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阿托莫西汀治疗儿童和青少年注意缺陷多动障碍 3 至 4 年的安全性和耐受性。

Safety and tolerability of atomoxetine over 3 to 4 years in children and adolescents with ADHD.

机构信息

Department of Child & Adolescent Psychiatry, Dartmouth-Hitchcock Medical Center, 1 Rope Ferry Road, Hanover, NH 03755-1404, USA.

出版信息

J Am Acad Child Adolesc Psychiatry. 2009 Feb;48(2):176-85. doi: 10.1097/CHI.0b013e318193060e.

Abstract

OBJECTIVE

To assess the long-term safety and tolerability of atomoxetine hydrochloride in children and adolescents with attention-deficit/hyperactivity disorder treated for > or = 3 years.

METHOD

Data from 13 double-blind, placebo-controlled trials and 3 open-label extension studies were pooled. Outcome measures were patient-reported treatment-emergent adverse events (AEs); discontinuations due to AEs, serious AEs, and changes in body weight, height, vital signs, electrocardiogram, and hepatic function tests.

RESULTS

In total, 714 patients were treated with atomoxetine for > or = 3 years (mean follow-up 4.8 years [SD 1.1 years]), including a subset of 508 treated for > or = 4 years (mean follow-up 5.3 years [SD 0.8 years]). Most subjects were younger than 12 years at entry (73.8%), male (78.4%), and white (88.9%). The mean final daily dose of atomoxetine was 1.35 mg/kg (SD 0.37 mg/kg). No new or unexpected AEs were observed compared with acute-phase treatment. Less than 6% of patients exhibited aggressive/hostile behaviors, and less than 1.6% reported suicidal ideation/behavior. No clinically significant effects were seen on growth rate, vital signs, or electrocardiographic parameters, and < or = 2% of patients showed potentially clinically significant hepatic changes.

CONCLUSION

Atomoxetine was safe and well tolerated for children and adolescents with > or = 3 and/or > or = 4 years of treatment.

摘要

目的

评估盐酸托莫西汀治疗注意缺陷/多动障碍儿童和青少年 > 或 = 3 年的长期安全性和耐受性。

方法

汇总来自 13 项双盲、安慰剂对照试验和 3 项开放标签扩展研究的数据。疗效评估指标为患者报告的治疗中出现的不良事件(AE);因 AE、严重 AE 和体重、身高、生命体征、心电图和肝功能检查变化而停药的情况。

结果

共有 714 例患者接受盐酸托莫西汀治疗 > 或 = 3 年(平均随访 4.8 年[SD 1.1 年]),其中 508 例患者接受治疗 > 或 = 4 年(平均随访 5.3 年[SD 0.8 年])。大多数患者入组时年龄小于 12 岁(73.8%)、男性(78.4%)和白人(88.9%)。盐酸托莫西汀的平均最终日剂量为 1.35mg/kg(SD 0.37mg/kg)。与急性治疗相比,未观察到新的或意外的 AE。不到 6%的患者出现攻击/敌对行为,不到 1.6%的患者报告有自杀意念/行为。生长速度、生命体征或心电图参数无临床显著影响,<或= 2%的患者出现潜在临床显著的肝变化。

结论

盐酸托莫西汀治疗 > 或 = 3 年和/或 > 或 = 4 年的儿童和青少年安全且耐受良好。

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