Division of Gastroenterology and Hepatology, Northwestern University Feinberg School of Medicine, , Chicago, Illinois, USA.
Gut. 2014 May;63(5):720-6. doi: 10.1136/gutjnl-2013-304883. Epub 2013 Jul 5.
Limited data exist on the impact of regurgitation on health-related quality of life (HRQOL) in gastro-oesophageal reflux disease (GORD). We assessed the relationship between regurgitation frequency and HRQOL before and after acid suppression therapy in GORD.
We used data from two randomised trials of AZD0865 25-75 mg/day versus esomeprazole 20 or 40 mg/day in non-erosive reflux disease (NERD) (n=1415) or reflux oesophagitis (RO) (n=1460). The Reflux Disease Questionnaire was used to select patients with frequent and intense heartburn for inclusion and to assess treatment response. The Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaire was used to assess HRQOL.
At baseline, 93% of patients in both the NERD and RO groups experienced regurgitation. Mean QOLRAD scores were similar for NERD and RO at baseline and at week 4 and disclosed decremental HRQOL with increasing frequency of regurgitation; a clinically relevant difference of >0.5 in mean QOLRAD scores was seen with regurgitation ≥4 days/week versus <4 days/week. The prevalence of frequent, persistent regurgitation (≥4 days/week) at week 4 among heartburn responders (≤1 day/week of mild heartburn) was 28% in NERD and 23% in RO. QOLRAD scores were higher among heartburn responders. There was a similar pattern of impact related to regurgitation frequency in heartburn responders compared with the group as a whole.
Frequent regurgitation was associated with a clinically relevant, incremental decline in HRQOL beyond that associated with heartburn before and after potent acid suppression in both NERD and RO.
NCT00206284 and NCT00206245.
在胃食管反流病（GORD）中，关于反流与健康相关生活质量（HRQOL）之间关系的资料有限。我们评估了 GORD 患者在抑酸治疗前后，反流频率与 HRQOL 之间的关系。
我们使用了 AZD0865 25-75mg/天与埃索美拉唑 20 或 40mg/天治疗非糜烂性反流病（NERD）（n=1415）或反流性食管炎（RO）（n=1460）的两项随机试验的数据。使用反流疾病问卷（Reflux Disease Questionnaire）选择烧心频繁且剧烈的患者纳入研究，并评估治疗反应。使用反流和消化不良生活质量问卷（Quality of Life in Reflux and Dyspepsia Questionnaire，QOLRAD）评估 HRQOL。
在基线时，NERD 和 RO 两组患者中均有 93%的患者存在反流。NERD 和 RO 两组的基线和第 4 周时 QOLRAD 评分相似，随着反流频率的增加，HRQOL 呈递减趋势；与每周反流＜4 天相比，每周反流≥4 天的患者 QOLRAD 评分平均差值＞0.5，存在临床相关差异。在每周≤1 天轻中度烧心的烧心缓解者中，第 4 周时频繁、持续反流（每周≥4 天）的发生率在 NERD 为 28%，RO 为 23%。烧心缓解者的 QOLRAD 评分较高。与总体人群相比，在烧心缓解者中，反流频率与 HRQOL 之间的影响也呈现出相似的模式。
在 NERD 和 RO 中，与烧心相关的 HRQOL 下降之外，频繁的反流与抑酸治疗前后的 HRQOL 进一步的、临床相关的下降相关。
NCT00206284 和 NCT00206245。
