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dc.contributor.author심기남-
dc.date.accessioned2018-01-11T16:30:45Z-
dc.date.available2018-01-11T16:30:45Z-
dc.date.issued2017-
dc.identifier.issn1011-8934-
dc.identifier.issn1598-6357-
dc.identifier.otherOAK-21430-
dc.identifier.urihttp://dspace.ewha.ac.kr/handle/2015.oak/239724-
dc.description.abstractThis study compared the efficacy of DA-9601 (Dong-A ST Co., Seoul, Korea) and its new formulation, DA-5204 (Dong-A ST Co.), for treating erosive gastritis. This phase III, randomized, multicenter, double-blind, non-inferiority trial randomly assigned 434 patients with endoscopically proven gastric mucosal erosions into two groups: DA-9601 3 times daily or DA-5,204 twice daily for 2 weeks. The final analysis included 421 patients (DA-5204, 209; DA-9601, 212). The primary endpoint (rate of effective gastric erosion healing) and secondary endpoints (cure rate of endoscopic erosion and gastrointestinal [ GI] symptom relief) were assessed using endoscopy after the treatment. Drug-related adverse events (AEs), including GI symptoms, were also compared. At week 2, gastric healing rates with DA-5204 and DA-9601 were 42.1% (88/209) and 42.5% (90/212), respectively. The difference between the groups was -0.4% (95% confidence interval, -9.8% to 9.1%), which was above the non-inferiority margin of -14%. The cure rate of gastric erosion in both groups was 37.3%. The improvement rates of GI symptoms with DA-5204 and DA-9601 were 40.4% and 40.8%, respectively. There were no statistically significant differences between the two groups in both secondary endpoints. AEs were reported in 18 (8.4%) patients in the DA-5204 group and 19 (8.8%) in the DA-9601 group. Rates of AE were not different between the two groups. No serious AE or adverse drug reaction (ADR) occurred. These results demonstrate the non-inferiority of DA-5204 compared to DA9601. DA-5204 is as effective as DA-9601 in the treatment of erosive gastritis.-
dc.languageEnglish-
dc.publisherKOREAN ACAD MEDICAL SCIENCES-
dc.subjectArtemisia-
dc.subjectGastritis-
dc.subjectDouble-blind Study-
dc.subjectAdverse Drug Event-
dc.subjectEndoscopy-
dc.titleEvaluation of the Efficacy and Safety of DA-9601 versus Its New Formulation, DA-5204, in Patients with Gastritis: Phase III, Randomized, Double-Blind, Non-Inferiority Study-
dc.typeArticle-
dc.relation.issue11-
dc.relation.volume32-
dc.relation.indexSCI-
dc.relation.indexSCIE-
dc.relation.indexSCOPUS-
dc.relation.indexKCI-
dc.relation.startpage1807-
dc.relation.lastpage+-
dc.relation.journaltitleJOURNAL OF KOREAN MEDICAL SCIENCE-
dc.identifier.doi10.3346/jkms.2017.32.11.1807-
dc.identifier.wosidWOS:000416688800014-
dc.identifier.scopusid2-s2.0-85030182288-
dc.author.googleChoi, Yoon Jin-
dc.author.googleLee, Dong Ho-
dc.author.googleChoi, Myung-Gyu-
dc.author.googleLee, Sung Joon-
dc.author.googleKim, Sung Kook-
dc.author.googleSong, Geun Am-
dc.author.googleRhee, Poong-Lyul-
dc.author.googleJung, Hwoon-Yong-
dc.author.googleKang, Dae-Hwan-
dc.author.googleLee, Yong Chan-
dc.author.googleLee, Si Hyung-
dc.author.googleChoi, Suck Chei-
dc.author.googleShim, Ki-Nam-
dc.author.googleSeol, Sang-Yong-
dc.author.googleMoon, Jeong Seop-
dc.author.googleShin, Yong Woon-
dc.author.googleKim, Hyun-Soo-
dc.author.googleLee, Soo Teik-
dc.author.googleCho, Jin Woong-
dc.author.googleChoi, Eun Kwang-
dc.author.googleLee, Oh Young-
dc.author.googleJang, Jin Seok-
dc.contributor.scopusid심기남(13604838300)-
dc.date.modifydate20180329112219-


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