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引用本文:叶子奇,王直滔,郑小卫,郑小春,黄萍,卢晓阳.靶向淋巴细胞抗体超说明书用药实践指引[J].中国现代应用药学,2024,41(20):55-65.
Ye Ziqi,Wang Zhitao,Zheng Xiaowei,Zheng Xiaochun,Huang Ping,Lu Xiaoyang.Practice guidelines for the off-label use of antibodies targeting lymphocyte[J].Chin J Mod Appl Pharm(中国现代应用药学),2024,41(20):55-65.
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靶向淋巴细胞抗体超说明书用药实践指引
叶子奇,王直滔,郑小卫,郑小春,黄萍,卢晓阳
1.浙江大学医学院附属第一医院;2.浙江省台州医院;3.浙江省人民医院
摘要:
目的 近年来,靶向淋巴细胞抗体不断有新药上市。由于说明书的滞后性,导致普遍存在超说明书用药情况,对该类药物的超说明书用药亟待建立相关管理标准。方法 成立来自多学科专家的编写组,查阅药品说明书及权威临床诊疗指南,并组织专家进行讨论。结果 根据现有的循证医学证据,结合专家多轮讨论的结果,制订了该类药物的用药实践指引。结论 通过制订本用药实践指引,以期为规范靶向淋巴细胞抗体的超说明书用药提供参考。
关键词:  靶向淋巴细胞抗体  专家共识  超说明书用药  合理用药  药物管理
DOI:
分类号:
基金项目:浙江省药学会基金(2022ZYYL01)
Practice guidelines for the off-label use of antibodies targeting lymphocyte
Ye Ziqi1, Wang Zhitao2, Zheng Xiaowei3,4,5, Zheng Xiaochun3,4,5, Huang Ping3,4,5, Lu Xiaoyang1
1.The First Affiliated Hospital, Zhejiang University School of Medicine;2.Taizhou Hospital of Zhejiang Province;3.Zhejiang Provincial People'4.'5.s Hospital
Abstract:
OBJECTIVE In recent years, many new drugs have been developed that target lymphocyte antibodies. Off-label use is common due to the delay in instructions. There is an urgent need to establish appropriate management standards for the off-label use of this type of medicine. METHODS Establish a team of multidisciplinary experts to review drug instructions and authoritative clinical diagnostic and treatment guidelines, and organize expert discussions. RESULTS Based on existing evidence and the results of several rounds of expert discussions, practical guidelines for the off-label use of this type of medicine have been developed. CONCLUSION We aim to provide a reference for the off-label use of targeted lymphocyte antibodies through the development of practice guidelines.
Key words:  antibodies targeting lymphocytes  practice guidelines  off-label use  rational use of drugs  medication management
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