一项针对医护人员比较布口罩与医用口罩的整群随机试验。
A cluster randomised trial of cloth masks compared with medical masks in healthcare workers.
作者信息
MacIntyre C Raina, Seale Holly, Dung Tham Chi, Hien Nguyen Tran, Nga Phan Thi, Chughtai Abrar Ahmad, Rahman Bayzidur, Dwyer Dominic E, Wang Quanyi
机构信息
Faculty of Medicine, School of Public Health and Community Medicine, University of New South Wales, Sydney, Australia.
National Institute of Hygiene and Epidemiology, Hanoi, Vietnam.
出版信息
BMJ Open. 2015 Apr 22;5(4):e006577. doi: 10.1136/bmjopen-2014-006577.
OBJECTIVE
The aim of this study was to compare the efficacy of cloth masks to medical masks in hospital healthcare workers (HCWs). The null hypothesis is that there is no difference between medical masks and cloth masks.
SETTING
14 secondary-level/tertiary-level hospitals in Hanoi, Vietnam.
PARTICIPANTS
1607 hospital HCWs aged ≥18 years working full-time in selected high-risk wards.
INTERVENTION
Hospital wards were randomised to: medical masks, cloth masks or a control group (usual practice, which included mask wearing). Participants used the mask on every shift for 4 consecutive weeks.
MAIN OUTCOME MEASURE
Clinical respiratory illness (CRI), influenza-like illness (ILI) and laboratory-confirmed respiratory virus infection.
RESULTS
The rates of all infection outcomes were highest in the cloth mask arm, with the rate of ILI statistically significantly higher in the cloth mask arm (relative risk (RR)=13.00, 95% CI 1.69 to 100.07) compared with the medical mask arm. Cloth masks also had significantly higher rates of ILI compared with the control arm. An analysis by mask use showed ILI (RR=6.64, 95% CI 1.45 to 28.65) and laboratory-confirmed virus (RR=1.72, 95% CI 1.01 to 2.94) were significantly higher in the cloth masks group compared with the medical masks group. Penetration of cloth masks by particles was almost 97% and medical masks 44%.
CONCLUSIONS
This study is the first RCT of cloth masks, and the results caution against the use of cloth masks. This is an important finding to inform occupational health and safety. Moisture retention, reuse of cloth masks and poor filtration may result in increased risk of infection. Further research is needed to inform the widespread use of cloth masks globally. However, as a precautionary measure, cloth masks should not be recommended for HCWs, particularly in high-risk situations, and guidelines need to be updated.
TRIAL REGISTRATION NUMBER
Australian New Zealand Clinical Trials Registry: ACTRN12610000887077.
目的
本研究旨在比较布口罩与医用口罩对医院医护人员的防护效果。无效假设为医用口罩和布口罩之间没有差异。
设置
越南河内的14家二级/三级医院。
参与者
1607名年龄≥18岁、在选定的高风险病房全职工作的医院医护人员。
干预措施
医院病房被随机分为：医用口罩组、布口罩组或对照组（常规做法，包括佩戴口罩）。参与者连续4周在每个班次使用相应口罩。
主要观察指标
临床呼吸道疾病（CRI）、流感样疾病（ILI）和实验室确诊的呼吸道病毒感染。
结果
所有感染结局的发生率在布口罩组最高，布口罩组的ILI发生率与医用口罩组相比在统计学上显著更高（相对风险（RR）=13.00，95%置信区间1.69至100.07）。与对照组相比，布口罩的ILI发生率也显著更高。按口罩使用情况分析显示，与医用口罩组相比，布口罩组的ILI（RR=6.64，95%置信区间1.45至28.65）和实验室确诊病毒（RR=1.72，95%置信区间1.01至2.94）显著更高。布口罩的颗粒穿透率近97%，医用口罩为44%。
结论
本研究是首个关于布口罩的随机对照试验，结果警示不要使用布口罩。这是一项为职业健康与安全提供信息的重要发现。布口罩的保湿性、重复使用性及过滤性差可能导致感染风险增加。需要进一步研究以为布口罩在全球的广泛使用提供信息。然而，作为预防措施，不应向医护人员推荐布口罩，尤其是在高风险情况下，且指南需要更新。
试验注册号
澳大利亚新西兰临床试验注册中心：ACTRN12610000887077。
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