艾美拉唑在未控制哮喘中的治疗作用
2009/05/18
背景：哮喘患者常合并有胃食道返流，但通常症状轻微或无明显胃肠道症状。目前，尚不明确，质子泵抑制剂是否能控制无胃食道返流症状的哮喘的发生。
方法：观察吸入类固醇治疗而未能控制、存在轻微的或无胃肠道症状的哮喘患者412例，采用平行、双盲、随机对照方法，分别给予艾美拉唑（Esomeprazol）40mg，, 每天2次，或安慰剂。随访24周，记录哮喘症状评分（哮喘日记）、肺活量测定（间隔4周测定1次）。予便携式PH胃食道测定仪测定患者是否存在胃食道返流。主要评价指标是哮喘发作的次数（根据哮喘日记记录）。
结果：艾美拉唑组哮喘发作次数与安慰剂组无显著性差异（每人每年的发作事件分别为2.3 和2.5 ，P=0.66)。两组间，在再次就诊的次数、肺功能，气道反应性，哮喘控制，症状记分，夜间觉醒，或生活质量等方面，均未见明显的治疗效果的差异。对予便携式PH测定仪发现的存在胃食道返流的哮喘患者（约40%），也未能观察到质子泵抑制剂所起的治疗效果。艾美拉唑组药物的不良事件低于安慰剂组（11比17）。
结论：尽管未控制哮喘患者的无症状胃食道返流发病率很高，但质子泵抑制剂不能明显控制哮喘的发作。无症状胃食道返流不一定是哮喘未控制的原因。
（张清玲 深圳市第二人民医院呼吸内科 518039 摘译）
（欧阳海峰第四军医大学西京医院呼吸内科 710032 摘译）
(N Engl J Med ,2009 Apr;360:1487-1499)
Efficacy of Esomeprazole for Treatment of Poorly Controlled Asthma.
John G. Mastronarde,M.D., Nicholas R. Anthonisen, M.D., Mario Castro, M.D., et al.
N Engl J Med ,2009 Apr;360:1487-99.
John G. Mastronarde,M.D., Nicholas R. Anthonisen, M.D., Mario Castro, M.D., et al.
N Engl J Med ,2009 Apr;360:1487-99.
Background：Gastroesophageal reflux is common among patients with asthma but often causes
mild or no symptoms. It is not known whether treatment of gastroesophageal reflux
with proton-pump inhibitors in patients who have poorly controlled asthma without
symptoms of gastroesophageal reflux can substantially improve asthma control.
Methods：In a parallel-group, double-blind trial, we randomly assigned 412 participants with
inadequately controlled asthma, despite treatment with inhaled corticosteroids, and
with minimal or no symptoms of gastroesophageal reflux to receive either 40 mg of
esomeprazole twice a day or matching placebo. Participants were followed for 24
weeks with the use of daily asthma diaries, spirometry performed once every 4 weeks,
and questionnaires that asked about asthma symptoms. We used ambulatory pH
monitoring to ascertain the presence or absence of gastroesophageal reflux in the
participants. The primary outcome was the rate of episodes of poor asthma control,
as assessed on the basis of entries in asthma diaries.
Results：Episodes of poor asthma control occurred with similar frequency in the placebo and
esomeprazole groups (2.3 and 2.5 events per person-year, respectively; P = 0.66).
There was no treatment effect with respect to individual components of the episodes
of poor asthma control or with respect to secondary outcomes, including pulmonary
function, airway reactivity, asthma control, symptom scores, nocturnal awakening,
or quality of life. The presence of gastroesophageal reflux, which was documented
by pH monitoring in 40% of participants with minimal or no symptoms,
did not identify a subgroup of patients that benefited from treatment with protonpump
inhibitors. There were fewer serious adverse events among patients receiving
esomeprazole than among those receiving placebo (11 vs. 17).
Conclusions：Despite a high prevalence of asymptomatic gastroesophageal reflux among patients
with poorly controlled asthma, treatment with proton-pump inhibitors does not
improve asthma control. Asymptomatic gastroesophageal reflux is not a likely
cause of poorly controlled asthma. (ClinicalTrials.gov number, NCT00069823.)
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改善居室供热对社区儿童哮喘的作用：随机对照研究
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长效β激动剂：哮喘临床试验中福莫特罗的安全性资料分析
