N95 Respirators vs Medical Masks for Preventing Influenza Among Health Care Personnel A Randomized Clinical Trial
N95 Respirators vs Medical Masks for Preventing Influenza Among Health Care Personnel A Randomized Clinical Trial
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DOI：
10.1001/jama.2019.11645
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发表时间：
2019-09-03
影响因子：
120.7
通讯作者：
Lessler, Justin
中科院分区：
文献类型：
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作者：
Radonovich, Lewis J., Jr.;Simberkoff, Michael S.;Lessler, Justin
重要性N95呼吸机和医用口罩在预防医护人员（HCP）获得工作场所病毒性呼吸道感染的有效性方面的临床研究尚未得出结论。目的比较N95呼吸机和医用口罩在HCP中预防流感和其他病毒性呼吸道感染的效果。一项在2011年9月至2015年5月期间在美国7个医疗中心的137个门诊研究中心进行的群集随机实用有效性研究，最终随访于2016年6月。每年4年，在病毒性呼吸道疾病高峰期的12周期间，每个中心内的（集群）被匹配并随机分配到N95呼吸器或医用口罩组。干预总体而言，1993名参与者随机分配到189个群组，佩戴N95呼吸器（2512 HCP-季节的观察）和2058在191个集群被随机分配到佩戴医用口罩（2668 HCP-季节）时，附近的呼吸道疾病患者。主要结局和措施的主要结局是实验室确诊的流感的发病率。次要结局包括急性呼吸道疾病、实验室检测的呼吸道感染、实验室确认的呼吸道疾病和流感样疾病的发生率。结果在2862名随机参与者中（平均[SD]年龄，43 [11.5]岁; 2369 [82.8%]）女性），2371人完成了研究，占5180 HCP季节。N95呼吸器组有207例实验室确认的流感感染事件（占HCP季节的8.2%），医用口罩组有193例（占HCP季节的7.2%）（差异，1.0%，[95%CI，-0.5%至2.5%]; P= 0.18）（调整后的比值比[OR]，1.18 [95%CI，0.95-1.45]）。呼吸器组有1556例急性呼吸道疾病事件，面罩组有1711例（差异，-21.9/1000 HCP-季节[95% CI，-48.2至4.4]; P= 0.10）;呼吸器组679例实验室检测出呼吸道感染，口罩组745例（差异，-8.9/1000 HCP-季节，[95% CI，-33.3至15.4]; P= 0.47）;呼吸机组371例实验室确认的呼吸道疾病事件，面罩组417例（差异，每1000个HCP季节-8.6起[95%CI，-28.2至10.9]; P= 0.39）;口罩组发生128起流感样疾病事件，口罩组发生166起（差异，每1000个HCP季节-11.3起[95%CI，-23.8至1.3]; P= 0.08）。在呼吸器组中，89.4%的参与者报告“总是”或“有时”戴着他们分配的设备与90.2%在口罩group.CONCLUSIONS和相关性在门诊医护人员，N95呼吸器与医用口罩，在本试验中的参与者佩戴导致实验室确诊的流感的发病率没有显着差异。
IMPORTANCE Clinical studies have been inconclusive about the effectiveness of N95 respirators and medical masks in preventing health care personnel (HCP) from acquiring workplace viral respiratory infections.OBJECTIVE To compare the effect of N95 respirators vs medical masks for prevention of influenza and other viral respiratory infections among HCP.DESIGN, SETTING, AND PARTICIPANTS A cluster randomized pragmatic effectiveness study conducted at 137 outpatient study sites at 7 US medical centers between September 2011 and May 2015, with final follow-up in June 2016. Each year for 4 years, during the 12-week period of peak viral respiratory illness, pairs of outpatient sites (clusters) within each center were matched and randomly assigned to the N95 respirator or medical mask groups.INTERVENTIONS Overall, 1993 participants in 189 clusters were randomly assigned to wear N95 respirators (2512 HCP-seasons of observation) and 2058 in 191 clusters were randomly assigned to wear medical masks (2668 HCP-seasons) when near patients with respiratory illness.MAIN OUTCOMES AND MEASURES The primary outcome was the incidence of laboratory-confirmed influenza. Secondary outcomes included incidence of acute respiratory illness, laboratory-detected respiratory infections, laboratory-confirmed respiratory illness, and influenzalike illness. Adherence to interventions was assessed.RESULTS Among 2862 randomized participants (mean [SD] age, 43 [11.5] years; 2369 [82.8%]) women), 2371 completed the study and accounted for 5180 HCP-seasons. There were 207 laboratory-confirmed influenza infection events (8.2% of HCP-seasons) in the N95 respirator group and 193 (7.2% of HCP-seasons) in the medical mask group (difference, 1.0%, [95% CI,-0.5% to 2.5%]; P=.18) (adjusted odds ratio [OR], 1.18 [95% CI, 0.95-1.45]). There were 1556 acute respiratory illness events in the respirator group vs 1711 in the mask group (difference,-21.9 per 1000 HCP-seasons [95% CI,-48.2 to 4.4]; P=.10); 679 laboratory-detected respiratory infections in the respirator group vs 745 in the mask group (difference,-8.9 per 1000 HCP-seasons, [95% CI,-33.3 to 15.4]; P=.47); 371 laboratory-confirmed respiratory illness events in the respirator group vs 417 in the mask group (difference,-8.6 per 1000 HCP-seasons [95% CI,-28.2 to 10.9]; P=.39); and 128 influenzalike illness events in the respirator group vs 166 in the mask group (difference,-11.3 per 1000 HCP-seasons [95% CI,-23.8 to 1.3]; P=.08). In the respirator group, 89.4% of participants reported "always" or "sometimes" wearing their assigned devices vs 90.2% in the mask group.CONCLUSIONS AND RELEVANCE Among outpatient health care personnel, N95 respirators vs medical masks as worn by participants in this trial resulted in no significant difference in the incidence of laboratory-confirmed influenza.