Svanborg Pär, Thernlund Gunilla, Gustafsson Per A, Hägglöf Bruno, Poole Lynne, Kadesjö Björn
Eli Lilly Sweden AB, Gustav III Boulevard 42, Box 721, 169 27, Solna, Sweden.
Eur Child Adolesc Psychiatry. 2009 Apr;18(4):240-9. doi: 10.1007/s00787-008-0725-5. Epub 2009 Jan 20.
The primary objective of this study was to assess the impact of atomoxetine in combination with psychoeducation, compared with placebo and psychoeducation, on health-related quality of life (HRQL) in Swedish stimulant-naïve pediatric patients with attention deficit/hyperactivity disorder (ADHD). HRQL results will be presented elsewhere. Here, psychoeducation as well as efficacy and safety of the treatment are described.
A total of 99 pediatric ADHD patients were randomized to a 10-week double-blind treatment with atomoxetine (49 patients) or placebo (50 patients). Parents of all patients received four sessions of psychoeducation. Atomoxetine was dosed up to approximately 1.2 mg/kg day (< or = 70 kg) or 80 mg/day (> 70 kg). Improvement of ADHD symptoms was evaluated using the ADHD rating scale (ADHD-RS) and clinical global impression (CGI) rating scales. Safety was assessed based on adverse events (AEs).
The study population was predominantly male (80.8%) and diagnosed with the combined ADHD subtype (77.8%). The least square mean (lsmean) change from baseline to endpoint in total ADHD-RS score was -19.0 for atomoxetine patients and -6.3 for placebo patients, resulting in an effect size (ES) of 1.3 at endpoint. Treatment response (reduction in ADHD-RS score of > or = 25 or > or = 40%) was achieved in 71.4 or 63.3% of atomoxetine patients and 28.6 or 14.3% of placebo patients. The lsmean change from baseline to endpoint in CGI-Severity was -1.8 in the atomoxetine group compared with -0.3 in the placebo group. The difference between treatments in CGI-Improvement at endpoint was -1.4 in favor of atomoxetine. No serious AEs occurred. The safety profile of atomoxetine was in line with the current label.
Atomoxetine combined with psychoeducation was superior to placebo and psychoeducation in ADHD core symptoms improvement. The large ES might be a result of including stimulant-naïve patients only, but also may indicate a positive interaction between atomoxetine treatment and psychoeducation, possibly by increased compliance.
本研究的主要目的是评估与安慰剂加心理教育相比，托莫西汀联合心理教育对瑞典未使用过兴奋剂的注意力缺陷/多动障碍（ADHD）儿科患者健康相关生活质量（HRQL）的影响。HRQL结果将在其他地方公布。在此，描述心理教育以及治疗的有效性和安全性。
总共99例儿科ADHD患者被随机分配接受为期10周的双盲治疗，其中49例患者使用托莫西汀，50例患者使用安慰剂。所有患者的家长均接受了4次心理教育课程。托莫西汀的剂量最高可达约1.2mg/kg/天（体重≤70kg）或80mg/天（体重＞70kg）。使用ADHD评定量表（ADHD-RS）和临床总体印象（CGI）评定量表评估ADHD症状的改善情况。根据不良事件（AE）评估安全性。
研究人群以男性为主（80.8%），诊断为ADHD混合型亚型（77.8%）。托莫西汀组患者从基线到终点的ADHD-RS总分最小二乘均值（lsmean）变化为-19.0，安慰剂组为-6.3，终点时效应大小（ES）为1.3。71.4%或63.3%的托莫西汀组患者以及28.6%或14.3%的安慰剂组患者实现了治疗反应（ADHD-RS评分降低≥25或≥40%）。托莫西汀组从基线到终点的CGI-严重程度lsmean变化为-1.8，而安慰剂组为-0.3。终点时治疗在CGI-改善方面的差异为-1.4，有利于托莫西汀。未发生严重不良事件。托莫西汀的安全性概况与当前标签一致。
托莫西汀联合心理教育在改善ADHD核心症状方面优于安慰剂加心理教育。较大的效应大小可能是仅纳入未使用过兴奋剂的患者的结果，但也可能表明托莫西汀治疗与心理教育之间存在积极的相互作用，可能是通过提高依从性实现的。
