OBJECTIVES To evaluate the healing efficacy of rebamipide and lansoprazole combination therapy with lansoprazole alone for endoscopic submucosal dissection (ESD)-induced ulcers and clarify the ulcer healing-associated factors. METHODS Three hundred patients were randomized into control and experimental groups after they underwent ESD. The patients received intravenous pantoprazole (30 mg) every 12 hours and oral rebamipide (100 mg, experimental group) or placebo (control group) 3 times daily on days 1-3. On days 4-56, patients received oral lansoprazole (30 mg daily) and rebamipide (100 mg) or placebo 3 times daily. Endoscopic evaluations were performed at postoperative weeks 4 and 8. RESULTS At week 4, the ulcer reduction rate was significantly higher in the experimental than in the control group (0.97 ± 0.034 vs. 0.94 ± 0.078; P < 0.001). The ulcer healing (18.2% vs 20.3%; P = 0.669) and ulcer improvement rates (94.2% vs 88.7%; P = 0.109) in the 2 groups were not significantly different. At week 8, the ulcer healing and ulcer improvement rates were 90.6% and 100%, respectively, in both groups. Multivariate analysis showed that the combination treatment was an independent factor associated with ulcer area reduction after ESD. The maximum diameter of the initial ulcer (≥35.5 mm vs <35.5 mm) was an independent factor associated with the ulcer improvement rate after ESD. CONCLUSIONS The rebamipide and lansoprazole combination therapy can help accelerate the reduction rate of post-ESD ulcer compared with the lansoprazole monotherapy at 4 weeks of therapy.

中文翻译：

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瑞巴派特加兰索拉唑的多中心随机对照试验，用于治疗内镜下黏膜下剥离性溃疡。

目的评价瑞巴派特和兰索拉唑联合兰索拉唑单独治疗内镜下黏膜下剥离（ESD）引起的溃疡的疗效，并明确溃疡愈合相关因素。方法将300例接受ESD的患者随机分为对照组和实验组。患者每12小时接受一次静脉注射pantoprazole（30 mg），并在第1-3天每天口服口服瑞巴派特（100 mg，实验组）或安慰剂（对照组）。在第4-56天，患者接受口服兰索拉唑（每天30 mg）和瑞巴派特（100 mg）或安慰剂每天3次。术后第4和第8周进行内窥镜评估。结果在第4周，实验组的溃疡减少率明显高于对照组（0.97±0.034 vs. 0.94±0.078； P <0.001）。两组的溃疡愈合（18.2％vs 20.3％； P = 0.669）和溃疡改善率（94.2％vs 88.7％； P = 0.109）没有显着差异。在第8周，两组的溃疡愈合率和溃疡改善率分别为90.6％和100％。多变量分析表明，联合治疗是与ESD后溃疡面积减少相关的独立因素。初始溃疡的最大直径（≥35.5mm vs <35.5 mm）是与ESD后溃疡改善率相关的独立因素。结论与兰索拉唑单药治疗4周相比，瑞巴派特和兰索拉唑联合治疗可帮助加快ESD后溃疡的减少率。109）在两组中没有显着差异。在第8周，两组的溃疡愈合率和溃疡改善率分别为90.6％和100％。多变量分析表明，联合治疗是与ESD后溃疡面积减少相关的独立因素。初始溃疡的最大直径（≥35.5mm vs <35.5 mm）是与ESD后溃疡改善率相关的独立因素。结论与兰索拉唑单药治疗4周相比，瑞巴派特和兰索拉唑联合治疗可帮助加快ESD后溃疡的减少率。109）在两组中没有显着差异。在第8周，两组的溃疡愈合率和溃疡改善率分别为90.6％和100％。多变量分析表明，联合治疗是与ESD后溃疡面积减少相关的独立因素。初始溃疡的最大直径（≥35.5mm vs <35.5 mm）是与ESD后溃疡改善率相关的独立因素。结论与兰索拉唑单药治疗4周相比，瑞巴派特和兰索拉唑联合治疗可帮助加快ESD后溃疡的减少率。多变量分析表明，联合治疗是与ESD后溃疡面积减少相关的独立因素。初始溃疡的最大直径（≥35.5mm vs <35.5 mm）是与ESD后溃疡改善率相关的独立因素。结论与兰索拉唑单药治疗4周相比，瑞巴派特和兰索拉唑联合治疗可帮助加快ESD后溃疡的减少率。多因素分析表明，联合治疗是与ESD后溃疡面积减少相关的独立因素。初始溃疡的最大直径（≥35.5mm vs <35.5 mm）是与ESD后溃疡改善率相关的独立因素。结论与兰索拉唑单药治疗4周相比，瑞巴派特和兰索拉唑联合治疗可帮助加快ESD后溃疡的减少率。