JAMA. 2012 Jan 25;307(4):373-81. doi: 10.1001/jama.2011.2035.
Asymptomatic gastroesophageal reflux (GER) is prevalent in children with asthma. Untreated GER has been postulated to be a cause of inadequate asthma control in children despite inhaled corticosteroid treatment, but it is not known whether treatment with proton pump inhibitors improves asthma control.
To determine whether lansoprazole is effective in reducing asthma symptoms in children without overt GER.
DESIGN, SETTING, AND PARTICIPANTS: The Study of Acid Reflux in Children With Asthma, a randomized, masked, placebo-controlled, parallel clinical trial that compared lansoprazole with placebo in children with poor asthma control who were receiving inhaled corticosteroid treatment. Three hundred six participants enrolled from April 2007 to September 2010 at 19 US academic clinical centers were followed up for 24 weeks. A subgroup had an esophageal pH study before randomization.
Participating children were randomly assigned to receive either lansoprazole, 15 mg/d if weighing less than 30 kg or 30 mg/d if weighing 30 kg or more (n = 149), or placebo (n = 157).
The primary outcome measure was change in Asthma Control Questionnaire (ACQ) score (range, 0-6; a 0.5-unit change is considered clinically meaningful). Secondary outcome measures included lung function measures, asthma-related quality of life, and episodes of poor asthma control.
The mean age was 11 years (SD, 3 years). The mean difference in change (lansoprazole minus placebo) in the ACQ score was 0.2 units (95% CI, 0.0-0.3 units). There were no statistically significant differences in the mean difference in change for the secondary outcomes of forced expiratory volume in the first second (0.0 L; 95% CI, -0.1 to 0.1 L), asthma-related quality of life (-0.1; 95% CI, -0.3 to 0.1), or rate of episodes of poor asthma control (relative risk, 1.2; 95% CI, 0.9-1.5). Among the 115 children with esophageal pH studies, the prevalence of GER was 43%. In the subgroup with a positive pH study, no treatment effect for lansoprazole vs placebo was observed for any asthma outcome. Children treated with lansoprazole reported more respiratory infections (relative risk, 1.3 [95% CI, 1.1-1.6]).
In this trial of children with poorly controlled asthma without symptoms of GER who were using inhaled corticosteroids, the addition of lansoprazole, compared with placebo, improved neither symptoms nor lung function but was associated with increased adverse events.
clinicaltrials.gov Identifier: NCT00442013.
哮喘患儿中存在无症状性胃食管反流（GER）。尽管接受了吸入皮质类固醇治疗，但未经治疗的 GER 被认为是儿童哮喘控制不佳的原因，但尚不清楚质子泵抑制剂（PPI）治疗是否能改善哮喘控制。
确定 Lansoprazole 是否能有效减轻无明显 GER 的哮喘患儿的哮喘症状。
设计、地点和参与者：哮喘患儿胃食管反流研究是一项随机、双盲、安慰剂对照、平行临床试验，比较了 Lansoprazole 与安慰剂在接受吸入皮质类固醇治疗但哮喘控制不佳的儿童中的疗效。2007 年 4 月至 2010 年 9 月，19 个美国学术临床中心共招募了 306 名参与者，随访 24 周。亚组在随机分组前进行了食管 pH 研究。
参与的儿童被随机分配接受 Lansoprazole（体重<30kg 者 15mg/d，体重≥30kg 者 30mg/d，n=149）或安慰剂（n=157）。
主要观察指标为哮喘控制问卷（ACQ）评分的变化（范围 0-6；0.5 个单位的变化被认为具有临床意义）。次要观察指标包括肺功能指标、哮喘相关生活质量和哮喘控制不佳的发作次数。
平均年龄为 11 岁（标准差 3 岁）。Lansoprazole 与安慰剂相比，ACQ 评分的变化差值的平均值为 0.2 个单位（95%置信区间，0.0-0.3 个单位）。次要结局指标的平均变化差值无统计学差异，包括用力呼气量（FEV1）（0.0L；95%置信区间，-0.1 至 0.1L）、哮喘相关生活质量（-0.1；95%置信区间，-0.3 至 0.1）或哮喘控制不佳的发作率（相对风险，1.2；95%置信区间，0.9-1.5）。在 115 名进行食管 pH 研究的儿童中，GER 的患病率为 43%。在 pH 研究阳性的亚组中，与安慰剂相比，Lansoprazole 治疗对任何哮喘结局均无治疗效果。接受 Lansoprazole 治疗的儿童报告的呼吸道感染更多（相对风险，1.3[95%置信区间，1.1-1.6]）。
在这项针对使用吸入皮质类固醇治疗但无 GER 症状的哮喘控制不佳的儿童的试验中，与安慰剂相比，Lansoprazole 的添加既不能改善症状，也不能改善肺功能，但与更多的不良事件有关。
clinicaltrials.gov 标识符：NCT00442013。
