Section of Gastroenterology, Aga Khan University, Karachi, Pakistan.
National Institute of Liver & GI Diseases, Dow University of Health Sciences, Karachi, Pakistan.
J Hepatol. 2014 Apr;60(4):757-64. doi: 10.1016/j.jhep.2013.11.019. Epub 2013 Nov 28.
BACKGROUND & AIMS: Esophageal variceal bleed is a major problem in patients with cirrhosis. Endoscopic variceal ligation (EVL) has been shown to be equal to or better than propranolol in preventing first bleed. Carvedilol is a non-selective β blocker with alpha-1 adrenergic blocker activity. Hemodynamic studies have shown carvedilol to be more effective than propranolol at reducing portal pressure. We compared efficacy of carvedilol with EVL for primary prophylaxis of esophageal variceal bleed.
Cirrhotic patients with esophageal varices were randomized to carvedilol 12.5mg daily or EVL at three university hospitals of Pakistan. End points were esophageal variceal bleeding, death or liver transplant.
Two hundred and nine patients were evaluated. Eighty two and eighty six patients were randomized in carvedilol and EVL arms respectively. Mean age was 48 ± 12.2 years; 122 (72.7%) were males; 89.9% had viral cirrhosis; mean Child-Pugh score was 7.3 ± 1.6 and mean follow up was 13.3 ± 12.1 months (range 1-50 months). Both EVL and carvedilol groups had comparable variceal bleeding rates (8.5% vs. 6.9%), bleed related mortality (4.6% vs. 4.9%) and overall mortality (12.8% vs. 19.5%) respectively. Adverse events in carvedilol group were hypotension (n=2), requiring cessation of therapy, while transient nausea (n=18) and dyspnea (n=30) resolved spontaneously. In the EVL arm, post banding ulcer bleed (n=1) and chest pain (n=17), were termed as serious adverse events while transient dysphagia (n=58) resolved without treatment.
Although our study is underpowered, the findings suggest that carvedilol is probably not superior to EVL in preventing first variceal bleed in patients with viral cirrhosis.
食管静脉曲张出血是肝硬化患者的一个主要问题。内镜下食管静脉曲张结扎术（EVL）已被证明在预防首次出血方面与普萘洛尔等效或更优。卡维地洛是一种非选择性β受体阻滞剂，具有α-1肾上腺素能阻滞剂活性。血流动力学研究表明，卡维地洛在降低门静脉压力方面比普萘洛尔更有效。我们比较了卡维地洛与 EVL 在预防食管静脉曲张出血中的疗效。
在巴基斯坦的三所大学医院，将患有食管静脉曲张的肝硬化患者随机分配至卡维地洛 12.5mg 每日组或 EVL 组。终点为食管静脉曲张出血、死亡或肝移植。
共评估了 209 例患者。82 例和 86 例患者分别被随机分配至卡维地洛组和 EVL 组。平均年龄为 48 ± 12.2 岁；122 例（72.7%）为男性；89.9%为病毒性肝硬化；平均 Child-Pugh 评分为 7.3 ± 1.6，平均随访时间为 13.3 ± 12.1 个月（范围 1-50 个月）。EVL 组和卡维地洛组的静脉曲张出血率（8.5% vs. 6.9%）、出血相关死亡率（4.6% vs. 4.9%）和总死亡率（12.8% vs. 19.5%）均相似。卡维地洛组的不良反应包括低血压（n=2），需要停止治疗，而短暂性恶心（n=18）和呼吸困难（n=30）自行缓解。在 EVL 组中，套扎后溃疡出血（n=1）和胸痛（n=17）被视为严重不良事件，而短暂性吞咽困难（n=58）无需治疗即可缓解。
尽管我们的研究规模较小，但结果表明，在预防病毒性肝硬化患者首次静脉曲张出血方面，卡维地洛可能并不优于 EVL。
