Kiljander Toni O, Harding Susan M, Field Stephen K, Stein Mark R, Nelson Harold S, Ekelund Jan, Illueca Marta, Beckman Ola, Sostek Mark B
Department of Pulmonary Diseases, Tampere University Hospital, FIN-33521, Tampere, Finland.
Am J Respir Crit Care Med. 2006 May 15;173(10):1091-7. doi: 10.1164/rccm.200507-1167OC. Epub 2005 Dec 15.
Gastroesophageal reflux disease (GERD) is common in patients with asthma, suggesting an interaction between the two conditions.
To assess the effect of gastric acid suppression with the proton pump inhibitor esomeprazole on asthma outcomes in subjects with persistent moderate to severe asthma treated with antiinflammatory asthma medication.
In this double-blind study, subjects were randomized to receive esomeprazole 40 mg or placebo twice daily for 16 wk. According to nocturnal respiratory symptoms (NOC) and GERD, subjects were divided into three strata: GERD-/NOC+, GERD+/NOC-, and GERD+/NOC+.
A total of 770 subjects were randomized. There was no statistically significant improvement in morning peak expiratory flow (PEF) over placebo in the overall study population: 6.3 L/min (p = 0.061). Over the whole treatment period, in GERD+/NOC+ subjects (n = 350), esomeprazole provided an 8.7-L/min improvement (p = 0.03) in morning PEF, and a 10.2-L/min improvement (p = 0.012) in evening PEF over placebo. Among 307 subjects taking long-acting beta2-agonists, improvements over placebo were observed in morning PEF (12.2 L/min, p = 0.017) and in evening PEF (11.1 L/min, p = 0.024); these improvements were more pronounced in GERD+/NOC+ subjects. Esomeprazole 40 mg twice daily was well tolerated and no safety concerns were noted.
Esomeprazole improved PEF in subjects with asthma who presented with both GERD and NOC. In subjects without both GERD and NOC, no improvement could be detected.
胃食管反流病（GERD）在哮喘患者中很常见，提示这两种疾病之间存在相互作用。
评估质子泵抑制剂埃索美拉唑抑制胃酸对接受抗炎性哮喘药物治疗的持续性中度至重度哮喘患者哮喘转归的影响。
在这项双盲研究中，受试者被随机分为两组，分别每日两次接受40 mg埃索美拉唑或安慰剂治疗，为期16周。根据夜间呼吸道症状（NOC）和GERD，受试者被分为三个亚组：GERD-/NOC+、GERD+/NOC-和GERD+/NOC+。
共有770名受试者被随机分组。在整个研究人群中，与安慰剂相比，早晨呼气峰值流速（PEF）没有统计学上的显著改善：为6.3升/分钟（p = 0.061）。在整个治疗期间，在GERD+/NOC+亚组（n = 350）中，与安慰剂相比，埃索美拉唑使早晨PEF提高了8.7升/分钟（p = 0.03），晚上PEF提高了10.2升/分钟（p = 0.012）。在307名服用长效β2受体激动剂的受试者中，与安慰剂相比，早晨PEF（12.2升/分钟，p = 0.017）和晚上PEF（11.1升/分钟，p = 0.024）均有改善；这些改善在GERD+/NOC+亚组中更为明显。每日两次服用40 mg埃索美拉唑耐受性良好，未发现安全问题。
埃索美拉唑改善了同时患有GERD和NOC的哮喘患者的PEF。在不同时患有GERD和NOC的患者中，未检测到改善。
