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

作　　者：严婷 廖德华[2] 符一岚[2] 谌赟[2] 刘妮[2] 罗佳[2] 曾媚姿 唐静怡 杨小平[1] YAN Ting;LIAO De-hua;FU Yi-lan;CHEN Yun;LIU Ni;LUO Jia;ZENG Mei-zi;TANG Jing-yi;YANG Xiao-ping(Key Laboratory of Study and Discovery of Small Targeted Molecules of Hunan,School of Medicine,Hunan Normal University,Changsha 410013;Department of Pharmacy,Hunan Cancer Hospital,Changsha 410013)

机构地区：[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 [2]湖南省肿瘤医院药学部,长沙410013

出　　处：《中南药学》2024年第5期1358-1364,共7页Central South Pharmacy

基　　金：湖南省药学会医院药学研究基金(No.2020YXH001)。

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。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 

分 类 号：R95[医药卫生—药学] R969.3