替加环素超说明书药物利用评价标准的建立与应用

Establishment and Application of Drug Use Evaluation Criteria of Off-label Drug Use of Tigecycline

目的:建立替加环素超说明书的药物利用评价(drug use evaluation,DUE)标准,为临床合理用药提供依据。方法:替加环素超说明书DUE标准包括管理指标、用药指征、用药过程和用药结果 4个部分,其中用药指征包括超适应证(占主导)、超剂量、超适应人群和超疗程用药。回顾性分析96例超说明书应用替加环素患者的临床资料,对超说明书用药情况及DUE监测结果进行综合性评价。结果:我院替加环素超说明书用药率为69.57%(96/138);替加环素超说明书DUE标准评价结果显示,对四环素类抗菌药物无过敏、每日至少测量体温2次的符合标准率均为100%,符合标准率较低的为降钙素原监测、肝功能监测及药品不良反应监测等。结论:我院替加环素超说明书用药情况常见,且存在一定问题,应不断完善医院替加环素超说明书合理用药质量保证体系,保证临床用药安全。。

OBJECTIVE： To establish the drug use evaluation（ DUE） criteria of off-label drug use of tigecycline,so as to provide basis for the rational drug use in clinic. METHODS： The DUE criteria of off-label drug use of tigecycline were respectively management indicators, medication indication, medication duration and medication results,among which the medication indication included off-indications（ leading role）,off-dosage,off-population and off-course of treatment. Retrospective analysis was conducted on clinical data of 96 cases of off-label drug use of tigecycline,and comprehensive evaluation was conducted on monitoring results of status of off-label drug use and DUE of off-label drug use of tigecycline. RESULTS： The off-label drug use rate of tigecycline was 69. 57%（ 96/138）. The DUE criteria of off-label drug use of tigecycline showed that qualified rate toward no allergy to tetracycline antibiotics and taking temperature at least twice a day was 100%; yet monitoring of PCT,liver function and adverse drug reactions had lower qualified rate. CONCLUSIONS： The phenomenon of off-label drug use of tigecycline is common in our hospital,and has some problems. It is necessary to constantly improve the quality assurance system of rational offlabel drug use of tigecycline,so as to ensure safe medication in clinic.