Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University of Wuerzburg, Wuerzburg, Germany.
Pharmacopsychiatry. 2010 Mar;43(2):58-65. doi: 10.1055/s-0029-1239540. Epub 2009 Dec 10.
The aim of this prospective naturalistic study was to examine for the first time the relationship between dosage, serum concentration and clinical outcome in children and adolescents with impulsive-aggressive symptoms during risperidone therapy.
Steady state trough serum concentrations of risperidone and 9-hydroxyrisperidone (the active moiety) were measured in 103 subjects. The therapeutic effect was assessed by the clinical global impression improvement subscale and side effects by the Udvalg for Kliniske Undersogelser-side effect rating scale.
We found a linear relationship between the risperidone dose and the serum concentration of the active moiety (Spearman rho=0.53) and no correlation between the serum concentration and either the therapeutic effect or side effects. There was no effect of gender and co-medication.
This study has the typical limitations of naturalistic studies, therefore our results should be interpreted with caution. Based on the serum concentrations at the therapeutically effective dose range (0.25-1.5 mg/day) we obtained first information on a possibly appropriate therapeutic serum range for the risperidone treatment of children and adolescents with impulsive-aggressive symptoms. Further studies with greater sample sizes are needed to validate our results and to examine the influence of genetic polymorphisms on the serum concentration of risperidone.
本前瞻性自然研究旨在首次探讨利培酮治疗伴有冲动攻击症状的儿童和青少年时，剂量、血清浓度与临床疗效之间的关系。
103 例患者测定利培酮及 9-羟利培酮（活性成分）的稳态谷浓度。采用临床总体印象改善量表评定疗效，用 Udvalg for Kliniske Undersogelser 副作用评定量表评定副作用。
我们发现利培酮剂量与活性成分的血清浓度之间存在线性关系（Spearman rho=0.53），而血清浓度与疗效或副作用之间无相关性。性别和合并用药无影响。
本研究具有自然研究的典型局限性，因此我们的结果应谨慎解释。根据治疗有效剂量范围（0.25-1.5 mg/日）的血清浓度，我们首次获得了有关利培酮治疗伴有冲动攻击症状的儿童和青少年的可能适当治疗血清范围的信息。需要更大样本量的进一步研究来验证我们的结果，并研究遗传多态性对利培酮血清浓度的影响。
