■各种免疫检查点抑制剂,如程序性细胞死亡蛋白-1(PD-1)及其配体(PD-L1),已被批准使用,但是它们对内分泌腺有副作用。
■从FDA不良事件报告系统(FAERS)中提取了2019年第一季度至2023年第一季度与PD-1/PD-L1抑制剂相关的不良事件报告,并采用报道的赔率比方法(ROR方法)和综合标准方法(MHRA方法)进行数据挖掘和分析。
■共收集了5,322份内分泌系统不良事件报告(占总报告的6.68%),包括1852年帕波珠单抗(34.80%),2,326例纳武利单抗(43.71%),54的西米普利单抗(1.01%),800的阿利珠单抗(15.03%),222个duvariumab(4.17%)和68个averumab(1.28%)。内分泌系统相关的AE主要存在于年龄≥65岁的男性(不包括接受派姆单抗治疗的男性)。6种药物的内分泌系统中AE成分的比例约为3-8%。参与AE的主要内分泌腺是甲状腺(pembrolizumab),垂体和肾上腺(nivolumab),肾上腺(cemiplimab,阿替珠单抗,和阿维鲁单抗),和甲状腺(durvalumab)。大多数患者出现不良事件在30到365之间(平均,117)天,中位时间为61d。在给予派姆单抗后,不良事件导致>40%的患者住院时间延长,>10%的患者死亡。Nivolumab,或者Durvalumab.
■年龄≥65岁的男性应关注内分泌相关的不良事件。PD-1/PD-L1抑制剂的使用与内分泌系统相关的不良事件发生有很长的间隔,但结果很严重。使用派姆单抗时应特别注意内分泌系统相关的不良事件,Nivolumab,或者Durvalumab.
UNASSIGNED: Various immune checkpoint inhibitors, such as programmed cell death protein-1 (PD-1) and its ligand (PD-L1), have been approved for use, but they have side effects on the endocrine glands.
UNASSIGNED: Adverse event reports related to PD-1/PD-L1 inhibitors from the FDA Adverse Event Reporting System (FAERS) from the first quarter of 2019 to the first quarter of 2023 were extracted, and the reported Odds ratio methods (ROR method) and comprehensive standard methods (MHRA methods) were used for data mining and analysis.
UNASSIGNED: A total of 5,322 reports (accounts for 6.68% of the total reports)of AEs in endocrine system were collected, including 1852 of pabolizumab (34.80%), 2,326 of navuliumab (43.71%), 54 of cimipriliumab (1.01%), 800 of atilizumab (15.03%), 222 of duvariumab (4.17%) and 68 of averumab (1.28%). Endocrine system-related AEs were mainly present in men (excluding those treated with pembrolizumab) aged ≥65 years. The ratio of AEs components in the endocrine system for the six drugs was approximately 3-8%. The main endocrine glands involved in AEs were the thyroid (pembrolizumab), pituitary and adrenal (nivolumab), adrenal (cemiplimab, atezolizumab, and avelumab), and thyroid (durvalumab). Most patients experienced AEs between 30 and 365 (mean, 117) days,the median time was 61d. AEs resulted in prolonged hospitalization in >40% and death in >10% of cases after administration of pembrolizumab, nivolumab, or durvalumab.
UNASSIGNED: Men aged ≥65 years should be concerned about endocrine-related AEs. There was a lengthy interval between the use of PD-1/PD-L1 inhibitors and endocrine system-related AEs, but the outcome was serious. Special attention should be given to endocrine system-related AEs when using pembrolizumab, nivolumab, or durvalumab.