某市新型抗肿瘤药物拓展性临床应用情况调查分析  

Investigation and analysis on the extended clinical application of new anti-tumor drugs in a city

作　　者：李庆妍 鹿琦 曲珍 胡丽丽 陈永刚[5] 张红旭[2] LI Qingyan;LU Qi;QU Zhen;HU Lili;CHEN Yonggang;ZHANG Hongxu(Department of Pharmacy,General Hospital of Xuzhou Mining Group,Jiangsu,Xuzhou 221006,China;Department of Pharmacy,Xuzhou Cancer Hospital,Jiangsu,Xuzhou 221005,China;Department of Pharmacy,Xuzhou First People’s Hospital,Jiangsu,Xuzhou 221002,China;Department of Pharmacy,the Affiliated Hospital of Xuzhou Medical University,Jiangsu,Xuzhou 221004,China;Department of Pharmacy,Xuzhou Central Hospital,Jiangsu,Xuzhou 221009,China)

机构地区：[1]徐州矿务集团总医院药剂科,江苏徐州221006 [2]江苏省徐州市肿瘤医院药剂科,江苏徐州221005 [3]江苏省徐州市第一人民医院药剂科,江苏徐州221002 [4]徐州医科大学附属医院药学部,江苏徐州221004 [5]江苏省徐州市中心医院药剂科,江苏徐州221009

出　　处：《中国医药科学》2024年第14期102-107,142,共7页China Medicine And Pharmacy

基　　金：江苏省徐州市卫生健康委药学科研项目(XWYXKY202207)。

摘　　要：目的促进某市医疗机构新型抗肿瘤药物临床合理应用。方法汇总2021年1月至2023年10月某市各大医疗机构新型抗肿瘤药物专项点评结果,统计新型抗肿瘤药物拓展性临床应用情况,并检索循证医学证据,对证据质量进行分级评价和合理性分析。结果共点评某市各大医疗机构临床使用新型抗肿瘤药物医嘱17000例(涉及110个品种),3864例(占22.7%,17个品种)存在拓展性应用情况(主要为超适应证用药),其中1级有效性证据用法181例(4.7%),推荐临床应用;2级有效性证据用法3064例(79.3%),建议临床应用;3级有效性证据用法564例(14.6%),在特定情况下可尝试临床应用;4级有效性证据用法55例(1.4%),不推荐临床应用。结论新型抗肿瘤药物拓展性临床应用情况较为普遍,同时新型抗肿瘤药物拓展性临床应用也有一定的合理性和客观必要性,医疗机构应制定制度及流程,加强新型抗肿瘤药物使用管理,促进临床合理应用。Objective To promote the rational clinical application of new anti-tumor drugs in medical institutions in a city.Methods The special review results of new anti-tumor drugs in all medical institutions in a city from January 2021 to October 2023 were summarized,the expanded clinical application of new anti-tumor drugs was counted,the evidence of evidence-based medicine was retrieved,and the quality of the evidence was graded and analyzed reasonably.Results A total of 17000 cases(involving 110 varieties)of clinical application of new anti-tumor drugs in all medical institutions in a city were reviewed.3864 cases(accounting for 22.7%,17 varieties)were used with expanded application(mainly including off-label drug use).In the 3864 cases,181 cases(4.7%)were based on grade 1 evidence of effectiveness,which were recommended for clinical application.3064 cases(79.3%)were based on grade 2 evidence of effectiveness,which were suggested for clinical application.564 cases(14.6%)were based on grade 3 evidence of effectiveness,which could be attempted for clinical application under certain circumstances.55 cases(1.4%)were based on grade 4 evidence of effectiveness,which were not recommended for clinical application.Conclusion The expanded clinical application of new anti-tumor drugs is common,and it is also reasonable and necessary.Medical institutions should formulate systems and procedures to strengthen the management of the use of new anti-tumor drugs and promote its rational clinical application.

关 键 词：新型抗肿瘤药物 拓展性临床应用 超适应证用药 循证医学证据 管理措施 

分 类 号：R979.1[医药卫生—药品]