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美国食品药品监督管理局静脉注射茶碱给药指南存在不足。

Inadequacy of FDA dosing guidelines for intravenous theophylline.

作者信息

Lopez L M, Russell W L, Hemmes R J, Ryerson E G

出版信息

Drug Intell Clin Pharm. 1984 Dec;18(12):987-91. doi: 10.1177/106002808401801210.

DOI:10.1177/106002808401801210
PMID:6510225
Abstract

The ability of a dosing regimen of intravenous theophylline to achieve therapeutic serum theophylline concentrations was evaluated. Intravenous theophylline was administered to 25 adult patients with acute bronchospasm using dosing guidelines 20 percent higher than FDA recommendations. The dose of theophylline was determined by assignment to one of four clinical categories. Blood samples for determination of serum theophylline concentrations were collected 12 and 24 hours after initiation of a constant infusion. Differences between mean observed and target theophylline concentrations did not achieve statistical significance. All patients in categories 1 and 2 achieved therapeutic concentrations of theophylline. Most of those with subtherapeutic levels were smokers suffering from multiple diseases. We conclude that current FDA recommendations for dosing intravenous theophylline are unreliable for routine use in category 3 and 4 patients. Further work is necessary to evaluate these recommendations in pediatric and category 1 and 2 patients.

摘要

评估了静脉注射茶碱给药方案达到治疗性血清茶碱浓度的能力。对25例急性支气管痉挛的成年患者使用比FDA建议高20%的给药指南静脉注射茶碱。茶碱剂量根据四种临床分类之一确定。在持续输注开始后12小时和24小时采集血样以测定血清茶碱浓度。观察到的平均茶碱浓度与目标浓度之间的差异未达到统计学显著性。第1类和第2类中的所有患者均达到了治疗性茶碱浓度。大多数治疗水平低于标准的患者是患有多种疾病的吸烟者。我们得出结论,FDA目前关于静脉注射茶碱给药的建议在3类和4类患者的常规使用中不可靠。有必要进一步开展工作,以评估这些建议在儿科患者以及1类和2类患者中的适用性。

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Inadequacy of FDA dosing guidelines for intravenous theophylline.美国食品药品监督管理局静脉注射茶碱给药指南存在不足。
Drug Intell Clin Pharm. 1984 Dec;18(12):987-91. doi: 10.1177/106002808401801210.
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