中国现代应用药学2024,Vol.41Issue(20) :2868-2878.DOI:10.13748/j.cnki.issn1007-7693.20240758

靶向淋巴细胞抗体超说明书用药实践指引

Practice Guidelines for the Off-label Use of Antibodies Targeting Lymphocyte

浙江省医院协会药事管理专业委员会 浙江省医院药事管理质控中心 浙江省抗癌协会肿瘤临床药学专业委员会 浙江省药学会抗肿瘤药物专业委员会
中国现代应用药学2024,Vol.41Issue(20) :2868-2878.DOI:10.13748/j.cnki.issn1007-7693.20240758

靶向淋巴细胞抗体超说明书用药实践指引

Practice Guidelines for the Off-label Use of Antibodies Targeting Lymphocyte

浙江省医院协会药事管理专业委员会 浙江省医院药事管理质控中心 浙江省抗癌协会肿瘤临床药学专业委员会 浙江省药学会抗肿瘤药物专业委员会
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摘要

目的 为靶向淋巴细胞抗体超说明书用药提供参考,推动该类药物的临床合理应用.方法 组建多学科专家团队,基于循证证据,经过多轮专家讨论,形成靶向淋巴细胞抗体用药实践指引.结果 共纳入有充分循证证据支持的超说明书用药条目148条,其中CD3和CD19双特异性抗体4条,CD20单抗103条,靶向CD30的抗体药物偶联物(antibody-drug conjugate,ADC)23条,CD38单抗17条,以及靶向CD79b的ADC 1条.结论 本指南明确了循证证据充分的靶向淋巴细胞抗体超说明书用药范围,为该类药物的超说明书用药管理提供了较好的参考资料.

Abstract

OBJECTIVE To provide a reference for the off-label use of antibodies targeting lymphocytes and to promote the rational clinical use of this type of drug.METHODS A multidisciplinary team of experts was established and the guidelines were developed through many rounds of expert discussion based on evidence-based medicine.RESULTS A total of 148 items on off-label use supported by sufficient evidence were included,including 4 items on CD3 and CD 19 bispecific antibodies,103 items on CD20 antibodies,23 items on antibody-drug conjugate(ADC)targeting CD30,17 items on CD38 antibodies and 1 item on ADC targeting CD79b.CONCLUSION This guideline clarifies the off-label use of antibodies targeting lymphocytes with sufficient evidence,and provides a practical reference for the off-label use of this type of drug.

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

Key words

antibodies targeting lymphocytes/practice guidelines/off-label use/rational use of drugs/medication management

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出版年

2024
中国现代应用药学
中国药学会

中国现代应用药学

CSTPCD北大核心
影响因子:0.877
ISSN:1007-7693
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