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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=108)、甲磺酸加贝酯对照组(n =103)，另设乌司他丁开放组(n=208)。用法为乌司他丁静脉滴注50 000IU，tid，持续3 d之后改qd,疗程共10 d。甲磺酸加贝酯100mg，tid，持续3 d后改为qd,疗程共10 d。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59.2％，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>0.05）。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 patien ts were enrolled into the study.They were randomly divided to receive ulinastati n 50 000 IU tid for 3d then reduced to 50 000 IU qd for 7d(n=108),or gabexat e mesylate injection 100 mg tid for 3d then reduced to 100 mg qd for 7d(n=10 3).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 gabexat e 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 th e 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 gabe xate mesylate group.Conclusion:Ulinastatin is an effective and safe ag ent for treatment of pancreatitis.