Full metadata record
DC Field | Value | Language |
---|---|---|
dc.contributor.author | 심기남 | * |
dc.date.accessioned | 2018-01-11T16:30:45Z | - |
dc.date.available | 2018-01-11T16:30:45Z | - |
dc.date.issued | 2017 | * |
dc.identifier.issn | 1011-8934 | * |
dc.identifier.issn | 1598-6357 | * |
dc.identifier.other | OAK-21430 | * |
dc.identifier.uri | https://dspace.ewha.ac.kr/handle/2015.oak/239724 | - |
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. | * |
dc.language | English | * |
dc.publisher | KOREAN ACAD MEDICAL SCIENCES | * |
dc.subject | Artemisia | * |
dc.subject | Gastritis | * |
dc.subject | Double-blind Study | * |
dc.subject | Adverse Drug Event | * |
dc.subject | Endoscopy | * |
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 | * |
dc.type | Article | * |
dc.relation.issue | 11 | * |
dc.relation.volume | 32 | * |
dc.relation.index | SCIE | * |
dc.relation.index | SCOPUS | * |
dc.relation.index | KCI | * |
dc.relation.startpage | 1807 | * |
dc.relation.lastpage | + | * |
dc.relation.journaltitle | JOURNAL OF KOREAN MEDICAL SCIENCE | * |
dc.identifier.doi | 10.3346/jkms.2017.32.11.1807 | * |
dc.identifier.wosid | WOS:000416688800014 | * |
dc.identifier.scopusid | 2-s2.0-85030182288 | * |
dc.author.google | Choi, Yoon Jin | * |
dc.author.google | Lee, Dong Ho | * |
dc.author.google | Choi, Myung-Gyu | * |
dc.author.google | Lee, Sung Joon | * |
dc.author.google | Kim, Sung Kook | * |
dc.author.google | Song, Geun Am | * |
dc.author.google | Rhee, Poong-Lyul | * |
dc.author.google | Jung, Hwoon-Yong | * |
dc.author.google | Kang, Dae-Hwan | * |
dc.author.google | Lee, Yong Chan | * |
dc.author.google | Lee, Si Hyung | * |
dc.author.google | Choi, Suck Chei | * |
dc.author.google | Shim, Ki-Nam | * |
dc.author.google | Seol, Sang-Yong | * |
dc.author.google | Moon, Jeong Seop | * |
dc.author.google | Shin, Yong Woon | * |
dc.author.google | Kim, Hyun-Soo | * |
dc.author.google | Lee, Soo Teik | * |
dc.author.google | Cho, Jin Woong | * |
dc.author.google | Choi, Eun Kwang | * |
dc.author.google | Lee, Oh Young | * |
dc.author.google | Jang, Jin Seok | * |
dc.contributor.scopusid | 심기남(13604838300) | * |
dc.date.modifydate | 20240118163912 | * |