Kooi Elisabeth M W, Schokker Siebrig, Marike Boezen H, de Vries Tjalling W, Vaessen-Verberne Anja A P H, van der Molen Thys, Duiverman Eric J
Department of Pediatrics, Division of Pediatric Pulmonology and Allergology, Beatrix Children's Hospital, University Medical Center Groningen, University of Groningen, P.O. Box 196, 9700 AD Groningen, The Netherlands.
Pulm Pharmacol Ther. 2008 Oct;21(5):798-804. doi: 10.1016/j.pupt.2008.06.004. Epub 2008 Jul 2.
Beneficial effects of anti-inflammatory therapy such as fluticasone propionate (FP) and montelukast (Mk) have been demonstrated in preschool children with asthma. However, comparative studies are lacking in this age group. Therefore, we conducted a study to evaluate and compare the effect of FP and Mk in preschool children with asthma-like symptoms.
In this multicenter, randomized, placebo-controlled, double-blind, double-dummy trial, children aged 2-6 years with asthma-like symptoms were included. In total, 63 children were randomly allocated to receive FP (25), Mk (18) or placebo (20) for 3 months. The primary outcome was the daily symptom score (wheeze, cough, shortness of breath) as recorded by caregivers in a symptom diary card. Secondary endpoints were rescue medication free days, blood eosinophils and lung function (interrupter technique and forced oscillation technique (FOT)).
During the 3 months study period, symptoms improved in all 3 groups, with a statistically significant difference between FP and placebo in favor of the FP group (p=0.021). A significant reduction in circulating eosinophils after 3 months of treatment was found in the Mk group only (p=0.008), which was significantly different from the change found in the placebo group (p=0.045). With the exception of frequency dependence (measured by FOT), which showed a difference between FP and Mk after 3 months of treatment in favor of the FP group (p=0.048), no differences in lung function within or between groups were found.
In spite of a lack of power, our results suggest that FP has a beneficial effect on symptoms and Mk on blood eosinophil level as compared to placebo. Except for a difference in one lung function parameter after 3 months between FP and Mk in favor of the FP group, this study revealed no differences between FP and Mk.
抗炎治疗如丙酸氟替卡松（FP）和孟鲁司特（Mk）对学龄前哮喘儿童的有益作用已得到证实。然而，该年龄组的比较研究尚缺乏。因此，我们开展了一项研究以评估和比较FP和Mk对有哮喘样症状的学龄前儿童的疗效。
在这项多中心、随机、安慰剂对照、双盲、双模拟试验中，纳入了2至6岁有哮喘样症状的儿童。总共63名儿童被随机分配接受FP（25名）、Mk（18名）或安慰剂（20名）治疗3个月。主要结局是照料者在症状日记卡中记录的每日症状评分（喘息、咳嗽、呼吸急促）。次要终点是无急救药物天数、血液嗜酸性粒细胞和肺功能（间断技术和强迫振荡技术（FOT））。
在3个月的研究期间，所有3组症状均有改善，FP组与安慰剂组之间存在统计学显著差异，有利于FP组（p=0.021）。仅在Mk组中发现治疗3个月后循环嗜酸性粒细胞有显著减少（p=0.008），这与安慰剂组的变化有显著差异（p=0.045）。除了频率依赖性（通过FOT测量）在治疗3个月后FP组和Mk组之间存在差异，有利于FP组（p=0.048）外，组内或组间肺功能均未发现差异。
尽管样本量不足，但我们的结果表明，与安慰剂相比，FP对症状有有益作用，Mk对血液嗜酸性粒细胞水平有有益作用。除了治疗3个月后FP组和Mk组在一个肺功能参数上存在有利于FP组的差异外，本研究未发现FP和Mk之间存在差异。
