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地昔帕明治疗注意力缺陷障碍的双盲安慰剂对照研究:I. 疗效

A double-blind placebo controlled study of desipramine in the treatment of ADD: I. Efficacy.

作者信息

Biederman J, Baldessarini R J, Wright V, Knee D, Harmatz J S

出版信息

J Am Acad Child Adolesc Psychiatry. 1989 Sep;28(5):777-84. doi: 10.1097/00004583-198909000-00022.

Abstract

The tricyclic antidepressant drug desipramine (DMI) was evaluated in the treatment of young patients with attention deficit disorder with hyperactivity (ADDH) in an unselected sample of 62 clinically referred patients, 43 (69%) of whom previously responded poorly to psychostimulant treatment. The 42 children and 20 adolescents were assigned randomly to receive DMI (N = 31) or placebo (N = 31) for up to 6 weeks in a parallel groups, double-blind study. Clinically and statistically significant differences in behavioral improvement were found for DMI over placebo, at an average (+/- SEM) maximal daily dose of 4.6 +/- 0.2 mg/kg; 68% of DMI-treated patients were considered very much or much improved, compared with only 10% of placebo patients (p less than 0.001). DMI was well tolerated, even at the relatively high doses used. These findings suggest that DMI can be an effective treatment in the management of pediatric patients with ADDH, including patients who failed to respond to stimulants.

摘要

在一项针对62名临床转诊患者的非选择性样本研究中,对三环类抗抑郁药去甲丙咪嗪(DMI)治疗患有注意力缺陷多动障碍(ADDH)的年轻患者进行了评估。其中43名(69%)患者此前对精神兴奋剂治疗反应不佳。在一项平行组双盲研究中,42名儿童和20名青少年被随机分配接受DMI(N = 31)或安慰剂(N = 31)治疗,为期6周。在平均(+/- SEM)最大日剂量为4.6 +/- 0.2 mg/kg时,发现DMI在行为改善方面与安慰剂相比具有临床和统计学上的显著差异;68%接受DMI治疗的患者被认为有很大改善或有较大改善,而接受安慰剂治疗的患者只有10%(p < 0.001)。即使在使用相对高剂量的情况下,DMI的耐受性也良好。这些发现表明,DMI可以作为治疗患有ADDH的儿科患者的有效方法,包括对兴奋剂无反应的患者。

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