Full metadata record
DC Field | Value | Language |
---|---|---|
dc.contributor.author | 이오영 | - |
dc.date.accessioned | 2019-12-02T04:59:03Z | - |
dc.date.available | 2019-12-02T04:59:03Z | - |
dc.date.issued | 2017-11 | - |
dc.identifier.citation | JOURNAL OF KOREAN MEDICAL SCIENCE, v. 32, no. 11, page. 1807-1813 | en_US |
dc.identifier.issn | 1011-8934 | - |
dc.identifier.issn | 1598-6357 | - |
dc.identifier.uri | https://jkms.org/DOIx.php?id=10.3346/jkms.2017.32.11.1807 | - |
dc.identifier.uri | https://repository.hanyang.ac.kr/handle/20.500.11754/116287 | - |
dc.description.abstract | This 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. | en_US |
dc.description.sponsorship | This study was supported by funding from Dong-A ST Co. | en_US |
dc.language.iso | en_US | en_US |
dc.publisher | KOREAN ACAD MEDICAL SCIENCES | en_US |
dc.subject | Artemisia | en_US |
dc.subject | Gastritis | en_US |
dc.subject | Double-blind Study | en_US |
dc.subject | Adverse Drug Event | en_US |
dc.subject | Endoscopy | en_US |
dc.title | Evaluation 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 | en_US |
dc.type | Article | en_US |
dc.relation.no | 11 | - |
dc.relation.volume | 32 | - |
dc.identifier.doi | 10.3346/jkms.2017.32.11.1807 | - |
dc.relation.page | 1807-1807 | - |
dc.relation.journal | JOURNAL OF KOREAN MEDICAL SCIENCE | - |
dc.contributor.googleauthor | Choi, Yoon Jin | - |
dc.contributor.googleauthor | Lee, Dong Ho | - |
dc.contributor.googleauthor | Choi, Myung-Gyu | - |
dc.contributor.googleauthor | Lee, Sung Joon | - |
dc.contributor.googleauthor | Kim, Sung Kook | - |
dc.contributor.googleauthor | Song, Geun Am | - |
dc.contributor.googleauthor | Rhee, Poong-Lyul | - |
dc.contributor.googleauthor | Jung, Hwoon-Yong | - |
dc.contributor.googleauthor | Kang, Dae-Hwan | - |
dc.contributor.googleauthor | Lee, Oh Young | - |
dc.relation.code | 2017002851 | - |
dc.sector.campus | S | - |
dc.sector.daehak | COLLEGE OF MEDICINE[S] | - |
dc.sector.department | DEPARTMENT OF MEDICINE | - |
dc.identifier.pid | leeoy | - |
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