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目的探讨不同剂量托莫西汀治疗注意缺陷多动障碍(ADHD)的疗效和安全性。方法将2008年11月至2009年10月广州医学院荔湾医院心理门诊及住院的44例7～16岁ADHD患儿分为大剂量组21例[剂量由0.5mg(/kg·d)增至1.2mg(/kg·d)];小剂量组23例[0.5mg(/kg·d)];均每日晨顿服,共8周。在治疗前和治疗8周末,以中文版SNAP-Ⅳ家长评定量表进行疗效评定,采用治疗副反应量表(TESS)评估其治疗过程中的副反应。结果治疗后两组SNAP-Ⅳ家长评定量表总分均较治疗前下降(P<0.01)。治疗8周后,大、小剂量组有效率分别为76.1%和60.3%,差异有统计学意义(P<0.05);完全缓解率分别为47.6%和26.1%,差异有统计学意义(P<0.01)。两组均未见严重副反应,大、小剂量组常见的副反应为食欲减退(28.6%、13.0%,P<0.01),恶心(9.5%、8.7%,P>0.05),瞌睡/疲倦(19.0%、8.7%,P<0.05),头晕(4.8%、4.3%,P>0.05),腹痛(9.6%、4.3%,P>0.05)和体重下降(23.8%、8.7%,P<0.01)。结论大剂量组托莫西汀治疗儿童ADHD的疗效优于小剂量组,且安全性均较好,未出现严重副反应。
Objective To investigate the efficacy and safety of different doses of atomoxetine in the treatment of attention deficit hyperactivity disorder (ADHD). Methods From November 2008 to October 2009, 44 children aged 7-16 years old with ADHD in psychiatric outpatient department and inpatient hospital of Liwan Hospital of Guangzhou Medical College were divided into high dose group (dose: 0.5mg / kg · d) 1.2mg (/ kg · d)]; small dose group of 23 patients [0.5mg (/ kg · d)]; Before treatment and 8 weeks after treatment, the Chinese version of the SNAP-IV Parent Rating Scale was used to evaluate the curative effect. TESS was used to evaluate side effects in the course of treatment. Results After treatment, the scores of SNAP-IV Parental Rating Scale in both groups were significantly lower than those before treatment (P <0.01). After 8 weeks of treatment, the effective rates of the large and small dose groups were 76.1% and 60.3%, respectively, with significant difference (P <0.05). The complete remission rates were 47.6% and 26.1%, respectively, with significant differences (P < 0.01). Serious side effects were not seen in both groups. The common adverse reactions in large and small dose groups were loss of appetite (28.6%, 13.0%, P <0.01), nausea (9.5%, 8.7%, P> 0.05), drowsiness / Dizziness (4.8%, 4.3%, P> 0.05), abdominal pain (9.6%, 4.3%, P> 0.05) and weight loss (23.8%, 8.7%, P <0.01) . Conclusion The high dose of atomoxetine is superior to the low dose group in the treatment of children with ADHD, and the safety is good without serious side effects.