论文部分内容阅读
背景:目前生长抑素及其类似物已广泛应用于肝硬化食管胃静脉曲张破裂出血的治疗。目的:评价国产注射用奥曲肽治疗肝硬化食管胃静脉曲张破裂出血的临床疗效和安全性。方法:采用随机、单肓、平行对照多中心临床研究。试验组和对照组分别使用国产和进口醋酸奥曲肽注射液,用法为0.1mg静脉推注,随后以0.6mg溶于5%葡萄糖注射液500ml中静脉滴注,1次/12h,24h内出血停止者再连续应用2d。结果:共99例患者入选,试验组67例,对照组32例。按意向治疗(ITT)分析,试验组24h止血率为80.6%,治疗期间再出血率为6.0%;对照组分别为84.4%和0%,组间差异均无统计学意义(P>0.05)。试验组输血例数29例,平均输血量280.6ml;对照组输血例数10例,平均输血量190.0ml,组间差异无统计学意义(P>0.05)。试验过程中两组均未发生与试验药物有关的严重不良事件。结论:国产醋酸奥曲肽注射液治疗肝硬化食管胃静脉曲张破裂出血安全有效。
Background: At present, somatostatin and its analogues have been widely used in the treatment of hepatic cirrhosis and esophagogastric variceal bleeding. Objective: To evaluate the clinical efficacy and safety of domestic octreotide injection for the treatment of hepatic cirrhosis with esophagogastric variceal bleeding. Methods: A randomized, single 肓, parallel control multicenter clinical study. Test group and control group were using domestic and imported octreotide acetate injection, the use of 0.1mg intravenous injection, followed by 0.6mg dissolved in 5% glucose injection 500ml intravenous infusion, 1 / 12h, 24h stop bleeding and then Continuous application 2d. Results: A total of 99 patients were enrolled, 67 in the experimental group and 32 in the control group. According to ITT analysis, the rate of hemostasis at 24h in experimental group was 80.6%, and the rate of rebleeding during treatment was 6.0%. The control group was 84.4% and 0% respectively. There was no significant difference between two groups (P> 0.05). In the experimental group, the number of transfusions was 29 and the average volume of transfusion was 280.6ml. In the control group, 10 cases were transfused, with an average blood transfusion volume of 190.0ml. There was no significant difference between the two groups (P> 0.05). There were no serious adverse events related to the test drugs in both groups during the trial. Conclusion: The domestic octreotide acetate injection is safe and effective for the treatment of hepatic cirrhosis with esophagogastric variceal bleeding.