Fleig W E, Stange E F, Hunecke R, Schönborn W, Hurler U, Rainer K, Gaus W, Ditschuneit H
Hepatology. 1987 Mar-Apr;7(2):355-61. doi: 10.1002/hep.1840070224.
To compare the efficacy of endoscopic paravariceal sclerotherapy and oral propranolol in the prevention of recurrent upper gastrointestinal bleeding, 78 cirrhotic patients were randomly assigned to either treatment after an endoscopically proven bleed from esophageal varices. After randomization, but before treatment had been started, a total of eight patients had to be withdrawn from the study due to early rebleeding (requiring emergency sclerotherapy) or violations of the protocol. Among the 70 patients analyzed (36 sclerotherapy, 34 propranolol), both treatment groups were comparable with respect to demographic, clinical and laboratory data. The groups also did not differ with respect to continued alcohol intake. Sclerotherapy was performed twice weekly using 1% polidocanol as the sclerosing agent until the varices were eradicated or well-covered by fibrous tissue. Propranolol was given twice daily at a dose reducing the resting heart rate by 25% (60 to 320 mg per day; mean +/- SD = 161 +/- 80 mg per day). Patients were followed for up to 2 years with visits at 3 monthly intervals (mean follow-up = sclerotherapy, 14 months; propranolol, 9.2 months). Life table analysis of patients without rebleeding from nonvariceal sites revealed a tendency in favor of propranolol; however, the difference did not reach statistical significance. No significant difference was observed between sclerotherapy and propranolol in the proportion of patients rebleeding from esophageal varices or from all sources of upper gastrointestinal bleeding. Furthermore, survival was similar in both treatment groups.(ABSTRACT TRUNCATED AT 250 WORDS)
为比较内镜下曲张静脉旁硬化疗法与口服普萘洛尔预防上消化道出血复发的疗效,78例肝硬化患者在内镜证实食管静脉曲张出血后被随机分配至两种治疗组。随机分组后但在开始治疗前,共有8例患者因早期再出血(需急诊硬化疗法)或违反方案而退出研究。在分析的70例患者中(36例行硬化疗法,34例服用普萘洛尔),两个治疗组在人口统计学、临床和实验室数据方面具有可比性。两组在持续饮酒量方面也无差异。使用1%聚多卡醇作为硬化剂,每周进行两次硬化疗法,直至静脉曲张消除或被纤维组织良好覆盖。普萘洛尔每日给药两次,剂量以降低静息心率25%为准(每日60至320毫克;平均±标准差 = 161±80毫克/天)。患者随访长达2年,每3个月复诊一次(平均随访时间:硬化疗法组为14个月;普萘洛尔组为9.2个月)。对非静脉曲张部位未再出血患者的生命表分析显示,普萘洛尔组有优势倾向;然而,差异未达到统计学显著性。硬化疗法与普萘洛尔在食管静脉曲张再出血患者比例或所有上消化道出血来源的再出血患者比例方面未观察到显著差异。此外,两个治疗组的生存率相似。(摘要截短于250字)