Muir J F, Georges D
Service de Pneumologie, CHU de Rouen Hôpital de Bois-Guillaume.
Rev Mal Respir. 1992;9 Suppl 1:R23-6.
Ninety-six patients with nocturnal asthma (FEV1 = 60-90% pred, reversibility greater than or equal to 15%, at least 2 awakenings in the week preceding the trial) were included in a double-blind, randomized, crossover, multicenter study which compared the efficacy and side effects of inhaled salmeterol (50 micrograms morning and evening) to the association theophylline-ketotifen (300 mg and 1 mg morning and evening, respectively). The trial included a run-in period of 14 days and 2 periods of successive treatment of 28 days each. The efficacy was expressed in terms of therapeutic success, defined by the total disappearance of nocturnal symptoms during the treatment week. A statistically significant difference (p less than 0.01) was found between salmeterol and the association for this criteria: during the first period, 46% of subjects treated by salmeterol did not present nocturnal awakenings during the last treatment week by comparison with 15% of subjects taking the association; during the second period, corresponding figures were 39% for salmeterol by comparison with 26% for the association. Differences were also significant, favoring salmeterol, for other criteria (lung function tests, extra-need for salbutamol). Side effects were 5 times more frequent for the association (p less than 0.004). Salmeterol is clearly superior to the association theophylline-ketotifen in the treatment of nocturnal asthma.
96例夜间哮喘患者（FEV1为预计值的60 - 90%，可逆性大于或等于15%，在试验前一周至少有2次夜间觉醒）被纳入一项双盲、随机、交叉、多中心研究，该研究比较了吸入沙美特罗（早晚各50微克）与茶碱 - 酮替芬联合用药（分别为早晚各300毫克和1毫克）的疗效和副作用。试验包括14天的导入期和两个连续各28天的治疗期。疗效以治疗成功来表示，定义为治疗周期间夜间症状完全消失。就这一标准而言，沙美特罗与联合用药之间存在统计学显著差异（p小于0.01）：在第一阶段，接受沙美特罗治疗的受试者中有46%在最后治疗周期间没有夜间觉醒，而服用联合用药的受试者中这一比例为15%；在第二阶段，沙美特罗的相应数字为39%，联合用药为26%。对于其他标准（肺功能测试、额外使用沙丁胺醇的需求），差异也很显著，有利于沙美特罗。联合用药的副作用发生率是沙美特罗的5倍（p小于0.004）。在治疗夜间哮喘方面，沙美特罗明显优于茶碱 - 酮替芬联合用药。
