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Can rebamipide and proton pump inhibitor combination therapy promote the healing of endoscopic submucosal dissection-induced ulcers? A randomized, prospective, multicenter study.

Abstract：

BACKGROUND:There has been no consensus regarding the optimal treatment durations and drug regimens in patients with endoscopic submucosal dissection (ESD)-induced ulcers. OBJECTIVE:To assess the efficacy of proton pump inhibitor (PPI) and rebamipide combination therapy compared with PPI monotherapy for ESD-induced ulcer healing. DESIGN:Randomized, prospective, controlled study; clinical trial. SETTING:Five hospitals in a University Medical Center group in Korea. PATIENTS:This study involved 290 adults (309 lesions) who underwent ESD for gastric adenoma or early gastric cancer. INTERVENTION:PPI and rebamipide combination therapy. MAIN OUTCOME MEASUREMENTS:The ulcer healing rate at 4 weeks after ESD. RESULTS:The ulcer healing rates at 4 weeks after ESD in the PPI and rebamipide combination therapy group were significantly higher than those in the PPI alone group, both in the full analysis (94.9% vs 89.9%; P < .0001) and in the per-protocol analysis (94.5% vs 91.2%; P = .020). This combination therapy was an independent predictive factor for a high ulcer healing rate (adjusted odds ratio [OR] 5.572; 95% confidence interval [CI], 2.615-11.876; P = .014). Additionally, the combination therapy group exhibited a higher quality of ulcer healing than the PPI monotherapy group (reviewer 1: P = .027; OR 1.949; 95% CI, 1.077-3.527; reviewer 2: P = .027; OR 1.933; 95% CI, 1.074-3.481). LIMITATIONS:Open-label study. CONCLUSION:PPI and rebamipide combination therapy had a superior 4-week ESD-induced ulcer healing rate and quality of ulcer healing compared with PPI monotherapy. ( CLINICAL TRIAL REGISTRATION NUMBER:NCT01167101.).

journal_name

Gastrointest Endosc

journal_title

Gastrointestinal endoscopy

authors

Shin WG,Kim SJ,Choi MH,Kim KO,Jang HJ,Park CH,Baek IH,Kim KH,Baik GH,Kae SH,Kim JH,Kim HY

doi

10.1016/j.gie.2011.11.004

subject

Has Abstract

pub_date

2012-04-01 00:00:00

pages

739-47

issue

eissn

0016-5107

issn

1097-6779

pii

S0016-5107(11)02393-5

journal_volume

pub_type

杂志文章,多中心研究,随机对照试验

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Can rebamipide and proton pump inhibitor combination therapy promote the healing of endoscopic submucosal dissection-induced ulcers? A randomized, prospective, multicenter study.