Department of Internal Medicine, College of Medicine, Ewha Womans University, Ewha Medical Research Institute, Seoul, Korea.
Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul, Korea.
Korean J Intern Med. 2019 Sep;34(5):1008-1021. doi: 10.3904/kjim.2017.370. Epub 2018 Jun 1.
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.
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.
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.
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.
背景/目的：马来酸伊索拉定是一种增强胃黏膜保护因子的药物，已被证实对各种胃黏膜损伤具有疗效。本研究旨在评估马来酸伊索拉定预防非甾体抗炎药（NSAIDs）或阿司匹林引起的消化性溃疡和胃炎的疗效和安全性。
这是一项多中心、随机、双盲、探索性临床试验，纳入了 100 名年龄在 50 岁以上、需要连续使用 NSAIDs 或阿司匹林超过 8 周的患者，将其随机分为试验组（马来酸伊索拉定 2mg，每日 2 次，39 例用于全分析）或安慰剂组（37 例用于全分析）。主要结局是消化性溃疡的发生率和改良 Lanza 评分（MLS）2-4 的比值。次要结局是 8 周时内镜确认的急性糜烂数量。还比较了不良反应。
试验组和安慰剂组的胃保护作用无显著差异。然而，安慰剂组出现了 2 例消化性溃疡，而试验组无此类病例。这两例消化性溃疡均为幽门螺杆菌阴性。此外，与治疗前相比，治疗后试验组的 MLS 评分（p=0.0247）和水肿评分（p=0.0154）有显著变化，而 H. pylori 阴性组有显著变化。两组不良反应无显著差异。
在 H. pylori 阴性组中发现了马来酸伊索拉定的疗效，表明其可能成为预防 NSAIDs 或阿司匹林引起的消化性溃疡和胃炎的保护剂。
