Aripiprazole Monotherapy in Children and Young Adolescents with Pervasive Developmental Disorders A Retrospective Study
Aripiprazole Monotherapy in Children and Young Adolescents with Pervasive Developmental Disorders A Retrospective Study
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DOI：
10.2165/00023210-200923060-00005
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发表时间：
2009-01-01
期刊：
影响因子：
6
通讯作者：
Salvadori, Francesco
中科院分区：
文献类型：
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作者：
Masi, Gabriele;Cosenza, Angela;Salvadori, Francesco
背景资料：广泛性发育障碍（PDD）是严重的精神疾病，其特征是社会互动、语言和非语言交流受损，以及兴趣和行为模式受限和定型，在出生后3年内发病。适当的药物治疗可以改善一些异常的症状和行为，并增加人对非药物干预的反应。目的：描述阿立哌唑单药治疗PDDs和严重行为障碍儿童的临床结果或症状变化，以及自然治疗期间的不良反应（如对自己和/或他人的攻击，敌意，多动症，严重的冲动）。方法：这项回顾性自然主义研究包括34名患者（23名男性和11名女性，年龄范围4.5-15岁，平均年龄10.2 +/- 3.3岁），2006-2007年住院，根据DSM-IV诊断标准，随访4-12个月，平均7.0 ± 3.6个月。结果的措施是三个全球措施的临床和功能障碍和改善从基线：临床总体印象严重程度（CGI-S）和CGI-I改善（CGI-I）规模;儿童的全球评估量表（C-GAS）;和儿童自闭症评定量表（汽车），PDD symptoms.Results的具体措施：平均基线CGI-S为5.7 +/- 0.8（显着生病/重病）。阿立哌唑的平均最终剂量为8.1 ± 4.9 mg/天。在终点时，11例患者（32.4%）为“大幅改善”或“非常改善”（CGI-I评分为1或2），12例患者（35.3%）为“轻微改善”（CGI-I评分为3），10例患者（29.4%）为“不变”或“恶化”（CGI-I评分为4或5）。C-GAS和汽车评分显著改善（p < 0.0001，效应量分别为0.59和0.62）。9名患者（26.5%）出现中度至重度激越，其中5名患者与自伤行为相关，5名患者出现睡眠障碍。12例患者（35.3%）在随访期间停止用药，因为缺乏疗效或不良反应。结论：在这些严重受损的儿童PDDs，阿立哌唑单药治疗与三分之一的患者的适应不良行为的显着改善。躁动和失眠是最常见的不良反应。需要在更大的样本中进行进一步的对照研究，以探索疗效的可能预测因素。
Background: Pervasive developmental disorders (PDDs) are severe psychiatric disorders characterized by impairment in social interactions, in verbal and non-verbal communication, and by restricted and stereotyped patterns of interest and behaviour, with onset in the First 3 years of life. The appropriate use of pharmacotherapy can improve some aberrant symptoms and behaviours and increase the person's response to non-pharmacological interventions.Objective: To describe clinical outcomes, or symptom changes, and adverse effects during naturalistic treatment with aripiprazole monotherapy in children with PDDs and severe behavioural disorders (such as aggression against self and/or others, hostility, hyperactivity, severe impulsiveness).Method: This retrospective naturalistic study included 34 patients (23 males and 11 females, age range 4.5-15 years, mean age 10.2 +/- 3.3 years), admitted during 2006-2007, diagnosed according to DSM-IV criteria and followed up for 4-12 months (mean 7.0 +/- 3.6 months). Outcome measures were three global measures of clinical and functional impairment and improvement from baseline: the Clinical Global Impression-Severity (CGI-S) and CGI-Improvement (CGI-I) scales; the Children's Global Assessment Scale (C-GAS); and the Childhood Autism Rating Scale (CARS), a specific measure of PDD symptoms.Results: The mean baseline CGI-S was 5.7 +/- 0.8 (markedly ill/severely ill). The mean final dosage of aripiprazole was 8.1 +/- 4.9 mg/day. At the endpoint, 11 patients (32.4%) were 'much improved' or 'very much improved' (CGI-I score of 1 or 2), 12 patients (35.3%) were 'minimally improved' (CGI-I score of 3) and 10 (29.4%) were 'unchanged' or 'worsened' (CGI-I score of 4 or 5). C-GAS and CARS scores significantly improved (p < 0.0001, effect sizes 0.59 and 0.62, respectively). Nine patients (26.5%) experienced moderate to severe agitation, which was associated with self-injurious behaviours in five of these patients, and five patients presented with sleep disorders. Twelve patients (35.3%) discontinued medication during the follow-up because of lack of efficacy or adverse effects.Conclusions: In these severely impaired children with PDDs, aripiprazole monotherapy was associated with a significant improvement in maladaptive behaviours in one-third of patients. Agitation and insomnia were the most frequent adverse effects. Further controlled studies in larger samples to explore possible predictors of efficacy are warranted.