托莫西汀与哌甲酯治疗儿童注意缺陷多动障碍门诊患者的随机双盲对照试验

Atomoxetine versus methylphenidate in paediatric outpatients with attention deficit hyperactivity disorder: a randomized, double-blind comparison trial.

作者信息

Wang Yufeng, Zheng Yi, Du Yasong, Song Dong H, Shin Yee-Jin, Cho Soo C, Kim Bung N, Ahn Dong H, Marquez-Caraveo Maria E, Gao Haitao, Williams David W, Levine Louise R

机构信息

Institute of Mental Health, Beijing Medical University, Beijing, China.

出版信息

Aust N Z J Psychiatry. 2007 Mar;41(3):222-30. doi: 10.1080/00048670601057767.

DOI:10.1080/00048670601057767

PMID:17464703

Abstract

OBJECTIVE

To (i) test whether atomoxetine is non-inferior to methylphenidate in treating symptoms of attention deficit hyperactivity disorder (ADHD) in paediatric patients; and (ii) determine the tolerability of the two drugs.

METHOD

This double-blind study was conducted in 6- to 16-year-old outpatients with ADHD (DSM-IV) in China, Korea and Mexico (January-October 2004). Patients were randomly assigned to once-daily atomoxetine (0.8-1.8 mg kg(-1) day(-1); n = 164) or twice-daily methylphenidate (0.2-0.6 mg kg(-1) day(-1); n = 166) for approximately 8 weeks. Primary efficacy assessment was the comparison of response rates (> or =40% reduction from baseline to end point in total score) on the Attention Deficit Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and -Scored. Tolerability measures included, but were not limited to, the assessment of treatment-emergent adverse events (TEAEs) and weight.

RESULTS

Atomoxetine was non-inferior to methylphenidate in improving ADHD symptoms based on response rates (atomoxetine, 77.4%; methylphenidate, 81.5%; one-sided 95% lower confidence limit = -11.7%, p = 0.404). Treatment-emergent adverse effects experienced significantly more frequently in the atomoxetine group, compared with the methylphenidate group, included anorexia (37.2% vs. 25.3%; p = 0.024), nausea (20.1% vs. 10.2%; p = 0.014), somnolence (26.2% vs. 3.6%; p <0.001), dizziness (15.2% vs. 7.2%; p = 0.024) and vomiting (11.6% vs. 3.6%; p = 0.007), most of which were of mild or moderate severity. Atomoxetine-treated patients experienced a small but significantly greater mean weight loss from baseline to end point than methylphenidate-treated patients (-1.2 kg vs. -0.4 kg; p <0.001).

CONCLUSIONS

This study suggests that atomoxetine is non-inferior to methylphenidate in the improvement of ADHD symptoms in paediatric outpatients. Although both of the drugs were well tolerated, atomoxetine was associated with a higher incidence of TEAEs than methylphenidate.

摘要

目的

（i）测试托莫西汀在治疗儿科患者注意力缺陷多动障碍（ADHD）症状方面是否不劣于哌甲酯；（ii）确定两种药物的耐受性。

方法

这项双盲研究于2004年1月至10月在中国、韩国和墨西哥对6至16岁的ADHD（DSM-IV）门诊患者进行。患者被随机分配至每日一次服用托莫西汀（0.8 - 1.8 mg·kg⁻¹·d⁻¹；n = 164）或每日两次服用哌甲酯（0.2 - 0.6 mg·kg⁻¹·d⁻¹；n = 166），疗程约8周。主要疗效评估是比较在注意力缺陷多动障碍评定量表第四版家长版（调查员实施及评分）上的有效率（从基线到终点总分降低≥40%）。耐受性指标包括但不限于对治疗中出现的不良事件（TEAE）和体重的评估。

结果

基于有效率，托莫西汀在改善ADHD症状方面不劣于哌甲酯（托莫西汀，77.4%；哌甲酯，81.5%；单侧95%置信下限 = -11.7%，p = 0.404）。与哌甲酯组相比，托莫西汀组治疗中出现的不良反应发生频率显著更高，包括厌食（37.2%对25.3%；p = 0.024）、恶心（20.1%对10.2%；p = 0.014）、嗜睡（26.2%对3.6%；p <0.001）、头晕（15.2%对7.2%；p = 0.024）和呕吐（11.