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 off-label drug use of tigecycline , so as to ensure safe medication in clinic .
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