한국의 주의력결핍/과잉행동장애 아동에서 Oros-Methylphenidate의 임상적 효능과 부작용에 대한 단기간의 다기관 개방연구
Short Term, Multicenter, Open-Label Study of Clinical Efficacy and Adverse Effects of Oros-Methylphenidate in Korean Children with Attention Deficit Hyperactivity Disorder
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Abstract
Objectives：This study was conducted to evaluate the clinical efficacy and adverse effects of Oros-Methylphenidate(MPH) in children with attention deficit hyperactivity disorder. Methods：A four week, open-label trial with forced flexible dosing strategy of Oros-methylphenidate was performed with 83 children with ADHD. For parental evaluation, parental version of SNAP-IV and visual analogue scale(VAS) were applied at baseline and endpoint. Every week CGS-S and adverse events chart were applied by the research clinicians. Baseline and endpoint body mass index(BMI) and blood pressure also compared. Results：Significant improvement in VAS and SNAP-IV were demonstrated between baseline and week four. Significant improvement of CGI-S in every weeks after trial of Oros-MPH, especially in first two weeks. 78.3% of the participants experienced at least one adverse effects. Anorexia and insomnia were most common adverse effects, which lasted for about two weeks. Significant decrease in BMI and significant elevation of diastolic blood pressure were observed. Conclusion：This study showed that Oros-MPH significantly reduced symptoms of ADHD in Korean children with ADHD, especially early period of medication trial. Meanwhile, many children also experienced adverse effects such as anorexia, insomnia. Moreover, increase in diastolic BP suggested that cautious evaluation of cardiac function should be needed.
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