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首页> 外文期刊>Journal of child and adolescent psychopharmacology >Steady-state pharmacokinetic, safety, and tolerability profiles of quetiapine, norquetiapine, and other quetiapine metabolites in pediatric and adult patients with psychotic disorders.
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Steady-state pharmacokinetic, safety, and tolerability profiles of quetiapine, norquetiapine, and other quetiapine metabolites in pediatric and adult patients with psychotic disorders.

机译：喹硫平，降血灵和其他喹硫平代谢物在小儿和成年精神病患者中的稳态药代动力学，安全性和耐受性概况。

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OBJECTIVE: The aim of this study was to investigate the steady-state pharmacokinetic, safety, and tolerability profiles of immediate-release quetiapine administered by similar dose-escalation regimens in pediatric and adult populations with psychotic or mood disorders. METHODS: Pediatric patients aged 10-17 years were titrated to a quetiapine dose of 200 mg twice daily (b.i.d. on days 5-7, 400 mg b.i.d. on days 11-12, with a final 400-mg dose on day 13. In a separate trial, adult patients aged 18-45 years were titrated to a quetiapine dose of 200 mg b.i.d. on days 4-6, 400 mg b.i.d. on days 10-11, with a final 400-mg dose on day 12. Concentrations of quetiapine and three metabolites (quetiapine sulfoxide, 7-hydroxy quetiapine, and norquetiapine) were quantified in plasma and urine. Adverse events, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory tests were evaluated throughout the studies. RESULTS: In both pediatric and adult populations, plasma concentrations of quetiapine and norquetiapine increased proportionately as the dose was escalated from 200 mg b.i.d. to 400 mg b.i.d. There were no age-related differences in the dose-normalized quetiapine plasma concentration-time curve (AUC(SS)) and maximum plasma concentration (C(SS,max)). Quetiapine was rapidly absorbed after 200-mg and 400-mg doses in pediatric patients [median t(max) (time to maximum plasma concentration) 1.5 hours, both doses] and adult patients (median t(max) 1.0 hour and 1.2 hours, respectively). The mean quetiapine t(1/2) (terminal elimination half-life) was approximately 6 hours for pediatric and 5 hours for adult patients. Norquetiapine displayed a similar median t(max) and a longer t(1/2) compared with quetiapine. Quetiapine was well tolerated, with no serious adverse events and no unexpected events reported. CONCLUSION: Pediatric and adult populations demonstrated similar pharmacokinetic, safety, and tolerability profiles for quetiapine administered by dose escalation. The predictability in quetiapine concentration profiles for children aged 10 years to adults suggests that no dosage adjustment may be required when treating patients of these ages.
机译：目的：本研究的目的是研究类似的剂量递增方案在患有精神病或情绪障碍的儿童和成人人群中，速释喹硫平的稳态药代动力学，安全性和耐受性。方法：将10-17岁的小儿患者每天两次滴定至200 mg喹硫平剂量（第5-7天出价，第11-12天出价400 mg，第13天最终剂量400 mg）。另一项试验是，将18-45岁的成年患者在第4-6天滴定为喹硫平剂量200 mg每日两次，在第10-11天定为400 mg每日两次，最后第12天为400 mg。定量分析了血浆和尿液中的三种代谢物（喹硫平亚砜，7-羟基喹硫平和去甲肾上腺素）不良事件，生命体征，12导联心电图（ECG）和临床实验室检查结果。和成年人口，随着剂量从200 mg bid增加到400 mg bid，喹硫平和去甲奎平的血浆浓度成比例增加。剂量归一化的喹硫平血浆浓度-时间曲线（AUC（SS））和年龄之间无年龄相关差异最大血浆浓度（C（SS，m斧头））。小儿患者[中位数t（max）（达到最大血浆浓度的时间）1.5小时，均为两剂）在200 mg和400 mg剂量后，喹硫平迅速吸收，成年患者（中位数t（max）1.0小时和1.2小时，分别）。小儿平均喹硫平t（1/2）（终末消除半衰期）约为6小时，成年患者约为5小时。与喹硫平相比，诺奎硫平的中值t（max）和更长的t（1/2）。喹硫平具有良好的耐受性，没有严重的不良事件，也没有意外事件的报道。结论：儿科和成人人群通过剂量递增对喹硫平表现出相似的药代动力学，安全性和耐受性特征。 10岁至成年儿童的喹硫平浓度分布的可预测性表明，治疗这些年龄段的患者时无需调整剂量。

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