Boeree M J, Peters F T, Postma D S, Kleibeuker J H
Dept of Pulmonary Medicine, University Hospital, Groningen, The Netherlands.
Eur Respir J. 1998 May;11(5):1070-4. doi: 10.1183/09031936.98.11051070.
Acid gastro-oesophageal reflux may aggravate respiratory symptoms in patients with asthma and chronic obstructive pulmonary disease (COPD) by increasing airway hyperresponsiveness through vagally-mediated pathways. We wanted to determine whether elimination of acid reflux could improve symptoms in such patients. In a randomized, double-blind, placebo-controlled study, 36 allergic and nonallergic subjects (17 males and 19 females, mean age 52 yrs), with airway obstruction and severe airway hyperresponsiveness despite maintenance treatment with an inhaled corticosteroid and with increased acid gastro-oesophageal reflux, were treated either with omeprazole, 40 mg b.i.d., or placebo for 3 months. Primary endpoints were: airway hyperresponsiveness, as determined by the provocative concentration of methacholine producing a 20% fall in forced expiratory volume in one second (PC20); and airway obstruction. Secondary endpoints were: peak expiratory flow variability; reversibility to inhaled ipratropium bromide as a parameter of vagal activity; asthma symptoms scores; and medication used. Reflux was measured by 24 h ambulatory intraoesophageal pH measurement. Omeprazole, 40 mg b.i.d., for 3 months had no beneficial effect on any of the pulmonary parameters, despite its profound effect on acid reflux and improvement of reflux symptoms scores, compared to placebo. The results of this study do not support a role for intensive antireflux therapy to improve pulmonary symptoms and function in patients with asthma and chronic obstructive pulmonary disease, who have severe airway hyperresponsiveness despite maintenance treatment with inhaled corticosteroids.
酸性胃食管反流可能通过迷走神经介导的途径增加气道高反应性，从而加重哮喘和慢性阻塞性肺疾病（COPD）患者的呼吸道症状。我们想确定消除酸性反流是否能改善这类患者的症状。在一项随机、双盲、安慰剂对照研究中，36名过敏和非过敏受试者（17名男性和19名女性，平均年龄52岁），尽管接受吸入性糖皮质激素维持治疗，但仍存在气道阻塞和严重气道高反应性，且伴有酸性胃食管反流增加，他们被给予奥美拉唑40mg，每日两次，或安慰剂治疗3个月。主要终点指标为：通过使一秒用力呼气量下降20%的乙酰甲胆碱激发浓度（PC20）来确定气道高反应性；以及气道阻塞。次要终点指标为：呼气峰值流速变异性；吸入异丙托溴铵后的可逆性作为迷走神经活动的参数；哮喘症状评分；以及所用药物。通过24小时动态食管内pH测量来检测反流情况。与安慰剂相比，每日两次服用40mg奥美拉唑，持续3个月，尽管对酸性反流有显著影响且反流症状评分有所改善，但对任何肺部参数均无有益作用。本研究结果不支持强化抗反流治疗对哮喘和慢性阻塞性肺疾病患者改善肺部症状和功能起作用，这些患者尽管接受吸入性糖皮质激素维持治疗，但仍有严重气道高反应性。
