免疫检查点抑制剂增加肾移植排斥风险：一项真实世界药物警戒研究。
Immune checkpoint inhibitors increase the risk of kidney transplant rejection: a real-world pharmacovigilance study.
作者信息
Wu Junyan, Huang Jianxiang, Zhu Jianhong, He Zhichao, Chen Mengting, Gao Siyuan, Liang Dan, Yu Xiaoxia, Lu Chengyu
机构信息
School of Pharmacy, Guangdong Medical University, Zhanjiang, Guangdong, China.
Department of Pharmacy, Sun-Yat-Sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China.
出版信息
Expert Opin Drug Saf. 2023 Mar;22(3):231-235. doi: 10.1080/14740338.2022.2110234. Epub 2022 Aug 9.
BACKGROUND
Kidney transplant recipients with cancer are at higher risk of kidney transplant rejection (KTR), and the safety of immune checkpoint inhibitors (ICIs) is unclear. The present study investigates the relationship between ICIs and KTR using data from the Food and Drug Administration Adverse Event Reporting System (FAERS).
RESEARCH DESIGN AND METHODS
Case reports of KTR inducted by ICIs in FAERS from 1 January 2011, to 30 June 2021, were collected, and a disproportionate analysis was performed to assess the correlation between ICIs and KTR.
RESULTS
A total of 99 cases of ICI-related KTR were reported in the FAERS database. Most of them were male patients (n = 63, 84.0%), and more than half of patients suffered from malignant melanoma (n = 46, 52.9%). The median onset time after the medication was 22 days, the withdrawal rates of ICIs were 78.0%, and the overall death rate was 29.3%. In general, there was a significant relevance between ICIs and KTR (ROR = 3.92[3.21-4.79] IC025 = 1.56), of which PD-1 was the most prominent (n = 81 ROR = 5.26[4.22-6.57] IC025 = 1.86).
CONCLUSIONS
ICIs may increase the risk of KTR in organ transplant recipients with cancer.
背景
患有癌症的肾移植受者发生肾移植排斥反应（KTR）的风险更高，免疫检查点抑制剂（ICI）的安全性尚不清楚。本研究使用美国食品药品监督管理局不良事件报告系统（FAERS）的数据，调查ICI与KTR之间的关系。
研究设计与方法
收集2011年1月1日至2021年6月30日FAERS中由ICI引发的KTR病例报告，并进行不成比例分析以评估ICI与KTR之间的相关性。
结果
FAERS数据库中共报告了99例与ICI相关的KTR。其中大多数为男性患者（n = 63，84.0%），超过一半的患者患有恶性黑色素瘤（n = 46，52.9%）。用药后的中位发病时间为22天，ICI的停药率为78.0%，总死亡率为29.3%。总体而言，ICI与KTR之间存在显著相关性（风险比（ROR）= 3.92[3.21 - 4.79]，IC025 = 1.56），其中程序性死亡受体1（PD - 1）最为突出（n = 81，ROR = 5.26[4.22 - 6.57]，IC025 = 1.86）。
结论
ICI可能会增加患有癌症的器官移植受者发生KTR的风险。
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