Department of Gastroenterology, Facultad de Medicina Pontifica Universidad Católica de Chile, Santiago, Chile.
Ann Hepatol. 2010 Jan-Mar;9(1):15-22.
Gastroesophageal variceal bleeding is a common complication of portal hypertension. Current guidelines recommend thorn-blockers for primary prophylaxis. However, evidence suggests that endoscopic variceal ligation (EVL) reduce bleeding episodes.
To compare endoscopic EVL with propranolol (PPL) for primary prophylaxis of variceal bleeding.
We conducted a randomized controlled trial. Over a 9-year period, 75 patients with cirrhosis and high-risk esophageal varices (HREV) were recruited and allocated to EVL (n=39) or PPL (n=36). Primary outcome was variceal bleeding. Secondary outcomes were survival, source of bleeding and serious adverse events. Analyses were made by intention-to-treat.
Baseline characteristics were similar. Medium follow-up was 1647+/-1096 days. complete follow-up was achieved in 85% of patients. Variceal bleeding occurred in 12% of EVL and in 25% of PPL group (p=0.17). The actuarial risks of bleeding after 2 years were similar in both groups. Overall mortality was 51% in EVL and 33% in PPL group (p=0.17). Patients in the EVL group showed a lower rate of esophageal variceal bleeding (5.1% v/s 25%, p=0.027) and a higher rate of subcardial variceal bleeding compared with PPL group (7.7% v/s 0%, p=0.027). Serious adverse events related to EVL occurred in 2 patients, including 1 death.
The present study supports that PPL should be considered the first choice in primary prophylaxis of variceal bleeding offering similar effects and lower severe adverse events compared with EVL.
胃食管静脉曲张出血是门静脉高压的常见并发症。目前的指南建议使用噻嗪类药物进行一级预防。然而,有证据表明内镜下食管静脉曲张结扎术(EVL)可减少出血事件。
比较 EVL 与普萘洛尔(PPL)在预防静脉曲张出血中的作用。
我们进行了一项随机对照试验。在 9 年期间,招募了 75 例肝硬化和高危食管静脉曲张(HREV)患者,并将其分为 EVL 组(n=39)或 PPL 组(n=36)。主要结局是静脉曲张出血。次要结局是生存、出血来源和严重不良事件。分析采用意向治疗。
基线特征相似。中位随访时间为 1647+/-1096 天。85%的患者完成了完整随访。EVL 组有 12%的患者发生静脉曲张出血,PPL 组有 25%的患者发生静脉曲张出血(p=0.17)。两组患者在 2 年内出血的累积风险相似。EVL 组的总死亡率为 51%,PPL 组为 33%(p=0.17)。EVL 组食管静脉曲张出血发生率较低(5.1%比 25%,p=0.027),与 PPL 组相比,贲门旁静脉曲张出血发生率较高(7.7%比 0%,p=0.027)。EVL 相关严重不良事件发生在 2 例患者中,包括 1 例死亡。
本研究支持 PPL 应作为静脉曲张出血一级预防的首选药物,与 EVL 相比,其疗效相似,但严重不良事件发生率较低。