Johnson David A, Orr William C, Crawley Joseph A, Traxler Barry, McCullough Joseph, Brown Kurt A, Roth Thomas
Eastern VA School of Medicine, Norfolk, Virginia, USA.
Am J Gastroenterol. 2005 Sep;100(9):1914-22. doi: 10.1111/j.1572-0241.2005.00285.x.
Sleep disturbances are common in patients with gastroesophageal reflux disease (GERD). This study examined the effects of esomeprazole on nighttime heartburn, GERD-related sleep disturbances, sleep quality, work productivity, and regular activities.
This multicenter, randomized, double-blind, placebo-controlled trial included adults with GERD-associated sleep disturbances and moderate-to-severe nighttime heartburn (recorded by patient diary during screening). Patients received oral esomeprazole 40 mg (n = 220) or 20 mg (n = 226) or placebo (n = 229) once daily for 4 wk. The primary outcome was relief of nighttime heartburn. Secondary outcomes included resolution of sleep disturbances, sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI) questionnaire, and work productivity measured by the Work Productivity and Activity Impairment Questionnaire.
Nighttime heartburn was relieved in 53.1% (111/209), 50.5% (111/220), and 12.7% (28/221) of patients who received esomeprazole 40 mg, esomeprazole 20 mg, and placebo, respectively. Differences (95% CI) versus placebo were 40.5% (32.4%, 48.5%) and 37.8% (29.9%, 45.7%) and were highly significant (p < 0.0001). GERD-related sleep disturbances resolved in significantly more (p < 0.0001) patients who received esomeprazole 40 (73.7%) or 20 mg (73.2%) than in those who received placebo (41.2%). Both esomeprazole groups had greater PSQI global score changes from baseline (p < 0.0001 vs placebo) and more (p < 0.0001 vs placebo) work hours saved per week per patient compared with baseline (esomeprazole 40 mg, 11.6 h; esomeprazole 20 mg, 12.3 h; placebo, 6.2 h).
Esomeprazole reduced nighttime heartburn and GERD-related sleep disturbances and improved sleep quality and work productivity.
睡眠障碍在胃食管反流病（GERD）患者中很常见。本研究探讨了埃索美拉唑对夜间烧心、GERD相关睡眠障碍、睡眠质量、工作效率和日常活动的影响。
这项多中心、随机、双盲、安慰剂对照试验纳入了患有GERD相关睡眠障碍和中度至重度夜间烧心的成年人（筛查期间通过患者日记记录）。患者每天口服40mg埃索美拉唑（n = 220）或20mg（n = 226）或安慰剂（n = 229），持续4周。主要结局是夜间烧心的缓解。次要结局包括睡眠障碍的解决、通过匹兹堡睡眠质量指数（PSQI）问卷测量的睡眠质量，以及通过工作效率和活动障碍问卷测量的工作效率。
接受40mg埃索美拉唑、20mg埃索美拉唑和安慰剂的患者中，夜间烧心缓解的比例分别为53.1%（111/209）、50.5%（111/220）和12.7%（28/221）。与安慰剂相比的差异（95%CI）分别为40.5%（32.4%，48.5%）和37.8%（29.9%，45.7%），差异具有高度显著性（p < 0.0001）。接受40mg（73.7%）或20mg（73.2%）埃索美拉唑的患者中，GERD相关睡眠障碍得到解决的比例显著高于接受安慰剂的患者（41.2%）（p < 0.0001）。与安慰剂相比，两个埃索美拉唑组的PSQI全球评分从基线的变化更大（p < 0.0001），并且每位患者每周节省的工作时间比基线更多（p < 0.0001）（40mg埃索美拉唑组为11.6小时；20mg埃索美拉唑组为12.3小时；安慰剂组为6.2小时）。
埃索美拉唑可减轻夜间烧心和GERD相关睡眠障碍，改善睡眠质量和工作效率。
