国产乌司他丁治疗急性胰腺炎的疗效和安全性

The efficacy and safety of domestic ulinastatin in the treatment of acute pancreatitis

目的 :观察国产乌司他丁治疗急性胰腺炎的疗效及安全性。方法 :本研究是一项随机对照和开放相结合的多中心临床试验。 419例急性胰腺炎患者随机分为乌司他丁试验组 (n =10 8)、甲磺酸加贝酯对照组 (n =10 3) ,另设乌司他丁开放组 (n =2 0 8)。用法为乌司他丁静脉滴注 5 0 0 0 0IU ,tid ,持续 3d之后改 qd ,疗程共 10d。甲磺酸加贝酯 10 0mg ,tid ,持续 3d后改为qd ,疗程共 10d。 结果 :乌司他丁对急性胰腺炎的治愈率为 71.5 % ,总有效率为 90 .2 %。对照药甲磺酸加贝酯的治愈率为 5 9.2 % ,总有效率 78.6 %。整体疗效比较乌司他丁高于甲磺酸加贝酯 ,但无统计学差异 (P >0 .0 5 )。乌司他丁有 1例 (0 .316 % )、对照药甲磺酸加贝酯也有 1例 (0 .971% )皮疹 ,未见其他不良反应。结论 :乌司他丁是治疗急性胰腺炎的一个安全有效的药物。

Objective:To observe the efficacy and safety of domestic ulinastatin in the treatment of acute pancreatitis.Methods:419 patients were enrolled into the study.They were randomly divided to receive ulinastatin 50 000 IU tid for 3d then reduced to 50 000 IU qd for 7d( n =108),or gabexate mesylate injection 100 mg tid for 3d then reduced to 100 mg qd for 7d( n =103).In addition to this,an open ulinastatin group( n =208) was also created.Results:The cure rate was 71.5% for ulinastatin group vs 59.2% for gabexate mesylate group.The effective rate was 90.2% for ulinastatin group vs 78.6% for gabexate mesylate group.There was no significant difference among groups but the data in ulinastatin group was slightly better than that of gabexate mesylate group.The incidence of side effect was 0.316% for ulinastatin group vs 0.971% for gabexate mesylate group.Conclusion:Ulinastatin is an effective and safe agent for treatment of pancreatitis. [