5-单硝酸异山梨醇酯和普萘洛尔预防肝硬化食管静脉曲张再出血的随机对照研究

目的 探讨5－单硝酸异山梨醇酯和普萘洛尔联合治疗预防食管曲张静脉再出血的有效性。方法 66例肝硬化食管胃底曲张静脉出血的病人被随机分成5－单硝酸慢山梨醇酯（IM）加普萘洛尔（PR）组（34例）和普萘洛尔（32例）组接受治疗。结果 5例PR＋IM组病人和9例PR组病人在接受治疗后随访1年期间发生再出血,PR＋IM组再出血的可能性低于单用PR组,但差异无显著意义。在把随访时间延长到20个月时,两组再出血的危险性下降差异有显著意义（P＝0．047）,但再出血指数和生存时间差异无显著意义,多元COX分析显示年龄（0．045）、肝病严重程度（0．03）和治疗（0．04）是再出血的预示指数,PR＋IM使再出血的危险减少了一半（相对危险度0．54）。结论 联用5－单硝酸异山梨醇酯增加了普萘洛尔预防肝硬化食管曲张静脉再出血的有效性,但未明显改善肝硬化病人的生存期。

The randomized controlled trial of isosorbide mononitrate plus propranolol compared with propranolol alone for the prevention of variceal rebleeding

Objective The aim of this study was to test the effectiveness of isosorbide 5 mononitrate (IM) as an adjunct to propranolol (PR) in the prevention of variceal rebleeding Methods Seventy six cirrhotic patients with variceal bleeding were randomly assigned to treatment with PR + IM (34 patients) or PR alone (32 patients) Results Seven patients in the PR + IM group and 13 in the PR group had rebleeding during the 1 year after randomization The actuarial probability of rebleeding 1 years after randomization was lower in the PR + IM group but the difference was not significant ( P =0 09) However, by adding an additional 8 months of follow up , the decrease in the risk of rebleeding reached statistical significance ( P =0 05) No significant difference was found in rebleeding index and survival The multivariate Cox analysis indicated both treatment ( P =0 04), severity of liver disease ( P =0 03) and age ( P =0 045) were factors predictive of rebleeding and second, that PR + MI reduced the risk of rebleeding by half (relative risk: 0 54 ) Conclusion These results suggest that the addition of IM improves the efficacy of PR alone in the prevention of variceal rebleeding in cirrhotic patients However no beneficial effects were observed on other parameters reflecting the efficacy of treatment