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利用FAERS数据库进行药物性自身免疫性脑炎的不成比例性分析。

Pharmacologically induced autoimmune encephalitis-disproportionality analysis utilizing FAERS database.

作者信息

Hu Kaikai, Jin Liuyin, Zhou Yixia, Xie Guoming

机构信息

Department of Neurology, The Affiliated Lihuili Hospital of Ningbo University, Ningbo University, Ningbo, China.

Science and Education Department, Lishui Second People's Hospital, Lishui, China.

出版信息

Expert Opin Drug Saf. 2024 Dec 27:1-9. doi: 10.1080/14740338.2024.2446425.

DOI:10.1080/14740338.2024.2446425
PMID:39714109
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.

摘要

背景

自身免疫性脑炎(AE)是一种神经免疫性疾病,在诊断上面临重大挑战。美国食品药品监督管理局不良事件报告系统(FAERS)数据库有助于探索药物与AE之间的关系,但缺乏全面的研究。本研究旨在利用FAERS数据库分析药物与AE之间的关联,为临床实践和药物警戒提供见解。

研究设计与方法

对FAERS数据库中的不良事件报告进行分析,重点关注药物性AE的发生率以及性别和年龄等特征。采用多种统计方法评估药物与不良反应之间的关联。

结果

研究表明,药物性AE主要发生在41岁及以上人群中,女性患者的患病率更高。纳武单抗和帕博利珠单抗是报告药物不良反应最频繁的药物之一。然而,只有少数药物标签提及了这些不良反应。

结论

本研究强调了药物性AE的潜在风险,提倡在临床实践中进行密切监测。有必要进行进一步的流行病学调查,以阐明药物与这些疾病的确切关系。虽然FAERS数据库为这类研究提供了关键线索,但仍需要更多的研究和验证。

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