召回的正气道压力 (PAP) 装置与阻塞性肺部疾病之间的关联:一项基于省的研究
Tetyana Kendzerska1, Robert Talarico2, Marcus Povitz3
1The Ottawa Hospital Research Institute, Ottawa, Ontario, Canada; ICES, Ontario, Canada; Department of Medicine, Faculty of Medicine, University of Ottawa, Ottawa, Ontario, Canada; School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada.
Chest
|May 18, 2025
概括
飞利浦呼吸器公司召回的正气道压力 (PAP) 设备并没有显著影响阻塞性肺病 (OLD) 的发展或进展. 需要进一步调查早期COPD的增加和晚期住院访问的影响.
科学领域:
- 呼吸系统医学 呼吸系统医学
- 公共卫生 公共卫生
- 医疗器械安全 医疗器械安全
背景情况:
- 关于飞利浦呼吸道正气压 (PAP) 装置召回对健康的影响,现实世界数据有限.
- 了解召回的PAP设备对阻塞性肺病 (OLD) 的影响,对于患者安全和医疗管理至关重要.
研究的目的:
- 调查气道正压 (PAP) 设备制造商与阻塞性肺病 (OLD) 的发展和进展之间的联系.
- 评估被召回的PAP设备对发生喘/COPD和医疗保健利用的实际健康影响.
主要方法:
- 使用安大略省卫生行政数据 (2012-2018) 进行的回顾性纵向研究.
- 包括新的成年PAP使用者,有或没有OLD,追踪到死亡或2023年3月.
- 使用逆概率权重来比较被召回和未被召回的PAP设备之间的结果,计算加权因特定危险比率 (csHR).
主要成果:
- 在248,358人中,被召回的设备与那些没有先前存在的OLD的人没有显著的关联,与发生的喘或COPD有关.
- 在患有OLD的个体中,没有观察到二次结果 (喘/COPD访问) 的显著差异.
- 探索性分析表明,在两年内,COPD风险略有增加,并且在PAP申请召回设备后6-10年内,COPD住院患者访问.
结论:
- 在这项现实研究中,召回的正气道压力 (PAP) 设备与阻塞性肺病 (OLD) 的发展或进展没有独立联系.
- 早期COPD发病率的增加以及与被召回设备相关的住院病人的后期影响需要进一步调查.
- 研究结果强调需要持续监测医疗器械召回对慢性呼吸道疾病的影响.
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