Ringbaek T J, Søes-Petersen U, Christensen M, Iversen E T, Rasmussen F V
Lungemedicinsk afdeling P, Bispebjerg Hospital, København.
Ugeskr Laeger. 1996 Jul 1;158(27):3940-3.
In a randomized, double-blind, double-dummy, cross-over study the efficacy and safety of inhaled salmeterol 50 mcg (b.i.d.) was compared with oral salbutamol controlled release 8 mg (b.i.d.). Fifty-nine patients with moderate asthma were randomized to two four-week periods of treatment with a two-week washout period. During the study period the patients were allowed to use inhaled Salbutamol on a prn. basis. Inhaled steroids, if any, were continued. On diary cards patients recorded peak expiratory flow rate (PEFR) morning and evening before medication, asthma symptom score, and use of inhaled salbutamol. Salmeterol was more effective than salbutamol CR in decreasing daily symptoms (p = 0.001) and increasing morning-PEFR (p = 0.004). Salmeterol resulted in significantly more days without symptoms (p = 0.0004) and days and nights without need for rescue medication (p = 0.01 and p = 0.01). Salmeterol was better tolerated than salbutamol CR.
在一项随机、双盲、双模拟、交叉研究中,对吸入50微克沙美特罗(每日两次)与口服8毫克控释沙丁胺醇(每日两次)的疗效和安全性进行了比较。59例中度哮喘患者被随机分为两个为期四周的治疗期,中间有两周的洗脱期。在研究期间,允许患者按需使用吸入性沙丁胺醇。如有吸入性糖皮质激素,则继续使用。患者在日记卡上记录用药前早晚的呼气峰值流速(PEFR)、哮喘症状评分以及吸入性沙丁胺醇的使用情况。在减轻每日症状方面,沙美特罗比控释沙丁胺醇更有效(p = 0.001),在提高早晨PEFR方面也是如此(p = 0.004)。沙美特罗导致无症状天数显著更多(p = 0.0004),无需急救药物的白天和夜晚天数也更多(p = 0.01和p = 0.01)。沙美特罗的耐受性比控释沙丁胺醇更好。