丙酸氟替卡松气雾剂治疗轻至中度哮喘成人患者。丙酸氟替卡松哮喘研究组。

Fluticasone propionate aerosol for the treatment of adults with mild to moderate asthma. The Fluticasone Propionate Asthma Study Group.

作者信息

Chervinsky P, van As A, Bronsky E A, Dockhorn R, Noonan M, LaForce C, Pleskow W

机构信息

Allergy and Asthma Center, North Dartmouth, MA 92747.

出版信息

J Allergy Clin Immunol. 1994 Oct;94(4):676-83. doi: 10.1016/0091-6749(94)90174-0.

DOI:10.1016/0091-6749(94)90174-0

PMID:7930300

Abstract

BACKGROUND

Recent emphasis on the control of airway inflammation in asthma highlights the need for safe and effective antiinflammatory agents. Fluticasone propionate is one of the most potent antiinflammatory corticosteroids developed to date.

OBJECTIVE

This study assessed the safety and efficacy of fluticasone propionate aerosol in the treatment of mild to moderate asthma.

METHODS

Fluticasone propionate aerosol (25, 100, or 500 micrograms twice daily) or placebo was given for as long as 8 weeks to adults with mild to moderate asthma in a randomized, double-blind, parallel-group study. Patients were removed from the study if they showed predefined signs of worsening asthma.

RESULTS

Sixty-three percent of placebo-treated patients and 23%, 13%, and 4% of patients treated with fluticasone propionate 25, 100, and 500 micrograms twice daily, respectively, were removed from the study. Mean forced expiratory volume in 1 second, forced vital capacity, and forced expiratory flow at midexpiratory phase at weekly visits throughout the study demonstrated that fluticasone propionate was more efficacious than placebo in maintaining asthma control. Measurements of peak expiratory flow and symptom scores significantly improved and nighttime awakenings and albuterol use to treat symptoms significantly declined in fluticasone propionate-treated groups relative to the placebo-treated group. Differences among fluticasone propionate groups for these variables were not statistically significant. Incidence and severity of adverse events were similar across groups. Fluticasone propionate did not affect morning or stimulated plasma cortisol concentrations, although slight, transient reductions in urinary free cortisol and urinary 17-hydroxy steroids occurred in the group receiving 500 micrograms fluticasone propionate twice daily.

CONCLUSION

These data indicate that fluticasone propionate provides safe and effective treatment for mild to moderate asthma.

摘要

背景

近期对哮喘气道炎症控制的重视凸显了对安全有效的抗炎药物的需求。丙酸氟替卡松是迄今为止研发出的最有效的抗炎皮质类固醇之一。

目的

本研究评估了丙酸氟替卡松气雾剂治疗轻至中度哮喘的安全性和有效性。

方法

在一项随机、双盲、平行组研究中，将丙酸氟替卡松气雾剂（每日两次，每次25、100或500微克）或安慰剂给予轻至中度哮喘的成人患者，持续8周。如果患者出现预先定义的哮喘恶化迹象，则将其从研究中剔除。

结果

分别有63%接受安慰剂治疗的患者以及23%、13%和4%接受每日两次25、100和500微克丙酸氟替卡松治疗的患者被剔除出研究。在整个研究期间，每周访视时的平均1秒用力呼气容积、用力肺活量和呼气中期用力呼气流量表明，丙酸氟替卡松在维持哮喘控制方面比安慰剂更有效。与安慰剂治疗组相比，丙酸氟替卡松治疗组的呼气峰值流量测量值和症状评分显著改善，夜间觉醒次数和用于治疗症状的沙丁胺醇使用量显著减少。丙酸氟替卡松组之间这些变量的差异无统计学意义。各组不良事件的发生率和严重程度相似。丙酸氟替卡松不影响早晨或刺激后的血浆皮质醇浓度，尽管每日两次接受500微克丙酸氟替卡松治疗的组中尿游离皮质醇和尿17-羟类固醇出现了轻微、短暂的降低。