Town G I, O'Donnell T V, Purdie G
Department of Medicine, Wellington School of Medicine.
N Z Med J. 1991 Jan 23;104(904):3-5.
Effects of a regimen of regular high dose beta agonist aerosol as sole therapy (fenoterol 400 micrograms qid) on FEV1 and bronchial responsiveness to methacholine provocation were examined monthly in 16 atopic moderately severe asthmatic subjects in an open uncontrolled four months study. Eleven completed the trial, four dropped out on account of severe acute asthma and one with muscle tremor. Overall there was a small significant drop of mean prebronchodilator FEV1 after one month of 0.27 L (95% confidence interval 0.12, 0.42) but not significant thereafter. The increase of bronchial responsiveness (mean decrease of PD20 of 0.50 doubling doses of methacholine) by the end of month four did not reach statistical significance. Our study which explored potentially adverse effects of this beta agonist regimen showed only small changes of doubtful clinical significance. Drop outs due to acute asthma complicate studies such as this and make conclusions difficult.
在一项为期四个月的开放性非对照研究中,对16名特应性中度重度哮喘患者每月检查一次常规高剂量β受体激动剂气雾剂作为唯一治疗方案(非诺特罗400微克,每日四次)对第一秒用力呼气容积(FEV1)和支气管对乙酰甲胆碱激发反应性的影响。11名患者完成了试验,4名因严重急性哮喘退出,1名因肌肉震颤退出。总体而言,在一个月后,支气管扩张剂使用前的平均FEV1有小幅显著下降,下降了0.27升(95%置信区间为0.12,0.42),但此后不显著。到第四个月末,支气管反应性的增加(乙酰甲胆碱双倍剂量的PD20平均下降0.50)未达到统计学显著性。我们探索该β受体激动剂方案潜在不良反应的研究仅显示出变化微小,临床意义存疑。因急性哮喘导致的退出使此类研究复杂化,难以得出结论。