A Controlled Trial of Nadolol Plus Isosorbide Mononitrate vs. Carvedilol for the Prevention of Variceal Rebleeding
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 121
- 主要终点
- variceal rebleeding
研究概览
简要总结
Carvedilol is shown to be superior to propranolol to reduce the portal pressure. This study was undertaken to compare the effectiveness and complication rates of nadolol and isosorbide mononitrate (ISMN) with carvedilol in the prevention of rebleeding from esophageal varices.
详细描述
Bleeding from esophageal varices is a severe complication of portal hypertension. After initial control of acute variceal bleeding, patients have up to a 70% risk of rebleeding. Of those do rebleed, there is a 20%-35% mortality rate. Therefore, preventive procedures are required for patients surviving an episode of acute variceal bleeding. Both endoscopic injection sclerotherapy (EIS) and propranolol have been well documented to be effective for the prevention of variceal rebleeding. In recent years, endoscopic variceal ligation (EVL) has replaced EIS as the endoscopic treatment of choice in the management of bleeding esophageal varices. On the other hand, the addition of isosorbide-5-mononitrate (ISMN) has been shown to be even more effective than propranolol alone in the reduction of portal pressure and in the prevention of variceal rebleeding. A controlled trial showed that the combination of nadolol and ISMN was better than EIS in terms of prevention of variceal rebleeding and complications. The combination of nadolol and ISMN has been shown to be better than EVL in preventing variceal rebleeding. However, our study showed a contradictory result. On the other hand, carvedilol is shown to be superior to propranolol to reduce the portal pressure. This study was undertaken to compare the effectiveness and complication rates of nadolol and ISMN with carvedilol in the prevention of rebleeding from esophageal varices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •acute or recent bleeding from esophageal varices (defined below),
- •the etiology of portal hypertension was cirrhosis, and
- •age was between 20 and 70 years old.
排除标准
- •association with hepatocellular carcinoma or other malignancy,
- •association with cerebral vascular accident, uremia, sepsis or other debilitating disease,
- •had history of gastric variceal bleeding,
- •received beta-blocker within 1 month prior to entry,
- •history of contraindication to the use of beta-blockers, such as asthma, heart failure, atrioventricular block, bradycardia (pulse rate <55/min) or arterial hypotension (systolic blood pressure < 90 mmHg),
- •history of prior shunt operation, TIPS (transjugular intrahepatic portosystemic stent shunt),
- •deep jaundice (serum bilirubin > 10 mg/dl),
- •encephalopathy greater than stage II,
- •failure in control of index variceal bleeding, or
- •refused to participate in the trial.
研究组 & 干预措施
Carvedilol
carvedilol 6.25mg per day
干预措施: carvedilol (Drug)
N+I
nadolol 40mg per day, ISMN 10 mg per day
干预措施: nadolol + ISMN (Drug)
结局指标
主要结局
variceal rebleeding
时间窗: 2 years
hematemesis or melena,requiring blood transfusion of 2 units or more bleeding source was proven endoscopically to be from esophageal varices
次要结局
- adverse events, mortality(2 years)