Article(id=1236357014478188653, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236357010644586638, articleNumber=null, orderNo=null, doi=null, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=null, receivedDateStr=null, revisedDate=null, revisedDateStr=null, acceptedDate=1675008000000, acceptedDateStr=2023-01-30, onlineDate=1772700082653, onlineDateStr=2026-03-05, pubDate=1702569600000, pubDateStr=2023-12-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1772700082653, onlineIssueDateStr=2026-03-05, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1772700082653, creator=13701087609, updateTime=1772700082653, updator=13701087609, issue=Issue{id=1236357010644586638, tenantId=1146029695717560320, journalId=1235980733773295621, year='2023', volume='32', issue='23', pageStart='2329', pageEnd='2440', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1772700081740, creator=13701087609, updateTime=1772700436936, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1236358500507513194, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236357010644586638, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1236358500507513195, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236357010644586638, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=2434, endPage=2440, ext={EN=ArticleExt(id=1236357014717263985, articleId=1236357014478188653, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Data mining of immune checkpoint inhibitors related adverse events of acute kidney injury based on FAERS, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=
Objective: To excavate and analyze signals of immune checkpoint inhibitors (ICIS) related adverse events of acute kidney injury through data mining methods based on the big data of FAERS, and to provide a reference for the safe clinical use of ICIS drugs.
Methods: Case reports were collected from April 2011 to March 2021 with immune checkpoint inhibitors (ICIS) as the first suspected drug and acute kidney injury (AKI) as the preferred term. Reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN) and multi-item gamma Poisson shrinker (MGPS) were used to study the relationship between ICIS and acute kidney injury. The incidence time, mortality and hospitalization rate of acute kidney injury were further studied.
Results: 1 528 cases of acute kidney injury were included. The proportion of people aged over 65 was the highest, reaching 65.38%. Males were about twice as large as females (64.66% vs 31.87%). Patients with chest cancer reported the most acute kidney injury (32.98%), followed by skin cancer (26.11%) and urogenital cancer (18.72%). Acute kidney injury was most reported in nivolumab monotherapy (54.78%). Cimepritimab had the strongest signal in immune checkpoint inhibitor monotherapy, which may be related to the patient population. The median onset time of acute kidney injury was 49 days in immune checkpoint inhibitor monotherapy regimens (interquartile range [IQR] 1~1 720).
Conclusions: The mechanism of action of immune checkpoint inhibitors differs from traditional cytotoxic and targeted drugs. The proper balance between activation and inhibition of immune molecule function is the key to a strong immune response, and sufficient attention should be given to its efficacy and safety.
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目的： 基于美国FDA不良事件报告系统（FDA adverse events reporting system, FAERS），评估和比较不同免疫检查点抑制剂和急性肾损伤之间的联系，以期为该类药物的安全合理使用提供警示参考。
方法： 收集2011年4月—2021年3月以免疫检查点抑制剂（immuno-checkpoint inhibitors, ICIs）作为首要怀疑药物，急性肾损伤（acute kidney injury, AKI）作为首选术语的病例报告。采用报告比值比（reporting odds ratio, ROR）、比例报告比（proportional reporting ratio, PRR）、贝叶斯置信传播神经网络（Bayesian confidence propagation neural network, BCPNN）和多项泊松收缩器（multi-item gamma Poisson shrinker, MGPS）算法研究ICIs与急性肾损伤之间的关系，并进一步研究了急性肾损伤的发病时间、病死率和住院率。
结果： 我们共发现了1 528例急性肾损伤的报告。年龄65岁以上占比最高，达65.38%。男性占比约为女性的2倍（64.66% vs 31.87%）。胸部癌症患者报告的急性肾损伤最多（32.98%），其次是皮肤癌（26.11%）和泌尿生殖系统癌症（18.72%）。急性肾损伤最常见报道为纳武利尤单抗单药治疗（54.78%）。西米普利单抗在免疫检查点抑制剂单药治疗中信号最强，考虑可能与使用人群有关。免疫检查点抑制剂单药治疗方案中，急性肾损伤的中位发病时间为49 d［四分位数范围（IQR）1~1 720］。
结论： 免疫检查点抑制剂的作用机制有别于传统细胞毒药物和靶向药物，在激活和抑制免疫分子功能之间的适当平衡是一个强大免疫反应的关键，其疗效和安全性应得到足够重视。
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崔向丽，女，博士，主要从事临床药学和药事管理研究。联系电话：(010)80838614，E-mail:
cui10@163.com。
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赵晓红，女，硕士，主要从事不良反应数据挖掘研究。联系电话：(010)80838514，E-mail: zhaoxiaohong1987@163.com。
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