利妥昔单抗超说明书用药专家共识

朱潇冉; 张幸国

引用本文:	朱潇冉,张幸国.利妥昔单抗超说明书用药专家共识[J].中国现代应用药学,2024,41(16):105-104.
	Zhu Xiaoran,Zhang Xingguo.Expert consensus on the off-label use of rituximabExpert group of the off-label use of rituximab[J].Chin J Mod Appl Pharm(中国现代应用药学),2024,41(16):105-104.

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利妥昔单抗超说明书用药专家共识
朱潇冉¹, 张幸国²
1.树兰（杭州）医院;2.浙江大学医学院附属第一医院

摘要:

利妥昔单抗(Rituximab, RTX)是特异性作用于B细胞表面的CD20抗原的单克隆抗体,已被国家药品监督管理局(NMPA)批准用于治疗非霍奇金淋巴瘤和慢性淋巴细胞白血病。而在临床实践中,RTX已用于多种自身免疫性相关疾病,如免疫性血小板减少症、干燥综合征、系统性红斑狼疮等,这些均属于超说明书用药。为科学指导RTX的超说明书用药,通过对国内外RTX的药品说明书、指南、专家共识、临床研究的循证医学证据进行分析和评价,制定本专家共识。

关键词: 利妥昔单抗超说明书用药共识

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基金项目:浙江省自然科学：基于miRNA介导的上皮细胞-见充质转化通路研究慢性肾炎发布机制及复方三棱颗粒的干预作用(项目编号: YY22H300974)

Expert consensus on the off-label use of rituximabExpert group of the off-label use of rituximab

Zhu Xiaoran¹, Zhang Xingguo²

1.Shulan (Hangzhou) Hospital;2.The First Affiliated Hospital, Zhejiang University School of Medicine

Abstract:

ABSTRACT Rituximab (RTX) is a monoclonal antibody specific for CD20 antigens on B cells and has been approved by the National Medical Products Administration (NMPA) for the treatment of non-Hodgkin's lymphoma and chronic lymphocytic leukemia. In the clinical, RTX has been used in a variety of autoimmune-associated diseases, such as immune thrombocytopenia, Sjogren's syndrome, systemic lupus erythematosus etc., all of which are beyond off-label drug use. The aim of this article is scientifically management of the off-label use of RTX based on international and domestic RTX medication instructions, guidelines, expert consensus, and trustworthy clinical trials.

Key words: rituximab off-label drug use expert consensus