托莫西汀治疗儿童注意缺陷多动障碍的疗效与安全性的系统评价

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托莫西汀治疗儿童注意缺陷多动障碍的疗效与安全性的系统评价

杨红双,马爱霞

中国药科大学国际医药商学院,中国药科大学国际医药商学院

收稿日期:2014-12-01 修回日期:2014-12-01 出版日期:2015-02-25 发布日期:2015-01-25

A Systematic Review of Therapeutic Efficacy and Safety of Atomoxetine in the Treatment of Attention Deficit Hyperactivity Disorder in ChildrenYANG Hong-shuang,MA Ai-xia

China Pharmaceutical University,

Received:2014-12-01 Revised:2014-12-01 Online:2015-02-25 Published:2015-01-25

摘要/Abstract

摘要： 目的：探讨盐酸托莫西汀治疗儿童注意缺陷多动障碍(ADHD)的疗效和安全性。方法：采用Meta分析对7项盐酸托莫西汀与安慰剂对比治疗ADHD对照研究的文献进行分析。结果：本研究纳入7篇文献,均为国外文献(Jadad评分≧3分)；样本含量为1304例；Meta分析结果显示,治疗后托莫西汀组的注意缺陷／多动评定量表(ADHD—RS)总分值[MD=-5.86,95﹪CI(-7.73,-3.99)P＜0.00001］、ADHD-RS多动/冲动分量表分值[MD=-2.64,95﹪CI(-3.75,-1.52)P＜0.00001］、ADHD-RS注意缺陷分量表分值[MD=-2.35,95﹪CI(-3.87,-0.83)P＜0.00001］改善均显著优于对照组,两组比较有显著性差异；托莫西汀组患儿比对照组更容易发生腹痛、恶心、呕吐、嗜睡和食欲减退等不良反应(P<0.05)。结论：托莫西汀治疗儿童ADHD具有良好的疗效,可显著改善儿童ADHD的多动／冲动以及注意缺陷,但应注意其不良反应。

Abstract: Objective: To assess the efficacy and safety of atomoxetine hydrochloride in the treatment of attention-deficit hyperactivity disorder (ADHD). Method: 7 comparative studies of tomoxetine hydrochloride in the treatment of ADHD were analyzed by meta-analysis. Results: A total of 7 RCTs were included. The sample size was 1304 patients. Results of Meta-analysis showed that the improvement of ADHD-RS[MD=-5.86,95﹪CI(-7.73,-3.99)P＜0.00001］、ADHD-RS Hyperactivity/Impulsive[MD=-2.64,95﹪CI(-3.75,-1.52)P＜0.00001］、ADHD-RS Inattention [MD=-2.35,95﹪CI(-3.87,-0.83)P＜0.00001］in atomoxetine group were significantly greater than in control group. The incidence of abdominal pain , nausea ,somnolence , decreased appetite and vomiting in atomoxetine group were higher than in control group(P<0.05). Conclusion: Atomoxetine is effective in the treatment of children with ADHD．and can improve hyperactivity／impulsivity and attention deficit in children with ADHD. But the side effects of them should be considered．

杨红双,马爱霞. 托莫西汀治疗儿童注意缺陷多动障碍的疗效与安全性的系统评价[J]. .

参考文献

[1] Shallice T,Marzoeehi GM,Coser S,el a1．Executive function profile of children with attention deficit hyperactivity disorder[J]．Developmental Neurochopsychology,2002,21(1)：43—71．
[2] Barbara SZ,Leelawatte PI ,William C,et a1．Adjustment,social skills, and self esteem in college students with symptoms of ADHD．J Att Dis,2005,8(3)：109-120．
[3]Barkley RA．Global issues related to the impact of untreated attention—deficit／hyperactivity disorder from childhood to young adulthood[J]．Postgrad Med,2008,120(3)：48—59．
[4] Adler L,Cohen J．Diagnosis and evaluation of adults with attention-deficit／hyperactivity disorder[J]．Psychiatr Clin North Am,2004,27(2)：187-201．
[5]Kollins SH,Marcll js．Advant：es in the phammeotherapy of attention deficit hyperactivity disorder[J]．Biol Psychiatry,2007,62(9)：951—953.
[6]Brown RT,Amler RW,Freeman WS．et a1．Treatment of attention—deficit)／hyperactivity disorder：0verwiew of the evidence f J]．Pediatrics．2005,l15(6)：749—757．
[7]SCHULZ KF, ALTMAN DG, MOHER D. CONSORT 2010 statement:Updated guidelines for reporting parallel group randomized trials[J].Ann Intern Med,2010,152(11):726-732.
[8]Michelson D,Faries D,Wernicke J,et al．Atomoxetine in the treatment of children and adolescents with attention．defieit／hyperactivity disorder：a randomized,placebo—controlled,dose-response study[J]．Pediatrics,2001,108(1)：1—9.
[9]Michelson D,Allen AJ,Busner J,et a1．Once—daily atomoxetine treatment for children and adoleseents with attention decit hyperactivity disorder：a randomized,placebo—controlled study[J]．Am J Psychiatry,2002,159(11)：1896—1901．
[10] Kelsey DK,Sumner CR,Casat CD,et a1．Once—daily atomoxetine treatment for children with attention—deficit／hyperactivity disorder,including an assessment of evening and morning behavior：a double—blind,placebo—controlled trial[J]．Pediatrics,2004,l14(1)：e1．
[11] W iss M,Tannock R,Kratochvi1 C,et a1．A randomized,placebo-controlled study of once—daily atomoxetine in the school setting in children with ADHD[J]．J Am AcadChild Adolesc Psychiatry,2005,44(7)：647．
[12] Takahashi M, Takita Y, Yamazaki K, et a1．A randomized, double-blind, placebo-controlled Study of Atomoxetine in Japanese Children and Adolescents with attention-deficit/hyperactivity disorder[J]．J Child Adolesc Psychopharmacol,2009,19(4):341-350.
[13]Montoya A, Hervas A, Cardo E,et al. Evaluation of atomoxetine for first-line treatment of newly diagnosed, treatment-na?ive children and adolescents with attention deficit/hyperactivity disorder[J]．Current Medical Research Opinion,2009,25(11):2745-2754.
[14]Martenyi F,Zavadenko NN,Jarkova NB,et a1．Atomoxetine in children and adolescents with attention-deficit／hyperactivity disorder：a 6-week,randomized,placebo—controlled,double—blind trial in Russia[J]．Eur Child Adolesc Psychia,2010,19(1)：57-66.
[15] Robert R,Larry M,Erin CC．Current strategies in the diagnosis and treatment of childhood attention—deficit／hyperactivity disorder[J]．American Family Physician,2009,79(8)：672 678．