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泮托拉唑治疗胃食管反流病和阻塞性睡眠呼吸障碍所致日间嗜睡的随机安慰剂对照试验

Randomized placebo-controlled trial of pantoprazole for daytime sleepiness in GERD and obstructive sleep disordered breathing.

作者信息

Suurna Maria V, Welge Jeff, Surdulescu Victoria, Kushner Jonathan, Steward David L

机构信息

Department of Otolaryngology, Head and Neck Surgery, University of Cincinnati College of Medicine, Cincinnati, OH 45267-0528, USA.

出版信息

Otolaryngol Head Neck Surg. 2008 Aug;139(2):286-90. doi: 10.1016/j.otohns.2008.03.012.

Abstract

OBJECTIVE

To determine the efficacy of pantoprazole therapy for daytime somnolence, psychomotor vigilance, and quality of life in patients with mild-moderate obstructive sleep disordered breathing (OSDB) and gastroesophageal reflux disease (GERD).

STUDY DESIGN

Randomized, double-blind, placebo-controlled crossover trial.

METHODS

Sixty patients with daytime sleepiness, mild-moderate OSDB and GERD were randomly assigned a 2-week treatment with pantoprazole 40 mg or placebo followed by a 2-week washout period and crossover respectively to 2-week treatment with placebo or pantoprazole. Outcomes included Epworth Sleepiness Score (ESS), sleep-related quality-of-life (FOSQ), and reaction time.

RESULTS

With pantoprazole, patients reported statistically significantly greater improvement of overall reflux symptoms (P = 0.0003) and in ESS (P = 0.04). A significant improvement was noted in FOSQ for both treatments with a trend toward greater improvement with pantoprazole (P = 0.058). No improvement in reaction times was observed.

CONCLUSION

Patients with coexistent GERD and OSDB noted significant improvement in daytime sleepiness after treatment with pantoprazole over placebo likely related to a reduction in nocturnal reflux-related arousals.

摘要

目的

确定泮托拉唑治疗对轻中度阻塞性睡眠呼吸障碍(OSDB)和胃食管反流病(GERD)患者白天嗜睡、精神运动警觉性及生活质量的疗效。

研究设计

随机、双盲、安慰剂对照交叉试验。

方法

60例有白天嗜睡、轻中度OSDB和GERD的患者被随机分配接受为期2周的40 mg泮托拉唑治疗或安慰剂治疗,随后为期2周的洗脱期,然后分别交叉接受为期2周的安慰剂或泮托拉唑治疗。观察指标包括爱泼沃斯嗜睡量表(ESS)、睡眠相关生活质量(FOSQ)和反应时间。

结果

使用泮托拉唑治疗时,患者报告总体反流症状有统计学意义的显著改善(P = 0.0003),ESS也有改善(P = 0.04)。两种治疗的FOSQ均有显著改善,泮托拉唑治疗有更大改善的趋势(P = 0.058)。未观察到反应时间的改善。

结论

GERD和OSDB并存的患者在接受泮托拉唑治疗后,白天嗜睡情况较安慰剂组有显著改善,这可能与夜间反流相关觉醒减少有关。

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