주의력결핍과잉행동장애 아동에서 OROS-Methylphenidate의 처방현황과 효능 및 부모 인식: 4주 동안의 다기관 관찰 연구 = Prescription Status and Efficacy of OROS-MPH and Parent Perception in Children with Attention Deficit Hyperactivity Disorder：Multi-Center, Observational Study during 4 Weeks

다국어 초록 (Multilingual Abstract)

Objective ：This study was performed to evaluate the curent prescription status by clinicians, the eficacy of once-daily OROS-methylphenidate (MPH) in the treatment of children with attention deficit hyperactivity dis-order (ADHD) and parent anticipation, concern and satisfaction about treatment.
Methods ：The subjects with ADHD betwen 6 and 18 years were prescribed 18, 36, 54 mg OROS-MPH, depending on clinicians judgment. ADHD symptoms and improvement were assessed by clinicians using the Clinical Global Impression-Severity (CGI-S) and the Clinical Global Impresion-Improvement (CGI-I)breviated Parent Rating Scale (CAPRS) and by the questionnaires inquiring about parental anticipation, concern, satisfaction about treatment at baseline and the 4th wek after OROS-MPH trial.
Results：A total of 704 subjects were enrolled in the observational study and 645 completed the trial. There was an 18% increase in mean daily by the CGI-I. CAPRS scores were significantly decreased from 14.8 to 8.81. Before treatment, parents antici-pated the symptom improvement firstly, followed by education material, parental education and non-pharmacolo-gical treatment. Parent concerned about side efect, growth, dependency and abuse. In general, 95% of parent were satisfied with OROS-MPH .
Conclusion ：According to this study, there was an increase in mean daily dose satisfactory to parents of children with ADHD.

국문 초록 (Abstract)

이 연구는 주의력결핍과잉행동장애 아동을 OROS- MPH로 치료하는데 있어 실제 임상 상황에서 임상가에 의해 처방되고 있는 현황 및 효능을 평가하고 치료에 대한 부모의 기대, 우려, 만족을 평가하고자 하였다. 6세 이상 18세 이하의 주의력결핍과잉행동장애 아동에서 임상가의 판단에 따라 18, 36, 54 mg의 OROS-MPH로 약물치료를 시작하거나 바꾸었다. 주의력결핍과잉행동장애의 증상과 호전은 임상가에 의해 CGI-S와 CGI-I로 평가되었다. 또한 부모는 치료 시작과 4주 후에 CAPRS를 작성하였으며 치료에 대한 기대, 우려, 만족을 기술할 수 있는 설문지에 응답하도록 하였다. 전체 704명이 관찰 연구에 참여하였으며 645명이 포함되었다. 4주간 처방된 OROS-MPH의 평균 일일 용량은 18% 증가하였으며 체중으로 교정하였을 때에는 14% 증가하였다. CGI-Ⅰ에 의한 평가에서 56%의 대상이 호전을 보였다. CAPRS 점수는 14.8에서 8.81로 유의하게 감소하였다. 치료 전에 부모들은 대부분 증상 호전에 대해 기대하였지만 이 밖에도 교육 자료, 부모 교육, 비약물 치료에 대해 바라고 있었다. 또한 부모들은 부작용, 성장에 대한 우려, 의존과 남용에 대해 걱정하고 있었다. 95%의 부모들이 전반적으로 OROS- MPH 치료에 만족한다고 응답하였다. 연구 기간 동안 처방된 OROS-MPH의 평균 일일 용량은 증가하고 있었으며 CGI-Ⅰ와 한국판 CAPRS의 변화를 통해 OROS-MPH가 치료에서 효과적임을 확인할 수 있었다. 부모 인식 설문지에 의하면 대부분의 부모가 OROS-MPH 치료에 만족하고 있는 것으로 보인다.

참고문헌 (Reference)

1 Krain AL, "The role of treatment acceptability in the initiation of treatment for ADHD" 9 : 425-434, 2005

2 Biederman J, "The Massachusets General Hospital studies of gender influences on atention-deficit/hyperactivity disorder in youth and relatives" 27 : 225-232, 2004

3 Remschmidt H, "Symptom control in children and adole-scents with attention-deficit/hyperactivity disorder on switching from immediate-release MPH to OROS MPH Results of a 3-week open-label study" 14 : 297-304, 205

4 Perwien A, "Stimulant treatment patterns and compliance in children and adults with newly treated attention-deficit/hyperactivity disorder" 10 : 122-129, 2004

5 Bukstein OG, "Satisfaction with treatment for attention-deficit/ hyperactivity disorder" 10 : 107-116, 2004

6 Wolraich ML, "Randomized, controlled trial of oros methyl-phenidate once a day in children with atention-deficit/hyper-activity disorder" 108 : 883-892, 201

7 Cho SC, "Prevalence of disruptive behavior disorder" 141-149,

8 Yang SJ, "Prevalence and corelates of attention deficit hyperactivity disorder: school-based mental health services in Seoul" 45 : 69-76, 206

9 Greenhil L, "Practice parameter for the use of stimulant medications in the treatment of children, adolescents, and adults" 41 : 26-49, 2002

10 Pelham WE, "Once-a-day Concerta methylphe-nidate versus thre-times-daily methylphenidate in laboratory and natural settings" 107 : E105-, 2001

11 Goyete CH, "Normative data on revised Conners Parent and Teacher Rating Scales" 221-236,

12 Wilens TE, "Multisite controled study of OROS methylph-enidate in the treatment of adolescents with attention-deficit/ hyperactivity disorder" 160 : 82-90, 2006

13 Kutcher S, "International consensus statement on attention-deficit/hyperactivity disorder(ADHD) and disruptive behaviour disorders(DBDs): clinical implications and treatment practice suggestions" 14 : 11-28, 2004

14 Schachter HM, "How efficacious and safe is short-acting methylphenidate for the treatment of attention-deficit disorder in children and adole-scents? A meta-analysis" 165 : 1475-1488, 2001

15 Levy F, "Gender differences in ADHD subtype comorbidity" 44 : 368-376, 205

16 Dosreis S, "Ellwood LC. Parental perceptions and satisfaction with stimulant medication for attention-deficit hyperactivity disorder" 24 : 155-162, 2003

17 American Psychiatric Asociation, "Diagnostic and statistical manual of mental disorders" 85-93,

18 Swanson J, "Development of a new once-a-day formulation of methyl-phenidate for the treatment of atention-deficit/hyperactivity disorder: prof-of-concept and proof-of-product studies" 60 : 204-211, 2003

19 Swanson J, "Compliance with stimulants for attention-deficit/hy-peractivity disorder: issues and approaches for improvement" 17 : 17-131, 2003

20 Hwang JW, "Compliance study of methylph-enidate in the treatment of ADHD" 15 : 160-167, 2004

21 Efron D, "Child and parent perceptions of stimulant medication treatment in attention deficit hyperactivity disorder" 34 : 288-292, 1998

22 Klasen A, "Attention-deficit hyperactivity disorder in children and youth: a quantitative systematic review of the efficacy of diferent management stra-tegies" 44 : 1007-1016, 199

23 Weis M, "Attention dificit hyperactivity disorder" Philadelphia: Lipincot Williams & Wilkins 645-665, 2002

24 Ahn DH, "Attention defict hyperactivity disorder" Seoul: Jungang Monhwa Co 220-248, 2005

25 Guy W, "Assessment manual for psychopharmacology US Department of Health National Institutes of Mental Health" Public Health Service pharmacologybranch;1976

26 Kim BS, "An observational multi-center study for evalu-ation of efficacy, safety and parental satisfaction of methylp-henidate-OROS in children with ADHD" 16 : 279-285, 2005

27 Kim JY, "An epidemiological study of atten-tion-deficit, hyperactivity disorder and learning disabilities in a rural area" 38 : 784-793, 1999

28 Oh KJ, "Abbreviated Conners Rating Scale as a eval-uation tool for ADHD poster of fal meeting of Korean Neuro-psychiatr Assoc;1989"

29 Wilens T, "ADHD treatment with once-daily OROS methylphenidate final results from a long-term open-label study" 44 : 1015-1023, 205

30 Wilens T, "ADHD treatment with once-daily OROS methylph-enidate: interim 12-month results from a long-term open-label study" 42 : 424-443, 2003

31 Steele M, "A randomized, controlled efectivenes trial of OROS-methy-lphenidate compared to usual care with immediate-release methylphenidate in attention deficit-hyperactivity disorder" 13 : 50-62, 2006

32 Biederman J, "A Randomized, Placebo-Controlled Trial of OROS Methylphenidate in Adults with Attention-Deficit/Hyperactivity Disorder" 59 : 829-835, 2006

33 Hoare P, "12-month efficacy and safety of OROS MPH in children and adolescents with attention-deficit/hyperactivity disorder switched from MPH" 14 : 305-309, 2005