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논문 기본 정보

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저자정보
김광하 (부산대학교) Lee Hang Lak (Department of Internal Medicine Hanyang University Hospital Seoul Korea) Joo Moon Kyung (Division of Gastroenterology Department of Internal Medicine Korea University Guro Hospital Seoul K) Park Hong Jun (Department of Internal Medicine Yonsei University Wonju College of Medicine Wonju Korea) Jung Sung Woo (Division of Gastroenterology Department of Internal Medicine Korea University Ansan Hospital Ansan) Lee Ok-Jae (Department of Internal Medicine Gyeongsang National University College of Medicine Jinju Korea) Kim Hyungkil (Department of Internal Medicine Inha University School of Medicine Incheon Korea) Chun Hoon Jai (Division of Gastroenterology and Hepatology Department of Internal Medicine Institute of Gastrointe) Lee Soo Teik (Department of Internal Medicine Jeonbuk National University Hospital Jeonju Korea) Kim Ji Won (Department of Internal Medicine SMG-SNU Boramae Medical Center Seoul National University of College) Jeon Han Ho (Department of Internal Medicine National Health Insurance Service Ilsan Hospital Goyang Korea) 정일권 (순천향대학교) 김현수 (전남대학교) 이동호 (서울대학교병원) 김경오 (가천대학교) 임윤정 (동국대학교) 박선자 (고신대학교) 조수정 (서울대학교병원) 김병욱 (가톨릭대학교) 고광현 (차의과학대학교) 전성우 (경북대학교) 김재규 (중앙대학교) 성인경 (건국대학교) 김태년 (영남대학교) 성재규 (충남대학교) Park Jong-Jae (Division of Gastroenterology Department of Internal Medicine Korea University Guro Hospital Seoul K)
저널정보
거트앤리버 발행위원회 Gut and Liver Gut and Liver 제15권 제6호
발행연도
2021.11
수록면
841 - 850 (10page)
DOI
10.5009/gnl20338

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Background/Aims: The mucoprotective drug rebamipide is used to treat gastritis and peptic ulcers. We compared the efficacy of Mucostaⓡ (rebamipide 100 mg) and its new formulation, AD-203 (rebamipide 150 mg), in treating erosive gastritis. Methods: This double-blind, active control, noninferiority, multicenter, phase 3 clinical trial randomly assigned 475 patients with endoscopically proven erosive gastritis to two groups: AD-203 twice daily or Mucostaⓡ thrice daily for 2 weeks. The intention-to-treat (ITT) analysis included 454 patients (AD-203, n=229; Mucostaⓡ, n=225), and the per-protocol (PP) analysis included 439 patients (AD-203, n=224; Mucostaⓡ, n=215). The posttreatment assessments included the primary (erosion improvement rate) and secondary endpoints (erosion and edema cure rates; improvement rates of redness, hemorrhage, and gastrointestinal symptoms). Drug-related adverse events were evaluated. Results: According to the ITT analysis, the erosion improvement rates (posttreatment) in AD-203-treated and Mucostaⓡ-treated patients were 39.7% and 43.8%, respectively. According to the PP analysis, the erosion improvement rates (posttreatment) in AD-203-treated and Mucostaⓡ-treated patients were 39.3% and 43.7%, respectively. The one-sided 97.5% lower limit for the improvement rate difference between the study groups was ?4.01% (95% confidence interval [CI], ?13.09% to 5.06%) in the ITT analysis and ?4.44% (95% CI, ?13.65% to 4.78%) in the PP analysis. The groups did not significantly differ in the secondary endpoints in either analysis. Twenty-four AD-203-treated and 20 Mucostaⓡ-treated patients reported adverse events but no serious adverse drug reactions; both groups presented similar adverse event rates. Conclusions: The new formulation of rebamipide 150 mg (AD-203) twice daily was not inferior to rebamipide 100 mg (Mucostaⓡ) thrice daily. Both formulations showed a similar efficacy in treating erosive gastritis.
#Adverse drug reaction #Gastritis #Intention-to-treat analysis #Phase III clinical trial #Rebamipide

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참고문헌 (29)

참고문헌 신청
Laine L / 1995 / Interobserver agreement and predictive value of endoscopic findings for H. pylori and gastritis in normal volunteers / Gastrointest Endosc 42:420~423 google schola Park HK / 2012 / The distribution of endoscopic gastritis in 25, 536 heath check-up subjects in Korea / Korean J Helicobacter Up Gastrointest Res 12:237~243 google schola Yoshikazu Kinoshita / 2018 / Advantages and Disadvantages of Long-term Proton Pump Inhibitor Use / Journal of Neurogastroenterology and Motility (JNM) 24(2):182~196 dbpia Jalving M / 2006 / Increased risk of fundic gland polyps during long-term proton pump inhibitor therapy / Aliment Pharmacol Ther 24:1341~1348 google schola Raghunath AS / 2005 / Review article : the long-term use of proton-pump inhibitors / Aliment Pharmacol Ther 22(Suppl 1):55~63 google schola

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