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卡维地洛与那多洛尔加单硝酸异山梨酯预防静脉曲张再出血的随机对照试验。

Randomized, controlled trial of carvedilol versus nadolol plus isosorbide mononitrate for the prevention of variceal rebleeding.

机构信息

Department of Medical Research, Digestive Center, E-DA Hospital, Kaohsiung, Taiwan.

出版信息

J Gastroenterol Hepatol. 2012 Nov;27(11):1681-7. doi: 10.1111/j.1440-1746.2012.07244.x.

DOI:10.1111/j.1440-1746.2012.07244.x
PMID:22849337
Abstract

BACKGROUND AND AIM

Carvedilol has been shown to be more effective than propranolol in decreasing portal pressure. Sufficient data from controlled trials remains limited. This trial compared the relative safety and efficacy between carvedilol and nadolol plus isosorbide mononitrate in preventing variceal rebleeding.

METHODS

After successful control of acute esophageal variceal bleeding, eligible patients were randomized to the carvedilol group, 61 patients, using carvedilol 6.25-12.5 mg daily or the N + I group, 60 patients, using nadolol 40-80 mg plus isorsorbide-5-mononitrate 20 mg daily. The end points were rebleeding from varices, adverse events or death.

RESULTS

After a median follow up of 30 months, recurrent upper gastrointestinal bleeding developed in 37 patients (61%) in the carvedilol group and 37 patients (62%) in the N + I group (P = 0.90). Recurrent bleeding from esophageal varices occurred in 31 patients (51%) in the carvedilol group and in 26 patients (43%) in the N + I group (P = 0.46). Recurrent bleeding from gastric varices occurred in two patients (3%) in the carvedilol group and in eight patients (13%) in the N + I group (P = 0.05). Severe adverse events occurred in one patient in the carvedilol group and 17 patients in the N + I group (P < 0.0001). Fifteen patients of the carvedilol group and 17 patients in the N + I group died (P = 0.83). Two patients in the carvedilol group and three patients in the N + I group died of variceal bleeding.

CONCLUSIONS

Carvedilol was as effective as nadolol plus isorsorbide-5 -mononitrate mononitrate in the prevention of gastroesophageal variceal rebleeding with fewer severe adverse events and similar survival.

摘要

背景与目的

卡维地洛已被证明在降低门静脉压方面比普萘洛尔更有效。但对照试验的充分数据仍然有限。本试验比较了卡维地洛和纳多洛尔加单硝酸异山梨酯在预防静脉曲张再出血方面的相对安全性和疗效。

方法

在成功控制急性食管静脉曲张出血后,合格的患者被随机分配到卡维地洛组,61 例,每天使用卡维地洛 6.25-12.5mg;或 N+I 组,60 例,每天使用纳多洛尔 40-80mg 加单硝酸异山梨酯 20mg。终点是静脉曲张再出血、不良事件或死亡。

结果

中位随访 30 个月后,卡维地洛组 37 例(61%)和 N+I 组 37 例(62%)患者发生再发性上消化道出血(P=0.90)。卡维地洛组 31 例(51%)和 N+I 组 26 例(43%)患者发生食管静脉曲张再出血(P=0.46)。卡维地洛组 2 例(3%)和 N+I 组 8 例(13%)患者发生胃静脉曲张再出血(P=0.05)。卡维地洛组 1 例患者出现严重不良事件,N+I 组 17 例(P<0.0001)。卡维地洛组 15 例和 N+I 组 17 例患者死亡(P=0.83)。卡维地洛组 2 例和 N+I 组 3 例患者死于静脉曲张出血。

结论

卡维地洛与纳多洛尔加单硝酸异山梨酯在预防胃食管静脉曲张再出血方面同样有效,且严重不良事件更少,生存率相似。

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