Clinical Endoscopy

The Korean Society of Gastrointestinal Endoscopy (대한소화기내시경학회)
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Efficacy and Safety of Albis$^{(R)}$ in Acute and Chronic Patients with Gastritis: A Double-blind, Placebo-controlled, Randomized Multi-center Study

미란성 위염에 대한 알비스$^{(R)}$의 효과: 스티렌$^{(R)}$ 대조 무작위 이중맹검 다기관 임상시험

  • Han, Hae-Won (Department of Internal Medicine, The Catholic University of Korea College of Medicine) ;
  • Choi, Myung-Gyu (Department of Internal Medicine, The Catholic University of Korea College of Medicine) ;
  • Seol, Sang-Young (Department of Internal Medicine, *Pusan Paik Hospital, Inje University College of Medicine) ;
  • Lee, Dong-Ho (Department of Internal Medicine, Seoul National University College of Medicine) ;
  • Jung, Hwoon-Yong (Department of Internal Medicine, University of Ulsan College of Medicine) ;
  • Kim, Tae-Nyeun (Department of Internal Medicine, Yeungnam University College of Medicine) ;
  • Choi, Suck-Chei (Department of Internal Medicine, Wonkwang University College of Medicine) ;
  • Kim, Hyen-Soo (Department of Internal Medicine, Chonnam National University Medical School)
  • 한혜원 (가톨릭대학교 의과대학 내과학교실) ;
  • 최명규 (가톨릭대학교 의과대학 내과학교실) ;
  • 설상영 (인제대학교 의과대학 부산백병원 내과학교실) ;
  • 이동호 (서울대학교 의과대학 내과학교실) ;
  • 정훈용 (울산대학교 의과대학 내과학교실) ;
  • 김태년 (영남대학교 의과대학 내과학교실) ;
  • 최석채 (원광대학교 의과대학 내과학교실) ;
  • 김현수 (전남대학교 의과대학 내과학교실)
  • Published : 2011.04.30
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Abstract

Background/Aims: Albis$^{(R)}$ is a newly developed drug comprised of ranitidine, bismuth and sucralfate. The aim of the study was to demonstrate the efficacy and safety superiority of Albis$^{(R)}$ compared to Stillen$^{(R)}$ for treating erosive gastritis. Methods: This study was a randomized, double-blind, multi-center trial. The primary endpoint was 2 weeks of treatment. Results: Of the 229 patients in the intention-to-treat (ITT) population, 87 from the Albis$^{(R)}$, and 96 from the Stillen$^{(R)}$ group were included in the per protocol (PP) analysis. The endoscopic improvement rate was not different between the Albis$^{(R)}$ group and the control in both the PP (42.5%, 39.6%) and ITT (35.3%, 34.5%) populations. The endoscopic cure of erosion was also not different in the Albis$^{(R)}$ group than that in the control group in both the PP (32.3%, 31.3%) and ITT (27.6%, 27.4%) populations. The endoscopic improvement rate for hemorrhage, edema, and erythema were also not different between the two groups in both the PP and ITT populations. No statistically significant differences were observed for adverse events between the two groups. Conclusions: Half of the approved dose of Albis$^{(R)}$ for peptic ulcers was superior to Stillen$^{(R)}$. A low dosage of Albis$^{(R)}$ is more cost efficient and safe than that of Stillen$^{(R)}$.

목적: 알비스$^{(R)}$는 ranitidine 75 mg과 tripotassium dicitrato bismuthate 100 mg, sucralfate 300 mg 복합 약제이다. 본 연구는 알비스$^{(R)}$의 1회 1정씩 2회의 저용량 요법의 미란성 위염에 대한 치료 효과와 안정성을 평가하였다. 대상 및 방법: 내시경상 미란이 확인된 19세 이상 65세 이하의 위염 환자를 대상으로, 이중 맹검, 무작위 배정, 스티렌$^{(R)}$대조, 다기관 임상 시험으로 설계되었다. 시험 군은 알비스$^{(R)}$ (1T, bid)와 스티렌$^{(R)}$ 위약(1T, tid)을, 대조군은 스티렌$^{(R)}$(1T,tid)과 알비스$^{(R)}$ 위약(1T, bid)을 2주간 투여했다. 주 평가 변수는 미란 점수가 50% 이상 감소한 증례로 유효율을 구하였다. 부평가 변수는 미란 완치율과 출혈 유효율이었다. 결과: 229명(알비스$^{(R)}$ 군 116명, 스티렌$^{(R)}$ 군 113명)이 등록, PP 분석 대상은 183명(알비스$^{(R)}$ 군 87명, 스티렌$^{(R)}$ 군 96명)이었다. 성별, 연령, 미란 개수, 출혈 등급 및 자각 증상 점수에서 유의한 차이는 없었다. 미란 유효율은 알비스$^{(R)}$ 군이 42.5% (37/87명)로 스티렌$^{(R)}$ 군 39.6%(38/96명)과 유의한 차이가 없었다(p=0.6858). 미란 유효율의 차이는 비열등성 한계 .15% 보다 높아, 알비스$^{(R)}$의 효과는 스티렌$^{(R)}$에 비해 열등하지 않았다. 미란 완치율과 출혈 유효율도 두 군간 유의한 차이가 없었다. ITT 분석 군에서도 유의한 차이는 없었다. 이상 반응을 경험한 피험자는 스티렌$^{(R)}$ 10명(8.6%, 15건), 알비스$^{(R)}$ 9명(7.8%, 9건)으로 유의한 차이는 없었고 중대한 이상 반응은 없었다. 결론: 알비스$^{(R)}$ 저용량 요법은 약제비 절감 및 최소 용량 투여로 약물 사용의 안전성을 높일 것으로 기대된다.

Keywords

References

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