Korean Journal of Gastrointestinal Endoscopy 2004;28(5): 230-236.
미란성 위염에 대한 Stillen 캅셀의 3상 임상시험
설상영*·김명환†·유종선‡·최명규§
*인제대학교 부산백병원 소화기내과, †서울아산병원 소화기내과,‡전남대학교 병원 소화기내과, §가톨릭대학교 강남성모병원 소화기내과
A Phase III Clinical Trial of StillenTM for Erosive Gastritis
Sang Yong Seol, M.D.*, Myung Hwan Kim, M.D.†, Jong Sun Rew, M.D.‡ and Myung Gyu Choi, M.D.§
*Department of Gastroenterology, Inje University College of Medicine, Busan, †Department of Gastroenterology, Ulsan University College of Medicine, Seoul, ‡Department of Gastroenterology, Chunnam University, College of Medicine, Gwangju, §Department of Gastroenterology, College of Medicine, The Catholic University of Korea, Seoul, Korea
Abstract
Background/Aims: Phase IIb clinical study of StillenTM, a novel cytoprotectant, for gastritis showed 180 mg of Stillen, t.i.d. for 2 weeks results in a significant increase of cure rate when compared with a placebo group. It is reported that antioxidative effect and strengthening the endogenous cytoprotective molecules of the gastric mucosa play a pivotal role for cytoprotective action of StillenTM. The aim of this phase III multicenter, double-blind comparative study was to assess the efficacy of StillenTM for the treatment of erosive gastritis. Methods: Five hundred and twelve patients with erosive gastritis were enrolled and divided into three groups. Each group received 180 mg or 360 mg of StillenTM or 600 mg of cetraxate (NeuerTM) t.i.d. for 2 weeks, respectively and a follow-up endoscopic examination for evaluation. Results: Patients treated with 180 mg and 360 mg of StillenTM had a significantly improved endoscopic cure rate of gastritis (55.6% and 57.5%, respectively) compared with patients treated with 600 mg of cetraxate (35.5%, p＜0.001). Endoscopic improvement rate was also significantly higher in 180 mg group (67.3%) and 360 mg group (65.0%) of StillenTM treated patients than cetraxate treated group (46.4%, p＜0.001). During the study, both StillenTM and cetraxate were well tolerated. Conclusions: These results clearly demonstrate that StillenTM is an efficacious, safe, and well-tolerated treatment for gastritis. (Korean J Gastrointest Endosc 2004;28:230236)
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