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随机对照试验:硬化结扎与单纯套扎治疗胃食管静脉曲张的疗效比较。

Randomized controlled trial of scleroligation versus band ligation alone for eradication of gastroesophageal varices.

机构信息

Tropical Medicine and Infectious Diseases Department, Tanta University, Tanta, Egypt.

Internal Medicine Department, Tanta University, Tanta, Egypt.

出版信息

Gastrointest Endosc. 2017 Aug;86(2):307-315. doi: 10.1016/j.gie.2016.12.026. Epub 2017 Jan 9.

Abstract

BACKGROUND AND AIMS

Gastric varices develop in 5% to 33% of patients with portal hypertension. Their most common form is concomitant gastroesophageal varices. Scleroligation (combined sclerotherapy and band ligation) has been used successfully in management of esophageal varices but has not been evaluated previously in the management of gastroesophageal varices. The aim of this work was evaluation of a new scleroligation technique for management of bleeding gastroesophageal varices regarding efficacy, adverse events, variceal recurrence, and survival.

METHODS

This study was conducted on 120 cirrhotic patients with bleeding gastroesophageal varices, whom we divided randomly into 2 groups of 60 patients each-a band ligation group and a scleroligation group.

RESULTS

The mean number of sessions was lower in the scleroligation group than in the band ligation group (2.22 ± 0.92 and 3.43 ± 0.67, respectively) (P < .001), as were the duration of treatment and total number of bands used. Cost and survival were comparable in the 2 groups. There was no significant difference between the 2 maneuvers regarding adverse events, recurrence rates, or rebleeding rates after obliteration. Recurrence was significantly higher in patients with larger varices, ulceration, and postprocedure pyrexia. Rebleeding was significantly higher among those who experienced postprocedure pyrexia and developed or had worsening of gastric antral vascular ectasia.

CONCLUSIONS

Scleroligation appears to achieve a faster rate of eradication with fewer treatment sessions and total number of bands deployed to achieve variceal obliteration than band ligation and is comparable in cost and in adverse event and recurrence rates. (Clinical trial registration number: NCT02646202.).

摘要

背景和目的

门脉高压症患者中,5%至 33%会发展为胃静脉曲张。最常见的形式是同时存在的胃食管静脉曲张。硬化结扎(联合硬化治疗和套扎)已成功应用于食管静脉曲张的治疗,但以前尚未评估其在胃食管静脉曲张治疗中的应用。本研究旨在评估一种新的硬化结扎技术治疗出血性胃食管静脉曲张的疗效、不良事件、静脉曲张复发和生存率。

方法

本研究纳入了 120 例肝硬化合并出血性胃食管静脉曲张患者,随机分为两组,每组 60 例患者-套扎组和硬化结扎组。

结果

与套扎组相比,硬化结扎组的治疗次数(2.22 ± 0.92 与 3.43 ± 0.67)较低(P<0.001),治疗持续时间和使用的套扎带总数也较低。两组的费用和生存率相当。在不良事件、复发率或闭塞后再出血率方面,两种操作之间没有显著差异。在较大静脉曲张、溃疡和术后发热的患者中,复发率明显较高。在经历术后发热、胃底静脉曲张加重或恶化的患者中,再出血率明显较高。

结论

与套扎相比,硬化结扎似乎可以更快地实现静脉曲张的消除,治疗次数更少,总套扎带数量更少,达到静脉曲张闭塞的目的,且成本相当,不良事件和复发率也相当。(临床试验注册号:NCT02646202.)。

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