机构地区:[1]Department of Gastroenterology Changhai Hospital, Second Military Medical University, Shanghai 200433, China [2]Department of Gastroenterology Department of Pathology , Changhai Hospital, Second Military Medical University, Shanghai 200433, China [3]Department of Gastroenterology, Beijing Chaoyang Hospital,Capital Medical University, Beijing 100020, China [4]Department of Gastroenterolog Tianjin Medical University General Hospital, Tianjin 300052, China [5]Department-of Gastroenterology, First Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong 510080, China [6]Department of Gastroenterology, Zhejiang First Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang 310003, China [7]Department of Gastroenterology, West China Hospital, Sichuan University, Chengdu, Sichuan 610041, China
出 处:《Chinese Medical Journal》2012年第16期2878-2884,共7页中华医学杂志(英文版)
摘 要:Background The role of gastro-protecting agents on symptomatic chronic gastritis is unclear. This multicenter, open, randomized trial was designed to compare the comprehensive effects of gefarnate with sucralfate on erosive gastritis with dyspeptic symptoms. Methods Totally 253 dyspepsia patients confirmed with erosive gastritis were enrolled from six centers in China. They randomly received either daily 300 mg gefarnate or 3 g sucralfate for six weeks. The primary endpoint was the effective rate of both treatments on endoscopic erosion at week six. Results Gefarnate showed an effective rate of 72% and 67% on endoscopic score and dyspeptic symptom release, which is statistically higher than sucralfate (40.1% and 39.3%, P 〈0.001, intension-to-treat). For histological improvement, gefarnate showed both effective in decreasing mucosal chronic inflammation (57.7% vs. 24.8%, P 〈0.001, intension-to-treat) and active inflammation (36.4% vs. 23.1%, P 〈0.05, intension-to-treat) than the control. A significant increase of prostaglandins and decrease of myeloperoxidase in mucosa were observed in gefarnate group. Severity of erosion is non-relevant to symptoms but Helicobacter pylori (H. pylor status does affect the outcome of therapy. Conclusions Gefarnate demonstrates an effective outcome on the mucosal inflammation in patients with chronic erosive qastritis. Endoscopic and inflammation score should be the major indexes used in gastritis-related trials.Background The role of gastro-protecting agents on symptomatic chronic gastritis is unclear. This multicenter, open, randomized trial was designed to compare the comprehensive effects of gefarnate with sucralfate on erosive gastritis with dyspeptic symptoms. Methods Totally 253 dyspepsia patients confirmed with erosive gastritis were enrolled from six centers in China. They randomly received either daily 300 mg gefarnate or 3 g sucralfate for six weeks. The primary endpoint was the effective rate of both treatments on endoscopic erosion at week six. Results Gefarnate showed an effective rate of 72% and 67% on endoscopic score and dyspeptic symptom release, which is statistically higher than sucralfate (40.1% and 39.3%, P 〈0.001, intension-to-treat). For histological improvement, gefarnate showed both effective in decreasing mucosal chronic inflammation (57.7% vs. 24.8%, P 〈0.001, intension-to-treat) and active inflammation (36.4% vs. 23.1%, P 〈0.05, intension-to-treat) than the control. A significant increase of prostaglandins and decrease of myeloperoxidase in mucosa were observed in gefarnate group. Severity of erosion is non-relevant to symptoms but Helicobacter pylori (H. pylor status does affect the outcome of therapy. Conclusions Gefarnate demonstrates an effective outcome on the mucosal inflammation in patients with chronic erosive qastritis. Endoscopic and inflammation score should be the major indexes used in gastritis-related trials.
关 键 词:GEFARNATE gastritis " functional dyspepsia " gastro-protection
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