Pharmacologically induced autoimmune encephalitis-disproportionality analysis utilizing FAERS database.

IF 3 3区 医学 Q2 PHARMACOLOGY & PHARMACY Expert Opinion on Drug Safety Pub Date : 2024-12-27 DOI:10.1080/14740338.2024.2446425
Kaikai Hu, Liuyin Jin, Yixia Zhou, Guoming Xie
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Abstract

Background: Autoimmune encephalitis (AE) is a neuroimmune disorder that presents significant diagnostic challenges. The FDA Adverse Event Reporting System (FAERS) database can help explore the relationship between drugs and AE, but comprehensive studies are lacking. This study aims to analyze the association between drugs and AE using the FAERS database, providing insights for clinical practice and pharmacovigilance.

Research design and methods: Adverse event reports in the FAERS database were analyzed, focusing on the incidence of drug-induced AE, as well as characteristics such as gender and age. Multiple statistical methods were employed to assess the association between drugs and adverse reactions.

Results: The study revealed that drug-induced AE predominantly occurred in individuals aged 41 and above, with a higher prevalence among female patients. Nivolumab and pembrolizumab were among the drugs most frequently reported for adverse drug reactions. However, only a minority of drug labels mentioned these adverse reactions.

Conclusion: This study underscores the potential risk of drug-induced AE, advocating for close monitoring in clinical practice. Further epidemiological investigations are warranted to elucidate the exact relationship between drugs and these disorders. While the FAERS database provides crucial leads for such research, additional studies and validation are necessary.

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药理学诱导的自身免疫性脑炎-利用FAERS数据库进行歧化分析。
背景:自身免疫性脑炎(AE)是一种神经免疫疾病,具有重要的诊断挑战。FDA不良事件报告系统(FAERS)数据库是探索药物与AE之间关系的资源,但该领域的综合研究仍然很少。本研究旨在利用FAERS数据库分析药物与AE之间的潜在关联,为临床实践和药物警戒提供新的见解。本研究旨在利用FAERS数据库对药物所致AE的发生情况进行综合评价,阐明药物与疾病的关系,发现潜在的不良反应。研究设计与方法:分析FAERS数据库中不良事件报告,重点分析药物性自身免疫性脑炎的发生率,以及性别、年龄等特征。采用多种统计方法评估药物与不良反应之间的关系。结果:药物性AE主要发生在41岁及以上人群中,女性患者患病率较高。纳武单抗和派姆单抗是最常报告的药物不良反应的药物。然而,只有少数药物标签提到了这些不良反应。结论:本研究强调了药物性AE的潜在风险,提倡在临床实践中密切监测。进一步的流行病学调查有必要阐明药物与这些疾病之间的确切关系。虽然FAERS数据库为此类研究提供了重要的线索,但还需要进一步的研究和验证。
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来源期刊
CiteScore
5.90
自引率
3.20%
发文量
97
审稿时长
6-12 weeks
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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