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硬化疗法与生长抑素输注预防肝硬化患者急性静脉曲张出血后早期再出血的随机对照试验。静脉曲张出血研究组

Randomized controlled trial of sclerotherapy versus somatostatin infusion in the prevention of early rebleeding following acute variceal hemorrhage in patients with cirrhosis. Variceal Bleeding Study Group.

作者信息

Escorsell A, Bordas J M, del Arbol L R, Jaramillo J L, Planas R, Bañares R, Albillos A, Bosch J

机构信息

Institut de Malalties Digestives, Department of Medicine, IDIBAPS, Hospital Clínic, Universitat de Barcelona, Spain.

出版信息

J Hepatol. 1998 Nov;29(5):779-88. doi: 10.1016/s0168-8278(98)80259-6.

DOI:10.1016/s0168-8278(98)80259-6
PMID:9833916
Abstract

BACKGROUND/AIMS: Early rebleeding is a very frequent complication of variceal hemorrhage. Sclerotherapy effectively controls variceal hemorrhage and prevents early rebleeding. Somatostatin infusion is as effective as sclerotherapy in controlling variceal hemorrhage, but no study has evaluated the efficacy of 5-day somatostatin infusion in preventing early rebleeding after the initial control of bleeding. The aim of the study was to compare the efficacy and safety of somatostatin and sclerotherapy in the prevention of early variceal rebleeding in cirrhotic patients.

METHODS

The study included 169 patients with acute variceal hemorrhage who were randomized within 24 h of controlling the acute bleeding to receive either sclerotherapy (n=79) or continuous somatostatin infusion for 5 days (250 microg/h after a 250-microg bolus, repeated every 24 h, n=90). Success of therapy was defined by absence of rebleeding during the 5 days following randomization.

RESULTS

Early (5 days) rebleeding occurred in 12/79 patients treated with sclerotherapy vs 14/90 of those receiving somatostatin (NS). The treatment was equally effective in Child's C patients (sclerotherapy: 18/20; somatostatin: 17/20; NS) and Child's A+B patients (sclerotherapy: 49/59; somatostatin: 59/70; NS). Complications occurred in 19/79 patients receiving sclerotherapy vs 4/90 in the somatostatin group (p= 0.00019), being severe in 6 vs 0 patients (p=0.0094). There were no differences between the two groups in the incidence of 6-week rebleeding (14% vs 15%, NS) and mortality (9% vs 9%).

CONCLUSIONS

Continuous somatostatin infusion is as effective as sclerotherapy in preventing early variceal rebleeding and maintaining low mortality following acute variceal hemorrhage. Somatostatin is associated with a lower rate of complications than sclerotherapy.

摘要

背景/目的:早期再出血是静脉曲张出血非常常见的并发症。硬化疗法能有效控制静脉曲张出血并预防早期再出血。生长抑素输注在控制静脉曲张出血方面与硬化疗法效果相当,但尚无研究评估持续5天输注生长抑素在出血初步控制后预防早期再出血的疗效。本研究的目的是比较生长抑素和硬化疗法在预防肝硬化患者早期静脉曲张再出血方面的疗效和安全性。

方法

本研究纳入169例急性静脉曲张出血患者,在急性出血得到控制后的24小时内随机分组,分别接受硬化疗法(n = 79)或持续5天输注生长抑素(首剂250μg推注后以250μg/h持续输注,每24小时重复,n = 90)。治疗成功的定义为随机分组后5天内无再出血。

结果

硬化疗法治疗的79例患者中有12例发生早期(5天内)再出血,而接受生长抑素治疗的90例患者中有14例发生早期再出血(无显著性差异)。在Child's C级患者中(硬化疗法:18/20;生长抑素:17/20;无显著性差异)以及Child's A + B级患者中(硬化疗法:49/59;生长抑素:59/70;无显著性差异),两种治疗方法效果相同。接受硬化疗法的79例患者中有19例发生并发症,而生长抑素组90例中有4例发生并发症(p = 0.00019),其中严重并发症在两组中的发生率分别为6例和0例(p = 0.0094)。两组在6周再出血发生率(14% 对15%,无显著性差异)和死亡率(9% 对9%)方面无差异。

结论

持续输注生长抑素在预防早期静脉曲张再出血以及急性静脉曲张出血后维持低死亡率方面与硬化疗法效果相当。与硬化疗法相比,生长抑素的并发症发生率较低。

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