仑伐替尼超说明书用药情况调查与评价

Investigation and Evaluation of the Off-label Use of Lenvatinib

目的调查某院仑伐替尼的超说明书用药情况,为临床用药提供参考。方法回顾性调查该院2022年门急诊使用仑伐替尼的处方,记录处方相关患者的诊断信息。参照仑伐替尼最新版的药品说明书,对收集的仑伐替尼处方是否存在超说明书用药进行判断。查阅相关文献和数据库,对被判定为超说明书用药的处方进行分类统计,并进行循证医学证据的收集。结果共收集仑伐替尼门诊处方2361张,其中超适应证用药81张,占3.43%,发生率最高的科室为外科和肿瘤科。81例超说明书用药中,有较强循证医学证据支持的共31例,占比38.27%;有较弱的循证医学证据支持的共40例,占比49.38%;无证据支持的处方共10张,占12.34%。结论仑伐替尼存在无证据支持的超说明书用药,应加强超说明书用药的管理,以提高用药的合理性与安全性。

OBJECTIVE To investigate the off-label use of lenvatinib in our hospital and provide reference for its clinical use.METHODS A retrospective study was conducted on the prescriptions of lenvatinib used in outpatient and emergency department of the hospital in 2022,and the diagnostic information of prescription-related patients was recorded.The existence of off-label drug use in the collected prescriptions of lenvatinib was judged by referring to the latest version of the drug instructions of lenvatinib.Consulting relevant literature and database,classifying and making statistics on the prescriptions judged to be off-label drug use,and collecting evidence-based medical evidence.RESULTSA total of 2361 outpatient prescriptions of lenvatinib were collected,of which 81 were off-label drug use,accounting for 3.43%.The department with the highest incidence were surgery and oncology.Among 81 cases of offlabel drug use,31 cases(38.27%)were supported by strong evidence-based medical evidence.There were 40 cases with weak evidence-based medical evidence,accounting for 49.38%;There were 10 prescriptions without evidence,accounting for 12.34%.CONCLUSION There are off-label drug use without evidence of lenvatinib,so the management of off-label drug use should be strengthened to improve the rationality and safety of drug use.