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长期应用质子泵抑制剂可降低食管静脉曲张套扎治疗失败率:一项随机对照试验。

Long-term administration of PPI reduces treatment failures after esophageal variceal band ligation: a randomized, controlled trial.

机构信息

Department of Gastroenterology, Internal Medicine, Kitasato University East Hospital, 2-1-1 Asamizodai, Minami-ku, Sagamihara, Kanagawa 252-0380, Japan.

出版信息

J Gastroenterol. 2012 Feb;47(2):118-26. doi: 10.1007/s00535-011-0472-0. Epub 2011 Sep 28.

Abstract

BACKGROUND AND PURPOSE

Elective esophageal variceal ligation (EVL) is performed to decrease the risk of variceal hemorrhage. EVL is associated with adverse effects, including post-ligated bleeding, chest pain, and dysphagia. Proton pump inhibitors (PPIs) are the most potent pharmacological agents for inhibition of gastric acid secretion. However, the long-term effect of PPIs after EVL remains unclear. The aim of this study was to assess the efficacy of rabeprazole, a PPI, after variceal eradication by EVL.

METHODS

We performed a randomized, controlled trial in Kitasato University East Hospital. The primary endpoint was treatment failure, defined as variceal hemorrhage or severe medical complications. Between July 2007 and September 2010, 43 patients were randomized into this study and followed up until September 2010.

RESULTS

Twenty-one patients in the rabeprazole arm received 10 mg rabeprazole daily after EVL, and 22 patients in the control received no antisecretory treatment from the same stage. Baseline characteristics did not differ between the groups (median Child-Pugh score, 6; median age, 62 years; median follow-up, 18.7 months). The trial was stopped early after an interim analysis showed that the risk of bleeding and failure of rabeprazole treatment was lower than that of no antisecretory treatment with the log-rank test showing a significant difference between the groups (P = 0.007) and a hazard ratio of 0.098 [95% confidence interval, 0.012-0.79 (P = 0.029)].

CONCLUSIONS

Long-term administration of PPIs reduced the risk of treatment failure after EVL. Acid suppression therapy should also be considered as a treatment option after EVL.

摘要

背景与目的

择期食管静脉曲张结扎术(EVL)可降低静脉曲张出血的风险。EVL 与不良事件相关,包括结扎后出血、胸痛和吞咽困难。质子泵抑制剂(PPIs)是抑制胃酸分泌最有效的药物。然而,EVL 后 PPI 的长期效果尚不清楚。本研究旨在评估 EVL 后通过 rabeprazole(一种 PPI)根除静脉曲张的疗效。

方法

我们在北里大学东医院进行了一项随机对照试验。主要终点是治疗失败,定义为静脉曲张出血或严重医疗并发症。2007 年 7 月至 2010 年 9 月,43 例患者被随机分为两组,并随访至 2010 年 9 月。

结果

21 例 rabeprazole 组患者在 EVL 后每天接受 10 mg rabeprazole 治疗,22 例对照组患者在同一阶段未接受任何抗分泌治疗。两组患者的基线特征无差异(中位 Child-Pugh 评分 6 分;中位年龄 62 岁;中位随访时间 18.7 个月)。中期分析显示,出血和 rabeprazole 治疗失败的风险低于无抗分泌治疗,log-rank 检验显示两组之间存在显著差异(P = 0.007),风险比为 0.098 [95%置信区间 0.012-0.79(P = 0.029)]。

结论

长期应用 PPI 降低了 EVL 后治疗失败的风险。EVL 后也应考虑抑酸治疗作为治疗选择。

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