比较食管静脉曲张套扎术与硬化疗法的前瞻性多中心随机试验。

Prospective multicenter randomized trial comparing banding ligation with sclerotherapy of esophageal varices.

作者信息

Masci E, Stigliano R, Mariani A, Bertoni G, Baroncini D, Cennamo V, Micheletti G, Casetti T, Tansini P, Buscarini E, Ranzato R, Norberto L

机构信息

Department of Gastroenterology and Digestive Endoscopy, San Raffaele Hospital-University of Milano, Milan, Italy.

出版信息

Hepatogastroenterology. 1999 May-Jun;46(27):1769-73.

PMID:10430341

Abstract

BACKGROUND/AIMS: Endoscopic variceal banding ligation (EVL), first described by Stiegmann in 1988, is now an accepted alternative to sclerotherapy (EVS) for esophageal varices with previous bleeding. However, results are conflicting in terms of complications, eradication, recurrence, rebleeding and mortality rate. We aimed to compare EVL with EVS in a prospective randomized trial in patients with previous esophageal bleeding proved by endoscopy. End points were rebleeding rate and death during a short (eradication period) or long-term follow-up (> 1 year).

METHODOLOGY

One hundred patients (50 EVL, 50 EVS) were enrolled. Eradication rate, number of treatments needed to achieve eradication, recurrence of varices, rebleeding and complications were recorded and analyzed.

RESULTS

No differences were observed between the two groups regarding age, sex and Child class. One patient dropped out in the EVL group and 6 in the EVS group. Eradication was obtained in 44 (88%) with EVL and 41 (82%) with EVS with a mean of 3.41 and 5.29 treatments (p<0.001), respectively. Rebleeding occurred during eradication in 6 patients (12%) in the EVL group and 21 (42%) in the EVS group (p=0.001); after eradication, 7 patients (14%) rebled in the EVL group and 4 (8%) in the EVS group (not significant). Non-variceal bleeding was observed in 5 patients (2 EVL and 3 EVS) during follow-up. Two patients in the EVL group died after variceal rebleeding; 3 died of gastric bleeding; and, 15 from non-hemorrhagic events (8 EVL and 7 EVS). In the EVL group 14 patients had recurrent varices and 7 rebled; in the EVS group 11 recurred, with rebleeding in 5. Major complications were fewer in the EVL group (1 stenosis, 4 chronic ulcers) compared to 18 patients in the EVS group (9 stenosis and 9 chronic ulcers) (p<0.005).

CONCLUSIONS

EVL might be preferable to EVS for faster reduction and obliteration of varices, with a lower rate of complications and rebleeding before eradication. No differences were observed in recurrence.

摘要

背景/目的：内镜下静脉曲张套扎术（EVL）于1988年由施蒂格曼首次描述，目前已成为既往有出血史的食管静脉曲张硬化治疗（EVS）的一种可接受的替代方法。然而，在并发症、根除、复发、再出血和死亡率方面，结果存在矛盾。我们旨在通过一项前瞻性随机试验，比较内镜证实有既往食管出血的患者中EVL与EVS的疗效。终点指标为短期（根除期）或长期随访（>1年）期间的再出血率和死亡率。

方法

招募了100例患者（50例行EVL，50例行EVS）。记录并分析根除率、实现根除所需的治疗次数、静脉曲张复发情况、再出血情况和并发症。

结果

两组在年龄、性别和Child分级方面无差异。EVL组有1例患者退出，EVS组有6例。EVL组44例（88%）实现根除，EVS组41例（82%）实现根除，平均治疗次数分别为3.41次和5.29次（p<0.001）。根除期间，EVL组有6例患者（12%）发生再出血，EVS组有21例（42%）发生再出血（p=0.001）；根除后，EVL组有7例患者（14%）再次出血，EVS组有4例（8%）再次出血（无统计学意义）。随访期间，5例患者（2例行EVL，3例行EVS）发生非静脉曲张出血。EVL组有2例患者在静脉曲张再出血后死亡；3例死于胃出血；15例死于非出血性事件（8例行EVL，7例行EVS）。EVL组有14例患者静脉曲张复发，7例再次出血；EVS组有11例复发，5例再次出血。EVL组的主要并发症较少（1例狭窄，4例慢性溃疡），而EVS组有18例患者（9例狭窄和9例慢性溃疡）（p<0.005）。