【摘要】 目的 通过前瞻性研究评价乌司他丁(ulinastatin)对急性胰腺炎的疗效，并与善得定作对比研究。方法 采用随机对照临床试验设计，按纳入标准筛选病例，治疗组和对照组针对轻型和重症急性胰腺炎采取规范用药。根据主要临床症状、体征和实验室指标将疗效分为痊愈、显效、有效和无效四级评价，记录不良反应。结果 自2000年8月～2006年2月共有68例符合标准的急性胰腺炎患者进入本研究，其中轻型44例，重症24例。乌司他丁治疗轻型急性胰腺炎，总有效率达96.0%，痊愈率达76.0%，略低于对照组，但差异无显著性(P>0.05)。腹痛、上腹胀等主要症状在3～5天内基本缓解或消失，血淀粉酶、尿淀粉酶在3～5天内恢复正常。乌司他丁治疗重症急性胰腺炎，总有效率与善得定相似(76.9%vs81.8%，P=0.769)。治疗急性胰腺炎出现的并发症主要为胰腺假性囊肿。仅1例在首次用药时出现恶心呕吐等胃肠道反应，未观察到乌司他丁的严重不良反应，肝肾功能和电解质等生化指标监测显示其具有较好的安全性。结论 乌司他丁治疗急性胰腺炎有类似善得定的较好疗效，且不良反应较少、治疗费用低。

    【关键词】 乌司他丁；急性胰腺炎

    【Abstract】 Objective To study the therapeutic effect of ulinastatin on mild and severe acute pancreatitis, which was compared with sandostatin.Methods Randomized clinical trial was performed. Patients were randomly allocated into the treatment group (with ulinastatin) and control group (with sandostatin), which were stratified by MAP or SAP. Clinical results were assessed as cured, significant effective, effective and non-effective according to laboratory tests, clinical symptoms and signs. All the side effects were recorded during the whole process.Results From August 2000 to February 2006, totally eighty-six patients were enrolled (MAP 44 cases, SAP 24 cases). The total effectiveness of ulinastatin in treating MAP was 96.0% with the cured rate 76.0%, a little lower than the control group with sandostatin, but no statistical significance existed. Clinical symptoms such as abdominal pain, fullness and laboratory tests such as blood/urine amylase almost recovered within 3～5 days. Total effectiveness of ulinastatin in treating SAP was similar as that of sandostatin (76.9% .vs. 81.8%, P=0.769). Pancreatic pseudocyst was the main complication of acute pancreatitis. Only one case showed nausea and vomiting without any other severe side effects.Conclusion As a broad-spectrum protease inhibitor, ulinastatin showed therapeutic effect in treating acute pancreatitis with fine safety and few side effects. ......