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

Kazuhiko Nakamura, Eikichi Ihara, Hirotada Akiho, Kazuya Akahoshi, Naohiko Harada, Toshiaki Ochiai, Norimoto Nakamura, Haruei Ogino, tsutomu iwasa, Akira Aso, Yoichiro Iboshi, Ryoichi Takayanagi

研究成果: ジャーナルへの寄稿記事

4 引用 (Scopus)

抄録

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).

元の言語英語
ジャーナルGut and Liver
10
発行部数6
DOI
出版物ステータス出版済み - 11 1 2016

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Proton Pump Inhibitors
Stomach Ulcer
Randomized Controlled Trials
Rabeprazole
Ulcer
Stomach Neoplasms
Cicatrix
Therapeutics
Adenoma
Registries
Multivariate Analysis
Genotype
rebamipide
Endoscopic Mucosal Resection
Clinical Trials
Neoplasms

All Science Journal Classification (ASJC) codes

  • Hepatology
  • Gastroenterology

これを引用

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. / Nakamura, Kazuhiko; Ihara, Eikichi; Akiho, Hirotada; Akahoshi, Kazuya; Harada, Naohiko; Ochiai, Toshiaki; Nakamura, Norimoto; Ogino, Haruei; iwasa, tsutomu; Aso, Akira; Iboshi, Yoichiro; Takayanagi, Ryoichi.

:: Gut and Liver, 巻 10, 番号 6, 01.11.2016.

研究成果: ジャーナルへの寄稿記事

Nakamura, Kazuhiko ; Ihara, Eikichi ; Akiho, Hirotada ; Akahoshi, Kazuya ; Harada, Naohiko ; Ochiai, Toshiaki ; Nakamura, Norimoto ; Ogino, Haruei ; iwasa, tsutomu ; Aso, Akira ; Iboshi, Yoichiro ; Takayanagi, Ryoichi. / 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. 2016 ; 巻 10, 番号 6.
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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).",
author = "Kazuhiko Nakamura and Eikichi Ihara and Hirotada Akiho and Kazuya Akahoshi and Naohiko Harada and Toshiaki Ochiai and Norimoto Nakamura and Haruei Ogino and tsutomu iwasa and Akira Aso and Yoichiro Iboshi and Ryoichi Takayanagi",
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T1 - Limited effect of rebamipide in addition to proton pump inhibitor (PPI) in the treatment of post-endoscopic submucosal dissection gastric ulcers

T2 - A randomized controlled trial comparing ppi plus rebamipide combination therapy with PPI monotherapy

AU - Nakamura, Kazuhiko

AU - Ihara, Eikichi

AU - Akiho, Hirotada

AU - Akahoshi, Kazuya

AU - Harada, Naohiko

AU - Ochiai, Toshiaki

AU - Nakamura, Norimoto

AU - Ogino, Haruei

AU - iwasa, tsutomu

AU - Aso, Akira

AU - Iboshi, Yoichiro

AU - Takayanagi, Ryoichi

PY - 2016/11/1

Y1 - 2016/11/1

N2 - 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).

AB - 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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