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与暴发性1型糖尿病发生相关的药物类别:一项使用美国食品药品监督管理局不良事件报告系统数据库的回顾性分析

Drug classes associated with the development of fulminant type 1 diabetes: a retrospective analysis using the FDA adverse event reporting system database.

作者信息

Zhou Yang, Chen Yupeng, Zhang Shan, Wen Zhige, Zhuang Zifan, Liu Xinyao, Ni Qing

机构信息

Department of Endocrinology, Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing, China.

出版信息

Expert Opin Drug Saf. 2025 Apr;24(4):461-467. doi: 10.1080/14740338.2024.2448202. Epub 2025 Jan 21.

Abstract

BACKGROUND

Fulminant type 1 diabetes mellitus (FT1DM) is a severe subtype of type 1 diabetes characterized by rapid onset, metabolic disturbances, and irreversible insulin secretion failure. Recent studies have suggested associations between FT1DM and certain medications, warranting further investigation.

OBJECTIVES

This study aims to identify drugs associated with an increased risk of FT1DM using the FDA Adverse Event Reporting System (FAERS) database, evaluate reporting patterns, and provide actionable insights to reduce FT1DM occurrence and improve medication safety.

METHODS

A retrospective analysis of FAERS data from 2013 to 2023 was conducted. Drug names were standardized using text mining tools, and safety signals were evaluated using reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS).

RESULTS

A total of 706 FT1DM cases were identified, predominantly in older individuals and males. Nineteen drugs were implicated, including immune checkpoint inhibitors (nivolumab, ipilimumab, pembrolizumab, avelumab, durvalumab, atezolizumab), lenvatinib, eribulin, psychiatric drugs (atomoxetine, carbamazepine, lamotrigine), anti-infectives (sulfamethoxazole, trimethoprim, amoxicillin), and metabolic modulators (dapagliflozin, sitagliptin, hydrochlorothiazide, allopurinol).

CONCLUSION

This study highlights drugs potentially triggering FT1DM and emphasizes the need for pharmacovigilance and glucose monitoring in patients treated with these medications.

摘要

背景

暴发性1型糖尿病(FT1DM)是1型糖尿病的一种严重亚型,其特征为起病迅速、代谢紊乱以及不可逆的胰岛素分泌衰竭。近期研究表明FT1DM与某些药物之间存在关联,值得进一步研究。

目的

本研究旨在使用美国食品药品监督管理局不良事件报告系统(FAERS)数据库识别与FT1DM风险增加相关的药物,评估报告模式,并提供可行的见解以减少FT1DM的发生并提高用药安全性。

方法

对2013年至2023年的FAERS数据进行回顾性分析。使用文本挖掘工具对药物名称进行标准化,并使用报告比值比(ROR)、比例报告比(PRR)、贝叶斯置信传播神经网络(BCPNN)和多项目伽马泊松收缩器(MGPS)评估安全信号。

结果

共识别出706例FT1DM病例,主要发生在老年人和男性中。涉及19种药物,包括免疫检查点抑制剂(纳武利尤单抗、伊匹木单抗、帕博利珠单抗、阿维鲁单抗、度伐利尤单抗、阿替利珠单抗)、乐伐替尼、艾瑞布林、精神科药物(托莫西汀、卡马西平、拉莫三嗪)、抗感染药物(磺胺甲恶唑、甲氧苄啶、阿莫西林)以及代谢调节剂(达格列净、西格列汀、氢氯噻嗪、别嘌醇)。

结论

本研究突出了可能引发FT1DM的药物,并强调了对接受这些药物治疗的患者进行药物警戒和血糖监测的必要性。

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