Department of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong, China.
J Gastroenterol. 2011 Jul;46(7):906-12. doi: 10.1007/s00535-011-0402-1. Epub 2011 May 3.
BACKGROUND: Evidence suggests that rates of gastroesophageal reflux disease are increasing in the Asia-Pacific region, where patients tend to have predominantly non-erosive reflux disease as opposed to erosive (reflux) esophagitis. At present, data for the responsiveness of non-erosive reflux disease to proton pump inhibition are scant. We aimed to study esomeprazole for the treatment of non-erosive reflux disease in Chinese patients. METHODS: Patients with a clinical diagnosis of gastroesophageal reflux, and a locally validated reflux index, the Chinese GerdQ, of equal to or greater than 12 were recruited and randomized to receive esomeprazole 20 mg daily or placebo for 8 weeks. Reflux index scores, quality of life (SF-36), and the hospital anxiety and depression (HAD) scale and symptom relief were evaluated before, during, and after treatment. RESULTS: A total of 175 patients were randomized. Patients in the esomeprazole group (n = 85) demonstrated statistically significant reductions in their GerdQ index, from 19.45 to 15.37 and to 14.32 (p = 0.013, p = 0.005) at weeks 4 and 8, respectively. Compared to placebo at week 8, 57.1% of patients on esomeprazole found that their symptoms had resolved or were acceptable compared with 37.2% in the placebo group (p = 0.001). There were no statistically significant differences in overall quality-of-life measures or the HAD scale related to treatment. CONCLUSIONS: This study suggests that esomeprazole is efficacious in treating Chinese patients with non-erosive reflux disease.
背景:有证据表明,亚太地区胃食管反流病的发病率正在上升,该地区的患者主要患有非糜烂性反流病,而不是糜烂性(反流性)食管炎。目前,关于质子泵抑制剂对非糜烂性反流病的反应性的数据很少。我们旨在研究埃索美拉唑治疗中国患者的非糜烂性反流病。
方法:招募了临床诊断为胃食管反流病的患者,并进行了局部验证的反流指数(中国 GerdQ)评估,其得分等于或大于 12 分,这些患者被随机分为接受埃索美拉唑 20mg 每日或安慰剂治疗 8 周。在治疗前、治疗期间和治疗后评估反流指数评分、生活质量(SF-36)、医院焦虑和抑郁量表(HAD)以及症状缓解情况。
结果:共有 175 名患者被随机分组。埃索美拉唑组(n=85)的患者 GerdQ 指数从治疗前的 19.45 分显著降低至治疗 4 周时的 15.37 分和治疗 8 周时的 14.32 分(p=0.013,p=0.005)。与安慰剂组相比,治疗 8 周时,埃索美拉唑组 57.1%的患者症状缓解或可接受,而安慰剂组为 37.2%(p=0.001)。治疗与总体生活质量测量或 HAD 量表无统计学显著差异。
结论:本研究表明,埃索美拉唑治疗中国非糜烂性反流病患者有效。
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