注意缺陷/多动障碍儿童服用盐酸托莫西汀治疗的疗效与安全性观察

Efficacy and safety of tomoxetine hydrochloride in children with attention deficit/hyperactivity disorder

目的评估盐酸托莫西汀治疗不同亚型和不同年龄段儿童注意缺陷/多动障碍(ADHD)的疗效。方法采用开放性研究方法,选取在本院确诊为ADHD的76例患儿口服盐酸托莫西汀胶囊(25 mg qd)治疗3个月,根据DSM-Ⅳ中ADHD的诊断和分型标准,将儿童分为多动型组、注意分散为主型组和混合型组,各亚型组再次分为学龄前(≤6岁)和学龄期(6~13岁)组。临床疗效采用Swanson儿童行为量表(SNAP-Ⅳ量表)和Conners父母问卷进行评定,不良反应采用TESS量表进行监测,儿童用药依从性采用Morisky量表进行评估。结果ADHD患者的症状与年龄有关,学龄期儿童各亚型组患者的典型症状比学龄前儿童更为突出。SNAP-Ⅳ量表和Conners父母问卷调查结果显示托莫西汀对ADHD患者的多动或冲动症状在各年龄段均较明显;对学龄期儿童的学习问题和品行问题等也有改善作用,但是对各组的注意力分散症状治疗效果不明显。服用盐酸莫西汀胶囊最主要的不良反应发生为胃肠道反应如食欲下降(19.74%)、恶心(5.26%)等;漏服药是影响ADHD儿童服药依从性的重要因素。结论托莫西汀胶囊对不同年龄段和不同亚型的ADHD患者均有治疗效果,其中以学龄期及多动或冲动型症状改善最为明显,且其安全性好。

Objective To evaluate the efficacy of tomoxetine hydrochloride for attention deficit/hyperactivity disorder(ADHD)in children of different subtypes and age.Methods The open research method was used,and 76 children with ADHD diagnosed in our hospital were treated with tomoxetine hydrochloride capsule(25 mg qd)for 3 months.According to the diagnosis and typing criteria of ADHD in DSM-Ⅳ,the children were divided into 3 groups:a hyperactivity group,a distraction group,and a mixed group.Each subtype group was divided into a pre-school(≤6 years old)and a school-age(6-13 years old)group.The clinical efficacy was assessed with SNAP-Ⅳand Conners Parent Symptoms Questionnaire.The adverse drug reactions were monitored with TESS.The compliance of children was assessed with Morisky scale.Results There was a correlation between age and the typical symptoms of ADHD patients.The typical symptoms of school-age groups were more prominent than those of the pre-school groups.According to the SNAP-Ⅳand Conners Parent Symptoms Questionnaire,the obvious effect of tomoxetine on hyperactivity symptomsis observed in both school-age and pre-school children,while the distraction symptoms of each group were not obvious.The most common adverse drug reactions included the gastrointestinal symptoms,mainly appetite decline(19.74%),nausea(5.26%),and so on.The main reason for poor compliance was missing medication.Conclusion Tomoxetine has a good therapeutic effect on ADHD patients with different ages and subtypes.The most obvious effect is on hyperactivity symptoms and school-age children,and it is safe.