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与嗜酸性粒细胞增多和全身症状的药物反应相关的致命结局:FAERS数据库的不成比例分析及病例系统评价

Fatal outcome related to drug reaction with eosinophilia and systemic symptoms: a disproportionality analysis of FAERS database and a systematic review of cases.

作者信息

Liang Chunsu, An Pengjiao, Zhang Yizhou, Liu Xin, Zhang Bo

机构信息

Department of Pharmacy, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.

State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Beijing, China.

出版信息

Front Immunol. 2024 Dec 16;15:1490334. doi: 10.3389/fimmu.2024.1490334. eCollection 2024.

Abstract

BACKGROUND

Drug rash with eosinophilia and systemic symptoms (DRESS) is a life-threatening severe cutaneous adverse reaction.

OBJECTIVE

This study aims to study fatal DRESS cases using FAERS database and systematic review.

METHODS

Data of the FDA Adverse Event Reporting System (FAERS) database were extracted and manipulated. Articles from Pubmed, Embase and CINAHL databases were screened.

RESULTS

0.13% of the adverse events submitted to FAERS was identified as DRESS and the percentage of fatal cases was up to 6.62%. The top five drugs calculated to induce DRESS with the highest number of reported cases were allopurinol, lamotrigine, vancomycin, amoxicillin and carbamazepine. The top five drugs statistically related to fatal outcome with the highest number of reported cases were allopurinol, vancomycin, trimethoprim, sulfamethoxazole and lamotrigine. Skin manifestations remained the main reason for admission and the average time from dose to rash onset was 27.19 days. The most commonly cited culprit medication type were antibiotics (50.00%), anti-gout agents (15.38%) and anti-epileptic drug (11.54%).

CONCLUSIONS

We discussed fatal cases of DRESS through FAERS system and case reports, hoping to raise awareness when using relevant drugs.

摘要

背景

药物超敏反应伴嗜酸性粒细胞增多和全身症状(DRESS)是一种危及生命的严重皮肤不良反应。

目的

本研究旨在利用美国食品药品监督管理局不良事件报告系统(FAERS)数据库并通过系统评价来研究DRESS致死病例。

方法

提取并处理FAERS数据库中的数据。筛选来自PubMed、Embase和CINAHL数据库的文章。

结果

提交至FAERS的不良事件中,0.13%被确定为DRESS,致死病例的比例高达6.62%。报告病例数最多的导致DRESS的前五种药物为别嘌醇、拉莫三嗪、万古霉素、阿莫西林和卡马西平。报告病例数最多的与致死结局有统计学关联的前五种药物为别嘌醇、万古霉素、甲氧苄啶、磺胺甲恶唑和拉莫三嗪。皮肤表现仍是入院的主要原因,从用药到皮疹出现的平均时间为27.19天。最常被提及的可疑药物类型为抗生素(50.00%)、抗痛风药(15.38%)和抗癫痫药(11.54%)。

结论

我们通过FAERS系统和病例报告讨论了DRESS致死病例,希望在使用相关药物时提高认识。

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