Phipatanakul Wanda, Greene Charles, Downes Sandra J, Cronin Beth, Eller T J, Schneider Lynda C, Irani Anne-Marie
Department of Pediatrics, Division of Allergy and Immunology, Children's Hospital, Harvard Medical School, Boston, Massachusetts 02115, USA.
Ann Allergy Asthma Immunol. 2003 Jul;91(1):49-54. doi: 10.1016/S1081-1206(10)62058-3.
Because of potential toxicities of inhaled corticosteroid (ICS) use in pediatric asthma, alternative or steroid-sparing therapy is desirable. There are no previous studies evaluating montelukast's steroid-sparing effects in children with asthma.
To evaluate whether (1) montelukast as add-on therapy improves asthma symptom control and (2) montelukast provides steroid-sparing effects in children with asthma treated with low to moderate doses of ICS therapy.
In a double-blind, placebo-controlled trial, 36 children ages 6 to 14 years with symptomatic asthma maintained on a stable low to moderate dose of ICSs were randomly assigned to receive montelukast or matching placebo for 24 weeks after a run-in period of 2 weeks (period I). During the trial, subjects kept daily asthma diary cards and monthly spirometry was performed. After a 4 week add-on period (period II), the subjects completed a 20-week (period III) ICS tapering period based on a predetermined protocol.
In period II, the difference in the number of rescue-free days was significantly higher in the montelukast group (P = 0.0001), and the number of rescue-free days per week was also significantly higher in montelukast-treated subjects compared with placebo subjects (P = 0.002). In period III, the percentage reduction in ICS dose was not significant between montelukast and placebo (P = 0.10), but the montelukast group experienced an average 17% decrease in ICS dose and the control group experienced an average 64% increase in ICS dose.
Montelukast treatment significantly increased the number of rescue-free days in symptomatic children with asthma.
由于吸入性糖皮质激素（ICS）用于儿童哮喘治疗时存在潜在毒性，因此需要替代疗法或减少激素用量的疗法。此前尚无研究评估孟鲁司特对哮喘儿童的激素节省作用。
评估（1）孟鲁司特作为附加疗法是否能改善哮喘症状控制，以及（2）孟鲁司特对接受低至中等剂量ICS治疗的哮喘儿童是否具有激素节省作用。
在一项双盲、安慰剂对照试验中，36名6至14岁有症状的哮喘儿童在维持稳定的低至中等剂量ICS治疗的基础上，经过2周的导入期（第一阶段）后，被随机分配接受孟鲁司特或匹配的安慰剂治疗24周。在试验期间，受试者每天记录哮喘日记卡，并每月进行一次肺功能测定。经过4周的附加期（第二阶段）后，受试者根据预定方案完成20周（第三阶段）的ICS减量期。
在第二阶段，孟鲁司特组无急救天数的差异显著更高（P = 0.0001），与安慰剂组相比，接受孟鲁司特治疗的受试者每周无急救天数也显著更高（P = 0.002）。在第三阶段，孟鲁司特组和安慰剂组之间ICS剂量的降低百分比无显著差异（P = 0.10），但孟鲁司特组的ICS剂量平均降低了17%，而对照组的ICS剂量平均增加了64%。
孟鲁司特治疗显著增加了有症状哮喘儿童的无急救天数。
