Kiljander Toni, Rantanen Tuomo, Kellokumpu Ilmo, Kööbi Tiit, Lammi Lauri, Nieminen Markku, Poussa Tuija, Ranta Arto, Saarelainen Seppo, Salminen Paulina
Department of Respiratory Diseases, Terveystalo Hospital, Turku, Finland.
Clin Respir J. 2013 Jul;7(3):281-7. doi: 10.1111/crj.12005. Epub 2012 Oct 24.
Gastro-oesophageal reflux disease (GORD) is suggested to cause or aggravate several respiratory conditions. Studies with proton pump inhibitors have resulted in only minor improvements in pulmonary outcomes in patients with GORD. It has been speculated that operative treatment of GORD might be more efficient as it also diminishes non-acidic reflux.
To compare the effects of esomeprazole 40 mg bid and fundoplication on airway responsiveness, forced expiratory volume in 1 s (FEV1), exhaled nitric oxide (NO) and respiratory symptoms in patients with moderate-to-severe GORD.
Sixty-nine GORD patients had methacholine inhalation challenge performed on them, and FEV1, exhaled NO and respiratory symptoms were measured at baseline, after a 3-month treatment with esomeprazole and 3 months after fundoplication. Primary outcome variable was dose-response slope (DRS), i.e. decline in FEV1 during methacholine challenge divided with the amount of methacholine administered (%/μmol). Pre-defined subgroup analysis was performed among those with concomitant asthma (n = 12).
There was no improvement in DRS, FEV1 or exhaled NO after esomeprazole treatment or fundoplication. Cough and dyspnoea measured with visual analog scale improved with esomeprazole treatment (P < 0.001), and further after fundoplication (P < 0.001). Among those with concomitant asthma, significant improvements in St George Respiratory Questionnaire (SGRQ) scores could be seen after fundoplication.
Neither esomeprazole treatment nor fundoplication diminishes airway responsiveness or exhaled NO, or improves FEV1 in patients with GORD. Improvements in respiratory symptoms and SGRQ scores after GORD treatments could be detected. However, as this was not a placebo-controlled study, the findings in these secondary endpoints should not be emphasised. ClinicalTrials.cov: NCT00994708.
胃食管反流病（GORD）被认为会引发或加重多种呼吸道疾病。使用质子泵抑制剂的研究仅使GORD患者的肺部预后有轻微改善。据推测，GORD的手术治疗可能更有效，因为它还能减少非酸性反流。
比较40毫克埃索美拉唑每日两次给药与胃底折叠术对中重度GORD患者气道反应性、一秒用力呼气容积（FEV1）、呼出一氧化氮（NO）及呼吸道症状的影响。
对69例GORD患者进行了乙酰甲胆碱吸入激发试验，并在基线、接受埃索美拉唑治疗3个月后以及胃底折叠术后3个月测量了FEV1、呼出NO和呼吸道症状。主要结局变量是剂量反应斜率（DRS），即乙酰甲胆碱激发试验期间FEV1的下降幅度除以给予的乙酰甲胆碱量（%/μmol）。对合并哮喘的患者（n = 12）进行了预定义的亚组分析。
埃索美拉唑治疗或胃底折叠术后，DRS、FEV1或呼出NO均无改善。用视觉模拟量表测量的咳嗽和呼吸困难在埃索美拉唑治疗后有所改善（P < 0.001），胃底折叠术后进一步改善（P < 0.001）。在合并哮喘的患者中，胃底折叠术后圣乔治呼吸问卷（SGRQ）评分有显著改善。
埃索美拉唑治疗和胃底折叠术均未降低GORD患者的气道反应性或呼出NO，也未改善FEV1。GORD治疗后呼吸道症状和SGRQ评分有所改善。然而，由于这不是一项安慰剂对照研究，这些次要终点的结果不应被过分强调。临床试验注册号：NCT00994708。
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