Acharya S K, Dasarathy S, Saksena S, Pande J N
Department of Gastroenterology, All India Institute of Medical Sciences, New Delhi.
J Hepatol. 1993 Sep;19(2):291-300. doi: 10.1016/s0168-8278(05)80585-9.
A prospective randomized double-blind study was conducted to evaluate the efficacy of propranolol in patients with portal hypertension undergoing long-term endoscopic sclerotherapy (EST) for recurrent variceal bleeding. Consecutive patients with portal hypertension (Child's class A or B) due to cirrhosis (n = 72), non-cirrhotic portal fibrosis (n = 29) and extrahepatic portal venous obstruction (n = 13) attending the liver clinic of a tertiary care center were included in the study. All patients had had at least one documented episode of variceal bleed in the previous 4 weeks. Fifty-eight patients received propranolol and 56 received placebo in addition to weekly EST. Rebleeding occurred in 12 (21%) patients in the placebo group and 10 (17%) patients in the propranolol group during a mean follow-up period of 24.4 +/- 10.4 months in the former and 23.8 +/- 9.2 months in the latter group (P > 0.1). The number of episodes of rebleeding (14 in the placebo and 12 in the propranolol group) were also similar (P > 0.1). The median bleeding-free period was more than 40 months in both treatment groups (P > 0.1). The mean transfusion requirements and the number of hospital admissions for rebleeding were also similar in the two treatment groups (P > 0.1). Complete obliteration of varices was achieved in 44 (78.9%) patients in the placebo group and 43 (75.5%) patients in the propranolol group (P > 0.1). Recurrence of new varices was seen in two patients in the placebo and in three of those in the propranolol group. Seven patients in the placebo group and five in the propranolol group died (P > 0.1). Complications related to EST were similar in the two treatment groups but additional adverse effects were observed in the propranolol group. The cumulative incidence of rebleeding in the placebo group was 12.7 and in the propranolol group it was 11.2 per 100 patient years of follow-up. It is concluded that the addition of propranolol in patients with portal hypertension and fair hepatic function on long-term EST does not confer any additional benefit.
开展了一项前瞻性随机双盲研究，以评估普萘洛尔对接受长期内镜硬化疗法（EST）治疗复发性静脉曲张出血的门静脉高压患者的疗效。本研究纳入了一家三级医疗中心肝病门诊的连续患者，这些患者因肝硬化（n = 72）、非肝硬化性门静脉纤维化（n = 29）和肝外门静脉阻塞（n = 13）导致门静脉高压（Child分级A或B级）。所有患者在过去4周内至少有一次记录在案的静脉曲张出血发作。58例患者接受普萘洛尔治疗，56例患者除每周接受EST外还接受安慰剂治疗。在安慰剂组的12例（21%）患者和普萘洛尔组的10例（17%）患者中出现再出血，前者的平均随访期为24.4±10.4个月，后者为23.8±9.2个月（P>0.1）。再出血发作次数（安慰剂组14次，普萘洛尔组12次）也相似（P>0.1）。两个治疗组的无出血期中位数均超过40个月（P>0.1）。两个治疗组的平均输血需求量和因再出血的住院次数也相似（P>0.1）。安慰剂组44例（78.9%）患者和普萘洛尔组43例（75.5%）患者实现了静脉曲张完全闭塞（P>0.1）。安慰剂组有2例患者和普萘洛尔组有3例患者出现新静脉曲张复发。安慰剂组7例患者和普萘洛尔组5例患者死亡（P>0.1）。两个治疗组与EST相关的并发症相似，但在普萘洛尔组观察到了额外的不良反应。安慰剂组每100患者年随访的再出血累积发生率为12.7，普萘洛尔组为11.2。结论是，对于门静脉高压且肝功能尚可的患者，在长期EST治疗中加用普萘洛尔不会带来任何额外益处。
