我院妇科抗肿瘤药物超说明书用药分析及循证评价  

Evidence-based evaluation of off-label use of antineoplastic drugs in the Gynecology Department in a hospital

作　　者：张芸婷 郭静 沈甫明 李冬洁 黄芳[1] ZHANG Yun-ting;GUO Jing;SHEN Fu-ming;LI Dong-jie;HUANG Fang(Department of Pharmacy,Shanghai Tenth People’s Hospital,Tongji University,Shanghai 200072;Department of Obstetrics and Gynecology,Shanghai Tenth People’s Hospital,Tongji University,Shanghai 200072)

机构地区：[1]同济大学附属第十人民医院药学部,上海200072 [2]同济大学附属第十人民医院妇产科,上海200072

出　　处：《中南药学》2024年第11期3086-3090,共5页Central South Pharmacy

基　　金：上海市医院协会临床药事管理专委会2021年抗肿瘤药物临床应用管理项目(No.YS2021002)。

摘　　要：目的调查分析本院妇科抗肿瘤药物超说明书用药情况,并进行循证评价,为临床合理用药提供参考依据。方法提取我院2022年7月—2023年6月妇科住院患者使用抗肿瘤药物的医嘱,整理所有超说明书用药信息并记录,包括适应证、用法用量等。根据我院循证评价标准对相关循证证据进行评价。结果共纳入患者218人次,涉及抗肿瘤药物21种,相关医嘱1417条。超说明书用药169人次(占77.53%),符合超说明书用药的抗肿瘤药物19种,相关医嘱658条(占46.43%),超说明书用药类型以超适应证用药为主(占94.98%)。循证评价分析显示证据强度多为中等强度及以上(占88.15%)。结论妇科抗肿瘤药物超说明书用药情况普遍,均有循证医学证据支持,但个别用法证据等级较低,需加强管理,保障用药安全。Objective To analyze the off-label use of antineoplastic drugs in the Gynecology Department in our hospital and perform evidence-based evaluation to provide a reference for rational drug use.Methods Antineoplastic drugs orders for inpatients from July 2022 to June 2023 were collected,and evaluated according to the evidence-based criteria.Results Totally 218 patients were included and 21 antineoplastic drugs with 1417 medical orders involved.Totally 169(77.53%)patients had off-label drug use concerning 19 antineoplastic drugs in 658(46.43%)medical orders.Off-label indication,accounted for 94.98%.The evidence was mostly moderate or strong in the review,reaching 88.15%.Conclusion Off-label use of antineoplastic drugs in Gynecology Department is common in this hospital.Standardized management is needed to ensure safe and rational drug use.

关 键 词：超说明书用药 抗肿瘤药物 妇科肿瘤 循证评价标准 药事管理 

分 类 号：R95[医药卫生—药学] R969.3