Arnold Donald H, Bowman Nena, Reiss Theodore F, Hartert Tina V, Seger Donna L
a Departments of Pediatrics and Emergency Medicine , Vanderbilt University School of Medicine , Nashville , TN , USA.
b Center for Asthma Research , Vanderbilt University School of Medicine , Nashville , TN , USA.
Clin Toxicol (Phila). 2018 Jan;56(1):25-29. doi: 10.1080/15563650.2017.1337123. Epub 2017 Jun 22.
Montelukast sodium is a leukotriene-receptor antagonist approved as a controller medication for chronic asthma and allergic rhinitis in children and adults. We sought to characterize adverse events associated with single montelukast exposures in children ages 5-17 years and to determine whether adverse events were dose related for all-dose and for ultra-high-dose (≥50 mg) exposures.
This is a retrospective analysis of data from the National Poison Data System for exposures that included montelukast in individuals aged 5-17 years for calendar years 2000-2016. Filters were applied to identify exposure events in which montelukast was the primary exposure and for which the exact or lowest-possible ingested dose was recorded. Characteristics of adverse events were examined using descriptive statistics and multivariable logistic models were used to examine whether associations of montelukast and adverse events were dose related.
During the 17-year study period, there were 17,069 montelukast exposures available for analyses. Patients were median [interquartile range] age 7 (5, 9) years, and 10,907 (64%) male gender. Abdominal pain was the most common adverse event (0.23%). There were 618 ultra-high-dose exposures (≥50 mg). These patients had median age 6 (5, 8) years, and 347 (56%) male gender. Abdominal pain was the most common adverse event (1.46%). Increasing ingested dose was associated with abdominal pain (adjusted odds ratio, 1.01, 95% confidence interval 1.01, 1.02) after adjustment for age and gender. No serious or life-threatening events were reported.
Single-dose exposures of montelukast up to 445 mg are rarely associated with any adverse events and are not associated with serious or life-threatening adverse events in children aged 5-17 years.
孟鲁司特钠是一种白三烯受体拮抗剂，被批准作为儿童和成人慢性哮喘及过敏性鼻炎的控制药物。我们试图描述5至17岁儿童单次服用孟鲁司特后的不良事件特征，并确定所有剂量及超高剂量（≥50毫克）服用情况下不良事件是否与剂量相关。
这是一项对2000年至2016年期间美国国家中毒数据系统中5至17岁个体服用孟鲁司特暴露数据的回顾性分析。应用筛选条件来识别以孟鲁司特为主要暴露且记录了确切或最低可能摄入剂量的暴露事件。使用描述性统计分析不良事件的特征，并使用多变量逻辑模型来检验孟鲁司特与不良事件的关联是否与剂量相关。
在17年的研究期间，共有17069例孟鲁司特暴露事件可供分析。患者的年龄中位数[四分位间距]为7（5，9）岁，男性有10907例（64%）。腹痛是最常见的不良事件（0.23%）。有618例超高剂量暴露（≥50毫克）。这些患者的年龄中位数为6（5，8）岁，男性有347例（56%）。腹痛是最常见的不良事件（1.46%）。在对年龄和性别进行调整后发现，摄入剂量增加与腹痛相关（调整后的比值比为1.01，95%置信区间为1.01，1.02）。未报告严重或危及生命的事件。
5至17岁儿童单次服用高达445毫克的孟鲁司特很少与任何不良事件相关，也未出现严重或危及生命的不良事件。
