• Journal of the Korean Academy of Child and Adolescent Psychiatry
• /
• 제16권2호
• /
• pp.279-285
• /
• 2005

목적 : 이 연구에서는 장시간 약물작용이 지속되는 MPH-OROS를 주의력결핍과잉운동장애 아동에게 투여하여 그 효용성과 안전성 및 부모 만족도를 평가하려고 하였다. 방법 : 연구대상은 DSM-IV의 진단기준을 이용하여 임상적으로 ADHD로 진단 받은 569명의 아동으로 하였다. 이미 약물을 복용중이거나 약을 복용한 적이 없는 아동을 대상으로 이전 약물에서 MPH-OROS로 약물을 바꾸거나 처음으로 MPH-OROS를 복용하였다. 증상의 정도는 MPH-OROS 약물 사용 전과 사용 1주 및 3주에 한국어판 Conners 부모용 평가척도를 사용하여 평가하였다. 임상 호전은 Clinical Global Impression Severity of illness(CGI-S)를 사용하여 MPH-OROS 약물 복용 전과 복용 1주 및 3주에 임상가가 평가하였고 Clinical global impression severity of improvement(CGI-I)로 약물 복용 1주 및 3주에 호전 정도를 평가하였다. 약물 복용 3주에는 약물 복용에 따른 부모 만족도를 설문 조사하였다. 결과 : MPH-OROS의 1일 평균 복용량은 기저선 $25.3{\pm}11.2mg$ 1주 $28.9{\pm}12.7mg$, 3주 $31.3{\pm}13.2mg$이었다. 시간에 따라 용량이 유의하게 증가하였고, 성에 따른 차이는 없었다. 전체의 $13\%$가 중도 탈락했으며, 그 원인으로는 부작용이 가장 많았다. CGI-I의 변화는 시간에 따라 유의하게 감소하는 모습을 보였고, 성에 따른 호전 정도의 차이는 나타나지 않았다. CGI-I에 의한 호전평가에서 MPH-OROS 치료 1주에 호전은 $72.3\%$이고 치료 3주에는 $87.4\%$였다. 한국판 Conners부모용 평가척도 합계 점수는 시간에 따라 유의하게 감소하였다. 한 가지 이상의 부작용을 경험하였던 환자는 119명으로 $20.7\%$에 달하였으며, 가장 많은 빈도로 나타난 것은 식욕부진이고, 불면, 두통, 오심의 순이었다. 기존에 속효성 메틸페니데이트를 사용하던 군과 약물을 처음 사용하는 군을 나누어 부작용 빈도를 살펴보았을 때 크게 차이가 나지 않았다. 부모만족도 설문 결과에서 MPH-OROS 약물치료에 대해 $94\%$의 부모는 전반적으로 만족한다고 응답하였다. 또한 부모가 보고하는 MPH-OROS 의 가장 큰 장점은 오후까지 약물효과 지속, 학교생활 및 수업태도, 가정생활 및 숙제, 과잉행동 개선의 순이었다. 결론 : MPH-OROS는 주의력결핍과잉운동장애의 치료에서 효과적이며 충분히 안전하다.

• Journal of the Korean Academy of Child and Adolescent Psychiatry
• /
• 제19권3호
• /
• pp.147-155
• /
• 2008

Objectives: The purpose of this study was to evaluate the efficacy and tolerability of osmotic release oral system-methylphenidate (OROS-MPH) in children with attention-deficit hyperactivity disorder (ADHD) and comorbid psychiatric disorders. Methods: This was an 8-week open label study of OROS-MPH monotherapy. The subjects were 113 children with ADHD aged 6-12 years. Outcome measures were the Korean version of the parent ADHD Rating Scale (K-ARS), Korean version of the Conners Parent Rating Scale (K-CPRS), Clinical Global Impression-Severity and Clinical Global Impression-Improvement. Side effects were monitored using Barkley's Side Effect Rating Scale. We compared the change-over-time in the mean scores of the outcome measure according to the comorbidity of disruptive behavior disorder, depressive disorder, anxiety disorder, and tic disorder. Results: The mean K-ARS and K-CPRS scores were significantly decreased, regardless of the comorbidity. The mean doses of OROS-MPH and dropout rate did not differ significantly according to comorbidity. The OROS-MPH was well tolerated, regardless of the comorbidity. However, children with tic disorder reported a higher frequency of tics or nervous movements between the $2^{nd}\;and\;8^{th}$ week than those without tic disorder. Conclusion: The OROS-MPH is effective for decreasing the symptoms of ADHD, and it is well tolerated, even by patients with comorbid psychiatric disorders.

• Journal of the Korean Academy of Child and Adolescent Psychiatry
• /
• 제21권2호
• /
• pp.63-71
• /
• 2010

Objectives : The aim of this study was to investigate the effect of the clinical and demographic variables such as body weight, dosage, family history of attention-deficit hyperactivity disorder (ADHD), and psychiatric co-morbidity on the side-effects of OROS-Methylphenidate (OROS-MPH), and to evaluate the relationship between drug response and side effect severity. Methods : A total of 144 children (ages 6-18) with diagnosed ADHD were treated with OROS-MPH. Children were examined at baseline and after 1, 3, 6, 9, and 12 weeks of each treatment condition. The stimulant drug side effect rating scale (SERS), pulse rate, systolic blood pressure, diastolic blood pressure, and electrocardiogram (ECG) were evaluated to assess side effect profiles. Changes in these parameters from baseline were examined and analyzed. Results : Anorexia (30.95%) and insomnia (13.10%) were the most commonly reported side effects during this study. Insomnia and loss of appetite score increased at one week follow-up, but was sustained or decreased as treatment progressed. Small but significant increases in pulse rate and diastolic blood pressure were observed during treatment ; however, no clinically meaningful changes in ECG parameters were noted during the study. Low body weight, high dosage of OROS-MPH, and family history of ADHD were associated with cardiovascular side effect. In contrast, there was no significant relationship between OROS-MPH treatment response and the severity of side effect and no difference resulted between the responder and non-responder groups with respect to OROS-MPH dosage in the 12 weeks of follow-up. Conclusion : To the best of our knowledge, this study is the first Korean study to investigate comprehensive side effect profiles and their correlates in OROS-MPH treatment for ADHD children. OROS-MPH was well tolerated with no clinically significant side effects during the treatment period. In conclusion, low body weight, high dosage of OROSMPH, and family history of ADHD could be used as predictive factors in increasing pulse rate and blood pressure.

• Journal of the Korean Academy of Child and Adolescent Psychiatry
• /
• 제25권2호
• /
• pp.82-88
• /
• 2014

Objectives : The aim of our study was to investigate association of norepinephrine transporter gene (SLC6A2) polymorphism and side effects of osmotic-release oral system methylphenidate (OROS MPH) in children with attention-deficit hyperactivity disorder (ADHD). Methods : We recruited drug naive children with ADHD (N=97). We administered OROS MPH by tolerable dosage. At week 8 of treatment, parents completed the Barkley's side effect rating scale. We analyzed two SLC6A2 single nucleotide polymorphisms (SNPs), rs192303 and rs3785143, with blood of subjects. We compared the frequency and severity of each side effect among SLC6A2 genotypes of 2 SNPs. Results : In the analysis of frequency of each side effect, irritability differed according to rs192303 and rs3785143 genotype. In comparisons of severity, talking less and disinterest differed according to rs192303 genotype. In the case of rs3785143, severities of disinterest and irritability were involved with genotype. Conclusion : Side effects of OROS MPH showed an association with SLC6A2 genotype.

• Journal of the Korean Academy of Child and Adolescent Psychiatry
• /
• 제23권3호
• /
• pp.103-108
• /
• 2012

Objectives : The aim of this study is to investigate the effectiveness of treatment with osmotic-release oral system methylphenidate (OROS-MPH) on quality of life (QOL) in children with attention-deficit hyperactivity disorder (ADHD). Another aim is to assess the relationship between change in QOL and other factors including children's symptoms and academic performance or parents' depression and parenting stress. Methods : A total of 111 medication-naive children with ADHD in a multicenter, open-label, 12-week trial of OROS-MPH completed an evaluation using diverse rating scales at two time points; at baseline and after 12 weeks of treatment. Scales for investigation of children included the Parent Report Form-Children's Health and Illness Profile-Children's Edition (PRF-CHIP-CE) on QOL, the ADHD Rating Scale-IV on symptoms, and the Academic Performance Rating Scale (APRS). The Beck Depression Inventory and Parenting Stress Index were used for assessment of their parents. Results : Total scores for mean PRF-CHIP-CE increased from $207.9{\pm}26.7$ at baseline to $226.3{\pm}25.9$ after 12 weeks of treatment (p<.001). The change of APRS showed the strongest correlation with the increment of PRF-CHIP-CE scores (Pearson coefficient=0.561, p<.001), even after controlling for other factors (partial correlation coefficient=0.420, p<.001). Conclusion : Treatment with MPH-OROS results in improvement of QOL in children with ADHD in Korea. The advance in academic performance plays a key role in this change of QOL.

• Journal of the Korean Academy of Child and Adolescent Psychiatry
• /
• 제24권3호
• /
• pp.157-163
• /
• 2013

Objectives : Previous studies reported that attention-deficit hyperactivity disorder (ADHD) resulted from a deficit of selective attention and sustained attention. In this study, we assessed the result of methylphenidate-induced changes of the cerebral frontal executive functions in patients with ADHD. Methods : The subjects in this study consisted of 16 ADHD patients whose age ranged from 7 to 12. We used ADHD Diagnostic System (ADS) for the attention improvement, and the Stroop Test for the executive function response to pharmacotherapy with MPH. Results : After pharmacotherapy with methylphenidate for 12 weeks, the study group showed improvement in the clinical aspects through Clinical Global Impression-Severity, ADHD-rating scale and Inattention/Overactivity With Aggression Conner's Parents Rating Scale. In the ADS test, only in auditory task there was a decrease of both the response time and the standard deviation of the response time significantly. In the Stroop Test, there was a decrease in the word task, color task and color-word task significantly. Conclusion : Our results show that psychostimulant medication improves neuropsychological function, including the cerebral frontal executive function. This study implies that we have to consider the improvement of executive function, as well as attention when evaluating the efficacy of treatment.