Kemp J P, Dockhorn R J, Busse W W, Bleecker E R, Van As A
Allergy and Asthma Medical Group and Research Center, San Diego, California 92123.
Am J Respir Crit Care Med. 1994 Dec;150(6 Pt 1):1612-5. doi: 10.1164/ajrccm.150.6.7952623.
Physical exercise is a common trigger for bronchial asthma. We evaluated the preventive effect on exercise-induced bronchospasm (EIB) of a single 42 micrograms dose of salmeterol, a uniquely long-acting inhaled bronchodilator, and compared salmeterol with 180 micrograms albuterol in two independent, randomized, double-blind, placebo-controlled studies involving 161 subjects. Three exercise challenges were conducted over 12 h, and bronchoconstriction following the serial challenges was assessed as change in FEV1 compared with predose values. The mean maximal percentage decrease in FEV1 after the three exercise challenges was 5% at 0.5 h, 8% at 5.5 h, and 13% at 11.5 h postdose in the salmeterol group compared with 7, 25, and 27%, respectively, in the albuterol group and 27, 27, and 26%, respectively, in the placebo group (p < 0.001, overall treatment difference). Albuterol provided complete protection against EIB (defined as < 10% decrease in FEV1 compared with predose values) only after the first exercise challenge, but salmeterol continued to provide complete protection in the majority of subjects after each exercise challenge: 80% (44 of 55) at 0.5 h, 70% (37 of 53) at 5.5 h, and 55% (29 of 53) at 11.5 h. Electrocardiographic monitoring revealed no clinically significant changes in any treatment group 15 and 30 min following each exercise challenge. In summary, these data demonstrate that salmeterol is effective against EIB and that a single 42 micrograms dose can prevent EIB for up to 12 h.
体育锻炼是支气管哮喘的常见诱因。我们评估了单次42微克剂量的沙美特罗(一种独特的长效吸入性支气管扩张剂)对运动诱发支气管痉挛(EIB)的预防效果,并在两项涉及161名受试者的独立、随机、双盲、安慰剂对照研究中,将沙美特罗与180微克沙丁胺醇进行了比较。在12小时内进行了三次运动激发试验,并将连续激发试验后的支气管收缩情况评估为与给药前值相比的第一秒用力呼气量(FEV1)变化。沙美特罗组在给药后0.5小时、5.5小时和11.5小时,三次运动激发试验后FEV1的平均最大百分比下降分别为5%、8%和13%,而沙丁胺醇组分别为7%、25%和27%,安慰剂组分别为27%、27%和26%(总体治疗差异,p<0.001)。沙丁胺醇仅在第一次运动激发试验后提供了针对EIB的完全保护(定义为与给药前值相比FEV1下降<10%),但沙美特罗在每次运动激发试验后在大多数受试者中持续提供完全保护:0.5小时时为80%(55名中的44名),5.5小时时为70%(53名中的37名),11.5小时时为55%(53名中的29名)。心电图监测显示,每次运动激发试验后15分钟和30分钟,任何治疗组均未出现临床显著变化。总之,这些数据表明沙美特罗对EIB有效,且单次42微克剂量可预防EIB长达12小时。