李娜 封甦婷 朱斌

摘 要 目的：评价PD-1抑制剂临床不良反应监测现状。方法：通过实时审方系统、电子病例系统筛选出使用PD-1抑制剂的患者，记录患者基本情况和治疗情况。结果：共82例患者使用PD-1抑制剂，免疫治疗前仅29例患者进行了全部基线水平监测，12例患者末做任何检查。在治疗期间，有66例患者进行了监测，但监测不到位存在缺项，16例患者未做任何不良反应监测。治疗期间出现的毒性反应多数为G1～2级，表现为皮肤毒性、血液毒性、肝腎毒性和内分泌毒性等。结论：临床使用PD-1抑制剂并未建立起不良反应监测评价体系，存在监测不到位、评价不规范。因此，临床医生和药师应加强对PD-1抑制剂临床不良反应的监测及评价。

关键词 免疫治疗 PD-1抑制剂 免疫相关不良反应 监测

中图分类号：R979.19 文献标志码：C 文章编号：1006-1533（2021）11-0048-04

Evaluation and discussion on the monitoring of clinical adverse reactions caused by PD-1 inhibitors

LI Na*， FENG Suting， ZHU Bin**

（Department of Pharmacy， Cancer Hospital affiliated to Fudan University； Department of Oncology， Shanghai Medical College， Fudan University， Shanghai 200032， China）

ABSTRACT Objective： To evaluate the current status of the monitoring of clinical adverse reactions caused by PD-1 inhibitors. Methods： The patients who used PD-1 inhibitors were screened out by the real-time review system and electronic case system and the basic conditions and treatment of these patients were recorded. Results： There were a total of 82 patients in the use of PD-1 inhibitors， only 29 patients underwent full baseline monitoring and 12 patients did not undergo any examination before immunotherapy. During the treatment period， 66 patients were monitored， but the monitoring was not in place and there existed deficiencies， and 16 patients were not monitored for any adverse reactions. During the treatment， most of the toxic reactions were G1-2 grade， manifested as skin toxicity， blood toxicity， liver and kidney toxicity and endocrine toxicity. Conclusion： The clinical use of PD-1 inhibitors has not yet established an adverse reaction monitoring and evaluation system， and therefore， clinicians and pharmacists should strengthen the monitoring and evaluation of clinical adverse reactions caused by PD-1 inhibitors.

KEy WORDS immunotherapy； PD-1 inhibitors； immune-related adverse effects； monitoring

近几年来，以免疫检查点抑制剂（immune checkpoint inhibitors，ICIs）为主的免疫治疗药物因其独特的作用机制和疗效，成为抗肿瘤治疗药物中的热点，吸引了众多临床医生和药师的关注。免疫检查点抑制剂通过抑制肿瘤细胞的免疫逃逸，增加T细胞的免疫应答来消除肿瘤[1]。2018年中国批准了两个程序性死亡蛋白-1（programmed death protein 1， PD-1）抑制剂上市，分别是纳武利尤单抗（欧狄沃）和帕博利珠单抗（可瑞达）。随着两个药物在临床中的广泛应用，其在增强细胞免疫抗肿瘤效应的同时，也可能增强机体正常的免疫反应，导致免疫耐受失衡，出现免疫相关不良反应（irAEs），使人们担心免疫治疗会不会也存在潜在的、不可预知的风险。……