背景：当加入血管活性药物时，内镜下硬化治疗在控制急性静脉曲张破裂出血方面的功效显著提高。内镜下静脉曲张结扎术（EVL）优于硬化治疗。EVL的功效是否也会随着生长抑素的添加而改善是未知的。我们比较了EVL加生长抑素与EVL加安慰剂对急性静脉曲张破裂出血的控制。
方法：纳入连续肝硬化急性食管静脉曲张破裂出血患者。紧急EVL后,患者随机接受生长抑素(250mcg/hr)或安慰剂输注.主要终点为5天内治疗失败。治疗失败定义为治疗开始后≥2小时的新鲜呕血，或血红蛋白下降3克，或死亡。
结果：纳入61例患者（EVL+生长抑素组，n=31和EVL加安慰剂组，n=30)。基线特征相似。在最初的5天内，两组治疗失败的频率相似(EVL+生长抑素组8/31[26%]与EVL+安慰剂组7/30[23%];P=1.000).两组的死亡率也相似(3/31[10%]vs.3/30[10%]；P=1.000）。基线HVPG≥19mmHg和索引内窥镜检查时的活动性出血是治疗失败的独立预测因素。
结论：在EVL治疗中添加生长抑素输注在控制急性静脉曲张破裂出血或降低死亡率方面没有任何优势。其原因可能是其在五天内未能保持门静脉压力的持续降低。索引内窥镜检查和高基线HVPG的活动性出血应有助于选择早期替代治疗方案。在ClincalTrials.govvideNCT01267669注册的试验。
BACKGROUND: Efficacy of endoscopic sclerotherapy in controlling acute variceal bleeding is significantly improved when vasoactive drug is added. Endoscopic variceal ligation (EVL) is superior to sclerotherapy. Whether efficacy of EVL will also improve with addition of somatostatin is not known. We compared EVL plus somatostatin versus EVL plus placebo in control of acute variceal bleeding.
METHODS: Consecutive cirrhotic patients with acute esophageal variceal bleeding were enrolled. After emergency EVL, patients were randomized to receive either somatostatin (250 mcg/hr) or placebo infusion. Primary endpoint was treatment failure within 5 days. Treatment failure was defined as fresh hematemesis ≥2 h after start of therapy, or a 3 gm drop in Hb, or death.
RESULTS: 61 patients were enrolled (EVL plus somatostatin group, n = 31 and EVL plus placebo group, n = 30). The baseline characteristics were similar. Within the initial 5-day period, the frequency of treatment failure was similar in both the groups (EVL plus somatostatin group 8/31 [26%] versus EVL plus placebo group 7/30 [23%]; P = 1.000). The mortality was also similar in the two groups (3/31 [10%] vs. 3/30 [10%]; P = 1.000). Baseline HVPG ≥19 mm Hg and active bleeding at index endoscopy were independent predictors of treatment failure.
CONCLUSIONS: Addition of somatostatin infusion to EVL therapy does not offer any advantage in control of acute variceal bleeding or reducing mortality. The reason for this may be its failure to maintain sustained reduction in portal pressure for five days. Active bleeding at index endoscopy and high baseline HVPG should help choose early alternative treatment options.
Trial registered with ClincalTrials.gov vide NCT01267669.
