| Therapeutic Efficacy of Gliptide(R) (Sulglycotide) on Gastritis - A Double Blind, Randomized, Active Drug Comparative, Multi-Center, Phase IV Study |
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Kwi Sook Choi, Hwoon Yong Jung, Jong Jae Park, Ki Nam Shim, Ho June Song, Kee Don Choi, Jun Won Chung, Kee Wook Jung, Do Hoon Kim, Jae Dong Lee, Yang Hee Joo, Ki Jun Song |
1Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea. hyjung@amc.seoul.kr
2Division of Gastroenterology, Department of Internal Medicine, Guro Hospital, Korea University College of Medicine, Seoul, Korea.
3Department of Internal Medicine, Mocdong Hospital, Ewha Womans University School of Medicine, Seoul, Korea.
4Department of Biostatistics, Yonsei University College of Medicine, Seoul, Korea. |
| 위염 환자에서 글립타이드Ⓡ정(Sulglycotide)의 치료 효과를 평가하기 위한 이중 맹검, 무작위 배정, 비교약 대조, 다기관 임상 시험 |
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최귀숙1, 정훈용1, 박종재2, 심기남3, 송호준1, 최기돈1, 정준원1, 정기욱1, 김도훈1, 이재동2, 주양희3, 송기준4 |
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울산대학교 의과대학 서울아산병원 소화기내과1, 고려대학교 의과대학 구로병원 소화기내과2, 이화여자대학교 의학전문대학원 목동병원 소화기내과3, 연세대학교 의과대학 의학통계학과4 |
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| Abstract |
BACKGROUND/AIMS
Sulglycotide is a sulphoglycopeptide isolated from porcine duodenal mucosa. It has antiulcer and cytoprotective activity with anti Helicobacter pylori (H. pylori) effect. This study was performed to assess the therapeutic efficacy and safety of gliptide(R) (sulglycotide) in comparison with another mucosal protective agent, selbex(R) (teprenone) for the treatment of gastritis. MATERIALS AND METHODS: One hundred and twenty one patients with symptomatic erosive gastritis were randomized to receive sulglycotide (gliptide(R)) or teprenone (selbex(R)) for 4 weeks. Improvement and cure rates on endoscopic findings, improvement rates of symptoms, and eradication rates of H. pylori were compared. RESULTS: Of the 121 intention-to-treat (ITT) population, 82 patients comprised the per protocol (PP) analysis. Endoscopic cure rates and improvement rates in the sulglycotide and teprenone group were 36.7% vs. 29.5% and 41.7% vs. 37.7% in ITT and 46.3% vs. 34.2% and 53.7% vs. 43.9% in PP population, respectively. Symptom improvement rates in the sulglycotide and teprenone group were 71.7% vs. 65.6% in ITT and 85.4% vs. 75.6% in PP. Eradication rates of H. pylori were not significantly different between the groups. Results of 95% CIs for the difference in endoscopic cure rate and improvement rate, symptom improvement rate, and eradication rate of H. pylori between the two groups met the criteria for the non-inferiority of sulglycotide to teprenone. No significant adverse events were encountered during the study period. CONCLUSIONS: Gliptide(R) (sulglycotide) is not inferior to selbex(R) (teprenone) in therapeutic efficacy and is a safe and useful therapeutic agent for the treatment of gastritis. |
| Key Words:
Gliptide(R); Sulglycotide; Gastritis |
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