medric medric
[닫기]
잠시만 기다려 주세요. 로딩중입니다.

The efficacy and safety of irsogladine maleate in nonsteroidal anti-inflammatory drug or aspirin-induced peptic ulcer and gastritis

Korean Journal of Internal Medicine 2019년 34권 5호 p.1008 ~ 1021
 ( Shim Ki-Nam ) - Ewha Womans University College of Medicine Department of Internal Medicine

 ( Kim Jin-Il ) - Catholic University College of Medicine Department of Internal Medicine
김나영 ( Kim Na-Young ) - Seoul National University Bundang Hospital Department of Internal Medicine
김상균 ( Kim Sang-Gyun ) - Seoul National University College of Medicine Department of Internal Medicine
 ( Jo Yun-Ju ) - Eulji University School of Medicine Department of Internal Medicine
 ( Hong Su-Jin ) - Soonchunhyang University College of Medicine Department of Internal Medicine
 ( Shin Jeong-Eun ) - Dankook University College of Medicine Department of Internal Medicine
김광하 ( Kim Gwang-Ha ) - Pusan National University Hospital Department of Internal Medicine
 ( Park Kyung-Sik ) - Keimyung University School of Medicine Department of Internal Medicine
 ( Choi Suck-Chei ) - Wonkwang University College of Medicine Department of Internal Medicine
 ( Kwon Joong-Goo ) - Catholic University of Daegu School of Medicine Department of Internal Medicine
 ( Kim Jie-Hyun ) - Yonsei University College of Medicine Gangnam Severance Hospital Department of Internal Medicine
김현진 ( Kim Hyun-Jin ) - Gyeongsang National University School of Medicine Department of Internal Medicine
 ( Kim Ji-Won ) - SMG-SNU Boramae Medical Center Department of Internal Medicine

Abstract


Background/Aims: Irsogladine maleate, an enhancer of gastric mucosal protective factors, has demonstrated its efficacy for various gastric mucosal injuries. The aim of this study was to evaluate the efficacy and safety of irsogladine for prevention of nonsteroidal anti-inflammatory drugs (NSAIDs) or aspirin-induced peptic ulcer and gastritis.

Methods: In this multicenter, randomized, double-blind, exploratory clinical trial, 100 patients over 50 years of age who needed continuous NSAIDs or aspirin for more than 8 weeks were randomly assigned to either test group (irsogladine maleate 2 mg, twice daily, 39 patients for full analysis) or placebo group (37 patients for full analysis). Primary outcomes were incidence of peptic ulcer and ratio of modified Lanza score (MLS) 2 to 4. Secondary outcome was the number of acute erosions confirmed by endoscopy at 8 weeks. Adverse effects were also compared.

Results: There were no significant differences in gastric protective effects between test and placebo groups. However, two cases of peptic ulcer in the placebo group but none in the test group were observed. These two cases of peptic ulcer were Helicobacter pylori-negative. In addition, H. pylori-negative group showed significant changes in MLS score (p = 0.0247) and edema score (p = 0.0154) after the treatment compared to those before treatment in the test group. There was no significant difference in adverse events between the two groups.

Conclusions: The efficacy of irsogladine maleate was found in H. pylori-negative group, suggesting its potential as a protective agent against NSAIDs or aspirin-induced peptic ulcer and gastritis.

키워드

Irsogladine maleate; Anti-inflammatory agents, non-steroidal; Aspirin; Peptic ulcer; Gastritis
원문 및 링크아웃 정보
  
등재저널 정보
SCI(E)
MEDLINE
KCI
KoreaMed
KAMS