Allergy Clinic, Suomen Terveystalo AllergyClinic, Turku, Finland.
Ann Allergy Asthma Immunol. 2011 Jun;106(6):518-26. doi: 10.1016/j.anai.2011.01.017. Epub 2011 Mar 4.
No standard, optimal treatment exists for severe intermittent (ie, episodic) asthma in children. However, evidence suggests that both daily and episode-driven montelukast are effective for this phenotype.
To assess the regimen-related efficacy of montelukast in treating pediatric episodic asthma.
A multicenter, randomized, double-blind, double-dummy, parallel-group, 52-week study was performed in children 6 months to 5 years of age comparing placebo with two regimens of montelukast 4 mg: (1) daily; or (2) episode-driven for 12 days beginning with signs/symptoms consistent with imminent cold or breathing problem. The main outcome measure was the number of asthma episodes (symptoms requiring treatment) culminating in an asthma attack (symptoms requiring physician visit, emergency room visit, corticosteroids, or hospitalization).
Five hundred eighty-nine patients were randomized to daily montelukast, 591 to intermittent montelukast, and 591 to placebo. Compared with placebo, no significant difference was seen between daily montelukast (P = .510) or intermittent montelukast (P = .884) in the number of asthma episodes culminating in an asthma attack over 1 year. Daily montelukast reduced symptoms over the 12-day treatment period of asthma episodes compared with placebo (P = .045). Beta-agonist use was reduced with both daily (P = .048) and intermittent montelukast (P = .028) compared with placebo. However, because of prespecified rules for multiplicity adjustments (requiring a positive primary endpoint), statistical significance for secondary endpoints cannot be concluded. All treatments were well tolerated.
Montelukast did not reduce the number of asthma episodes culminating in an asthma attack over 1 year in children 6 months to 5 years of age, although numerical improvements occurred in some endpoints.
目前对于儿童间歇性（即发作性）重度哮喘尚无标准的最佳治疗方法。但是，有证据表明，无论是每日用药还是按需用药，孟鲁司特对这种表型均有效。
评估孟鲁司特治疗儿童发作性哮喘的方案相关疗效。
进行了一项多中心、随机、双盲、双模拟、平行分组、52 周研究，纳入 6 个月至 5 岁的儿童，比较安慰剂与孟鲁司特 4 mg 两种方案：（1）每日用药；或（2）发作时用药，共 12 天，起始于有即将出现的感冒或呼吸问题迹象/症状时。主要结局指标为哮喘发作（需要治疗的症状）的哮喘发作次数（需要就诊、急诊、皮质激素或住院治疗的症状）。
589 例患者被随机分配至每日孟鲁司特组、591 例患者至间歇性孟鲁司特组、591 例患者至安慰剂组。与安慰剂相比，在 1 年内哮喘发作导致哮喘发作的哮喘发作次数方面，每日孟鲁司特（P =.510）或间歇性孟鲁司特（P =.884）无显著差异。与安慰剂相比，每日孟鲁司特在哮喘发作的 12 天治疗期间可减少症状（P =.045）。与安慰剂相比，每日（P =.048）和间歇性孟鲁司特（P =.028）均可减少β-激动剂的使用。但是，由于存在多重调整的预设规则（需要阳性主要终点），因此不能得出次要终点的统计学意义。所有治疗均耐受良好。
在 6 个月至 5 岁的儿童中，孟鲁司特在 1 年内并未减少哮喘发作导致哮喘发作的次数，尽管一些终点指标有所改善。
