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一名发生免疫相关不良事件的患者在使用类固醇后出现肠壁积气:病例报告、文献综述及美国食品药品监督管理局不良事件报告系统分析

Pneumatosis intestinalis post steroid use in a patient with immune-related adverse events: Case report, literature review and FAERS analysis.

作者信息

Zhang Tingting, Cao Mingnan, Zhao Bin, Pan Chen, Lin Li, Tang Chuanhao, Zhao Zhigang, Duan Jingli, Wang Li, Liang Jun

机构信息

Department of Clinical Oncology, Peking University International Hospital, Beijing, China.

Department of Pharmacy, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.

出版信息

Front Pharmacol. 2023 Mar 14;14:1133551. doi: 10.3389/fphar.2023.1133551. eCollection 2023.

DOI:10.3389/fphar.2023.1133551
PMID:36998618
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10043198/
Abstract

The accurate diagnosis of pneumatosis intestinalis (PI) is increasing despite patients' limited identification of etiologic factors. Recently a patient with lung squamous carcinoma who developed pneumatosis intestinalis following methylprednisolone administration for immune-related adverse events was treated at our hospital. Subsequent a literature review and an analysis of the FDA Adverse Event Reporting System (FAERS) database enabled the identification of additional cases of pneumatosis intestinalis. A literature review of the MEDLINE/PubMed and Web of Science Core Collection databases using standard pneumatosis intestinalis search terms to identify published cases of immune checkpoint inhibitors (ICIs) or steroids causing pneumatosis intestinalis were performed. A separate retrospective pharmacovigilance study of FAERS enabled the extraction of unpublished cases of pneumatosis intestinalis between the first quarter of 2005 and the third quarter of 2022. Disproportionality and Bayesian analyses were performed to identify signal detection in reported odds ratios, proportional reporting ratios, information components, and empirical Bayesian geometric means. Ten case reports of steroid-related pneumatosis intestinalis were retrieved from six published studies. The implicated drug therapies included pre-treatment with steroids before chemotherapy, combination therapy with cytotoxic agents and steroids, and monotherapy with steroids. In the FAERS pharmacovigilance study, 1,272 cases of immune checkpoint inhibitors or steroid-related pneumatosis intestinalis were incidentally reported. The signal detected in five kinds of immune checkpoint inhibitors and six kinds of steroids implied a positive correlation between the drugs and adverse events. Steroids might be the etiologic factors in the current case of pneumatosis intestinalis. Reports supporting the role of steroids in suspected cases of pneumatosis intestinalis can be found in literature databases and the FAERS database. Even so, as documented in FAERS, immune checkpoint inhibitors-induced pneumatosis intestinalis should not be excluded.

摘要

尽管患者对病因的识别有限,但肠气囊肿(PI)的准确诊断仍在增加。最近,我院收治了一名患有肺鳞状癌的患者,该患者在接受甲基强的松龙治疗免疫相关不良事件后出现了肠气囊肿。随后,通过文献综述和对美国食品药品监督管理局不良事件报告系统(FAERS)数据库的分析,发现了更多肠气囊肿病例。使用标准的肠气囊肿搜索词对MEDLINE/PubMed和科学网核心合集数据库进行文献综述,以识别已发表的免疫检查点抑制剂(ICI)或类固醇导致肠气囊肿的病例。对FAERS进行了一项单独的回顾性药物警戒研究,以提取2005年第一季度至2022年第三季度未发表的肠气囊肿病例。进行了不成比例分析和贝叶斯分析,以确定报告比值比、比例报告比值、信息成分和经验贝叶斯几何均值中的信号检测。从六项已发表的研究中检索到十例与类固醇相关的肠气囊肿病例报告。涉及的药物治疗包括化疗前使用类固醇预处理、细胞毒性药物与类固醇联合治疗以及类固醇单一治疗。在FAERS药物警戒研究中,偶然报告了1272例免疫检查点抑制剂或类固醇相关的肠气囊肿病例。在五种免疫检查点抑制剂和六种类固醇中检测到的信号表明药物与不良事件之间存在正相关。类固醇可能是当前肠气囊肿病例的病因。在文献数据库和FAERS数据库中可以找到支持类固醇在疑似肠气囊肿病例中作用的报告。即便如此,正如FAERS中所记录的,也不应排除免疫检查点抑制剂引起的肠气囊肿。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/22ba/10043198/c3baab383a3a/fphar-14-1133551-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/22ba/10043198/c3baab383a3a/fphar-14-1133551-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/22ba/10043198/c3baab383a3a/fphar-14-1133551-g001.jpg

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