摘要
目的调查某三级医院门诊抗肿瘤药物超说明书用药现状,为规范合理用药提供参考。方法通过合理用药系统全样本抽取2022年1月~2024年12月门诊抗肿瘤药物处方2876张,依据说明书判定超说明书用药类型,结合Micromedex、PubMed、中国知网等数据库进行循证证据评价,并与医院备案目录比对分析。结果超说明书用药发生率为33.55%(965/2876),以超适应证为主(97.20%)。抗肿瘤化疗药物(65.91%)和内分泌治疗药物(33.16%)占比最高。37项超说明书用药中,35项(99.48%)有循证医学证据支持,其中17项(45.95%)已备案,涉及821张处方(85.08%);未备案的20项(54.05%)中,有2项(5张处方,0.52%)缺乏证据。结论该院门诊抗肿瘤药物超说明书用药发生率较高(33.55%)且以超适应证为主,绝大多数有循证支持,但备案率不足。建议完善合理用药系统智能审核及预警功能,并通过多学科协作优化临床用药决策,加强医院备案管理,保障患者用药安全。
OBJECTIVE To examine the current status of off-label use of anti-tumor drugs in the outpatient department of a tertiary hospital and provide a reference for promoting standardized and rational drug use.METHODS A total of 2876 outpatient anti-tumor drug prescriptions from January 2022 to December 2024 were sampled using the rational drug use system.Types of off-label drug use were identified based on the drug instructions.Evidencebased evaluations were conducted by consulting databases such as Micromedex,PubMed,and CNKI,and results were compared and analyzed against the hospital′s approved off-label use directory.RESULTS The incidence of off-label drug use was 33.55%(965/2876),predominantly for off-label indications(97.20%).Anti-tumor chemotherapy drugs(65.91%)and endocrine therapy drugs(33.16%)accounted for the largest proportions.Among the 37 instances of off-label drug use,35(99.48%)were supported by evidence-based medicine,of which 17(45.95%)had been registered,involving 821 prescriptions(85.08%).Among the unregistered 20 items(54.05%),2 items(5 prescriptions,0.52%)lacked supporting evidence.CONCLUSION Off-label drug use is prevalent and predominantly involves off-label indications.The vast majority are supported by evidence;however,the registration rate remains insufficient.It is recommended to enhance the intelligent prescription review and early warning systems in the rational drug use system,optimize clinical drug use decisions through multidisciplinary collaboration,strengthen hospital registration management,and ensure patient drug safety.
作者
南婷婷
蔡瑞娜
吴小红
蔡玉梅
黄宇虹
曾国富
黎碧云
NAN Ting-ting;CAI Rui-na;WU Xiao-hong;CAI Yu-mei;HUANG Yu-hong;ZENG Guo-fu;LI Bi-yun(Department of Pharmacy,Xiamen Haicang Hospital,Xiamen 361026,China)
出处
《海峡药学》
2025年第11期72-76,共5页
Strait Pharmaceutical Journal
关键词
抗肿瘤药物
超说明书用药
循证医学
Anti-tumor drugs
Off-label drug use
Evidence based medicine
