与生物药物相关的肺真菌感染风险:FAERS数据库不成比例性分析
Jing Li1, Zhi Wu Han1, Shan Shan Gao1
1Department of Pharmacy, Affiliated Hospital of Qingdao University, Qingdao, China.
Frontiers in immunology
|November 5, 2025
概括
类风湿性关节炎和牛皮性关节炎的生物药物增加了肺部真菌感染 (PFI) 的风险,特别是因弗利西马布和利图西马布. 老年患者和女性面临更高的风险,治疗的发病时间不同.
科学领域:
- 类风湿病学 类风湿病学
- 传染性疾病 传染性疾病
- 药物监督 药物监督 药物监督
背景情况:
- 生物药物已经彻底改变了类风湿性关节炎 (RA) 和牛皮性关节炎 (PsA) 的治疗方法.
- 关于特定生物制剂的肺真菌感染 (PFI) 风险的现实数据有限.
- 了解这些风险对于患者安全至关重要.
研究的目的:
- 调查与用于RA和PSA的不同生物药物相关的PFI的发生率和风险.
- 识别具有较高PFI风险信号的特定生物制品.
- 分析与PFI相关的患者人口统计和临床特征.
主要方法:
- 对FDA不良事件报告系统 (FAERS) 数据库 (2004-2024) 的不成比例分析.
- 包括3695名在生物治疗后患有PFI的患者.
- 对临床特征,并发不良事件和发病时间 (TTO) 的分析.
主要成果:
- 恩弗利西玛布 (ROR=26.02),利图西玛布 (ROR=16.23),托西利祖马布 (ROR=14.45),和巴里西提尼布 (ROR=11.01) 显示了最高的PFI风险信号.
- 女性和老年患者表现出增加的PFI风险和致命结果.
- 发病时间有显著的变化,从30天 (托西利祖马布) 到393天 (埃坦塞普特).
结论:
- 某些生物制剂与PFI的显着不成比例信号有关.
- 同时使用生物药物可能会放大PFI风险.
- 由于FAERS的局限性,需要进行进一步的大规模前性研究来验证这些发现.
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