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药物性带状疱疹:对2004年至2024年美国食品药品监督管理局不良事件报告的药物警戒分析

Drug-induced herpes zoster: a pharmacovigilance analysis of FDA adverse event reports from 2004 to 2024.

作者信息

Xia Jiali, Zhang Jing, Zhu Hongyu, Ding Li

机构信息

Department of Dermatology, The Affiliated Xuzhou Municipal Hospital of Xuzhou Medical University, Xuzhou, China.

Department of Critical Care Medicine, The Affiliated Xuzhou Municipal Hospital of Xuzhou Medical University, Xuzhou, China.

出版信息

Front Pharmacol. 2025 Mar 26;16:1565480. doi: 10.3389/fphar.2025.1565480. eCollection 2025.

Abstract

BACKGROUND

Herpes zoster severely impacts patients' quality of life and therapeutic results. This research utilized data from the FDA Adverse Event Reporting System (FAERS) to examine the prevalence and attributes of drug-induced herpes zoster.

METHODS

We analyzed FAERS reports about zoster from Q1 2004 to Q3 2024 and developed a list of possible pathogenic agents. Ranked the 30 medicines with the greatest incidence of reported herpes zoster cases. Statistical disproportionality analysis was employed to identify an elevated reporting frequency of herpes zoster linked to a particular medication.

RESULTS

Herpes zoster was referenced in 50,164 FAERS reports from 2004 to 2024. The majority of the implicated drugs were immunosuppressants. Anifrolumab exhibited the greatest ROR and PRR ratings among the drugs evaluated. Furthermore, rozanolixizumab, tozinameran, elapegademase, and other medications not indicated for inducing herpes zoster were recognized, underscoring the necessity for increased clinical vigilance and awareness. Nonetheless, these correlations should be regarded with caution, as they do not establish a direct causative relationship.

CONCLUSION

This study underscores the need of pharmacovigilance in recognizing and comprehending drug-induced herpes zoster. Additional research is required to validate these findings and to design strategies for risk management and reduction to enhance treatment outcomes in patients.

摘要

背景

带状疱疹严重影响患者的生活质量和治疗效果。本研究利用美国食品药品监督管理局不良事件报告系统(FAERS)的数据,调查药物性带状疱疹的患病率和特征。

方法

我们分析了2004年第一季度至2024年第三季度FAERS中关于带状疱疹的报告,并列出了可能的致病因素清单。对报告带状疱疹病例发生率最高的30种药物进行排名。采用统计不均衡性分析来确定与特定药物相关的带状疱疹报告频率升高情况。

结果

2004年至2024年期间,FAERS报告中有50164份提及带状疱疹。大多数相关药物为免疫抑制剂。在评估的药物中,阿尼鲁单抗的报告比值比(ROR)和比例报告比值(PRR)评分最高。此外,还识别出了罗扎诺利单抗、托珠单抗、伊拉培加酶等未表明可诱发带状疱疹的药物,这凸显了提高临床警惕性和认识的必要性。然而,这些关联应谨慎看待,因为它们并未确立直接的因果关系。

结论

本研究强调了药物警戒在识别和理解药物性带状疱疹方面的必要性。需要进一步研究来验证这些发现,并设计风险管理和降低风险的策略,以改善患者的治疗效果。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/180c/11979123/b5dde9438179/fphar-16-1565480-g001.jpg

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