Kemp J P, Dockhorn R J, Shapiro G G, Nguyen H H, Reiss T F, Seidenberg B C, Knorr B
Allergy and Asthma Medical Group and Research Center, San Diego, California, USA.
J Pediatr. 1998 Sep;133(3):424-8. doi: 10.1016/s0022-3476(98)70281-1.
To determine whether montelukast, a leukotriene receptor antagonist, attenuates exercise-induced bronchoconstriction (EIB) in 6- to 14-year-old children with asthma.
Double-blind, multicenter, 2-period crossover study. Children (n = 27) with forced expiratory volume in 1 second (FEV1) > or =70% of the predicted value and a fall in FEV1 > or =20% after exercise on 2 occasions. Patients received montelukast (5-mg chewable tablet) or placebo once daily in the evening for 2 days in crossover fashion (at least 4 days between treatment periods). Standardized exercise challenges were performed 20 to 24 hours after the last dose in each period. End points included area above the postexercise percent fall in FEV1 versus time curve (AAC0-60 min), maximum percent fall in FEV1 from pre-exercise baseline, and time to recovery of FEV1 to within 5% of pre-exercise baseline.
Montelukast significantly reduced AAC0-60 min (265 vs 590% x min for montelukast and placebo, respectively, P < or = .05; approximately 59% protection relative to placebo) and the maximum percent fall (18% vs 26% for montelukast and placebo, respectively, P < or = .05). Montelukast treatment resulted in a shorter time to recovery (18 vs 28 minutes for montelukast and placebo, respectively, P = .079).
Montelukast attenuates EIB at the end of the dosing interval in 6- to 14-year-old children with asthma.
确定白三烯受体拮抗剂孟鲁司特是否能减轻6至14岁哮喘儿童的运动诱发支气管收缩（EIB）。
双盲、多中心、两阶段交叉研究。入选儿童（n = 27）一秒用力呼气容积（FEV1）≥预测值的70%，且有两次运动后FEV1下降≥20%。患者以交叉方式每晚服用孟鲁司特（5毫克咀嚼片）或安慰剂，持续2天（治疗期之间至少间隔4天）。在每个阶段最后一剂用药后20至24小时进行标准化运动激发试验。终点指标包括运动后FEV1下降百分比与时间曲线（AAC0 - 60分钟）上方的面积、相对于运动前基线FEV1的最大下降百分比，以及FEV1恢复到运动前基线的5%以内的时间。
孟鲁司特显著降低了AAC0 - 60分钟（孟鲁司特和安慰剂分别为265和590%·分钟，P≤0.05；相对于安慰剂有大约59%的保护作用）以及最大下降百分比（孟鲁司特和安慰剂分别为18%和26%，P≤0.05）。孟鲁司特治疗使恢复时间缩短（孟鲁司特和安慰剂分别为18和28分钟，P = 0.079）。
孟鲁司特可减轻6至14岁哮喘儿童在给药间隔期末的EIB。
