本院住院患者乌司他丁超说明书用药情况分析

Analysis of ulinastatin off-label use on inpatients in our hospital

目的分析本院注射用乌司他丁用药医嘱的合理性,促进乌司他丁的安全应用。方法 2013年7月至2014年5月,每月随机抽取本院住院患者使用乌司他丁的医嘱30条。将患者的诊断、用法用量,与乌司他丁药品说明书进行对比分析,统计超药品说明书情况。同时整理汇总乌司他丁超说明书使用相关文献报道,分析医嘱的合理性。结果共随机抽取乌司他丁医嘱330条,其中完全符合药品说明书用法的38条(11.5%),超药品说明书用药292条(88.5%),超适应证261条(79.1%)。在所有超适应证用药医嘱中,以心脏手术术后和肠道恶性肿瘤术后使用为主,分别为138条(52.9%)和46条(17.6%)。患者治愈率68.8%(227/330),好转率23.3%(77/330),死亡率3.6%(12/330)。临床无文献依据的超说明书使用共11例。结论本院乌司他丁超说明书较为普遍,但大多数有文献依据支持,患者转归情况良好。

AIM To promote the safety application of ulinastatin by rational analysis of ulinastatin prescription. METHODS Prescriptions of ulinastatin were collected 30 per month randomly from July 2013 to May 2014. The patients＇ diagnosis and drug dose were compared with drug label to analyze the off-label use of ulinastatin. The existing researches of ulinastatin were collected and the pharmacist analyzed the reasonableness of ulinastatin use. RESULTS Three hundred and thirty prescriptions were randomly taken, of which 38 （11.5%） fully met the usages of medication instruction and 292 （88.5%） were off-label used. Two hundred and sixty-one prescriptions （79.1%） were off-label indications. Postoperative use of cardiac and intestinal cancer accounted for the largest proportion in all off-indication uses of ulinastatin, which were 138 （52.9%） and 46 （17.6%）. Of those patients, the cure rate was 68.8% （227/330）, the improvement rate was 23.3% （77/330） and the mortality was 3.6% （12/330） . During the commenting on ulinastatin, the off-label use of ulinastatin without evidence was 11. CONCLUSION Off-label uses of ulinastatin is common in our hospital, most of which are evidence-based and the outcomes of those patients are good.