替雷利珠单抗在非小细胞肺癌患者中安全性的单中心回顾性研究  

Safety of Tislelizumab in Patients with Non-small Cell Lung Cancer:A Single-center Retrospective Study

作　　者：任晓蕾[1] 詹轶秋[1] 刘刚[1] 刘一[1] 黄琳[1] 张晓红[1] REN Xiaolei;ZHAN Yiqiu;LIU Gang;LIU Yi;HUANG Lin;ZHANG Xiaohong(Department of Pharmacy,People's Hospital,Peking University,Beijing 100044,China)

机构地区：[1]北京大学人民医院药学部,北京100044

出　　处：《中国药学杂志》2024年第13期1262-1266,共5页Chinese Pharmaceutical Journal

基　　金：医院药物警戒研究协作组医院药学科研专项资助(DRM2022021)。

摘　　要：目的对替雷利珠单抗在非小细胞肺癌(non-small-cell lung cancer,NSCLC)患者中的风险信号进行识别与评估,为今后免疫治疗相关不良反应(immune-related adverse events,irAEs)的管理,及NSCLC患者更好实现肿瘤的免疫治疗提供依据。方法回顾性分析2021年4月至2023年4月北京大学人民医院住院接受替雷利珠单抗治疗的NSCLC患者的临床资料。观察替雷利珠单抗治疗期间irAEs的发生情况,对irAEs的发生率进行汇总,并将irAEs组和非irAEs组的临床特征进行比较。结果68例NSCLC患者使用替雷利珠单抗,其中22例发生irAEs,发生率为32.35%。共有22名患者发生了32次irAEs,主要表现为肺毒性(17.65%)、皮肤毒性(11.76%)、内分泌毒性(5.88%)、胃肠毒性(4.41%)、心血管毒性(4.41%)和血液毒性(2.94%)。总irAEs发生的中位时间为79 d(1~706 d)。有13例(59.09%)应用糖皮质激素治疗。irAEs组和非irAEs组临床特征比较,有肝功能不全患者irAEs发生率更高,差异有统计学意义(P<0.05),其余差异均无统计学意义(P>0.05)。结论irAEs累及多个系统/器官,临床应重视免疫相关性毒性的管理,及时发现并处理irAEs,更好的实现肿瘤免疫治疗。OBJECTIVE To identify and evaluate the risk signals of tislelizumab in non-small-cell lung cancer(NSCLC)patients,so as to provide basis for future management of irAEs and better tumor immunotherapy in NSCLC patients.METHODS The clinical data of NSCLC patients who received tislelizumab in Peking University People's Hospital from April 2021 to April 2023 were retrospectively analyzed.The occurrence of irAEs during tislelizumab treatment was observed,the incidence of irAEs was summarized,and the clinical features of irAEs and non-irAEs groups were compared.RESULTS Sixty-eight NSCLC patients received tislelizumab,of whom 22(32.35%)developed 32 irAEs.The main manifestations were pulmonary toxicity(17.65%),skin toxicity(11.76%),endocrine toxicity(5.88%),gastrointestinal toxicity(4.41%),cardiovascular toxicity(4.41%),and hematological toxicity(2.94%).The median duration of irAEs was 79 d(1-706 d).Thirteen cases(59.09%)were treated with glucocorticoids.Comparison of the clinical characteristics of irAEs group and non-irAEs group showed that the incidence of irAEs in patients with hepatic insufficiency was higher(P<0.05),the other differences were not statistically significant(P>0.05).CONCLUSION irAEs involve multiple systems/organs,so attention should be paid to the management of immune-related toxicity,timely detection,and treatment of irAEs,to achieve better effects of tumor immunotherapy.

关 键 词：免疫相关不良反应 真实世界研究 替雷利珠单抗 非小细胞肺癌 

分 类 号：R969[医药卫生—药理学]