Peroni D G, Piacentini G L, Pietrobelli A, Loiacono A, De Gasperi W, Sabbion A, Micciolo R, Boner A L
Clinica Pediatrica, University of Verona, Italy.
Eur Respir J. 2002 Jul;20(1):104-7. doi: 10.1183/09031936.02.00234902.
The aim of the study was to evaluate the protective effect of single-dose, combination treatment comprising montelukast (5 mg) and loratadine (10 mg), on exercise-induced bronchoconstriction in asthmatic children. The combination was compared to placebo, loratadine and montelukast alone. Nineteen children were enrolled in a double-blind randomised, single-dose, crossover study. For each treatment patients undertook two treadmill exercise tests, 2 and 12 h respectively after single-dose administration. No significant differences were seen in the maximum fall in forced expiratory volume in one second (FEV1) 2 h after treatment and placebo. Whereas significant differences in maximum fall in FEV1 were observed between treatment groups 12 h after administration. Loratadine alone did not show any significant protection or any additional effect in comparison with montelukast alone. Single doses of montelukast and montelukast plus loratadine were significantly more effective than loratadine at 12 h. The present study, performed using single-dose treatments, demonstrated that maximal protective effect by montelukast was obtained 12 h after dosing and that montelukast plus loratadine did not result in significant additive bronchoprotective effects on exercise-induced bronchoconstriction.
本研究旨在评估单剂量孟鲁司特（5毫克）和氯雷他定（10毫克）联合治疗对哮喘儿童运动诱发支气管收缩的保护作用。将该联合用药与安慰剂、单独使用氯雷他定和单独使用孟鲁司特进行比较。19名儿童参与了一项双盲随机单剂量交叉研究。对于每种治疗，患者在单剂量给药后分别于2小时和12小时进行两次跑步机运动试验。治疗后2小时，一秒用力呼气量（FEV1）的最大下降幅度与安慰剂相比无显著差异。而给药后12小时，各治疗组之间观察到FEV1最大下降幅度存在显著差异。与单独使用孟鲁司特相比，单独使用氯雷他定未显示出任何显著的保护作用或任何额外效果。单剂量孟鲁司特以及孟鲁司特加氯雷他定在12小时时比氯雷他定显著更有效。本研究采用单剂量治疗，结果表明，孟鲁司特在给药12小时后获得最大保护作用，且孟鲁司特加氯雷他定对运动诱发支气管收缩未产生显著的附加支气管保护作用。
