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硬化疗法与结扎术治疗择期出血性食管静脉曲张的前瞻性随机试验。

A prospective randomized trial of sclerotherapy versus ligation in the elective treatment of bleeding esophageal varices.

作者信息

Baroncini D, Milandri G L, Borioni D, Piemontese A, Cennamo V, Billi P, Dal Monte P P, D'Imperio N

机构信息

Dept. of Gastroenterology and Gastrointestinal Endoscopy, Bellaria Hospital, Bologna, Italy.

出版信息

Endoscopy. 1997 May;29(4):235-40. doi: 10.1055/s-2007-1004182.

DOI:10.1055/s-2007-1004182
PMID:9255524
Abstract

BACKGROUND AND STUDY AIMS

Endoscopic ligation (EVL) and endoscopic variceal sclerotherapy (EVS) are known to be equally effective in eradicating bleeding esophageal varices in patients with hepatic cirrhosis, but the long-term safety and efficacy of the two techniques have not been clearly established. The aim of this study was to determine the relative frequency of rebleeding, recurrence of varices, and survival after treatment with the two techniques during a relatively long follow-up period.

PATIENTS AND METHODS

A total of 111 patients without bleeding at the index endoscopy were randomly assigned to either EVL (n = 57) or EVS (n = 54). After eradication of the varices, the patients received endoscopic examinations every three months and for each episode of rebleeding.

RESULTS

The mean follow-up periods were 534 +/- 42 days in the EVS group and 496 +/- 40 days in the EVL group. The two techniques were equally effective in eradicating varices (93% in EVL group and 92.5% in EVS group). The mean number of sessions required to obtain eradication was slightly lower (mean +/- SE) in the EVL group (3.5 +/- 0.1 vs. 4.0 +/- 0.1, P = 0.004), while the time required for eradication was longer (33.8 +/- 2.1 vs. 27.3 +/- 1.4, P = 0.01). The comparison of the Kaplan-Meier estimates of survival and time to first rebleeding did not show any statistically significant differences between the two groups. The rate of complications was significantly higher in the EVS group than in the EVL group (31% vs. 11%, P = 0.001), while the rate of recurrent varices during follow-up was higher in the EVL group (30% vs. 13%, P = 0.03).

CONCLUSIONS

While the two techniques are equally effective, ligation treatment shows greater advantages in the short-term follow-up, but is associated with more frequent recurrence of varices in the longer term. These two aspects should be considered for evaluation in the cost-benefit ratio and quality of life analysis. All patients should have frequent endoscopic evaluations (every three or four months) throughout the first year of follow-up.

摘要

背景与研究目的

内镜下套扎术(EVL)和内镜下静脉曲张硬化疗法(EVS)在消除肝硬化患者食管静脉曲张出血方面被认为同样有效,但这两种技术的长期安全性和有效性尚未明确确立。本研究的目的是确定在相对较长的随访期内,两种技术治疗后再出血、静脉曲张复发的相对频率以及生存率。

患者与方法

共有111例在初次内镜检查时未出血的患者被随机分配至EVL组(n = 57)或EVS组(n = 54)。静脉曲张消除后,患者每三个月接受一次内镜检查,并对每次再出血情况进行检查。

结果

EVS组的平均随访期为534±42天,EVL组为496±40天。两种技术在消除静脉曲张方面同样有效(EVL组为93%,EVS组为92.5%)。EVL组实现消除所需的平均治疗次数略少(均值±标准误)(3.5±0.1对4.0±0.1,P = 0.004),而消除所需时间更长(33.8±2.1对27.3±1.4,P = 0.01)。两组间生存和首次再出血时间的Kaplan-Meier估计值比较未显示出任何统计学显著差异。EVS组的并发症发生率显著高于EVL组(31%对11%,P = 0.001),而随访期间EVL组的静脉曲张复发率更高(30%对13%,P = 0.03)。

结论

虽然两种技术同样有效,但套扎治疗在短期随访中显示出更大优势,但从长期来看与更频繁的静脉曲张复发相关。在成本效益比和生活质量分析评估中应考虑这两个方面。所有患者在随访的第一年都应频繁进行内镜评估(每三到四个月一次)。

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