同种异体移植物排斥反应后免疫检查点抑制剂在实体器官移植受者：从文献复习和药物警戒系统的安全性分析。
Allograft rejection following immune checkpoint inhibitors in solid organ transplant recipients: A safety analysis from a literature review and a pharmacovigilance system.
机构信息
Pharmacy Department of Beijing Friendship Hospital, Capital Medical University, Beijing, China.
Liver Transplantation Center, Beijing Friendship Hospital, Capital Medical University, Beijing, China.
出版信息
Cancer Med. 2023 Mar;12(5):5181-5194. doi: 10.1002/cam4.5394. Epub 2022 Dec 12.
AIM
This study aimed to systematically characterize transplant rejection after immune checkpoint inhibitors (ICIs) initiation in solid organ transplant recipients (SOTRs).
METHODS
Data were extracted from the US FDA Adverse Event Reporting System (FAERS) database and case reports in the literature. Disproportionality analysis including information component and reported odds ratio (ROR) was performed to access potential risk signals.
RESULTS
A total of 168 patients with transplant rejection after ICIs usage were identified in the FAERS database, and 89 cases were identified in the literature review. ICIs were significantly associated with transplant rejection (ROR : 2.2). A strong risk signal was found for combination therapy with pembrolizumab and ipilimumab compared to monotherapy.
CONCLUSION
Immune checkpoint inhibitors were significantly associated with transplant rejection in SOTRs.
目的
本研究旨在系统描述接受免疫检查点抑制剂（ICI）治疗后的实体器官移植受者（SOTR）发生移植排斥反应的情况。
方法
从美国 FDA 不良事件报告系统（FAERS）数据库和文献中的病例报告中提取数据。采用信息成分和报告比值比（ROR）进行比例失调分析，以评估潜在的风险信号。
结果
在 FAERS 数据库中共确定了 168 例接受 ICI 治疗后发生移植排斥反应的患者，在文献综述中确定了 89 例。ICI 与移植排斥反应显著相关（ROR：2.2）。与单药治疗相比，pembrolizumab 和 ipilimumab 联合治疗具有更强的风险信号。
结论
ICI 与 SOTR 发生移植排斥反应显著相关。
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