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地昔帕明与安慰剂治疗慢性抽动障碍合并注意缺陷多动障碍儿童及青少年的双盲对照研究

A double-blind comparison of desipramine and placebo in children and adolescents with chronic tic disorder and comorbid attention-deficit/hyperactivity disorder.

作者信息

Spencer Thomas, Biederman Joseph, Coffey Barbara, Geller Daniel, Crawford Margaret, Bearman Sarah Kate, Tarazi Reem, Faraone Stephen V

机构信息

Pediatric Psychopharmacology Unit, Psychiatry Service, Massachusetts General Hospital, Boston, MA 02114, USA.

出版信息

Arch Gen Psychiatry. 2002 Jul;59(7):649-56. doi: 10.1001/archpsyc.59.7.649.

Abstract

BACKGROUND

Currently, there is no consensus on the best therapeutic approach to chronic tic disorders and comorbid attention-deficit/hyperactivity disorder (ADHD). To address this issue, we evaluated the tolerability and efficacy of the noradrenergic tricyclic antidepressant desipramine hydrochloride in the treatment of children and adolescents with chronic tic disorders and comorbid ADHD.

METHODS

Forty-one children and adolescents with chronic tic disorders, including Tourette disorder and comorbid ADHD, were studied in a 6-week, double-blind, placebo-controlled, parallel trial. Desipramine was titrated weekly up to 3.5 mg/kg per day. We rated ADHD and tic symptoms weekly and monitored adverse effects, laboratory findings, and cardiovascular parameters.

RESULTS

Treatment with desipramine (mean total daily dose, 3.4 mg/kg per day) was well tolerated without meaningful adverse effects. Desipramine significantly reduced core symptoms of ADHD (ADHD Rating Scale; 42% decrease from baseline relative to placebo, P<.001), with equal response in inattentive symptoms and hyperactive/impulsive symptoms (P<.001 for both). The ADHD response rate was robust (71% vs 0%; desipramine vs placebo, P<.001). Likewise, desipramine significantly reduced tic symptoms (Yale Global Tic Severity Scale; 30% decrease from baseline relative to placebo, P<.001), with equal response in motor and phonic tic symptoms (P<.01 for both). The tic response rate was substantial (58% vs 5%; desipramine vs placebo, P<.001). There were small but statistically significant differences between desipramine and placebo in heart rate and blood pressure.

CONCLUSIONS

Treatment with desipramine was well tolerated and was associated with robust clinically significant reductions in tic and ADHD symptoms in children and adolescents with chronic tic disorders and ADHD diagnoses.

摘要

背景

目前,对于慢性抽动障碍及共病注意力缺陷多动障碍(ADHD)的最佳治疗方法尚无共识。为解决这一问题,我们评估了去甲肾上腺素能三环类抗抑郁药盐酸地昔帕明治疗患有慢性抽动障碍及共病ADHD的儿童和青少年的耐受性和疗效。

方法

在一项为期6周的双盲、安慰剂对照、平行试验中,对41名患有慢性抽动障碍(包括图雷特氏障碍及共病ADHD)的儿童和青少年进行了研究。地昔帕明每周滴定至每日3.5毫克/千克。我们每周对ADHD和抽动症状进行评分,并监测不良反应、实验室检查结果和心血管参数。

结果

地昔帕明治疗(平均每日总剂量为3.4毫克/千克)耐受性良好,无明显不良反应。地昔帕明显著降低了ADHD的核心症状(ADHD评定量表;相对于安慰剂,从基线下降42%,P<0.001),在注意力不集中症状和多动/冲动症状方面反应相同(两者均P<0.001)。ADHD的反应率很高(地昔帕明组与安慰剂组相比为71%对0%,P<0.001)。同样,地昔帕明显著降低了抽动症状(耶鲁综合抽动严重程度量表;相对于安慰剂,从基线下降30%,P<0.001),在运动性和发声性抽动症状方面反应相同(两者均P<0.01)。抽动的反应率很高(地昔帕明组与安慰剂组相比为58%对5%,P<0.001)。地昔帕明与安慰剂在心率和血压方面存在微小但具有统计学意义的差异。

结论

地昔帕明治疗耐受性良好,与患有慢性抽动障碍和ADHD诊断的儿童和青少年抽动及ADHD症状的显著临床改善相关。

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