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比较特利加压素和生长抑素治疗急性静脉曲张出血的双盲随机对照试验。静脉曲张出血研究组。

Double-blind randomized controlled trial comparing terlipressin and somatostatin for acute variceal hemorrhage. Variceal Bleeding Study Group.

作者信息

Feu F, Ruiz del Arbol L, Bañares R, Planas R, Bosch J

机构信息

Hospital Clinic i Provincial, Department of Medicine, University of Barcelona, Spain.

出版信息

Gastroenterology. 1996 Nov;111(5):1291-9. doi: 10.1053/gast.1996.v111.pm8898643.

DOI:10.1053/gast.1996.v111.pm8898643
PMID:8898643
Abstract

BACKGROUND & AIMS: Terlipressin and somatostatin decrease portal pressure and have been used to treat variceal hemorrhage, but they have not been adequately compared. The aim of this study was to compare the efficacy and safety of these drugs in the treatment of variceal bleeding in cirrhotic patients.

METHODS

Of 161 patients with variceal bleeding. 80 were randomized to receive (double-blind) intravenous terlipressin (2 mg/4 h) and 81 to receive somatostatin (continuous infusion of 250 micrograms/h after an intravenous injection of 250 micrograms). Success of therapy was defined as a 24-hour bleeding-free period within 48 hours from randomization.

RESULTS

Success of therapy was similar with terlipressin (80%) and somatostatin (84%). In patients with Child's class A and B disease, terlipressin was effective in 52 of 60 (87%) and somatostatin in 48 of 55 (87%). Success rates in class C were 60% and 77% (P = 0.33). No differences were observed in rebleeding rates (30% vs. 28.4%) and 6-week mortality rates (13 vs. 13 patients). Incidence of side effects was significantly higher in the terlipressin group (38.8% vs. 23.5%; P = 0.042). Severe side effects requiring intervention occurred in 5 of 80 and 4 of 81 patients, respectively.

CONCLUSIONS

Terlipressin and somatostatin are highly effective as first-line treatment of variceal hemorrhage in cirrhotic patients. The low incidence of severe side effects suggests that drug therapy may be maintained for longer periods to prevent early rebleeding.

摘要

背景与目的

特利加压素和生长抑素可降低门静脉压力,已用于治疗静脉曲张出血,但二者尚未得到充分比较。本研究旨在比较这两种药物治疗肝硬化患者静脉曲张出血的疗效和安全性。

方法

161例静脉曲张出血患者中,80例随机接受(双盲)静脉注射特利加压素(2毫克/4小时),81例接受生长抑素(静脉注射250微克后持续输注250微克/小时)。治疗成功定义为随机分组后48小时内有24小时无出血期。

结果

特利加压素组(80%)和生长抑素组(84%)的治疗成功率相似。在Child's A级和B级疾病患者中,特利加压素在60例中的52例(87%)有效,生长抑素在55例中的48例(87%)有效。C级患者的成功率分别为60%和77%(P = 0.33)。再出血率(30%对28.4%)和6周死亡率(13例对13例)无差异。特利加压素组的副作用发生率显著更高(38.8%对23.5%;P = 0.042)。分别有80例中的5例和81例中的4例出现需要干预的严重副作用。

结论

特利加压素和生长抑素作为肝硬化患者静脉曲张出血的一线治疗非常有效。严重副作用的低发生率表明药物治疗可维持更长时间以预防早期再出血。

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