Effect of Esomeprazole 40 mg Once or Twice Daily on Asthma A Randomized, Placebo-controlled Study
Effect of Esomeprazole 40 mg Once or Twice Daily on Asthma A Randomized, Placebo-controlled Study
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DOI：
10.1164/rccm.200910-1537oc
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发表时间：
2010-05-15
影响因子：
24.7
通讯作者：
Lind, Tore
中科院分区：
文献类型：
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作者：
Kiljander, Toni O.;Junghard, Ola;Lind, Tore
基本原理：胃食管反流病（GERD）在哮喘患者中很常见;然而，研究质子泵抑制剂对哮喘结局的影响的研究报告了相互矛盾的结果。目的：研究埃索美拉唑40毫克每日一次或两次对伴有GERD.Methods症状的患者哮喘转归的影响：这项为期26周的随机、双盲、安慰剂对照研究（NCT 00317044）纳入了患有中度至重度哮喘和症状性GERD的成人患者（18 - 70岁）。早晨呼气峰流量（主要变量），晚上呼气峰流量，FEV1，哮喘症状，哮喘生活质量问卷，反流病问卷，和tolerances.Measures和主要结果的变化进行了评估：共有961例患者被随机分组，828完成了研究。相对于基线，埃索美拉唑40 mg每日一次（+3.5 L/min; 95% CI，-3.2至10.2）和40 mg每日两次（+5.5 L/min; 95% CI，-1.2至12.2）均观察到晨间呼气峰流速改善，但治疗间差异无统计学意义。在治疗结束时，两种剂量的埃索美拉唑与安慰剂相比均显著改善FEV1（分别为+0.09 L和+0.12 L; P = 0.0039和P <0.0001）。然而，当计算整个26周期间的FEV1时，只有埃索美拉唑40 mg每日两次显示出显著改善（+0.07 L; P = 0.0042）。与安慰剂组相比，两种剂量的埃索美拉唑组的哮喘生活质量问卷总分均有显著改善（分别为+0.28和+0.41; P = 0.0006和P <0.0001）。结论：埃索美拉唑可改善肺功能和哮喘相关生活质量。然而，这些改善很小，临床意义不大。在www.example.com注册的临床试验（NCT 00317044）。
Rationale: Gastroesophageal reflux disease (GERD) is common among patients with asthma; however, studies investigating the effect of proton pump inhibitors on asthma outcomes report conflicting results. Objectives: To investigate the effect of esomeprazole 40 mg once or twice daily on asthma outcomes in patients with concomitant symptoms of GERD.Methods: This 26-week, randomized, double-blind, placebo-controlled study (NCT00317044) included adult patients (18-70 yr) with moderate-to-severe asthma and symptomatic GERD. The change in morning peak expiratory flow (primary variable), evening peak expiratory flow, FEV1, asthma symptoms, Asthma Quality of Life Questionnaire, Reflux Disease Questionnaire, and tolerability were assessed.Measurements and Main Results: A total of 961 patients were randomized and 828 completed the study. Relative to baseline, improvement in morning peak expiratory flow was observed for both esomeprazole 40 mg once daily (+3.5 L/min; 95% Cl, -3.2 to 10.2) and 40 mg twice daily (+5.5 L/min; 95% CI, -1.2 to 12.2), although no statistically significant between-treatment differences were apparent. At treatment end, both doses of esomeprazole significantly improved FEV1 versus placebo (+0.09 L and +0.12 L; P = 0.0039 and P < 0.0001, respectively). However, only esomeprazole 40 mg twice daily demonstrated a significant improvement when FEV1 was calculated over the entire 26-week period (+0.07 L; P = 0.0042). Significant improvements in Asthma Quality of Life Questionnaire total score were demonstrated for both esomeprazole doses compared with placebo (+0.28 and +0.41; P = 0.0006 and P < 0.0001, respectively).Conclusions: Esomeprazole may improve pulmonary function and asthma-related quality of life. However, the improvements were minor and of small clinical significance. Clinical trial registered with www.clinicaltrials.gov (NCT00317044).