某院免疫检查点抑制剂类药物超说明书用药分析  

Off-Label Drug Use of Immune Checkpoint Inhibitors Drugs in a Hospital

作　　者：钱灿[1] 蒋倩 李超[1] 袁婷 宿怀予 QIAN Can;JIANG Qian;LI Chao;YUAN Ting;SU Huaiyu(People's Hospital of Deyang City,Deyang,Sichuan,China 618000;Sichuan Cancer Institute·Department of Pharmacy,Sichuan Cancer Hospital,Chengdu,Sichuan,China 610000)

机构地区：[1]四川省德阳市人民医院,四川德阳618000 [2]四川省肿瘤研究所·四川肿瘤医院药学部,四川成都610000

出　　处：《中国药业》2022年第9期5-10,共6页China Pharmaceuticals

基　　金：北京医卫健康公益基金会医学科学研究基金资助项目[B20021CS];2020年度成都中医药大学“杏林学者”学科人才科研提升计划项目[YYZX2020105]。

摘　　要：目的促进免疫检查点抑制剂(ICIs)类药物的临床合理用药。方法收集四川省德阳市人民医院2019年4月至2021年3月使用ICIs类药物患者的病历信息,分析其ICIs使用概况与超说明书用药情况,参考已有临床试验证据,使用Thomson超说明书用药分析系统对超说明书用药进行分级、分析和评价,并提出管理要点。结果142例患者共使用7种ICIs类药物,均存在超说明书用药现象。患者首次用药时,超说明书用药占85.92%(122/142),其中国产与进口ICIs类药物发生超说明书用药现象分别占89.34%(109/122)和65.00%(13/20),差异显著(χ^(2)=8.42,P<0.05)。ICIs类药物超说明书用药类型中,超癌种占68.85%(84/122),超用法使用占2.46%(3/122),跨期治疗占4.92%(6/122),跨线治疗占23.77%(29/122)。该院Thomson分级证据为B级以上超说明书用药涉及6种药品(15种用法),另外14种超说明书用药尚未达到B级证据。结论该院ICIs类药物的使用尚处于起步阶段,药品品种选择由相对集中向相对分散的趋势变化,存在部分超说明书用药证据强度不足的现状。鼓励该院完善实施ICIs类药物的超说明书用药备案,在实现患者利益最大化的同时降低医疗风险。Objective To promote the clinical rational use of immune checkpoint inhibitors(ICIs)drugs.Methods The medical record information of patients who treated with ICIs drugs in the People′s Hospital of Deyang City from April 2019 to March 2021 was collected to analyze the use and off-label drug use of ICIs.Based on the existing clinical trial evidence,the Thomson off-label drug use analysis system was used to grade,analyze and evaluate off-label drug use,and the key points of management were put forward.Results Seven kinds of ICIs drugs were used for 142 patients,and all of them had the phenomenon of off-label drug use.The incidence of off-label drug use was 85.92%(122/142)when the patients used drugs for the first time.Among them,the incidence of off-label drug use of domestic and imported ICIs drugs was 89.34%(109/122)and 65.00%(13/20),respectively,with a significant difference(χ^(2)=8.42,P<0.05).Among the types of off-label drug use of ICIs drugs,cross carcinoma type accounted for 68.85%(84/122),over usage accounted for 2.46%(3/122),interphase therapy accounted for 4.92%(6/122),and cross-line therapy accounted for 23.77%(29/122).The off-label drug use with above Thomson Category B involved six kinds of drugs(15 kinds of usage),and the other 14 kinds of off-label drug use did not reach the Category B.Conclusion The use of ICIs drugs in this hospital is still in its infancy,and the selection of drug varieties changes from relatively centralized to relatively decentralized.The strength of evidence for some off-label drug use is insufficient.We should encourage the hospital to improve the implementation of off-label drug use recordation of ICIs drugs,so as to maximize the benefits of patients and reduce medical risks.

关 键 词：免疫检查点抑制剂 超说明书用药 抗肿瘤药物 循证医学 合理用药 

分 类 号：R95[医药卫生—药学] R979.5