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抗耐甲氧西林金黄色葡萄球菌(MRSA)药物所致嗜酸性粒细胞性肺炎的药物警戒研究:基于美国食品药品监督管理局(FDA)不良事件报告系统的分析

Pharmacovigilance Study on Eosinophilic Pneumonia Induced by Anti-MRSA Agents: Analysis Based on the FDA Adverse Event Reporting System.

作者信息

Okada Naoto, Niimura Takahiro, Saisyo Atsuyuki, Kawaguchi Yoshitaka, Ishizawa Keisuke, Kitahara Takashi

机构信息

Pharmacy Department, Yamaguchi University Hospital, Yamaguchi, Japan.

Clinical Research Center for Developmental Therapeutics, Tokushima University Hospital, Tokushima, Japan.

出版信息

Open Forum Infect Dis. 2023 Aug 2;10(8):ofad414. doi: 10.1093/ofid/ofad414. eCollection 2023 Aug.

Abstract

BACKGROUND

Eosinophilic pneumonia (EP) is a rare adverse event caused by several types of drugs, such as antibiotics; however, its characteristics remain poorly described. This study aimed to analyze the disproportionality between the occurrence of EP and anti-methicillin-resistant (anti-MRSA) agents and to characterize anti-MRSA agent-induced EP events using the Food and Drug Administration Adverse Event Reporting System (FAERS).

METHOD

Disproportionality linking EP and anti-MRSA agents was analyzed through bayesian confidence propagation neural networks of information components and reporting odds ratio methodologies. The FAERS data set for the fourth quarter of 2012 to the fourth quarter of 2022 was used. We also analyzed the characteristics of EP induced by anti-MRSA agents.

RESULTS

A total of 14 805 795 reports were obtained from FAERS. Disproportionality analysis revealed that the EP signal was detected only in cases with the administration of daptomycin (DAP). This disproportionality signal was consistently detected in the sensitivity analysis. When compared with other reports of DAP-related adverse events, the reports of DAP-related EP were characterized by male sex (odds ratio [OR], 1.94; 95% CI, 1.12-3.37), older age (>70 years; OR, 2.70; 95% CI, 1.68-4.33), and longer duration of treatment (>21 days; OR, 5.08; 95% CI, 3.21-8.05).

CONCLUSIONS

This study revealed that among the anti-MRSA agents, disproportionality in the occurrence of EP was observed only with DAP. Our results suggest that sex, age, and treatment duration may affect the occurrence of DAP-induced EP. Clinicians should exercise caution regarding EP during DAP administration.

摘要

背景

嗜酸性粒细胞性肺炎(EP)是由多种药物(如抗生素)引起的罕见不良事件;然而,其特征仍描述不足。本研究旨在分析EP的发生与抗耐甲氧西林金黄色葡萄球菌(抗MRSA)药物之间的不成比例关系,并使用美国食品药品监督管理局不良事件报告系统(FAERS)对抗MRSA药物引起的EP事件进行特征描述。

方法

通过信息成分的贝叶斯置信传播神经网络和报告比值比方法分析EP与抗MRSA药物之间的不成比例关系。使用2012年第四季度至2022年第四季度的FAERS数据集。我们还分析了抗MRSA药物引起的EP的特征。

结果

从FAERS获得了总共14805795份报告。不成比例分析显示,仅在使用达托霉素(DAP)的病例中检测到EP信号。在敏感性分析中始终检测到这种不成比例信号。与其他DAP相关不良事件报告相比,DAP相关EP报告的特征为男性(比值比[OR],1.94;95%可信区间,1.12 - 3.37)、年龄较大(>70岁;OR,2.70;95%可信区间,1.68 - 4.33)和治疗持续时间较长(>21天;OR,5.08;95%可信区间,3.21 - 8.05)。

结论

本研究表明,在抗MRSA药物中,仅DAP出现了EP发生的不成比例情况。我们的结果表明,性别、年龄和治疗持续时间可能影响DAP诱导的EP的发生。临床医生在使用DAP期间应警惕EP。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/17c1/10438871/fc29bfe5485e/ofad414_ga1.jpg

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