利妥昔单抗超说明书用药专家共识

    Expert Consensus on the Off-Label Use of Rituximab

    • 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。

       

      Abstract: Rituximab(RTX) is a monoclonal antibody specific for CD20 antigens on B cells and has been approved by the National Medical Products Administration 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.

       

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