CAJ | 학술논문

国产乌司他丁治疗急性胰腺炎的疗效和安全性
국산오사타정치료급성이선염적료효화안전성
The efficacy and safety of domestic ulinastatin in the treatment of acute pancreatitis

万方数据

中国新药杂志中國新藥雜誌 중국신약잡지
CHINESE NEW DRUGS JOURNAL
2001年 3期 204-206 ,共3页

王化虹%胡伏莲%林三仁%周丽雅%ZHOU Li-ya%屈汉廷%袁爱力%侯淑琴%孙士其%张小勇%刘平%王家胧

왕화홍%호복련%림삼인%주려아%ZHOU Li-ya%굴한정%원애력%후숙금%손사기%장소용%류평%왕가롱

乌司他丁%急性胰腺炎%甲磺酸加贝酯%药物不良反应烏司他丁%急性胰腺炎%甲磺痠加貝酯%藥物不良反應
오사타정%급성이선염%갑광산가패지%약물불량반응

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。
목적：관찰국산오사타정치료급성이선염적료효급안전성。방법：본연구시일항수궤대조화개방상결합적다중심림상시험。419례급성이선염환자수궤분위오사타정시험조(n=108)、갑광산가패지대조조(n =103)，령설오사타정개방조(n=208)。용법위오사타정정맥적주50 000IU，tid，지속3 d지후개qd,료정공10 d。갑광산가패지100mg，tid，지속3 d후개위qd,료정공10 d。결과：오사타정대급성이선염적치유솔위71.5％，총유효솔위90.2%。대조약갑광산가패지적치유솔위59.2％，총유효솔78.6％。정체료효비교오사타정고우갑광산가패지，단무통계학차이（P>0.05）。오사타정유1례（0.316%）、대조약갑광산가패지야유1 례(0.971%)피진，미견기타불량반응。결론：오사타정시치료급성이선염적일개안전유효적약물。
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.