中国药业2025，Vol.34Issue(20)：26-31,6.DOI:10.3969/j.issn.1006-4931.2025.20.007
某院新型抗肿瘤药物合理用药现状调研和超药品说明书用药循证评价
Investigation on the Current Status of Rational Drug Use and Evidence-Based Evaluation of Off-Label Use of Novel Anti-Tumor Drugs in A Hospital
摘要
Abstract
Objective To investigate the rational use of novel anti-tumor drugs in a hospital,and to conduct evidence-based evaluation on their off-label use.Methods The prescriptions and medical orders of novel anti-tumor drugs in a hospital from January 2022 to December 2023 were selected,and the rational drug use was evaluated according to the latest specification approved by the National Medical Products Administration;the specification approved by the U.S.Food and Drug Administration(FDA),the Guidelines for Clinical Application of Novel Anti-Tumor Drugs(2024 Edition)issued by the National Health Commission and relevant literature were consulted and taken as evidence-based evidence.The effectiveness level,recommendation level and evidence level of off-label drug use were evaluated according to the Thomson classification in the Micromedex database.Results A total of 3 567 medical orders and prescriptions were selected in this investigation,involving 46 kinds of novel anti-tumor drugs,including 23 kinds of small-molecule targeted drugs(venetoclax,etc.),18 kinds of monoclonal antibody drugs(obinutuzumab,etc.),and 5 kinds of other drugs.Among them,20 kinds of off-label were used,mainly including indications,dosage regimen,dose range,route of administration and synergy concentration,which were inconsistent with the contents of the specification,and the off-label indications were the most common.There were more than 5 kinds of this type included rituximab,thalidomide,camrelizumab and penpulimab.In Thomson classification,the effectiveness level,recommendation level and evidence level were mainly gradeⅡa,gradeⅡb and grade B,and the recommendation level of the guidelines was mainly gradeⅠ.There were 12 indications and 7 indications of grade A and B,respectively,and 10 indications of grade C.66 indications off-label use items were found,including 4 indications of FDA specification instructions,10 indications were included in the Micromedex database,and 11 indications were from domestic and foreign guidelines;29 indications were supported by literature,including expert consensus;20 indications were not supported by evidence-based evidence.The proportion of usage and dosage and the drug combination of recombinant human endostatin off-label use were 98.93%and 100%,respectively.Conclusion The proportion of novel anti-tumor drugs in the hospital that exceed the indications in the off-label use is the highest,followed by the over dosage regimen.The incidence of off-label use of penpulimab and recombinant human endostatin is relatively high.This study can provide reference for the standardized management of anti-tumor drugs,thereby improving the level of rational use of such drugs and ensuring the safety and rational drug use of patients.关键词
新型抗肿瘤药物/合理用药/超药品说明书用药/循证评价/回顾性分析Key words
novel anti-tumor drugs/rational drug use/off-label use/evidence-based evaluation/retrospective analysis分类
医药卫生引用本文复制引用
高靓,景露,王小萌,吴睿,赵振营,史桂玲..某院新型抗肿瘤药物合理用药现状调研和超药品说明书用药循证评价[J].中国药业,2025,34(20):26-31,6.基金项目
天津市人民医院科研项目[2022YJ020]. （）
