Department of Pediatric Allergy, Gaziantep University School of Medicine, Gaziantep, Turkey.
Department of Pediatric Allergy, Hacettepe University School of Medicine, Ankara, Turkey.
Pediatr Allergy Immunol. 2018 Feb;29(1):50-57. doi: 10.1111/pai.12822. Epub 2017 Dec 12.
Cysteinyl-leukotrienes are increased in the airways of infants with virus-associated wheezing. We aimed to determine the effects of a cysteinyl-leukotriene-1 receptor antagonist on symptoms during an early-life wheezing illness and to investigate the factors that affect the response to this drug.
This placebo-controlled double-blinded randomized controlled trial recruited children aged 3-36 months with wheezing illness and randomized to active drug or placebo for 56 days. A symptom score diary (SSD) was kept by the children's caregivers.
One-hundred patients completed the study, and 62 (30 montelukast and 32 placebo) were analyzed. There were no significant differences in the percent of symptom-free days, symptom scores, and the need for rescue salbutamol between the two groups. However, the percent of symptom-free days within the first week was significantly higher for the montelukast than for the placebo group (13.8 ± 4.1% vs. 5.4 ± 3.4%; P = 0.028); wheezing score at 7th day was significantly lower for the montelukast than for the placebo group (0.5 ± 0.1 vs. 1.4 ± 0.2; P = 0.002). In addition, the number of inhaled ß -agonist rescue episodes per day during the first week was significantly lower for the montelukast compared with the placebo group (12.7 ± 1.8 vs. 19.2 ± 1.6; P = 0.013). Conclusions Our results indicate that montelukast may be effective for reducing caregiver-observed wheezing and the need for salbutamol during the first week of treatment for early-life wheezing. The impact for caregivers and the optimal duration of treatment will need to be explored in studies of larger size.
半胱氨酰白三烯在病毒相关性喘息婴儿的气道中增加。我们旨在确定半胱氨酰白三烯-1 受体拮抗剂对婴儿期喘息疾病期间症状的影响，并研究影响对该药物反应的因素。
这项安慰剂对照的双盲随机对照临床试验招募了年龄在 3-36 个月有喘息病的儿童，并随机分配接受活性药物或安慰剂治疗 56 天。儿童的照顾者保留了症状评分日记（SSD）。
100 名患者完成了这项研究，其中 62 名（30 名孟鲁司特和 32 名安慰剂）进行了分析。两组之间无症状天数、症状评分和需要抢救沙丁胺醇的百分比无显著差异。然而，孟鲁司特组的无症状天数百分比在前一周明显高于安慰剂组（13.8±4.1%对 5.4±3.4%；P=0.028）；孟鲁司特组第 7 天的喘息评分明显低于安慰剂组（0.5±0.1 对 1.4±0.2；P=0.002）。此外，孟鲁司特组在前一周每天吸入的β-激动剂抢救次数明显低于安慰剂组（12.7±1.8 对 19.2±1.6；P=0.013）。结论：我们的结果表明，孟鲁司特可能有效减少婴儿期喘息早期治疗第一周内照顾者观察到的喘息和沙丁胺醇的需求。需要在更大规模的研究中探讨对照顾者的影响和最佳治疗持续时间。
