385例PD-1抗肿瘤治疗的安全性研究及风险因素分析
Safety assessment and risk factor analysis of PD-1 immunotherapy in a cohort of 385 patients
杨波 1王梦娇 2胡丽丽 2王来成 3李倩 3孔飞飞 3吕冬梅 3沈佳妮4
作者信息
- 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;徐州医科大学药学院,江苏 徐州 221000
- 3. 徐州医科大学附属医院药学部,江苏徐州 221006
- 4. 徐州医科大学药学院,江苏 徐州 221000
- 折叠
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.
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.
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Key words
PD-1/adverse drug reactions/immune-related adverse effects/incidence rate/safety assessment/risk factors/malignant tumor引用本文复制引用
基金项目
江苏省药学会恒瑞医院药学基金专项科研项目(H202041)
徐州市科技局医药卫生面上项目(KC22263)
江苏省卫生健康委药品临床综合评价项目(2023)(WJ20221507)
出版年
2024
NETL
NSTL
万方数据