《JAMA》最新研究，N95 与医用外科口罩差不多
《JAMA》最新研究
国际权威医学期刊《JAMA》前不久刊登了一项随机临床试验，来比较医务人员使用 N95 型口罩和医用外科口罩，在门诊与疑似呼吸系统疾病患者接触中二者的防护作用。
研究人员将二者进行比较，探讨哪款口罩更有效。
《JAMA》
参加者和环境
该试验在各种为急性呼吸道疾病患病率较高的患者，提供服务的门诊环境中进行。包括初级保健设施、口腔诊所、成人和儿科诊所、透析部门、急救设施和急诊科以及紧急运输服务系统。所有参与者都在同一门诊环境中工作。
我们来看一下研究结果。
N95 组和医用外科口罩组实验室确认的流感感染事件的发生率分别为 8.2% 和 7.2%。
总体而言，N95 组发生了 371 项实验室确认的呼吸系统疾病事件，而医用口罩组为 417 例，二者无显著差异！调整后结果相似（具体见以下图表）。
《JAMA》
《JAMA》
除此之外，N95 组的参与者依从率为 89.4%，医用外科口罩组为 90.2%。N95 组在第 3 年和第 4 年，有 19 位参与者出现皮肤刺激或痤疮恶化。
《JAMA》的这项研究可以得出结论：
N95 型口罩和医用外科口罩在预防实验室疾病方面的有效性上没有显著差异。此外，在急性呼吸道疾病、实验室检测到的呼吸道感染、实验室确认的呼吸道疾病和流感样疾病的发生率上也没有显著差异。
N95 Respirators vs Medical Masks for Preventing Influenza Among Health Care Personnel A Randomized Clinical Trial
JAMA. 2019;322(9):824-833. doi:10.1001/jama.2019.11645
Key Points
Question Is the use of N95 respirators or medical masks more effective in preventing influenza infection among outpatient health care personnel in close contact with patients with suspected respiratory illness?
Findings In this pragmatic, cluster randomized clinical trial involving 2862 health care personnel, there was no significant difference in the incidence of laboratory-confirmed influenza among health care personnel with the use of N95 respirators (8.2%) vs medical masks (7.2%).
Meaning As worn by health care personnel in this trial, use of N95 respirators, compared with medical masks, in the outpatient setting resulted in no significant difference in the rates of laboratory-confirmed influenza.
Abstract
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.