中国药物警戒 ›› 2018, Vol. 15 ›› Issue (9): 555-559.

• 安全与合理用药 • 上一篇    下一篇

CAR-T的临床应用及潜在安全风险分析

许先兴1, 杨静文2*   

  1. 1国家食品药品监督管理总局药品评价中心,北京 100045;
    2解放军总医院第一附属医院,北京 100048
  • 收稿日期:2018-11-02 修回日期:2018-11-02 出版日期:2018-09-20 发布日期:2018-11-02
  • 通讯作者: 杨静文,女,博士,助理研究员,细胞生物学。E-mail: 8537505@sina.com
  • 作者简介:许先兴,男,博士,主管药师,药代动力学与药品不良反应监测。

Clinical Application and Potential Risk of CAR-T

XU Xianxing1, YANG Jingwen2*   

  1. 1Center for Drug Reevaluation, CFDA, Beijing 100045, China;
    2The First Affiliated Hospital of PLA General Hospital, Beijing 100048, China
  • Received:2018-11-02 Revised:2018-11-02 Online:2018-09-20 Published:2018-11-02

摘要: 目的 介绍嵌合抗原受体(chimeric antigen receptor,CAR)T细胞疗法(CAR-T)的发展及临床应用情况,探讨疗效影响因素及潜在风险。方法 检索国内外文献资料和相关数据库,分析影响CAR-T疗效和安全性的相关因素。结果 CAR-T为广大肿瘤患者提供了新的治疗选择,但其疗效受诸多因素影响,潜在安全性风险不容忽视。结论 尽管目前还存在各种问题,但CAR-T的出现已经使肿瘤的免疫治疗进入一个全新阶段,其应用前景值得期待。

关键词: CAR-T, 细胞免疫技术, 脱靶效应, 细胞因子释放综合征

Abstract: Objective To introduce clinical application of chimeric antigen receptor T-cell therapy (CAR-T) and to explore the influencing factors of efficacy and potential risks. Methods Analyze information that affects the efficacy and safety of CAR-T therapy by retrieving literature and related databases at home and aboard. Results CAR-T provides a new treatment for cancer patients, but there are still many problems to be solved in terms of efficacy and safety. Conclusion CAR-T has shown great potential and will bring tumor immunotherapy to a new stage though many challenges ahead.

Key words: CAR-T, cell immunotherapy technology, on-target/off-tumor, cytokine release syndrome

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