Mei Zhan, Qinran Long, Jinhan He, Litao Huang, Ran Liu, Bin Wu, Ting Xu
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引用次数: 0
摘要
背景：免疫检查点抑制剂（ICI）诱导的胰腺不良事件（ae）是罕见的，文献记载很少。研究设计和方法：我们对截至2023年6月的ICI患者进行了回顾性研究。患者随访时间延长至死亡或2024年5月。主要终点是重症ici相关胰腺不良事件的发生率。采用Logistic回归分析临床特征与严重ici相关胰腺不良事件之间的关系。结果：该研究包括7840名接受ICI的参与者。研究人群以男性为主（74.50%），中位年龄59.20岁[IQR 51.90 ~ 67.70岁]。其中49例（0.63%）发生严重ici相关性胰腺不良事件。Logistic回归分析显示胰腺癌(OR 5.47；(95% CI, 1.12 - -26.82), p = 0.036),肺癌(或2.62;[95% CI, 1.09-6.34], p = 0.032)，年轻患者(OR 0.97；[95% CI, 0.94-0.99], p = 0.015)和使用PD-L1抑制剂（OR 3.09, [95% CI 1.46 - 6.52], p = 0.003）与严重ici相关胰腺ae的高风险相关。结论：本研究表明，大多数ici相关的胰腺ae是无症状的。原发肿瘤类型、年龄和ICI类型可能是严重ICI相关胰腺ae的预测因素。临床试验注册：https://www.chictr.org.cn标识符：ChiCTR2300075974。
Pancreatic adverse events induced by immune checkpoint inhibitors: a real-world observational study.
Background: Immune checkpoint inhibitor (ICI)-induced pancreatic adverse events (AEs) are rare occurrences that are poorly documented in the literature.
Research design and methods: We conducted a retrospective review of patients who had ICI up to June 2023. Patient follow-up was extended until death or to May 2024. The primary outcome was the incidence of severe ICI-related pancreatic AEs. Logistic regression was used to investigate the associations between clinical characteristics and severe ICI-related pancreatic AEs.
Results: The study included 7,840 participants who received ICI. The study population was predominantly male (74.50%), with a median age of 59.20 years [IQR 51.90-67.70 years]. Among them, 49 patients (0.63%) developed severe ICI-related pancreatic AEs. Logistic regression revealed that pancreatic cancer (OR 5.47; [95% CI, 1.12-26.82], p = 0.036), lung cancer (OR 2.62; [95% CI, 1.09-6.34], p = 0.032), younger patients (OR 0.97; [95% CI, 0.94-0.99], p = 0.015), and using PD-L1 inhibitor (OR 3.09, [95% CI 1.46 to 6.52], p = 0.003) were associated with a higher risk of severe ICI-related pancreatic AEs.
Conclusions: This study demonstrated that most ICI-related pancreatic AEs were asymptomatic. Primary tumor type, age, and ICI type may be predictive factors for severe ICI-related pancreatic AEs.
Clinical trial registration: https://www.chictr.org.cn identifier is ChiCTR2300075974.
期刊介绍：
Expert Opinion on Drug Safety ranks #62 of 216 in the Pharmacology & Pharmacy category in the 2008 ISI Journal Citation Reports.
Expert Opinion on Drug Safety (ISSN 1474-0338 [print], 1744-764X [electronic]) is a MEDLINE-indexed, peer-reviewed, international journal publishing review articles on all aspects of drug safety and original papers on the clinical implications of drug treatment safety issues, providing expert opinion on the scope for future development.
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