盐酸托莫西汀治疗儿童多动症合并短暂性抽动障碍的临床疗效及安全性评价

Clinical efficacy and safety of atomoxetine hydrochloride in the treatment of attention deficit hyperactivity disorder with transient tic disorder

目的评价盐酸托莫西汀治疗儿童多动症合并短暂性抽动障碍的临床疗效和安全性。方法将60例多动症合并短暂性抽动障碍的患儿随机分为对照组30例和试验组30例。对照组予以盐酸哌甲酯10 mg,qd;试验组予以盐酸托莫西汀0.5 mg·kg^(-1),qd,第1~7天,7 d后,增加剂量到1.2 mg·kg^(-1),但最大剂量不得超过1.4 mg·kg^(-1)。2组患儿均连续服药2个月。比较2组患儿的临床疗效、治疗前后注意缺陷(AD)、多动冲动(HI)、注意缺陷多动障碍(ADHD)的评分和不良反应发生率。结果治疗后,试验组ADHD和短暂性抽动障碍的总有效率显著高于对照组(83.33%vs 76.67%,80.00%vs 53.33%,P<0.05)。治疗后,2组患儿的AD、HI、ADHD评分较治疗前均有所下降,且试验组治疗后评分明显低于对照组(P<0.05)。试验组的不良反应发生率为56.67%略低于对照组的60.00%,差异无统计学意义(P>0.05)。结论盐酸托莫西汀治疗儿童多动症合并短暂性抽动障碍的临床疗效明显优于盐酸哌甲酯,且不增加不良反应的发生率。

Objective To evaluate the clinical efficacy and safety of atomoxetine on attention deficit hyperactivity disorder（ADHD） children with transient tic disorder. Methods Sixty children of ADHD combined with transient tic disorder were randomly divided into control group（n = 30） and treatment group（n = 30）. Control group was treated with hydrochloric acid 10 mg,once a day. Treatment group was treated with atomoxetine hydrochloride 0. 5 mg·kg^-1,qd,day 1-7,after 7 days,increase the dose to 1. 2 mg · kg^-1,but the maximum dose should not exceed 1. 4 mg · kg^-1. Two groups of children were treated for 2months. The clinical efficacy,attention deficit（AD）,hyperactivity impulse（HI）,ADHD score and the incidence of adverse drug reactions were compared between two groups. Results After treatment,the total effective rates of ADHD symptoms and transient tic disorder in treatment group were significantly higher than those of control group（83. 33% vs76. 67%,80. 00% vs 53. 33%,P〈0. 05）. After treatment,the AD,ADHD,HI scores of two groups were significantly lower than those before treatment,and the score of treatment group was significantly better than that of control group（P〈0. 05）. The incidence of adverse drugreactions in the treatment group was slightly lower than that of control group without statistically significant difference（56. 67% vs 60. 00%,P〉0. 05）. Conclusion Atomoxetine hydrochloride has a definitive clinical efficacy for the treatment of ADHD combined with transient tic disorder,without increasing of the incidence of adverse drug reactions.