Montelukast reduces asthma exacerbations in 2-to 5-year-old children with intermittent asthma
Montelukast reduces asthma exacerbations in 2-to 5-year-old children with intermittent asthma
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DOI：
10.1164/rccm.200407-894oc
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发表时间：
2005-02-15
影响因子：
24.7
通讯作者：
Polos, P
中科院分区：
文献类型：
--
作者：
Bisgaard, H;Zielen, S;Polos, P
PREVIA研究旨在研究孟鲁司特（一种白三烯受体拮抗剂）在预防有间歇性哮喘症状史的2 - 5岁儿童病毒诱导的哮喘急性发作中的作用。该研究是一项为期12个月的多中心、双盲、平行组研究，研究对象为哮喘急性发作伴呼吸道感染和发作间轻微症状的患者。患者随机接受口服孟鲁司特4或5 mg（取决于年龄）（n = 278）或安慰剂（n = 271），每天一次，持续12个月。护理人员在日记卡上记录儿童的症状、P-激动剂的使用和卫生保健资源的使用。在12个月的治疗中，与安慰剂相比，孟鲁司特显著降低了31.9%的哮喘急性发作率。孟鲁司特组每例患者的平均急性发作率为每年1.60次，而安慰剂组为2.34次。与安慰剂相比，孟鲁司特还使首次急性加重的中位时间延迟约2个月（p = 0.024），吸入性皮质类固醇疗程的发生率（p = 0.027）。孟鲁司特在12个月的治疗中有效地减少了2至5岁间歇性哮喘患者的哮喘急性发作，并且通常耐受良好。
The PREVIA study was designed to investigate the role of montelukast, a leukotriene receptor antagonist, in the prevention of viral-induced asthma exacerbations in children aged 2 to 5 years with a history of intermittent asthma symptoms. The study was a 12-month multicenter, double-blind, parallel-group study of patients with asthma exacerbations associated with respiratory infections and minimal symptoms between episodes. Patients were randomized to receive oral montelukast 4 or 5 mg (depending on age) (n = 278) or placebo (n = 271) once per day for 12 months. Caregivers recorded children's symptoms, P-agonist use, and health care resource use in a diary card. Over 12 months of therapy, montelukast significantly reduced the rate of asthma exacerbations by 31.9% compared with placebo. The average rate of exacerbation episodes per patient was 1.60 episodes per year on montelukast compared with 2.34 episodes on placebo. Montelukast also delayed the median time to first exacerbation by approximately 2 months (p = 0.024), and the rate of inhaled corticosteroid courses (p = 0.027) compared with placebo. Montelukast effectively reduced asthma exacerbations in 2- to 5-year-old patients with intermittent asthma over 12 months of treatment and was generally well tolerated.