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内镜下注射硬化疗法与N-丁基-2-氰基丙烯酸酯注射治疗活动性出血性食管静脉曲张的随机对照试验。

Endoscopic injection sclerotherapy versus N-Butyl-2 Cyanoacrylate injection in the management of actively bleeding esophageal varices: a randomized controlled trial.

作者信息

Elsebaey Mohamed A, Tawfik Mohamed A, Ezzat Sherif, Selim Amal, Elashry Heba, Abd-Elsalam Sherief

机构信息

Internal Medicine Department, Faculty of Medicine, Tanta University, Tanta, Egypt.

Tropical Medicine Department, Faculty of Medicine, Tanta University, Tanta, Egypt.

出版信息

BMC Gastroenterol. 2019 Feb 4;19(1):23. doi: 10.1186/s12876-019-0940-1.

Abstract

BACKGROUND

The management of acute esophageal variceal bleeding remains a clinical challenge. Band ligation is the main therapeutic option, but it may be technically difficult to perform in active bleeders. This may necessitate an alternative therapy for this group of patients. This study was conducted to assess the safety and efficacy of sclerotherapy versus cyanoacrylate injection for management of actively bleeding esophageal varices in cirrhotic patients.

METHODS

This prospective study included 113 cirrhotic patients with actively bleeding esophageal varices. They were randomly treated by endoscopic sclerotherapy or cyanoacrylate injection as banding was not suitable for those patients due to profuse bleeding making unclear endoscopic visual field. Primary outcome was incidence of active bleeding control and secondary outcomes were incidence of six weeks rebleeding, complications, and mortality among the studied patients.

RESULTS

Initial bleeding control was significantly higher in cyanoacrylate versus sclerotherapy groups (98.25, 83.93% respectively, P = 0.007). No significant differences between sclerotherapy and cyanoacrylate groups regarding rebleeding (26.79, 19.30% respectively, P = 0.344), complications, hospital stay or mortality rate were observed.

CONCLUSIONS

Based on this single-center prospective study, both of these therapies appear to have relatively favorable outcomes, although cyanoacrylate injection may be superior to sclerotherapy for initial control of active bleeding.

TRIAL REGISTRATION

[ClinicalTrials.gov Identifier: NCT03388125 ]-Date of registration: January 2, 2018 "Retrospectively registered".

摘要

背景

急性食管静脉曲张出血的管理仍然是一项临床挑战。套扎术是主要的治疗选择,但对于活动性出血患者,实施起来可能存在技术困难。这可能需要为这类患者选择替代疗法。本研究旨在评估硬化疗法与氰基丙烯酸酯注射治疗肝硬化患者活动性出血食管静脉曲张的安全性和有效性。

方法

这项前瞻性研究纳入了113例患有活动性出血食管静脉曲张的肝硬化患者。由于出血量大导致内镜视野不清,套扎术不适用于这些患者,因此他们被随机接受内镜硬化疗法或氰基丙烯酸酯注射治疗。主要结局是活动性出血控制的发生率,次要结局是研究患者六周再出血的发生率、并发症及死亡率。

结果

氰基丙烯酸酯组的初始出血控制率显著高于硬化疗法组(分别为98.25%和83.93%,P = 0.007)。硬化疗法组与氰基丙烯酸酯组在再出血(分别为26.79%和19.30%,P = 0.344)、并发症、住院时间或死亡率方面未观察到显著差异。

结论

基于这项单中心前瞻性研究,这两种疗法似乎都有相对良好的结果,尽管氰基丙烯酸酯注射在初始控制活动性出血方面可能优于硬化疗法。

试验注册

[ClinicalTrials.gov标识符:NCT03388125 ] - 注册日期:2018年1月2日 “回顾性注册”

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/33fd/6362581/38b2b3c37299/12876_2019_940_Fig1_HTML.jpg

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