Chodosh S, Crooks L A, Tuck J
Department of Pulmonary Research, VA Outpatient Clinic, Jamaica Plain, Massachusetts 02130.
J Asthma. 1989;26(5):309-15. doi: 10.3109/02770908909073268.
This single-center, double-blind, randomized study compared the efficacy and safety of single-dose pirbuterol aerosol (0.2 mg and 0.4 mg) with metaproterenol (1.3 mg) and placebo aerosols. Twenty-four patients with asthma or chronic obstructive pulmonary disease (COPD) completed this crossover design study. Statistically significant improvement over placebo (p less than 0.05 to p less than 0.001) was noted for pirbuterol 0.2 mg and 0.4 mg in FEV1 (forced expiratory volume in 1 second) duration, peak, and area under the curve (AUC) responses, and in maximum midexpiratory flow rate (MMEF) peak and AUC responses. Pirbuterol at both the 0.2 mg and 0.4 mg doses demonstrated statistically significant improvements in pulmonary function tests and clinical assessment over metaproterenol 1.3 mg. Both drugs were well-tolerated and neither drug increased cardiac ectopy, as measured on 5-h Holter monitor tapes.
这项单中心、双盲、随机研究比较了单剂量吡布特罗气雾剂(0.2毫克和0.4毫克)与间羟异丙肾上腺素(1.3毫克)气雾剂及安慰剂气雾剂的疗效和安全性。24例哮喘或慢性阻塞性肺疾病(COPD)患者完成了这项交叉设计研究。在第1秒用力呼气量(FEV1)持续时间、峰值和曲线下面积(AUC)反应以及最大呼气中期流速(MMEF)峰值和AUC反应方面,0.2毫克和0.4毫克的吡布特罗与安慰剂相比有统计学显著改善(p小于0.05至p小于0.001)。0.2毫克和0.4毫克剂量的吡布特罗在肺功能测试和临床评估方面比1.3毫克的间羟异丙肾上腺素显示出统计学显著改善。两种药物耐受性良好,5小时动态心电图监测均未显示两种药物增加心脏异位搏动。