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安非他酮与哌甲酯治疗儿童注意力缺陷/多动障碍的随机双盲研究

Bupropion versus methylphenidate in the treatment of children with attention-deficit/hyperactivity disorder: randomized double-blind study.

作者信息

Jafarinia Morteza, Mohammadi Mohammad-Reza, Modabbernia Amirhossein, Ashrafi Mandana, Khajavi Danial, Tabrizi Mina, Yadegari Noorollah, Akhondzadeh Shahin

机构信息

Psychiatric Research Centre, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran.

出版信息

Hum Psychopharmacol. 2012 Jul;27(4):411-8. doi: 10.1002/hup.2242.

Abstract

OBJECTIVE

To compare the safety and efficacy of bupropion with methylphenidate in children and adolescents with attention-deficit/hyperactivity disorder (ADHD).

METHODS

In a 6-week randomized double-blind study, 44 patients with a DSM-IV-TR diagnosis of ADHD were randomly assigned to receive bupropion 100-150 mg/day (100 mg/day for <30 kg and 150 mg/day for >30 kg) or methylphenidate 20-30 mg/day. Symptoms were assessed using Teacher and Parent Attention-Deficit/Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) at baseline and weeks 3 and 6.

RESULTS

Forty patients had at least one post-baseline measurement, and 38 patients completed the trial. No significant difference was found between the two groups on the Parent and Teacher ADHD-RS-IV scores ([F(1, 38) = 0.266, p = 0.609] and [F(1, 38) = 0.001, p = 0.972], respectively). By week 6, 18 patients (90%) in each group achieved response on the Parent scale (Fisher's exact test p-value = 1.0). With the Teacher ADHD-RS-IV used, eight (40%) patients in the bupropion group and 12 (60%) patients in the methylphenidate group achieved response by week 6 (χ(2) (1) = 1.600, p = 0.206). Headache was observed more frequently in the methylphenidate group. Frequency of other side effects was not significantly different between the two groups.

CONCLUSIONS

Bupropion has a comparable safety and efficacy profile with methylphenidate in children and adolescents with ADHD.

摘要

目的

比较安非他酮与哌甲酯治疗儿童及青少年注意力缺陷多动障碍(ADHD)的安全性和疗效。

方法

在一项为期6周的随机双盲研究中,44例符合DSM-IV-TR诊断标准的ADHD患者被随机分配接受安非他酮100 - 150毫克/天(体重<30千克者100毫克/天,体重>30千克者150毫克/天)或哌甲酯20 - 30毫克/天。在基线、第3周和第6周时,使用教师和家长注意力缺陷多动障碍评定量表-IV(ADHD-RS-IV)对症状进行评估。

结果

40例患者至少有一次基线后测量数据,38例患者完成试验。两组在家长和教师ADHD-RS-IV评分上无显著差异(分别为[F(1, 38) = 0.266, p = 0.609]和[F(1, 38) = 0.001, p = 0.972])。到第6周时,每组18例患者(90%)在家长评定量表上达到有效反应(Fisher精确检验p值 = 1.0)。使用教师ADHD-RS-IV评定时,安非他酮组8例(40%)患者和哌甲酯组12例(60%)患者在第6周时达到有效反应(χ(2) (1) = 1.600, p = 0.206)。哌甲酯组头痛的发生率更高。两组其他副作用的发生率无显著差异。

结论

在治疗儿童及青少年ADHD方面,安非他酮与哌甲酯具有相当的安全性和疗效。

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