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沙丁胺醇口服给药稳定性的提高,使成年哮喘患者的支气管扩张变异性降低。

Improved stability in oral delivery of albuterol provides less variability in bronchodilation in adults with asthma.

作者信息

Grossman J, Morris R J, White K D, Cocchetto D M

机构信息

Department of Medicine, Albany Medical College, New York.

出版信息

Ann Allergy. 1991 Apr;66(4):324-7.

PMID:2014933
Abstract

The objective of this randomized, single-blind, parallel group study was to determine whether a more constant rate of albuterol delivery from tablets provides less variability in bronchodilation. Thirty-eight adult patients were enrolled with FEV1 between 40% to 80% of predicted normal and greater than or equal to 15% reversibility. Eighteen patients received Volmax, 8 mg bid, and 20 patients received Proventil Repetabs, 8 mg (as two 4-mg tablets) bid. The magnitude and duration of bronchodilation were determined after the first dose and at steady state on treatment day 7 by measuring serial values of pulmonary function for 12 hours on each day. Interpatient variability in bronchodilation was calculated for each study day did not differ significantly between treatments, the interpatient variability in bronchodilation with Volmax was, on average, one-half of that experienced with Proventil Repetabs. Adverse events, mainly headache and tremor, were comparable between Volmax and Proventil Repetabs. This study demonstrates that Volmax achieves less variable bronchodilation through a more constant rate of drug delivery from the onset of therapy.

摘要

这项随机、单盲、平行组研究的目的是确定从片剂中以更恒定速率递送的沙丁胺醇是否能减少支气管扩张的变异性。38名成年患者入组,其第一秒用力呼气容积(FEV1)为预测正常值的40%至80%,且可逆性大于或等于15%。18名患者接受Volmax,每日两次,每次8毫克,20名患者接受Proventil Repetabs,8毫克(两片4毫克片剂),每日两次。在首剂给药后以及治疗第7天的稳态时,通过测量每天12小时的肺功能系列值来确定支气管扩张的程度和持续时间。计算每个研究日支气管扩张的患者间变异性,两种治疗之间无显著差异,使用Volmax时支气管扩张的患者间变异性平均为使用Proventil Repetabs时的一半。不良事件主要为头痛和震颤,Volmax和Proventil Repetabs之间相当。这项研究表明,Volmax从治疗开始就通过更恒定的药物递送速率实现了变异性较小的支气管扩张。

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