食管静脉曲张首次出血前药物干预的随机对照研究

Porspective study on the effects of drug intervention is preventing the first bleeding of esophageal varices:A Randomize controlled trial with propranolol,ISMN and spironolactone in combination

目的探讨普萘洛尔、5-单硝酸异山梨醇酯(ISMN)和螺内酯联合运用预防首次食管胃底静脉曲张破裂出血的有效性。方法106例肝硬化食管静脉曲张患者,肝功能child-pugh分级为A级和B级随机分成治疗组54例,接受口服普萘洛尔、5-单硝酸异山梨醇酯和螺内酯联合治疗;对照组52例未接受以上药物,对两组患者进行前瞻性对照观察。随访时间为24个月,完成随访治疗组51例、对照组51例。结果在观察期间,治疗组发生出血27.5%(14/51),对照组为52.9%(27/51)(P<0.01);发生多次出血者低于对照组13.7%vs37.3%(P<0.05)。因出血接受输血人数治疗组低于对照组(分别为50%和81.5%P<0.05);累计输血量低于对照组(P<0.01)。治疗组随访终点脾静脉内径、脾静脉和门静脉血流量低于对照组(P分别<0.05、<0.01和<0.05);血小板计数、凝血酶原活动度高于对照组(P<0.05);Child-Pugh计分低于对照组(P<0.05)。结论普萘洛尔、ISMN和螺内酯联合应用可有效预防食管静脉曲张出血的发生。

Objective The aim of this study was to test the efficacy and safety of the association of nadolol： isosorbide-5- mononitrate（ISMN） and spironolactone for the prevention of the first hemorrhage in patients with esophageal varices. Methods 106 patients with esophageal varices with liver function child-pugh A or B grade were randomized treated with propranolol, ISMN and spironolactone （54 cases） or patients without above treatment as controls （52 cases） , Patients were followed up to 23.82±1.52 and 23.74± 1.87 months, respectively. Both groups had 51 patients completed visit. Results First hemorrhage took place was 27.5 % （ 14/51 ） in treatment group and 52.9% （27/51） in control group （ P 〈 0.01 ） ; Times of hemorrhage in treatment group was fewer than that of control group 13.7% vs 37.3% （P 〈 0.05）. A number of patients who needed blood transfusion were lower in the treatment group than that in the control group 50% vs 81.5% （ P 〈 0.05） and the accumulated amount of the blood transfusion was less in the treatment group （ P 〈 0.01 ）. The diameter of splenic vein, the amount of splenic bloodstream and portal vein bloodstream were lower in treatment group than those in the control group at the end point of observation （P 〈 0.05, P 〈 0.01 and P 〈 0.05 respectively）; The number of blood platelet and plasma prothrombin activity were higher in treatment group than those in the control group （ P 〈 0.05 ） ; Childpugh grade is lower in therapy group than that in control group （ P 〈 0.05 ）. Conclusion Abrove results suggest propranolol, ISMN and spironolactone in combination can effectively prevent the occurrence of hemorrhage in cirrhotic patients with esophageal vances.