Department of Child and Adolescent Psychiatry, Ege University School of Medicine, Bornova, Izmir, Turkey.
Pharmacopsychiatry. 2012 Jan;45(1):13-9. doi: 10.1055/s-0031-1286348. Epub 2011 Oct 12.
The aim of this study was to determine the eff ectiveness and safety of aripiprazole in children and adolescents with both attention deficit/hyperactivity disorder (ADHD) and conduct disorder (CD).
20 children and adolescents, ranging in age from 6–16 years, participated in a singlecenter, open-label study (19 to completion). We began treating patients with 2.5 mg of aripiprazole in an open-label fashion for 8 weeks. Outcome measures included the Turgay DSM-IVbased child and adolescent behavior disorders screening and rating scale (T-DSM-IV), the clinical global impressions-severity and improvement scales (CGI-S and CGI-I), the child behavior checklist (CBCL), the teachers report form (TRF) and the extrapyramidal symptom rating scale (ESRS), along with laboratory assessments.
The mean daily dosage of aripiprazole at the end of 8 weeks was 8.55 mg (SD = 1.73), with a maximum dosage of 10 mg. Based on the global improvement subscale of the CGI, we classified 12 of 19 patients (63.1 %) as responders (very much or much improved). We observed significant improvements after aripiprazole treatment with regard to inattention, hyperactivity/impulsivity, ODD, and CD subscales of the T-DSMIV (parent, teacher and clinician forms). We also observed significant improvements on many of the CBCL and TRF subscales (e. g., attention problems as well as delinquent and aggressive behavior). The participants tolerated aripiprazole, and no patient was excluded from the study because of adverse drug events.
Aripiprazole is an eff ective and well-tolerated treatment for ADHD and CD symptoms; however, additional studies (specifically, placebo-controlled and double-blind studies) are needed to better defi ne the clinical use of aripiprazole in children and adolescents with ADHD-CD.
本研究旨在确定阿立哌唑治疗伴有注意缺陷多动障碍(ADHD)和品行障碍(CD)的儿童和青少年的疗效和安全性。
20 名年龄在 6-16 岁的儿童和青少年参加了一项单中心、开放标签研究(19 例完成)。我们以开放标签的方式开始用 2.5mg 阿立哌唑治疗患者,为期 8 周。疗效评估包括基于 DSM-IV 的儿童和青少年行为障碍筛查和评定量表(T-DSM-IV)、临床总体印象严重程度和改善量表(CGI-S 和 CGI-I)、儿童行为检查表(CBCL)、教师报告表(TRF)和锥体外系症状评定量表(ESRS),以及实验室检查。
8 周末阿立哌唑的平均日剂量为 8.55mg(SD=1.73),最大剂量为 10mg。根据 CGI 的总体改善子量表,我们将 19 例患者中的 12 例(63.1%)归类为应答者(明显改善)。我们观察到阿立哌唑治疗后 T-DSMIV 的注意力不集中、多动/冲动、对立违抗性障碍和品行障碍子量表(家长、教师和临床医生评定表)有显著改善。我们还观察到 CBCL 和 TRF 的许多子量表(例如,注意力问题以及违法行为和攻击行为)有显著改善。参与者耐受阿立哌唑,没有患者因药物不良反应而被排除研究。
阿立哌唑是治疗 ADHD 和 CD 症状的有效且耐受性良好的药物;然而,需要进一步的研究(特别是安慰剂对照和双盲研究)来更好地定义阿立哌唑在 ADHD-CD 儿童和青少年中的临床应用。