某肿瘤医院免疫检查点抑制剂超说明书用药分析
Off-label usage of immune checkpoint inhibitors in a cancer hospital
严婷 1廖德华 2符一岚 2谌赟 2刘妮 2罗佳 2曾媚姿 2唐静怡 2杨小平3
作者信息
- 1. 湖南师范大学医学院,小分子靶向药物研究与创制湖南省重点实验室,湖南师范大学医学院,长沙 410013;湖南省肿瘤医院药学部,长沙 410013
- 2. 湖南省肿瘤医院药学部,长沙 410013
- 3. 湖南师范大学医学院,小分子靶向药物研究与创制湖南省重点实验室,湖南师范大学医学院,长沙 410013
- 折叠
摘要
目的 探讨某医院免疫检查点抑制剂(ICIs)超说明书用药使用情况及管理要点,为临床合理用药提供借鉴.方法 回顾性调查某肿瘤医院2023年1月至6月ICIs使用概况及超说明书用药情况,参考高级别循证医学证据,对超说明书用药进行分析、评价并对循证依据进行归纳记录.结果 527例患者共使用15个ICIs,共涉及16个肿瘤类型,16.88％(89/527)存在超说明书用药现象.超说明书用药中,肿瘤类型排名前三的为宫颈癌(50.56％)、肝细胞癌(13.48％)、鼻咽癌(10.11％);ICIs排名前三为替雷利珠单抗(26.97％)、卡瑞利珠单抗(16.85％)、赛帕利单抗(15.73％).结论 该院89例超说明书用药均有高级别循证医学证据支持.超说明书用药规范管理有助于促进临床合理使用.循证医学证据日新月异,药师应紧跟研究前沿,提高循证药学水平,为患者用药安全有效提供保障.
Abstract
Objective To explore the off-label use and management points of immune checkpoint inhibitors(ICIs)in a cancer hospital,providing a reference for rational clinical drug use.Methods A retrospective investigation was conducted on the usage profile and off-label medication use of ICIs in a cancer hospital from January to June 2023.Analyse,evaluate and summarise the evidence base for off-label drug use with reference to high-level evidence-based medical evidence.Results Totally 527 patients were treated with 15 ICIs,involving 16 tumor types,and 16.88％(89/527)of them had the off-label drug use.Among them,the top three tumor type were cervical cancer(50.56％),hepatocellular carcinoma(13.48％),and nasopharyngeal carcinoma(10.11％),and the top three ICIs were tislelizumab(26.97％),camrelizumab(16.85％),and zimberelimab(15.73％).Conclusion All cases of off-label usage are supported by high-level evidence-based medical evidence.Standardised management of off-label usage can promote rational clinical use of medication.As drug label and guidelines are updated constantly,pharmacists should keep abreast of the research frontiers and pay attention to the evidence-based medical evidence simultaneously,so as to guarantee for the safe and effective use of medication.
关键词
免疫检查点抑制剂/超说明书用药/肿瘤Key words
immune checkpoint inhibitor/off-label use/cancer引用本文复制引用
基金项目
湖南省药学会医院药学研究基金(2020YXH001)
出版年
2024
NETL
NSTL
万方数据