中国药物警戒 ›› 2024, Vol. 21 ›› Issue (4): 447-450.
DOI: 10.19803/j.1672-8629.20230304

• 安全与合理用药 • 上一篇    下一篇

385例PD-1抗肿瘤治疗的安全性研究及风险因素分析

杨波1, 王梦娇2,3, 胡丽丽2,3,*, 王来成2, 李倩2, 孔飞飞2, 吕冬梅2, 沈佳妮3   

  1. 1徐州市检验检测中心不良反应监测中心,江苏 徐州221018;
    2徐州医科大学附属医院药学部,江苏 徐州 221006;
    3徐州医科大学药学院,江苏 徐州 221000
  • 收稿日期:2023-05-18 出版日期:2024-04-15 发布日期:2024-04-18
  • 通讯作者: *胡丽丽,女,硕士,副主任药师,临床药学与临床药理学。E-mail: elieven1982@163.com
  • 作者简介:杨波,男,本科,主管药师,药品不良反应监测及药物警戒。
  • 基金资助:
    江苏省药学会恒瑞医院药学基金专项科研资助项目（H202041）; 徐州市科技局医药卫生面上项目（KC22263）; 江苏省卫健委2023年度药品临床综合评价项目(WJ20221507)

Safety assessment and risk factor analysis of PD-1 immunotherapy in a cohort of 385 patients

YANG Bo1, WANG Mengjiao2,3, HU Lili2,3,*, WANG Laicheng2, LI Qian2, KONG Feifei2, LYU Dongmei2, SHEN Jiani3   

  1. 1Adverse reaction Monitoring Center, Xuzhou Inspection and Testing Center, Xuzhou Jiangsu 221018, China;
    2Department of Pharmacy, Affiliated Hospital of Xuzhou Medical University, Xuzhou Jiangsu 221006, China;
    3School of Pharmacy, Xuzhou Medical University, Xuzhou Jiangsu 221000, China
  • Received:2023-05-18 Online:2024-04-15 Published:2024-04-18

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摘要： 目的 探讨国产PD-1免疫相关不良反应（irAE）相关危险因素,以期为临床PD-1安全用药提供预判因素和经验。方法 收集某院2020年6月至2022年12月所有使用PD-1药物肿瘤患者的性别、年龄、体重指数、肿瘤类型、既往病史、PD-1品类等信息,开展随访,鉴别和评估irAE种类和严重程度。通过单因素分析和多因素Logistic回归分析,分析危险因素。结果 共收集385例,irAE 134例（34.81%）,非irAE 251例（65.19%）,≥3级irAE 29例（7.53%）。单因素分析显示,irAE的发生率与年龄,吸烟,原患疾病类型有关（P<0.05）,多因素分析显示,年龄<65岁患者发生irAE的风险增加1.590倍（95%CI：1.006, 2.512）,吸烟患者风险增加1.920倍（95%CI: 1.021, 3.611）,呼吸系统疾病较易发生irAE,风险增加2.061倍（95%CI：1.205, 3.527）,相比信迪利、替雷利珠与特瑞普利,卡瑞利珠发生irAE的风险较高（P<0.05）。结论 年龄<65岁、吸烟、呼吸系统疾病为PD-1安全用药的高危因素,卡瑞利珠发生近期irAE风险偏高,应重视该类人群irAE的监护和处理。

关键词: PD-1药物, 药品不良反应, 免疫相关不良反应, 发生率, 安全性评估, 风险因素, 恶性肿瘤

Abstract: Objective To explore the risk factors of domestic PD-1 related ADR, and provide prognostic indexes and experience for the safety of PD-1 immunotherapy. Methods Collected and recorded domestic PD-1 cases from June 2020 to December 2022 in our hospital: Gender, age, body mass index, tumor type, underlying disease, PD-1variety. etc. Followed up for at least two treatment cycles, identified and evaluated the type and degree of irAE. Then evaluated with univariate and multivariate Logistic regression analysis. Results A total of 385 cases were collected, including 134(34.81%) irAE, 251(65.19%) non-irAE, and 29(7.53%) ≥grade 3 irAE. Univariate analysis showed that the incidence of irAE was related to age, smoking, type of tumor and PD-1(P<0.05). Multivariate analysis showed that age<65 increased 1.590 times(95%CI: 1.006, 2.512), smoking increased 1.920 times(95%CI: 1.021, 3.611), respiratory diseases were 2.061 times (95%CI: 1.205, 3.527) more likely to develop irAE, Carrilizul had a higher risk than sindilid, Tirelizul and triripril (P<0.05). Conclusion Age<65, smoking and respiratory tumor is the higher risk factors of irAE of PD-1, the short-term irAE rate of Carrilizumab is higher, more attention should be paid to monitoring such patients and offering irAE treatment in time.

Key words: PD-1, adverse drug reactions, immune-related adverse effects, incidence rate, safety assessment, risk factors, malignant tumor

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