注意缺陷多动障碍儿童服用盐酸托莫西汀治疗的有效性和安全性研究

目的 注意缺陷多动障碍（ADHD）儿童服用盐酸托莫西汀治疗12周,评价其疗效和安全性.方法 共110例ADHD儿童,口服盐酸托莫西汀治疗12周,在第0、4、8、12周,采用Swanson儿童行为量表第4版（SNAP-Ⅳ）评分量表和第0和12周Conners父母问卷评估疗效,副反应量表评估用药安全性.结果 SNAP-Ⅳ量表显示评分在第4周、第8周、第12周与基线相比明显降低,且与基线相比有统计学差异（P＜0.01）；在第12周时,Conners父母问卷评分与基线相比,6个观察因子（品行问题、学习问题、心身障碍、冲动-多动、焦虑、多动指数）评分均降低,且有统计学意义（P＜0.01）.最多见的副反应是消化系统症状,发生率约为30％,主要表现为食欲减退或厌食；其次是神经系统症状,发生率为4.55％,但所有的副反应均为轻度或可疑.结论 ADHD儿童服用盐酸托莫西汀有效,起效较慢,无严重不良反应,使用安全,但要及时处理出现的药物不良反应,提高用药依从性.

An efficacy and safety study on atomoxetine hydrochloride which was used to treat children with attention deficit hyperactivity disorder

Objective To evaluate the efficacy and safety after a 12-week treatment with atomoxetine hydrochloride（ATX） for the children with attention deficit hyperactivity disorder（ADHD）.Methods For a total of 110 cases of the children with ADHD,who were treated with oral ATX for 12 weeks,estimate the efficacy by using Swanson Child Behavior Scale Ⅳ （SNAP-Ⅳ）for the weeks of 0,4th,8th and 12th,and by using Conners Parents Questionnaire for the weeks of 0 and 12th; and assess the safety by using Treatment Emergent Symptom Scale （TESS）.Results The scores of the SNAP-Ⅳfor the weeks of 4th,8th and 12th were significantly lower than the baseline,and the difference was statistically significant（P 〈 0.01）.The score of Conners Parents Questionnaire for the week of 12th was lower than the baseline and statistically significant （P 〈 0.01）,for all 6 observing factors,including morality problem,study problem,psychosomatic disorder,impulse-hyperactivity,anxiety and hyperactive index.The most common side effect was the gastrointestinal symptoms with an incidence rate of about 30%,mainly appeared with anorexia or apocleisis;the secondly common side effect was neurological symptoms with an incidence rate of 4.55%.But all these side effects were mild or doubtable.Conclusions This study shows that it＇s effective for the ADHD children to be treated with ATX,although ATX works slowly,it＇s also safe,and no serious adverse even occurred.However,the drug adverse reaction should be taken care in time to improve the compliance.