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沙美特罗与特布他林治疗成人哮喘的4周对比研究

A 4-week comparison of salmeterol and terbutaline in adult asthma.

作者信息

Hermansson B A, Jenkins R J

机构信息

Lungkliniken, Lasarettet, Boras, Sweden.

出版信息

Allergy. 1995 Jul;50(7):551-8. doi: 10.1111/j.1398-9995.1995.tb01198.x.

Abstract

This was a 4-week, open-label, parallel-group study designed to compare the efficacy and safety of the long-acting inhaled bronchodilator, salmeterol, with the established inhaled bronchodilator, terbutaline, in the treatment of patients with mild to moderate asthma. A total of 243 adult patients was randomized to receive treatment with either salmeterol 50 micrograms bd via a Diskhaler (Glaxo) inhaler (n = 121) or terbutaline 500 micrograms qds via a reservoir powder inhaler device (n = 122). Apart from all bronchodilator treatment which was withdrawn at the start of the run-in period and replaced by inhaled salbutamol to be used as required for symptom relief, all concurrent medications were kept constant throughout the study. Salmeterol produced a significantly greater increase in mean morning peak expiratory flow (PEF) than terbutaline (difference in adjusted means after treatment = 28 l/min; 95% CI = 19-37 l/min; P < 0.001). Likewise, the increase in mean evening PEF was significantly greater following treatment with salmeterol than with terbutaline (difference in adjusted means = 9 l/min; 95% CI = 0-17 l/min; P = 0.045). Salmeterol was associated with a significant reduction in diurnal variation in PEF by comparison with terbutaline (difference in adjusted means = -18 l/min; 95% CI = -24, -12 l/min; P < 0.001). Significant improvements with salmeterol by comparison with terbutaline were also observed in daytime and night-time asthma scores, percentage of symptom-free days and nights, use of additional inhaled bronchodilator, and percentage of days and nights when no additional inhaled bronchodilator was needed.(ABSTRACT TRUNCATED AT 250 WORDS)

摘要

这是一项为期4周的开放标签平行组研究,旨在比较长效吸入型支气管扩张剂沙美特罗与已确立的吸入型支气管扩张剂特布他林在治疗轻至中度哮喘患者中的疗效和安全性。总共243名成年患者被随机分配接受治疗,其中121名患者通过Diskhaler(葛兰素史克)吸入器每日两次吸入50微克沙美特罗,122名患者通过储库型干粉吸入装置每日四次吸入500微克特布他林。除了在导入期开始时停用所有支气管扩张剂治疗并替换为按需使用的吸入型沙丁胺醇以缓解症状外,在整个研究过程中所有同时使用的药物都保持不变。沙美特罗使平均早晨呼气峰值流速(PEF)的增加显著大于特布他林(治疗后调整均值的差异=28升/分钟;95%置信区间=19 - 37升/分钟;P<0.001)。同样,沙美特罗治疗后平均夜间PEF的增加显著大于特布他林(调整均值的差异=9升/分钟;95%置信区间=0 - 17升/分钟;P = 0.045)。与特布他林相比,沙美特罗使PEF的日变化显著降低(调整均值的差异=-18升/分钟;95%置信区间=-24,-12升/分钟;P<0.001)。与特布他林相比,在白天和夜间哮喘评分、无症状日和夜的百分比、额外吸入支气管扩张剂的使用以及不需要额外吸入支气管扩张剂的日和夜的百分比方面,沙美特罗也有显著改善。(摘要截短于250字)

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