Berezuk G P, Schondelmeyer S W, Seidenfeld J J, Jones W N, Bootman J L
Clin Pharm. 1983 Mar-Apr;2(2):129-34.
The clinical effectiveness of albuterol, isoetharine, and metaproterenol administered by aerosol inhalation at manufacturer-recommended doses was compared. A double-blind, placebo-controlled, crossover comparison of albuterol 280 micrograms, isoetharine 680 micrograms, and metaproterenol 1300 micrograms was conducted in 10 adult men with reversible, chronic pulmonary obstruction. FEV1 (forced expiratory volume at one second), FEF25-75 (forced expiratory flow rate from 25 to 75% of vital capacity), and FVC (forced vital capacity) were determined periodically for six hours after drug administration. Bronchodilator effects, adverse effects, and cost of treatments were compared. Theophylline therapy was unaltered during the study, and serum theophylline concentration was determined periodically to control for its effect on pulmonary function. Serum theophylline concentration was not used as a covariate since it resulted in minimal change in the pulmonary-function measures. The mean maximum percent change from baseline for FEV1 for each drug was superior to placebo; there were no differences among drugs. Comparing area under the curve of mean percent change in FEV1 versus time, albuterol and metaproterenol produced changes that were greater than placebo but not different from each other or isoetharine. For FEF25-75 and FVC, albuterol and metaproterenol, respectively, were superior. No pattern of adverse effects was identifiable among the four treatments. The average wholesale cost of albuterol products was approximately 1.7 times the cost of metaproterenol products. Under the conditions of this study, metaproterenol was superior to isoetharine and therapeutically equivalent to and less expensive than albuterol.
比较了按制造商推荐剂量通过气雾剂吸入给予的沙丁胺醇、异丙喘宁和间羟异丙肾上腺素的临床疗效。对10名患有可逆性慢性肺阻塞的成年男性进行了一项双盲、安慰剂对照的交叉比较,分别给予280微克沙丁胺醇、680微克异丙喘宁和1300微克间羟异丙肾上腺素。在给药后6小时内定期测定第一秒用力呼气量(FEV1)、25%至75%肺活量的用力呼气流量(FEF25-75)和用力肺活量(FVC)。比较了支气管扩张作用、不良反应和治疗费用。在研究期间茶碱治疗未改变,并定期测定血清茶碱浓度以控制其对肺功能的影响。血清茶碱浓度未用作协变量,因为它对肺功能指标的影响极小。每种药物的FEV1相对于基线的平均最大百分比变化均优于安慰剂;各药物之间无差异。比较FEV1平均百分比变化与时间的曲线下面积,沙丁胺醇和间羟异丙肾上腺素产生的变化大于安慰剂,但彼此之间以及与异丙喘宁之间无差异。对于FEF25-75和FVC,沙丁胺醇和间羟异丙肾上腺素分别更优。在四种治疗中未发现不良反应模式。沙丁胺醇产品的平均批发成本约为间羟异丙肾上腺素产品成本的1.7倍。在本研究条件下,间羟异丙肾上腺素优于异丙喘宁,在治疗上与沙丁胺醇等效且成本低于沙丁胺醇。