Lo G-H, Chen W-C, Wang H-M, Lin C-K, Chan H-H, Tsai W-L, Cheng L-C, Yu H-C, Tsay F-W
Digestive Center, E-DA Hospital, Division of Gastroenterology, Department of Medicine, Kaohsiung Veterans General Hospital, I-Shou University, Taipei, Taiwan.
Gut. 2009 Sep;58(9):1275-80. doi: 10.1136/gut.2008.165910. Epub 2009 Apr 21.
Very early rebleeding is frequently encountered in patients with acute oesophageal variceal bleeding. A trial was designed to assess the efficacy and safety in patients with no active bleeding at endoscopy, receiving banding ligation association with terlipressin to prevent very early rebleeding.
Patients with no active variceal bleeding at endoscopy were evaluated. Eligible patients were randomised to receive terlipressin infusion alone for 5 days (Terlipressin group) or banding ligation plus terlipressin infusion for 2 days (Combined group). Primary endpoints were treatment failure and very early rebleeding.
The terlipressin group was composed of 46 patients and the Combined group was composed of 47 patients. Both groups were comparable in terms of baseline data. Forty-eight-hour haemostasis was achieved in 91% in the Terlipressin group and 98% in the Combined group (p = 0.20). Very early rebleeding within 48-120 h occurred in 7 patients (15%) in the Terlipressin group but not in any patients (0%) in the Combined group (p = 0.006). Treatment failure was 24% in the Terlipressin group and 2% in the Combined group (p = 0.002). Multivariate analysis revealed that treatment (OR 0.081; 95% CI 0.010 to 0.627) was the only predictive factor of very early rebleeding. Blood requirement was significantly lower in the Combined group than in the Terlipressin group. Complications and 6-week survival were similar in both groups.
Combination of banding ligation and terlipressin infusion for 2 days was superior to only infusion of terlipressin for 5 days in the reduction of very early rebleeding and treatment failure in patients with inactive variceal bleeding at endoscopy.
ISRCTN28353453.
急性食管静脉曲张出血患者常出现极早期再出血。本试验旨在评估在内镜检查时无活动性出血的患者中，联合使用特利加压素进行套扎结扎预防极早期再出血的疗效和安全性。
对在内镜检查时无活动性静脉曲张出血的患者进行评估。符合条件的患者被随机分为单独接受特利加压素输注5天（特利加压素组）或套扎结扎加特利加压素输注2天（联合组）。主要终点为治疗失败和极早期再出血。
特利加压素组由46例患者组成，联合组由47例患者组成。两组在基线数据方面具有可比性。特利加压素组91%的患者在48小时内实现止血，联合组为98%（p = 0.20）。特利加压素组7例患者（15%）在48 - 120小时内发生极早期再出血，联合组无患者发生（0%）（p = 0.006）。特利加压素组治疗失败率为24%，联合组为2%（p = 0.002）。多因素分析显示，治疗（比值比0.081；95%置信区间0.010至0.627）是极早期再出血的唯一预测因素。联合组的血液需求量显著低于特利加压素组。两组的并发症和6周生存率相似。
在内镜检查时无活动性静脉曲张出血的患者中，套扎结扎与特利加压素输注2天联合使用在减少极早期再出血和治疗失败方面优于单独使用特利加压素输注5天。
ISRCTN28353453。
