Abstract
// Bin Yan 1, * , Zhongsheng Lu 1, * , Zhizheng Ge 2 , Side Liu 3 , Xuegang Guo 4 , Dean Tian 5 , Yuxiu Yang 6 , Xiaobo Li 2 , Wei Gong 3 , Zhiguo Liu 4 , Mei Liu 5 , Bingxi Zhou 6 , Kabing Zhao 1 , Jing Yang 1 and Yunsheng Yang 1 1 Department of Gastroenterology and Hepatology, Chinese PLA General Hospital, Beijing, China 2 Department of Gastroenterology and Hepatology, Renji Hospital, Shanghai, China 3 Department of Gastroenterology and Hepatology, Nanfang Hospital, Guangzhou, Guangdong Province, China 4 Department of Gastroenterology and Hepatology, Xijing Hospital, Xian, Shanxi province, China 5 Department of Gastroenterology and Hepatology, Tongji Hospital, Wuhan, Hubei province, China 6 Department of Gastroenterology and Hepatology, Henan Provincial People’s Hospital, Zhengzhou, Henan Province, China * These authors contributed equally to this work Correspondence to: Yunsheng Yang, email: sunny301ddc@126.com Keywords: randomized clinical trial; endoscopic submucosal dissection; ulcer; lansoprazole; rebamipide Received: September 29, 2017 Accepted: November 15, 2017 Published: January 02, 2018 ABSTRACT Objective: 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. Materials and Methods: Three hundred patients were randomized into control and experimental groups after undergoing ESD. The patients received intravenous pantoprazole (30 mg) every 12 hours and oral rebamipide (100 mg, experimental group) or placebo (control group) three times daily on days 1–3. On days 4–56, patients received oral lansoprazole (30 mg daily) and rebamipide (100 mg) or placebo three times daily. Endoscopic evaluations were performed at postoperative 4 and 8 weeks. Results: At week 4, the ulcer reduction rate was significantly higher in the experimental than in the control group (0.94 ± 0.078 vs. 0.97 ± 0.034; P < 0.001). The ulcer healing (20.3% vs 18.2%; P = 0. 669) and ulcer improvement rates (88.7% vs 94.2%; P = 0. 109) in the two 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 four weeks of therapy.
Highlights
Endoscopic submucosal dissection (ESD), developed in Japan in the 1990s [1, 2], is currently a widely accepted treatment for early gastric mucosal lesions as it is minimally invasive and enables the en bloc resection of mucosal lesions [3]
Multivariate analysis showed that the combination treatment was an independent factor associated with ulcer area reduction after endoscopic submucosal dissection (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
Summary
Endoscopic submucosal dissection (ESD), developed in Japan in the 1990s [1, 2], is currently a widely accepted treatment for early gastric mucosal lesions as it is minimally invasive and enables the en bloc resection of mucosal lesions [3]. Due to the widespread use of endoscopy and the higher rate of early lesion detection, the application of ESD has become increasingly common. This trend has been accompanied by increasing concern about ESD www.impactjournals.com/oncotarget s1183. Rebamipide has been evaluated for the treatment of post-ESD ulcers, and its clinical efficacy has been verified by numerous investigators [8]. Effective treatment regimens for post-ESD ulcers might involve rebamipide alone or in combination with PPIs. Some studies have indicated that the clinical efficacy of rebamipide alone is similar, or even superior, to that of PPIs alone [9]. The present study was to determine whether PPIs combined with rebamipide would promote post-ESD ulcer healing more effectively than PPIs alone and explore the ulcer healing-associated factors
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