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布洛芬混悬液、咀嚼片和片剂在囊性纤维化儿童中的药代动力学。

The pharmacokinetics of ibuprofen suspension, chewable tablets, and tablets in children with cystic fibrosis.

作者信息

Scott C S, Retsch-Bogart G Z, Kustra R P, Graham K M, Glasscock B J, Smith P C

机构信息

School of Pharmacy, Division of Pharmacotherapy and Drug Development, The University of North Carolina at Chapel Hill, 27599-7360, USA.

出版信息

J Pediatr. 1999 Jan;134(1):58-63. doi: 10.1016/s0022-3476(99)70387-2.

Abstract

OBJECTIVES

The objectives of this study were to compare the pharmacokinetic parameters of ibuprofen administered as a suspension, chewable tablet, or tablet in children with cystic fibrosis and to determine the optimal blood sampling times for measuring ibuprofen peak concentrations.

STUDY DESIGN

A single oral 20 mg/kg dose of ibuprofen was administered, and blood samples were obtained at 15, 30, 45, 60, 120, 240, and 360 minutes after the dose was administered. Peak plasma concentration (Cmax ), time to peak concentration (Tmax ), and other pharmacokinetic parameters were determined and compared (analysis of variance and analysis of covariance).

RESULTS

Thirty-eight children were included (22, 4, and 12 in the suspension, chewable tablet, and tablet groups, respectively). Tmax was the only parameter for which statistical differences were noted (suspension vs tablet, P </=.02). After age and sex were removed as potential confounding variables, Tmax remained statistically different (P </=.001).

CONCLUSIONS

A 20 mg/kg dose of ibuprofen suspension is recommended, with blood samples for pharmacokinetic analysis obtained 30, 45, and 60 minutes after the dose is administered. Obtaining the first blood sample 1 hour after dose administration will miss approximately 90% of peak concentrations, increasing the likelihood of overdosing.

摘要

目的

本研究的目的是比较布洛芬以混悬液、咀嚼片或片剂形式给药于囊性纤维化儿童后的药代动力学参数,并确定测量布洛芬峰值浓度的最佳采血时间。

研究设计

单次口服20mg/kg剂量的布洛芬,并在给药后15、30、45、60、120、240和360分钟采集血样。测定并比较血浆峰浓度(Cmax)、达峰时间(Tmax)及其他药代动力学参数(方差分析和协方差分析)。

结果

共纳入38名儿童(混悬液组、咀嚼片组和片剂组分别为22名、4名和12名)。Tmax是唯一观察到有统计学差异的参数(混悬液与片剂比较,P≤0.02)。在去除年龄和性别作为潜在混杂变量后,Tmax仍有统计学差异(P≤0.001)。

结论

推荐使用20mg/kg剂量的布洛芬混悬液,给药后30、45和60分钟采集血样进行药代动力学分析。给药后1小时采集第一份血样会错过约90%的峰值浓度,增加用药过量的可能性。

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