A cluster randomized clinical trial comparing fit-tested and non-fit-tested N95 respirators to medical masks to prevent respiratory virus infection in health care workers.
A cluster randomized clinical trial comparing fit-tested and non-fit-tested N95 respirators to medical masks to prevent respiratory virus infection in health care workers.
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DOI：
10.1111/j.1750-2659.2011.00198.x
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发表时间：
2011-05
影响因子：
4.4
通讯作者：
Ferguson N
中科院分区：
文献类型：
--
作者：
MacIntyre CR;Wang Q;Cauchemez S;Seale H;Dwyer DE;Yang P;Shi W;Gao Z;Pang X;Zhang Y;Wang X;Duan W;Rahman B;Ferguson N
请引用这篇论文：MacIntyre et al.（2011年）一项群集随机临床试验，比较了经过适合性测试和未经适合性测试的N95呼吸机与医用口罩，以预防医护人员的呼吸道病毒感染。流感和其他呼吸道病毒DOI：10.1111/j.1750 - 2659.2010.00198.x。 背景我们比较了医疗保健工作者（HCW）使用医用口罩（N95口罩）（经适合性测试和未经适合性测试）的效果。 方法2008/2009年冬季对北京市15家医院的1441名医护人员进行整群随机临床试验。 参与者在4周的整个轮班期间佩戴口罩或口罩。 结局包括临床呼吸道疾病（CRI）、流感样疾病（ILI）、实验室确认的呼吸道病毒感染和流感。比较了来自9家医院的481名卫生工作者的便利无面罩/呼吸器组。 与医用口罩相比，N95组的CRI（3.9%对6.7%）、ILI（0.3%对0.6%）、实验室确认的呼吸道病毒（1.4%对2.6%）和流感（0.3%对1%）感染率始终较低。通过意向治疗分析，当对P值进行聚类调整时，未经拟合检验的N95呼吸机比医用口罩对CRI的保护作用显著更强，但其他结局均不显著。与干预组相比，方便无面罩组的所有结局发生率均较高。N95组在进行和不进行拟合测试时的结局无显著差异。拟合测试失败率较低。在针对潜在混杂因素调整的事后分析中，N95口罩和医院水平具有显著性，但医用口罩、疫苗接种、洗手和高风险程序不具有显著性。 医用口罩组的感染率是N95组的两倍。建议使用呼吸机的益处，但需要通过更大规模的试验来证实，因为这项研究可能动力不足。适合性测试的结果是特定于研究中使用的呼吸器类型，不能推广到其他呼吸器。 试验注册澳大利亚新西兰临床试验注册中心（ANZCTR），ACTRN：ACTRN 12609000257268（http：www.anzctr.org.au）。
Please cite this paper as: MacIntyre et al. (2011) A cluster randomized clinical trial comparing fit‐tested and non‐fit‐tested N95 respirators to medical masks to prevent respiratory virus infection in health care workers. Influenza and Other Respiratory Viruses DOI: 10.1111/j.1750‐2659.2010.00198.x. Background We compared the efficacy of medical masks, N95 respirators (fit tested and non fit tested), in health care workers (HCWs). Methods A cluster randomized clinical trial (RCT) of 1441 HCWs in 15 Beijing hospitals was performed during the 2008/2009 winter. Participants wore masks or respirators during the entire work shift for 4 weeks. Outcomes included clinical respiratory illness (CRI), influenza‐like illness (ILI), laboratory‐confirmed respiratory virus infection and influenza. A convenience no‐mask/respirator group of 481 health workers from nine hospitals was compared. Findings The rates of CRI (3·9% versus 6·7%), ILI (0·3% versus 0·6%), laboratory‐confirmed respiratory virus (1·4% versus 2·6%) and influenza (0·3% versus 1%) infection were consistently lower for the N95 group compared to medical masks. By intention‐to‐treat analysis, when P values were adjusted for clustering, non‐fit‐tested N95 respirators were significantly more protective than medical masks against CRI, but no other outcomes were significant. The rates of all outcomes were higher in the convenience no‐mask group compared to the intervention arms. There was no significant difference in outcomes between the N95 arms with and without fit testing. Rates of fit test failure were low. In a post hoc analysis adjusted for potential confounders, N95 masks and hospital level were significant, but medical masks, vaccination, handwashing and high‐risk procedures were not. Interpretation Rates of infection in the medical mask group were double that in the N95 group. A benefit of respirators is suggested but would need to be confirmed by a larger trial, as this study may have been underpowered. The finding on fit testing is specific to the type of respirator used in the study and cannot be generalized to other respirators. Trial registration Australian New Zealand Clinical Trials Registry (ANZCTR), ACTRN: ACTRN12609000257268 (http://www.anzctr.org.au).