Department of Comprehensive Medicine and Psychosomatic Medicine, Tohoku University Hospital, 1-1 Seiryo-machi, Aoba, Sendai, Miyagi 980-8574, Japan.
J Gastroenterol. 2011 Mar;46(3):297-304. doi: 10.1007/s00535-010-0342-1. Epub 2010 Nov 17.
Despite many reports from Western nations describing endoscopic and symptomatic improvements in patients with reflux esophagitis (RE) using proton pump inhibitors (PPI), PPI effects on the health-related quality of life (HRQOL), particularly for a dose duration of less than 8 weeks, have not been sufficiently clarified in Japanese RE patients.
RE patients (n = 9,029) in general practice settings took rabeprazole once daily for 8 weeks. HRQOL, using the 8-item Short-Form Health Survey (SF-8™), and symptoms, using a frequency scale for the symptoms of gastroesophageal reflux disease (GERD), were evaluated at the initiation of therapy (0 W), week 4 (4 W), and week 8 (8 W). Endoscopy was performed at 0 and 8 W where possible.
In efficacy analysis (n = 6,839), the mean ± SD values for the physical component summary of the SF-8™ at 0, 4, and 8 W were 45.005 ± 7.534, 48.517 ± 6.336, and 49.328 ± 6.207, respectively, while those for the mental component summary were 46.465 ± 7.743, 49.460 ± 6.470, and 50.388 ± 6.049, respectively. Significant improvements, compared to 0 W, were observed in eight domains and two summary scores at 4 W (P < 0.001), and further QOL score elevations were seen by 8 W. Regarding symptoms, the mean total frequency scale for the symptoms of GERD (FSSG) scores at 0, 4, and 8 W were 16.4 ± 9.8, 7.8 ± 7.4, and 6.0 ± 6.8, respectively. Significant improvements, compared to 0 W, were seen in the total, reflux, and dysmotility scores and in the scores for all 12 items at 4 W (P < 0.001).
The score for the HRQOL of RE patients before rabeprazole therapy was below 50 points (the national mean for the general Japanese population), indicating harmed QOL. Rabeprazole markedly improved the HRQOL at 4 W, with recovery to the national mean by 8 W. Symptoms had also improved significantly at 4 W, with further improvements observed at 8 W.
尽管有许多来自西方国家的报告描述了质子泵抑制剂 (PPI) 可使反流性食管炎 (RE) 患者的内镜和症状得到改善，但 PPI 对健康相关生活质量 (HRQOL) 的影响，特别是在 8 周以下的剂量持续时间内，在日本 RE 患者中尚未得到充分阐明。
在一般实践环境中，RE 患者（n = 9029）每天服用一次雷贝拉唑，持续 8 周。在治疗开始时（0 周）、第 4 周（4 周）和第 8 周（8 周）评估 HRQOL，使用 8 项简短健康调查 (SF-8™)，使用胃食管反流病 (GERD) 症状频率量表评估症状。在可能的情况下，在 0 和 8 周时进行内镜检查。
在疗效分析中（n = 6839），SF-8™ 物理成分综合得分在 0、4 和 8 周时的平均值 ± 标准差分别为 45.005 ± 7.534、48.517 ± 6.336 和 49.328 ± 6.207，而心理成分综合得分分别为 46.465 ± 7.743、49.460 ± 6.470 和 50.388 ± 6.049。与 0 周相比，在 4 周时，八个领域和两个综合评分均观察到显著改善（P < 0.001），8 周时 QOL 评分进一步升高。关于症状，0、4 和 8 周时 GERD 症状总频率量表 (FSSG) 评分的平均值 ± 标准差分别为 16.4 ± 9.8、7.8 ± 7.4 和 6.0 ± 6.8。与 0 周相比，在总评分、反流评分和动力障碍评分以及所有 12 项评分中，在 4 周时均观察到显著改善（P < 0.001）。
雷贝拉唑治疗前 RE 患者的 HRQOL 评分低于 50 分（日本一般人群的全国平均水平），表明 QOL 受损。雷贝拉唑在 4 周时显著改善 HRQOL，8 周时恢复到全国平均水平。症状也在 4 周时得到显著改善，8 周时进一步改善。
