靶向淋巴细胞抗体超说明书用药实践指引

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

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

摘要

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 CD19 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.

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