首页|31例肝癌患者使用PD-1/PD-L1抑制剂不良反应监测分析

31例肝癌患者使用PD-1/PD-L1抑制剂不良反应监测分析

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目的 针对肝癌患者使用PD-1/PD-L1 抑制剂不良反应监测及安全性等问题,在文献资料循证分析及研究方案优化设计的基础上,联合珠海哨点医院,开展免疫相关不良反应回顾性分析,为防范与及时处置相关严重不良反应及临床安全合理用药提供参考。方法 采用回顾性分析研究方法,收集 2019 年 1 月 1 日~2023 年 12 月 31 日珠海市ADR/ADE自发呈报系统数据库共 31 例肝癌患者使用PD-1/PD-L1 抑制剂病例的ADR/ADE报告,采用描述性方法对报告信息、患者人口学特征、用药情况及临床表现等进行分析。结果 对肝癌患者使用PD-1/PD-L1 抑制剂的主要临床表现为骨髓抑制、瘙痒、皮疹。报告类型中严重报告 21 例(占比 67。74%),一般报告 10 例(占比 32。26%)。不良反应病例中,最常见的不良反应为骨髓抑制,共 6 例,占 19。35%。不良反应可累及机体多个系统,其中以皮肤及附件损害最为常见,发生 14 例(45。16%)。结论 在应用PD-1/PD-L1 抑制剂治疗肝癌患者的过程中,应根据患者的年龄、性别制定相应的药物治疗方案,并做好随访及监测工作,及时防止可能发生的ADR,对提高临床用药安全性及改善此类患者的预后具有重要作用。
Adverse drug reactions of PD-1/PD-L1 inhibitors were monitored in 31 patients with liver cancer
Objective In order to monitor the adverse reactions and safety issues of PD-1/PD-L1 inhibitors in patients with liver cancer,and provide reference for preventing and timely handling of related serious adverse reactions and clinical safe and rational drug use,a retrospective analysis of immune-related adverse reactions was conducted jointly with Zhuhai Sentinel Hospital,based on the evidence-based analysis of literature data and the optimization design of research protocols.Methods The clinical data of 31 patients with liver cancer treated with PD-1/PD-L1 inhibitor from January 1,2019 to December 31,2023 in Zhuhai ADR/ADE spontaneous reporting system database,were analyzed retrospectively.Descriptive methods were used to analyze the reporting information,demographic characteristics,medication status and clinical manifestations of patients.Results The main clinical manifestations of the use of PD-1/PD-L1 inhibitors in patients with hepatocellular carcinoma are myelosuppression,pruritus,and rash.There were 21 cases of severe report(67.74%)and 10 cases of general report(32.26%).Among the cases of adverse reactions,the most common adverse reaction was bone marrow suppression,with a total of 6 cases,accounting for 19.35%.Adverse reactions could involve multiple systems of the body,among which skin and appendage damage was the most common,with 14 cases(45.16%).Conclusion In the process of treating liver cancer patients with PD-1/PD-L1 inhibitors,it is important to develop individualized drug treatment plans based on the patient's age and gender,and to conduct follow-up and monitoring to prevent potential ADRs in a timely manner,which plays a crucial role in improving the clinical safety of drug use and improving the prognosis of these patients.

PD-1/PD-L1 inhibitorsLiver cancer patientsAdverse reactions

张英男、刘又菁、吴愫青

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珠海市食品药品检验所/珠海市食品药品(医疗器械)不良反应监测中心,广东 珠海 519000

珠海市药学会,广东 珠海 519000

PD-1/PD-L1抑制剂 肝癌患者 不良反应

2024

中国处方药
南方医药经济研究所

中国处方药

影响因子:0.649
ISSN:1671-945X
年,卷(期):2024.22(12)