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一项关于计算机化茶碱药代动力学给药与经验性医生给药的随机对照试验。

A randomized controlled trial of computerized pharmacokinetic theophylline dosing versus empiric physician dosing.

作者信息

Casner P R, Reilly R, Ho H

机构信息

Department of Internal Medicine, Texas Tech University, Health Sciences Center, El Paso 79905.

出版信息

Clin Pharmacol Ther. 1993 Jun;53(6):684-90. doi: 10.1038/clpt.1993.90.

Abstract

This study was undertaken to determine if a computerized pharmacokinetic program for adjusting theophylline infusion rates could attain a goal serum theophylline level more accurately than physician-derived adjustments and what clinical impact this would have. Thirty-five patients with diagnoses of asthma or chronic obstructive pulmonary disease were randomized to a control group (empiric) or experimental group (kinetic) after initial theophylline levels were drawn from each group. After second levels were drawn, patients in the kinetic group had their infusion rates adjusted by the computerized pharmacokinetic program to achieve a level of 15 mg/L, whereas patients in the empiric group had their infusions adjusted empirically by the primary care physicians to achieve a serum theophylline level of 15 mg/L. A final theophylline level was obtained just before the infusion was discontinued. The kinetic group was closer to the goal level of 15 mg/L than the empiric group, but this was not statistically significant (14.8 +/- 4.4 versus 12.6 +/- 4.1; p > 0.05). The total number of days that patients were receiving intravenous theophylline was slightly longer for the kinetic group (4.1 +/- 3.3 versus 3.2 +/- 1.5; p > 0.05) as was the total number of hospital days, but neither of these were statistically significant (11.4 +/- 21.6 versus 8.8 +/- 15.4 days; p > 0.05). There were no differences between the two groups in the number of subtherapeutic or toxic levels, and there were no significant differences in arterial blood gas measurements.(ABSTRACT TRUNCATED AT 250 WORDS)

摘要

本研究旨在确定用于调整茶碱输注速率的计算机药代动力学程序是否比医生根据经验进行的调整更能准确地达到目标血清茶碱水平,以及这会产生何种临床影响。在从每组抽取初始茶碱水平后,35例诊断为哮喘或慢性阻塞性肺疾病的患者被随机分为对照组(经验组)和实验组(动力学组)。在抽取第二次水平后,动力学组的患者通过计算机药代动力学程序调整输注速率以达到15mg/L的水平,而经验组的患者由初级保健医生根据经验调整输注速率以达到血清茶碱水平15mg/L。在停止输注前刚好获得最终的茶碱水平。动力学组比经验组更接近15mg/L的目标水平,但差异无统计学意义(14.8±4.4与12.6±4.1;p>0.05)。动力学组患者接受静脉茶碱治疗的总天数略长(4.1±3.3与3.2±1.5;p>0.05),住院总天数也是如此,但两者均无统计学意义(11.4±21.6与8.8±15.4天;p>0.05)。两组在低于治疗水平或中毒水平的数量上没有差异,动脉血气测量也没有显著差异。(摘要截短至250字)

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