Lansoprazole for children with poorly controlled asthma: a randomized controlled trial.
Lansoprazole for children with poorly controlled asthma: a randomized controlled trial.
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DOI：
10.1001/jama.2011.2035
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发表时间：
2012-01-25
影响因子：
120.7
通讯作者：
Teague, W. Gerald
中科院分区：
文献类型：
--
作者：
Holbrook, Janet T.;Wise, Robert A.;Gold, Benjamin D.;Blake, Kathryn;Brown, Ellen D.;Castro, Mario;Dozor, Allen J.;Lima, John J.;Mastronarde, John G.;Sockrider, Marianna M.;Teague, W. Gerald
无症状胃食管反流（GER）在哮喘儿童中普遍存在。目前尚不清楚使用质子泵抑制剂（PPI）治疗胃食管反流是否能改善哮喘控制情况。
为了确定兰索拉唑在无明显胃食管反流的儿童中是否能有效减轻哮喘症状。
在18个学术临床中心进行了一项多中心、随机、设盲、安慰剂对照、平行临床试验，比较兰索拉唑与安慰剂对吸入糖皮质激素治疗后哮喘控制不佳的儿童的疗效。参与者随访24周。一个亚组在随机分组前进行了食管pH值检测。
儿童接受兰索拉唑（体重<30kg者每日15mg；体重≥30kg者每日30mg）或安慰剂治疗，分配比例为1∶1。
主要结局是哮喘控制评分（ACQ，范围从0到6）的变化。次要结局包括肺功能指标、哮喘相关生活质量以及哮喘控制不佳的急性发作情况。
2010年8月至2011年4月期间招募了306名儿童，中位年龄为11岁。兰索拉唑组和安慰剂组的ACQ评分平均变化（95%置信区间（CI））分别为 -0.1（-0.2，0.1）和 -0.2（-0.4，-0.1）单位（P = 0.12）。次要结局方面未检测到治疗差异（第一秒用力呼气容积（FEV₁）为平均（95% CI）0.00（-0.08，0.08），哮喘生活质量为 -0.1（-0.4，0.1），哮喘控制不佳发作的风险比为1.18（95% CI 0.91，1.53）。在进行食管pH值检测的115名儿童中，胃食管反流的患病率为43%。在pH值检测呈阳性的亚组中，对于任何哮喘结局，兰索拉唑与安慰剂相比均未观察到治疗效果。接受兰索拉唑治疗的儿童报告上呼吸道感染（63%对49%，P = 0.02）、喉咙痛（52%对39%，P = 0.02）和支气管炎（7%对2%，P = 0.05）的发生率更高。
在使用吸入糖皮质激素但无胃食管反流症状且哮喘控制不佳的儿童中，与安慰剂相比，添加兰索拉唑既未改善症状也未改善肺功能，还与不良事件增加有关。
Asymptomatic gastroesophageal reflux (GER) is prevalent in children with asthma. It is not known whether treatment of GER with a proton-pump inhibitor (PPI) improves asthma control. To determine whether lansoprazole is effective in reducing asthma symptoms in children without overt GER. A multicenter, randomized, masked, placebo controlled, parallel clinical trial comparing lansoprazole to placebo in children with poor asthma control on inhaled corticosteroid treatment conducted at 18 academic clinical centers. Participants were followed for 24 weeks. A subgroup had an esophageal pH study before randomization. Children received either lansoprazole (15 mg daily < 30 kg; 30 mg ≥ 30 kg) or placebo, 1:1 allocation ratio. The primary outcome was the change in Asthma Control score (ACQ, range from 0 to 6). Secondary outcomes included lung function measures, asthma-related quality of life and acute episodes of poor asthma control. 306 children were enrolled from April 2011 to August 2010, the median age was 11. The mean change (95% confidence interval (CI)) in the ACQ score was −0.1 (−0.2, 0.1) and −0.2 (−0.4, −0.1) units for the lansoprazole and placebo groups, respectively (P=0.12). There were no detectable treatment differences in secondary outcomes (mean (95% CI) for FEV1(0.00 (−0.08, 0.08)), asthma quality of life (−0.1 (−0.4, 0.1) or episodes of poor asthma control, hazard ratio of 1.18 (95% CI 0.91, 1.53). 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 versus placebo was observed for any asthma outcome. Children treated with lansoprazole reported more upper respiratory infections (63% vs 49%, P=0.02), sore throats (52% vs 39%, P=0.02), and bronchitis (7% vs 2%, P=0.05). Among children with poorly controlled asthma without symptoms of GER who were using inhaled corticosteroids, the addition of lansoprazole, as compared to placebo, did not improve symptoms nor lung function but was associated with increased adverse events.
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作者：
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通讯作者：
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DOI：
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