来那度胺超说明书用药情况调查与循证评价  

Investigation and evidence-based evaluation of the off-label use of lenalidomide

作　　者：吕元庆 张晓明 杨玉琴 谢加力 赵敏 LÜ Yuanqing;ZHANG Xiaoming;YANG Yuqin;XIE Jiali;ZHAO Min(Department of Pharmacy,the Second People’s Hospital of Wuhu,Wuhu 241000,China;Department of Hematology,the Second People’s Hospital of Wuhu,Wuhu 241000,China)

机构地区：[1]芜湖市第二人民医院药剂科,安徽芜湖241000 [2]芜湖市第二人民医院血液内科,安徽芜湖241000

出　　处：《现代药物与临床》2024年第7期1891-1898,共8页Drugs & Clinic

摘　　要：目的 采用循证医学方法对芜湖市第二人民医院来那度胺超说明书用药情况进行评价,为促进临床合理使用新型抗肿瘤药物提供参考。方法 按照《超说明书用药循证评价规范》与权威指南建立新型抗肿瘤药物超说明书用药评价标准与循证医学评价流程。回顾性调查芜湖市第二人民医院2021年1月—2023年12月住院患者使用来那度胺的病例资料,统计来那度胺超说明书用药情况。根据评价标准对超说明书用药进行循证评价。结果 共收集使用来那度胺的病例资料87例,其中超说明书用药39例,占比44.83%,超说明书用药类型包括适应证、剂量与疗程。39例超说明书用药中处于复发/难治阶段患者的构成比为64.10%。评价为“建议使用”“限制使用”“特殊使用”“不建议使用”构成比分别为15.39%、56.41%、25.64%、2.56%。结论 来那度胺超说明书用药较常见,存在评价结果为不建议使用的超说明书用药,医疗机构应加强超说明书用药管理。该院利用循证医学方法制定的评价标准为新型抗肿瘤药物超说明书用药评价提供参考价值。Objective To evaluate the off-label use of lenalidomide using evidence-based medicine methods in the Second People’s Hospital of Wuhu, in order to provide reference for promoting the rational use of new anti-tumor drugs in clinical practice. Methods Establish evaluation criteria and evidence-based medical evaluation process for the off-label use of new anti-tumor drugs in accordance with Evidence-Based Evaluation Specification for Off-label Drug Use and Authoritative Guidelines. Case data from inpatients that using lenalidomide were retrospectively investigated in the Second People’s Hospital of Wuhu from January 2021 to December 2023, and the off-label drug use were statistically analyzed and reviewed by evidence-based evaluation criteria. Results A total of 87 cases using lenalidomide were collected from the hospital, of 39 cases were off-label drug use, accounting for 44.83%, the main categories of off-label drug use were indication, dosage, course of treatment. Among the off-label use of lenalidomide, 64.10% were in the stage of relapsed/refractory treatment. The proportions of “recommended use” “restricted use” “special use” and “not recommended use” were 15.39%, 56.41%, 25.64%, 2.56%, respectively. Conclusion The off-label use of lenalidomide is more common, and there are evaluation results indicating that it is not recommended to use. Medical institutions should strengthen the management of the off-label drug use. The evaluation criteria established by using evidence-based medicine methods provide reference value for evaluation of the off-label use of new anti-tumor drugs.

关 键 词：来那度胺 超说明书 循证医学 评价标准 适应证 剂量 疗程 

分 类 号：R979.1[医药卫生—药品]