4种准入中国医保的PD-1抑制剂药学特性及临床应用评价

Pharmaceutical Characteristics and Clinical Application Evaluation of Four PD-1 Inhibitors Approved for Medical Insurance in China

关键词:  特瑞普利单抗  信迪利单抗  卡瑞利珠单抗  替雷利珠单抗  药学特点  临床应用评价

Key words:  toripalimab  sintilimab  camrelizumab  tislelizumab  pharmaceutical characteristics  clinical application evaluation

摘要:

PD-1抑制剂是一种免疫检查点抑制剂，其通过阻断PD-1/PD-L1信号通路可使T细胞活化上调，激活内源性抗肿瘤免疫反应，从而发挥对肿瘤的治疗作用，已成为肿瘤治疗领域中最大的突破。2020年12月中国公布的新版医保目录中，有4种PD-1抑制剂通过药品谈判准入，并于2021年3月1日正式执行医保报销。鉴于进入医保的4种PD-1抑制剂，上市时间较短，尚缺乏较为系统、全面的药学评价，故本研究对这4种PD-1抑制剂药学特点、药品说明书适应证、医保获批适应证及临床应用等内容进行总结评价，以期为中国临床合理使用PD-1抑制剂提供参考。

Abstract:

PD-1 inhibitor is a kind of immune checkpoint inhibitor. By blocking PD-1/PD-L1 signaling pathway, it can up regulate the activation of T cells and activate the endogenous anti-tumor immune response, so as to play a role in the treatment of tumor. It has become the biggest breakthrough in the field of tumor treatment. In December, 2020, China announced the new medical insurance catalogue, four PD-1 inhibitors were admitted through drug negotiation, and medical insurance reimbursement was officially implemented on March 1, 2021. In consideration of the short marketing time and lack of systematic and comprehensive pharmaceutical evaluation of the four PD-1 inhibitors, this paper summarizes and evaluates the pharmaceutical characteristics, indications of drug instructions, approved indications of medical insurance and clinical application of the four PD-1 inhibitors, so as to provide reference for the rational use of PD-1 inhibitors in China.