Limited Effect of Rebamipide in Addition to Proton Pump Inhibitor (PPI) in the Treatment of Post-Endoscopic Submucosal Dissection Gastric Ulcers: A Randomized Controlled Trial Comparing PPI Plus Rebamipide Combination Therapy with PPI Monotherapy
Gut and Liver 2016³â 10±Ç 6È£ p.917 ~ p.924
(Nakamura Kazuhiko) - Kyushu University Graduate School of Medical Sciences Department of Medicine and Bioregulatory Science
(Ihara Eikichi) - Kyushu University Graduate School of Medical Sciences Department of Medicine and Bioregulatory Science
(Akiho Hirotada) - Kitakyushu Municipal Medical Center Department of Gastroenterology
(Akahoshi Kazuya) - Aso Iizuka Hospital Department of Gastroenterology
(Harada Naohiko) - National Hospital Organization Kyushu Medical Center Department of Gastroenterology
(Ochiai Toshiaki) - Saiseikai Fukuoka General Hospital Division of Gastroenterology
(Nakamura Norimoto) - Harasanshin Hospital Department of Gastroenterology
(Ogino Haruei) - Kyushu University Graduate School of Medical Sciences Department of Medicine and Bioregulatory Science
(Iwasa Tsutomu) - Kyushu University Graduate School of Medical Sciences Department of Medicine and Bioregulatory Science
(Aso Akira) - Kyushu University Graduate School of Medical Sciences Department of Medicine and Bioregulatory Science
(Iboshi Yoichiro) - Kyushu University Graduate School of Medical Sciences Department of Medicine and Bioregulatory Science
(Takayanagi Ryoichi) - Kyushu University Graduate School of Medical Sciences Department of Medicine and Bioregulatory Science
Abstract
Background/Aims: The ability of endoscopic submucosal dissection (ESD) to resect large early gastric cancers (EGCs) results in the need to treat large artificial gastric ulcers. This study assessed whether the combination therapy of rebamipide plus a proton pump inhibitor (PPI) offered benefits over PPI monotherapy.
Methods: In this prospective, randomized, multicenter, open-label, and comparative study, patients who had undergone ESD for EGC or gastric adenoma were randomized into groups receiving either rabeprazole monotherapy (10 mg/day, n=64) or a combination of rabeprazole plus rebamipide (300 mg/day, n=66). The Scar stage (S stage) ratio after treatment was compared, and factors independently associated with ulcer healing were identified by using multivariate analyses.
Results: The S stage rates at 4 and 8 weeks were similar in the two groups, even in the subgroups of patients with large amounts of tissue resected and regardless of CYP2C19 genotype. Independent factors for ulcer healing were circumferential location of the tumor and resected tissue size; the type of treatment did not affect ulcer healing.
Conclusions: Combination therapy with rebamipide and PPI had limited benefits compared with PPI monotherapy in the treatment of post-ESD gastric ulcer (UMIN Clinical Trials Registry, UMIN000007435).
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Stomach ulcer, Therapeutics, Endoscopy, Antiulcer agents, Proton pump inhibitors
KMID :
1188320160100060917
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rebamipide add-on therapy to PPI did not show substantial benefits, when compared with PPI monotherapy, in the treatment of post-ESD ulcers.