Tripathi Dhiraj, Ferguson James W, Kochar Narendra, Leithead Joanna A, Therapondos George, McAvoy Norma C, Stanley Adrian J, Forrest Ewan H, Hislop William S, Mills Peter R, Hayes Peter C
Royal Infirmary, Edinburgh, United Kingdom.
Hepatology. 2009 Sep;50(3):825-33. doi: 10.1002/hep.23045.
Current therapy for preventing the first variceal bleed includes beta-blocker and variceal band ligation (VBL). VBL has lower bleeding rates, with no differences in survival, whereas beta-blocker therapy can be limited by side effects. Carvedilol, a non-cardioselective vasodilating beta-blocker, is more effective in reducing portal pressure than propranolol; however, there have been no clinical studies assessing the efficacy of carvedilol in primary prophylaxis. The goal of this study was to compare carvedilol and VBL for the prevention of the first variceal bleed in a randomized controlled multicenter trial. One hundred fifty-two cirrhotic patients from five different centers with grade II or larger esophageal varices were randomized to either carvedilol 12.5 mg once daily or VBL performed every 2 weeks until eradication using a multibander device. Seventy-seven patients were randomized to carvedilol and 75 to VBL. Baseline characteristics did not differ between the groups (alcoholic liver disease, 73%; median Child-Pugh score, 8; median age, 54 years; median follow-up, 20 months). On intention-to-treat analysis, carvedilol had lower rates of the first variceal bleed (10% versus 23%; relative hazard 0.41; 95% confidence interval 0.19-0.96 [P = 0.04]), with no significant differences in overall mortality (35% versus 37%, P = 0.71), and bleeding-related mortality (3% versus 1%, P = 0.26). Six patients in the VBL group bled as a result of banding ulcers. Per-protocol analysis revealed no significant differences in the outcomes.
Carvedilol is effective in preventing the first variceal bleed. Carvedilol is an option for primary prophylaxis in patients with high-risk esophageal varices.
目前预防首次静脉曲张出血的治疗方法包括使用β受体阻滞剂和静脉曲张套扎术（VBL）。VBL的出血率较低，生存率无差异，而β受体阻滞剂治疗可能会受到副作用的限制。卡维地洛是一种非选择性血管舒张β受体阻滞剂，在降低门静脉压力方面比普萘洛尔更有效；然而，尚无临床研究评估卡维地洛在一级预防中的疗效。本研究的目的是在一项随机对照多中心试验中比较卡维地洛和VBL预防首次静脉曲张出血的效果。来自五个不同中心的152例患有II级或更大食管静脉曲张的肝硬化患者被随机分为两组，一组每天服用一次12.5mg卡维地洛，另一组每2周进行一次VBL，直至使用多环扎装置根除静脉曲张。77例患者被随机分配至卡维地洛组，75例患者被随机分配至VBL组。两组的基线特征无差异（酒精性肝病，73%；Child-Pugh评分中位数，8；年龄中位数，54岁；随访中位数，20个月）。在意向性分析中，卡维地洛组首次静脉曲张出血率较低（10%对23%；相对风险0.41；95%置信区间0.19 - 0.96 [P = 0.04]），总体死亡率（35%对37%，P = 0.71）和出血相关死亡率（3%对1%，P = 0.26）无显著差异。VBL组有6例患者因套扎溃疡出血。符合方案分析显示结果无显著差异。
卡维地洛在预防首次静脉曲张出血方面有效。卡维地洛是高危食管静脉曲张患者一级预防的一种选择。
