基于循证证据的抗肿瘤药物超说明书用药审核与管理探讨

Evidence-based Review and Management of Antitumor Drugs Off-label Use

目的制定基于循证的抗肿瘤药物超说明书用药分级审核管理模式,科学管理抗肿瘤药物超说明书用药。方法利用Micromedex数据库Thomson分级系统,建立抗肿瘤药物超说明书用药的分级审核管理模式,分析该管理模式建立前后抗肿瘤药物超说明书用药的合理性。结果抗肿瘤药物超说明书用药以超适应证用药居多,其次为超剂量用药、超给药途径用药。实行分级审核管理后,超说明书用药的合理率较管理前明显升高(p<0.05)。结论基于循证的分级审核管理模式,有利于促进抗肿瘤药物的合理使用。

Objective To establish an evidence-based grading review and management model for off-label use of antitumor drugs and scientifically manage off-label use of antitumor drugs.Methods A grading review management model for off-label use of antitumor drugs was established by means of Thomson grading system of Micromedex database,and the rationality of off-label use of antitumor drugs before and after the establishment of the management model was analyzed.Results Most of the off-label drug use of antitumor drugs was over indication drug use,followed by over dose drug use and over route drug use.After the implementation of grading review management,the rational rate of off-label drug use was significantly higher than that before(p<0.05).Conclusion The evidence-based grading review management model is conductive to the rational use of antitumor drugs.