与trimethoprim/sulfamethoxazole相关的肺毒性:药监数据的审查
F Givry1, F Lebargy2, D Lebrun1
1Department of Infectious Diseases, University Hospital of Reims, Reims, France.
The Journal of antimicrobial chemotherapy
|February 24, 2025
概括
甲/硫甲可以引起罕见但严重的肺毒性 (LT). 这项研究发现了多个LT模式的药监信号,其中一些是致命的,强调了医生意识和患者教育的必要性.
科学领域:
- 药物监督和药物安全研究.
- 肺部医学和重症监护.
- 抗生素相关的不良事件.
背景情况:
- 已知trimethoprim/sulfamethoxazole具有皮肤,肝脏和血液毒性等副作用.
- 据报道,trimethoprim/sulfamethoxazole造成的严重肺毒性 (LT) 是罕见的,但很少发生.
研究的目的:
- 为了调查与三甲prim/硫甲zole相关的肺毒性 (LT) 的药监数据.
- 通过不成比例性分析检测三甲/硫甲醇诱导的LT的潜在安全信号.
主要方法:
- 来自法国国家药监数据库 (FPVD) 和世卫组织全球数据库 (VigiBase®) 的自发报告的分析.
- 数据收集时间为2023年12月31日.
- 不成比例分析,以识别LT模式的报告信号.
主要成果:
- 在VigiBase®中总共发现了755个与三甲胺/硫甲醇相关的LT病例,其中17个来自FPVD.
- 间歇性肺病是最常见的LT模式 (30.5%),而26.1%的病例是致命的.
- 对于各种LT模式,包括急性肺损伤 (OR 7.5) 和eosinophilic肺炎 (OR 4.1) 发现了显著的药监信号.
结论:
- 对于几个与三甲prim/sulfamethoxazole相关的LT模式的统计学上显著的不成比例表明了药监信号.
- 虽然很少见,三甲烯/硫甲醇诱导的LT可能是危急的和危及生命的.
- 医生必须意识到并告知患者关于早期干预和改善结果的潜在LT风险.
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