Center for Esophageal Diseases and Swallowing, University of North Carolina School of Medicine, Chapel Hill, NC 27599-7080, USA.
Am J Gastroenterol. 2013 Apr;108(4):529-34. doi: 10.1038/ajg.2012.447. Epub 2013 Jan 15.
Approximately 20-30% of patients with gastroesophageal reflux disease (GERD) do not experience complete symptom resolution during proton pump inhibitor (PPI) therapy. The aim of this study was to determine the prevalence of esophageal mucosal breaks among patients who have a partial response to PPI therapy.
This was an analysis of data from a phase 2b clinical trial carried out to assess the efficacy and safety of a reflux inhibitor, lesogaberan (AZD3355), as an add-on to PPI therapy in this patient population (clinicaltrials.gov reference: NCT01005251). A total of 661 patients with persistent GERD symptoms who had received a minimum of 4 weeks of PPI therapy were included in the study. The prevalence of esophageal mucosal breaks was assessed according to (i) the most recent endoscopy results from within the previous 24 months, if available ("historical" endoscopies), and (ii) the results of endoscopies performed at study baseline ("baseline" endoscopies). Baseline endoscopies were not carried out in patients who had a historical endoscopy showing an absence of esophageal mucosal breaks.
Historical endoscopy results were available for 244 patients, of whom 48 (19.7%) had esophageal mucosal breaks. Baseline endoscopies were carried out in 465 patients, of whom 146 (31.4%) had esophageal mucosal breaks. Sensitivity analyses showed a prevalence of esophageal mucosal breaks of 20-30%. In both the historical and baseline endoscopies, most esophageal mucosal breaks were Los Angeles grades A or B.
In patients with GERD symptoms partially responsive to PPI therapy, mild-to-moderate severity esophageal mucosal breaks are common (prevalence 20-30%), and may contribute to symptom etiology.
约 20-30% 的胃食管反流病 (GERD) 患者在质子泵抑制剂 (PPI) 治疗期间无法完全缓解症状。本研究旨在确定对 PPI 治疗有部分反应的患者中食管黏膜破裂的发生率。
这是一项 2b 期临床试验数据的分析，该试验旨在评估一种反流抑制剂 lesogaberan (AZD3355) 作为 PPI 治疗的附加治疗在该患者人群中的疗效和安全性 (clinicaltrials.gov 参考：NCT01005251)。共有 661 名持续存在 GERD 症状且接受至少 4 周 PPI 治疗的患者纳入研究。根据 (i) 最近 24 个月内的内镜结果（如果有）（“历史”内镜）和 (ii) 研究基线时进行的内镜结果（“基线”内镜）评估食管黏膜破裂的发生率。如果有历史内镜显示无食管黏膜破裂，则基线内镜不会进行。
244 名患者有历史内镜结果，其中 48 名 (19.7%) 有食管黏膜破裂。465 名患者进行了基线内镜检查，其中 146 名 (31.4%) 有食管黏膜破裂。敏感性分析显示食管黏膜破裂的发生率为 20-30%。在历史和基线内镜检查中，大多数食管黏膜破裂为洛杉矶分级 A 或 B。
在对 PPI 治疗有部分反应的 GERD 症状患者中，轻度至中度严重程度的食管黏膜破裂很常见（发生率为 20-30%），可能导致症状发生的原因。
