Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea.
Hepatology. 2014 Sep;60(3):954-63. doi: 10.1002/hep.27006. Epub 2014 Jul 25.
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, noninferiority trial was to characterize the effects of terlipressin, somatostatin, and octreotide when they are initiated before endoscopic treatment in patients with acute variceal bleeding. 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 nonvariceal 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 noninferiority margin of 0.1. In total, 780 patients with variceal bleeding were enrolled: 261 in the terlipressin group; 259 in the somatostatin group; and 260 in the 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), rebleeding (3.4%, 4.8%, and 4.4%; P=0.739), or mortality (8.0%, 8.9%, and 8.8%; P=0.929). The absolute values of the lower bound of confidence intervals for terlipressin versus somatostatin, terlilpressin versus octreotide, and octreotide versus somatostatin were 0.095, 0.090, and 0.065, respectively.
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.
本前瞻性、多中心、随机、非劣效性试验旨在探讨特利加压素、生长抑素和奥曲肽在急性食管胃静脉曲张出血患者内镜治疗前开始使用时的疗效。
将肝硬化伴明显上消化道出血的患者随机分配接受特利加压素、生长抑素或奥曲肽早期治疗，然后进行内镜治疗。内镜检查后排除非静脉曲张性出血患者。主要终点为 5 天治疗成功，定义为无抢救治疗、再出血或死亡率的出血控制，非劣效性边界为 0.1。
共纳入 780 例静脉曲张出血患者：特利加压素组 261 例，生长抑素组 259 例，奥曲肽组 260 例。在初次内镜检查时，分别有 43.7%、44.4%和 43.5%的患者有活动性出血（P=0.748），第 5 天治疗成功率分别为 86.2%、83.4%和 83.8%（P=0.636），无抢救治疗的止血控制率相似（89.7%、87.6%和 88.1%；P=0.752）、再出血率（3.4%、4.8%和 4.4%；P=0.739）或死亡率（8.0%、8.9%和 8.8%；P=0.929）。特利加压素与生长抑素、特利加压素与奥曲肽、奥曲肽与生长抑素的置信区间下限的绝对值分别为 0.095、0.090 和 0.065。
特利加压素、生长抑素和奥曲肽作为急性胃食管静脉曲张出血患者内镜治疗的辅助药物，其止血效果和安全性无显著差异。
