONS

These results with aripiprazole in this difficult-to-treat population suggest that this medication warrants controlled studies of its effectiveness and safety.

摘要

目的

本研究旨在报告阿立哌唑治疗发育障碍(DDs)儿童行为症状的临床疗效及副作用。

设计/方法:对一家城市儿童发育障碍诊所首批接受阿立哌唑治疗的32例儿童进行回顾性病历审查。

结果

年龄范围为5至19岁;9例(28%)为女性。24例患有自闭症谱系诊断,18例患有智力障碍(MR)。其他疾病包括:注意力缺陷/多动障碍/破坏性行为障碍(n = 13)、情绪障碍(n = 7)、反应性依恋障碍(n = 2)和睡眠障碍(n = 2)。目标症状包括攻击行为、多动、冲动和自伤行为。28例儿童由另一种抗精神病药物换药而来。阿立哌唑平均每日起始剂量为7.1±0.32 mg(0.17 mg/kg/天),平均每日维持剂量为10.55±6.9 mg(0.27 mg/kg/天)。阿立哌唑使用时间为6至15个月。56%的患儿目标症状有改善。在治疗智力障碍儿童时,同时存在自闭症谱系诊断预示预后较差。16例(50%)报告有副作用,最常见的是嗜睡(n = 6)。在随访期间,平均体重指数(BMI)从22.5升至24.1(p = 0.003),BMI z评分有变化。这些变化在12岁以下儿童中更明显。

结论

阿立哌唑在这一难治性人群中的这些结果表明,该药物有必要进行有效性和安全性的对照研究。

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