위염환자에서 글립타이드정Ⓡ 200 mg (Sulglycotide)의 치료 효과- 단일맹검, 무작위 배정, 비교약 대조, 다기관 4상 임상시험 -

Abstract

Background/Aims: Sulglycotide is a glycopeptide isolated from pig duodenum constituents. Sulglycotide is know to induce increased excretion of bicarbonate and prostaglandins in gastric juice and recent studies have shown various anti H. pylori effect of sulglycotide in vitro and in vivo. The purpose of this study was to assess the therapeutic efficacy and safety of GliptideTM (sulglycotide) in comparison with another mucosal protectants, StillenTM for the treatment of gastritis. Methods: One hundread and fifty patients with acute or chronic gastritis with various dyspeptic symptoms were enrolled and underwent a single-blind, randomized, active drug comparative trial vs Stillen. Each group received either GliptideTM (oral, 200 mg t.i.d. for 4 weeks, n=76) or StillenTM (oral, 180 mg t.i.d. for 4 weeks, n= 74). Drug effectiveness was evaluated in terms of apparent clinical symptom improvements and follow-up endoscopic scorings for evaluations. Results: GliptideTM or StillenTM treatment have resulted in endoscopic improvement rates of gastritis by 38.2% vs. 32.4% (ITT) and 47.5% vs. 39.3% (PP) respectively. Both treatments have resulted in the prompt improvements of the dyspeptic symptoms effectively (gliptide group, 63.2% and stillen group, 56.8% respectively, ITT). Endoscopic cure rates in gliptide and stillen groups were comparable to each other (25.0% vs. 20.3% by ITT, 32.2% vs. 26.8% by PP respectively). Endoscopic cure rates and improvement rates as well as symptom improvements indices were not significantly different between GliptideTM and StillenTM treated groups. No significant adverse events were encountered during the study period. Conclusions: This study clearly shows that the GliptideTM is an effective and safe drug for the treatment of gastritis accompanied by dyspeptic symptoms in Korea.