한빛사 논문
Abstract
Yeon Seok Seo1, Soo Young Park2, Moon Young Kim3, Ju Hyun Kim4, Jun Yong Park5, Hyung Joon Yim1, Byoung Kuk Jang6, Hong Soo Kim7, Taeho Hahn8, Byung Ik Kim9, Jeong Heo10, Hyonggin An11, Won Young Tak2, Soon Koo Baik3,12, Kwang Hyub Han5,12, Jae Seok Hwang6, Sang Hoon Park8, Mong Cho10, Soon Ho Um1,12,*
Department of Internal Medicine, Korea University College of Medicine, Seoul1; Kyungpook National University School of Medicine, Daegu2; Yonsei University Wonju College of Medicine, Wonju3; Gachon Medical School, Gil Medical Center, Incheon4; Yonsei University College of Medicine, Seoul5; Keimyung University College of Medicine, Daegu6; Soonchunhyang University College of Medicine, Cheonan7; Hallym University College of Medicine, Anyang8; Sungkyunkwan University College of Medicine, Kangbuk Samsung Hospital, Seoul9; Pusan National University College of Medicine, Busan10; Department of Biostatistics, Korea University College of Medicine, Seoul11; Liver Cirrhosis Clinical Research Center, Seoul, Korea12
Correspondence: Soon Ho Um, MD, PhD
Division of Gastroenterology and Hepatology, Department of Internal Medicine, Korea University College of Medicine, 126-1, 5-Ga, Anam-Dong, Seongbuk-Gu, Seoul 136-705, Korea
ABSTRACT
Background & Aims: Vasoactive drugs are recommended to be started as soon as possible in suspected variceal bleeding, even before diagnostic endoscopy. However, it is still unclear whether the therapeutic efficacies of the various vasoactive drugs used are comparable. The aim of this prospective multicenter randomized non-inferiority trial was to characterize the effects of terlipressin, somatostatin, and octreotide, when they are initiated before endoscopic treatment in patients with acute variceal bleeding.
Methods: Patients with liver cirrhosis and significant upper gastrointestinal bleeding were randomly assigned to receive early administration of terlipressin, somatostatin, or octreotide, followed by endoscopic treatment. Patients with non-variceal bleeding were excluded after endoscopy. The primary endpoint was 5-day treatment success, defined as control of bleeding without rescue treatment, rebleeding or mortality, with a non-inferiority margin of 0.1.
Results: In total, 780 patients with variceal bleeding were enrolled: 261 in terlipressin group, 259 in somatostatin group, and 260 in octreotide group. At the time of initial endoscopy, active bleeding was noted in 43.7%, 44.4%, and 43.5% of these patients, respectively (P=0.748), and treatment success was achieved by day 5 in 86.2%, 83.4%, and 83.8% (P=0.636) with similar rates of control of bleeding without rescue treatment (89.7%, 87.6%, and 88.1%, P=0.752), or rebleeding (3.4%, 4.8%, and 4.4%, P=0.739), mortality (8.0%, 8.9%, and 8.8%, P=0.929). The absolute values of lower bound of confidence interval for terlipressin vs somatostatin, terlilpressin vs octreotide, and octreotide vs somatostatin were 0.095, 0.090, and 0.065, respectively.
Conclusion: The hemostatic effects and safety did not differ significantly between terlipressin, somatostatin, and octreotide as adjuvants to endoscopic treatment in patients with acute gastroesophageal variceal bleeding. (Hepatology 2014;)
Keywords: variceal bleeding; hemostasis; safety; vasoactive drug; cirrhosis
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