부산대학교 도서관

Objective: Mazindol has been proposed as a potential treatment of children with attention deficit/hyperactivity disorder (ADHD). The purpose of this pilot study was to assess its pharmacokinetics, short-term efficacy, and safety. Subjects and methods: A total of 24 children (aged 9-12 years) with ADHD (according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, text-revision criteria) received a daily dose of 1 mg for 7 days and were followed for 3 additional weeks. Pharmacokinetic samples were collected after the first administration. ADHD symptoms were assessed using the ADHD Rating Scale (RS)-IV, Conners' Parent Rating Scale--Revised: Long (CPRS-R:L) at screening, baseline, and the end of the study. The Clinical Global Impression Severity (CGI-S) scale was assessed at baseline, and the CGI--Improvement (CGI-I) scale was assessed at subsequent visits. Results: Twenty-one subjects (aged 10 ± 1 years) were analyzed. Pharmacokinetic data were described by a one-compartment model with first-order absorption, elimination, and lag time. The typical apparent clearance and apparent volume of distribution were 27.9 L/h and 234 L, and increased with fat-free mass and age, respectively. The mean change in score in ADHD RS-IV after 1 week of mazindol was -24.1 (PC0.0001), greater than a 90% improvement from baseline. Reduction of CPRS-R:L and CGI-S scores were -52.1 (PC0.0001) and -2.5 (PC0.01), respectively. Adverse events were mild to moderate, decreased appetite and upper abdominal pain being the most common. Conclusion: This preliminary study shows that mazindol might be an effective, well-tolerated, and long-acting (more than 8 hours) agent for the treatment of ADHD in children. Keywords: pharmacokinetics, efficacy, safety, mazindol, ADHD, pediatrics
Introduction Attention deficit/hyperactivity disorder (ADHD) is a common neurobehavioral disorder of childhood, affecting 3%-12% of school-age children (1-4) and characterized by developmentally inappropriate symptoms of inattention, hyperactivity, and impulsivity. (5,6) [...]