A double-blind placebo controlled study of desipramine in the treatment ADD: II. Serum drug levels and cardiovascular findings.
A double-blind placebo controlled study of desipramine in the treatment ADD: II. Serum drug levels and cardiovascular findings.
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地昔帕明治疗 ADD 的双盲安慰剂对照研究：II。
DOI：
10.1097/00004583-198911000-00015
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发表时间：
1989
影响因子：
13.3
通讯作者：
Goldblatt,A
中科院分区：
文献类型：
--
作者：
Biederman,J;Baldessarini,RJ;Wright,V;Knee,D;Harmatz,JS;Goldblatt,A
在一项为期6周的儿童和青少年注意缺陷障碍伴多动（ADDH）研究中，地昔帕明（DMI）非常有效且耐受性良好，DMI治疗患者（N= 31）的平均最大每日口服剂量为4.6 ± 0.2 mg/kg。获得了27名安慰剂无应答者的额外数据，这些患者按照几乎相同的方案和平均日剂量（总计N = 58）开放给药6周。在给定剂量下，个体血清药物浓度变化很大。总的中位数血清肌酐水平为152 ng/ml，56例血清肌酐测定病例中有6例的肌酐水平超过500 ng/ml。随着年龄的增长和临床改善程度的提高，血清水平往往会升高。舒张压、心率和心电图传导参数仅出现较小的、临床上不重要但具有统计学意义的升高。DMI治疗的患者在右束支分支传导阻滞型窦性心动过速和室内传导缺陷（IVCD）的ECG证据的治疗期间显示出更高的发生率，其中2例患者发展为完全IVCD。心室率和心电图传导参数的增加，以及IVCD的发生率，在血清肌酐水平高于中位数的患者中更高。这些结果表明，尽管在某些儿童ADDH病例中可能需要使用日剂量高于3.5 mg/kg的BAD治疗，但在儿科人群中使用此类剂量时需要谨慎并监测血清药物水平和ECG。
In a 6-week study of children and adolescents with attention deficit disorder with hyperactivity (ADDH) in which desipramine (DMI) was highly effective and well tolerated, the mean maximal daily oral dose in the DMI-treated patients (N= 31) was 4.6 ± 0.2 mg/kg. Additional data were obtained for 27 placebo nonresponders given DMI openly for 6 additional weeks following a nearly identical protocol and mean daily doses (totalN= 58). Individual serum drug concentration varied widely at a given dose. The overall median serum DMI level was 152 ng/ml and in 6 of 56 cases with assayed serum (DMI), the level exceeded 500 ng/ml. Serum tended to be higher with older age and greater clinical improvement. Only small, clinically unimportant but statistically significant increases in diastolic blood pressure, heart rate, and electrocardiographic conduction parameters occurred. DMI-treated patients showed higher incidence during DMI treatment of sinus tachycardia and ECG evidence of intraventricular conduction defect (IVCD) of the right bundle branch block type, with two of these patients developing complete IVCD. Increases in ventricular rate and in ECG conduction parameters, as well as the incidence of IVCD, were higher in patients attaining serum levels of DMI above the median. These findings suggest that, although treatment with DMI at daily doses above 3.5 mg/kg may be needed in some cases of childhood ADDH, such doses require caution and monitoring of serum drug levels and ECG when they are used in the pediatric population.
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