Prince J B, Wilens T E, Biederman J, Spencer T J, Millstein R, Polisner D A, Bostic J Q
Consolidated Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston 02114, USA.
J Child Adolesc Psychopharmacol. 2000 Fall;10(3):193-204. doi: 10.1089/10445460050167304.
To study the efficacy and tolerability of nortriptyline (NT) in the treatment of pediatric attention deficit hyperactivity disorder (ADHD).
Subjects were outpatient children and adolescents with ADHD ascertained from clinical referrals. Subjects were enrolled in a 6-week open study in which NT was titrated to 2 mg/kg/day as tolerated over 2 weeks. Using either a 30 % reduction in the ADHD rating scale or a score of 1 or 2 on the Clinical Global Impression (CGI) scale for ADHD improvement, responders to treatment were then randomized into a 3-week, controlled discontinuation phase. During this phase, subjects either continued on their current dose of NT or were tapered to placebo under double-blind conditions. Subjects were monitored for symptoms of ADHD, oppositionality, anxiety, and depression.
Of the 35 subjects enrolled in the study, 32 completed the open phase and 23 completed the discontinuation phase. The mean dose of NT was 80 mg (1.8 mg/kg/day), resulting in a serum level of 81 ng/ml. At the conclusion of the open 6-week study, NT was related to a significant reduction in ADHD (p < 0.001) and oppositional symptoms (p < 0.001). At the conclusion of the discontinuation phase, the 12 subjects randomized to NT had significantly lower scores on the DSM-IV ADHD symptom checklist than those 11 subjects randomized to placebo (31 versus 21; t = 2.2; p < 0.04). No significant adverse events were observed, and children were noted to have weight gain during the trial.
These data suggest that NT is effective in reducing symptoms not only of ADHD but also of oppositionality. This group of children and adolescents tolerated robust dosing of NT well, with few clinical or cardiovascular adverse events.
研究去甲替林（NT）治疗小儿注意力缺陷多动障碍（ADHD）的疗效和耐受性。
研究对象为经临床转诊确诊的门诊ADHD儿童及青少年。研究对象参与了一项为期6周的开放性研究，在2周内根据耐受情况将NT滴定至2mg/kg/天。以ADHD评定量表评分降低30%或临床总体印象（CGI）量表中ADHD改善评分为1或2作为标准，将治疗有效者随机分为为期3周的对照停药阶段。在此阶段，研究对象要么继续服用当前剂量的NT，要么在双盲条件下逐渐减量至安慰剂。监测研究对象的ADHD、对立违抗、焦虑和抑郁症状。
该研究纳入的35名研究对象中，32名完成了开放阶段，23名完成了停药阶段。NT的平均剂量为80mg（1.8mg/kg/天），血清水平为81ng/ml。在为期6周的开放性研究结束时，NT与ADHD（p<0.001）及对立违抗症状（p<0.001）的显著减轻相关。在停药阶段结束时，随机分配至NT组的12名研究对象在DSM-IV ADHD症状清单上的得分显著低于随机分配至安慰剂组的11名研究对象（31分对21分；t=2.2；p<0.04）。未观察到显著不良事件，且在试验期间注意到儿童体重增加。
这些数据表明，NT不仅对减轻ADHD症状有效，对减轻对立违抗症状也有效。这群儿童及青少年对大剂量NT耐受性良好，临床或心血管不良事件较少。
