Amirav Israel, Luder Anthony S, Kruger Natalie, Borovitch Yael, Babai Ilan, Miron Dan, Zuker Miriam, Tal Gay, Mandelberg Avigdor
Ziv Medical Centre, Department of Pediatrics, Safed 13100, Israel.
Pediatrics. 2008 Dec;122(6):e1249-55. doi: 10.1542/peds.2008-1744. Epub 2008 Nov 4.
Cysteinyl leukotrienes are implicated in the inflammation of bronchiolitis. Recently, a specific cysteinyl leukotriene receptor antagonist, montelukast (Singulair [MSD, Haarlem, Netherlands]), has been approved for infants in granule sachets.
Our goal was to evaluate the effect of montelukast on clinical progress and on cytokines in acute bronchiolitis.
This was a randomized, placebo-controlled, double-blind, parallel-group study in 2 medical centers. Fifty-three infants (mean age: 3.8+/-3.5 months) with a first episode of acute bronchiolitis were randomly assigned to receive either 4-mg montelukast sachets or placebo, every day, from hospital admission until discharge. The primary outcome was length of stay, and secondary outcomes included clinical severity score (maximum of 12) and changes in type 1 and 2 cytokine levels (including interleukin4/IFN-gamma ratio as a surrogate for the T-helper 2/T-helper 1 ratio) in nasal lavage.
Both groups were comparable at baseline, and cytokine levels correlated positively with disease severity. There were neither differences in length of stay (4.63+/-1.88 [placebo group] vs 4.65+/-1.97 days [montelukast group]) nor in clinical severity score and cytokine levels between the 2 groups. No differences in interleukin 4/IFN-gamma ratio between the 2 groups were seen. There was a slight tendency for infants in the montelukast group to recover more slowly than those in the placebo group (clinical severity score at discharge: 6.1+/-2.4 vs 4.8+/-2.2, respectively).
Montelukast did not improve the clinical course in acute bronchiolitis. No significant effect of montelukast on the T-helper 2/T-helper 1 cytokine ratio when given in the early acute phase could be demonstrated.
半胱氨酰白三烯与细支气管炎的炎症反应有关。最近，一种特异性半胱氨酰白三烯受体拮抗剂孟鲁司特（顺尔宁[默克雪兰诺公司，荷兰哈勒姆]）已被批准用于婴儿的颗粒剂。
我们的目标是评估孟鲁司特对急性细支气管炎临床进展和细胞因子的影响。
这是一项在2个医学中心进行的随机、安慰剂对照、双盲、平行组研究。53例首次发作急性细支气管炎的婴儿（平均年龄：3.8±3.5个月）从入院至出院被随机分配，每天接受4毫克孟鲁司特颗粒剂或安慰剂。主要结局是住院时间，次要结局包括临床严重程度评分（最高12分）以及鼻灌洗中1型和2型细胞因子水平的变化（包括白细胞介素4/干扰素-γ比值作为辅助性T细胞2/辅助性T细胞1比值的替代指标）。
两组在基线时具有可比性，细胞因子水平与疾病严重程度呈正相关。两组在住院时间（4.63±1.88天[安慰剂组]对4.65±1.97天[孟鲁司特组]）、临床严重程度评分和细胞因子水平方面均无差异。两组间白细胞介素4/干扰素-γ比值未见差异。孟鲁司特组婴儿的恢复速度略慢于安慰剂组婴儿（出院时临床严重程度评分分别为6.1±2.4对4.8±2.2）。
孟鲁司特并未改善急性细支气管炎的临床病程。在急性早期给予孟鲁司特对辅助性T细胞2/辅助性T细胞1细胞因子比值无显著影响。
