Schepke Michael, Kleber Gerhard, Nürnberg Dieter, Willert Jörg, Koch Lydia, Veltzke-Schlieker Wilfried, Hellerbrand Claus, Kuth Johannes, Schanz Stefan, Kahl Stefan, Fleig Wolfgang E, Sauerbruch Tilman
Department of Internal Medicine I, University of Bonn, Bonn, Germany.
Hepatology. 2004 Jul;40(1):65-72. doi: 10.1002/hep.20284.
In this randomized controlled multicenter trial, we compared endoscopic variceal banding ligation (VBL) with propranolol (PPL) for primary prophylaxis of variceal bleeding. One hundred fifty-two cirrhotic patients with 2 or more esophageal varices (diameter >5 mm) without prior bleeding were randomized to VBL (n = 75) or PPL (n = 77). The groups were well matched with respect to baseline characteristics (age 56 +/- 10 years, alcoholic etiology 51%, Child-Pugh score 7.2 +/- 1.8). The mean follow-up was 34 +/- 19 months. Data were analyzed on an intention-to-treat basis. Neither bleeding incidence nor mortality differed significantly between the 2 groups. Variceal bleeding occurred in 25% of the VBL group and in 29% of the PPL group. The actuarial risks of bleeding after 2 years were 20% (VBL) and 18% (PPL). Fatal bleeding was observed in 12% (VBL) and 10% (PPL). It was associated with the ligation procedure in 2 patients (2.6%). Overall mortality was 45% (VBL) and 43% (PPL) with the 2-year actuarial risks being 28% (VBL) and 22% (PPL). 25% of patients withdrew from PPL treatment, 16% due to side effects. In conclusion, VBL and PPL were similarly effective for primary prophylaxis of variceal bleeding. VBL should be offered to patients who are not candidates for long-term PPL treatment.
在这项随机对照多中心试验中，我们比较了内镜下静脉曲张套扎术（VBL）与普萘洛尔（PPL）用于静脉曲张出血一级预防的效果。152例患有2条或更多条食管静脉曲张（直径>5mm）且既往未出血的肝硬化患者被随机分为VBL组（n = 75）或PPL组（n = 77）。两组在基线特征方面匹配良好（年龄56±10岁，酒精性病因占51%，Child-Pugh评分7.2±1.8）。平均随访时间为34±19个月。数据按意向性分析。两组之间的出血发生率和死亡率均无显著差异。VBL组25%的患者发生静脉曲张出血，PPL组为29%。2年后出血的精算风险分别为20%（VBL）和18%（PPL）。VBL组12%的患者和PPL组10%的患者发生致命性出血。其中2例患者（2.6%）的致命性出血与套扎操作有关。总体死亡率在VBL组为45%，PPL组为43%，2年精算风险分别为28%（VBL）和22%（PPL）。25%的患者退出PPL治疗，其中16%是由于副作用。总之，VBL和PPL在静脉曲张出血一级预防中同样有效。对于不适合长期PPL治疗的患者，应采用VBL治疗。
