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用于预防医护人员因接触受污染体液而感染高传染性疾病的个人防护装备。

Personal protective equipment for preventing highly infectious diseases due to exposure to contaminated body fluids in healthcare staff.

作者信息

Verbeek Jos H, Ijaz Sharea, Mischke Christina, Ruotsalainen Jani H, Mäkelä Erja, Neuvonen Kaisa, Edmond Michael B, Sauni Riitta, Kilinc Balci F Selcen, Mihalache Raluca C

机构信息

Cochrane Work Review Group, Finnish Institute of Occupational Health, PO Box 310, Kuopio, Finland, 70101.

出版信息

Cochrane Database Syst Rev. 2016 Apr 19;4:CD011621. doi: 10.1002/14651858.CD011621.pub2.

Abstract

BACKGROUND

In epidemics of highly infectious diseases, such as Ebola Virus Disease (EVD) or SARS, healthcare workers (HCW) are at much greater risk of infection than the general population, due to their contact with patients' contaminated body fluids. Contact precautions by means of personal protective equipment (PPE) can reduce the risk. It is unclear which type of PPE protects best, what is the best way to remove PPE, and how to make sure HCWs use PPE as instructed.

OBJECTIVES

To evaluate which type or component of full-body PPE and which method of donning or removing (doffing) PPE have the least risk of self-contamination or infection for HCWs, and which training methods most increase compliance with PPE protocols.

SEARCH METHODS

We searched MEDLINE (PubMed up to 8 January 2016), Cochrane Central Register of Trials (CENTRAL up to 20 January 2016), EMBASE (embase.com up to 8 January 2016), CINAHL (EBSCOhost up to 20 January 2016), and OSH-Update up to 8 January 2016. We also screened reference lists of included trials and relevant reviews, and contacted NGOs and manufacturers of PPE.

SELECTION CRITERIA

We included all eligible controlled studies that compared the effect of types or components of PPE in HCWs exposed to highly infectious diseases with serious consequences, such as EVD and SARS, on the risk of infection, contamination, or noncompliance with protocols. This included studies that simulated contamination with fluorescent markers or a non-pathogenic virus.We also included studies that compared the effect of various ways of donning or removing PPE, and the effects of various types of training in PPE use on the same outcomes.

DATA COLLECTION AND ANALYSIS

Two authors independently selected studies, extracted data and assessed risk of bias in included trials. We intended to perform meta-analyses but we did not find sufficiently similar studies to combine their results.

MAIN RESULTS

We included nine studies with 1200 participants evaluating ten interventions. Of these, eight trials simulated the exposure with a fluorescent marker or virus or bacteria containing fluids. Five studies evaluated different types of PPE against each other but two did not report sufficient data. Another two studies compared different types of donning and doffing and three studies evaluated the effect of different types of training.None of the included studies reported a standardised classification of the protective properties against viral penetration of the PPE, and only one reported the brand of PPE used. None of the studies were conducted with HCWs exposed to EVD but in one study participants were exposed to SARS. Different types of PPE versus each otherIn simulation studies, contamination rates varied from 25% to 100% of participants for all types of PPE. In one study, PPE made of more breathable material did not lead to a statistically significantly different number of spots with contamination but did have greater user satisfaction (Mean Difference (MD) -0.46 (95% Confidence Interval (CI) -0.84 to -0.08, range 1 to 5, very low quality evidence). In another study, gowns protected better than aprons. In yet another study, the use of a powered air-purifying respirator protected better than a now outdated form of PPE. There were no studies on goggles versus face shields, on long- versus short-sleeved gloves, or on the use of taping PPE parts together. Different methods of donning and doffing procedures versus each otherTwo cross-over simulation studies (one RCT, one CCT) compared different methods for donning and doffing against each other. Double gloving led to less contamination compared to single gloving (Relative Risk (RR) 0.36; 95% CI 0.16 to 0.78, very low quality evidence) in one simulation study, but not to more noncompliance with guidance (RR 1.08; 95% CI 0.70 to 1.67, very low quality evidence). Following CDC recommendations for doffing led to less contamination in another study (very low quality evidence). There were no studies on the use of disinfectants while doffing. Different types of training versus each otherIn one study, the use of additional computer simulation led to less errors in doffing (MD -1.2, 95% CI -1.6 to -0.7) and in another study additional spoken instruction led to less errors (MD -0.9, 95% CI -1.4 to -0.4). One retrospective cohort study assessed the effect of active training - defined as face-to-face instruction - versus passive training - defined as folders or videos - on noncompliance with PPE use and on noncompliance with doffing guidance. Active training did not considerably reduce noncompliance in PPE use (Odds Ratio (OR) 0.63; 95% CI 0.31 to 1.30) but reduced noncompliance with doffing procedures (OR 0.45; 95% CI 0.21 to 0.98, very low quality evidence). There were no studies on how to retain the results of training in the long term or on resource use.The quality of the evidence was very low for all comparisons because of high risk of bias in studies, indirectness of evidence, and small numbers of participants. This means that it is likely that the true effect can be substantially different from the one reported here.

AUTHORS' CONCLUSIONS: We found very low quality evidence that more breathable types of PPE may not lead to more contamination, but may have greater user satisfaction. We also found very low quality evidence that double gloving and CDC doffing guidance appear to decrease the risk of contamination and that more active training in PPE use may reduce PPE and doffing errors more than passive training. However, the data all come from single studies with high risk of bias and we are uncertain about the estimates of effects.We need simulation studies conducted with several dozens of participants, preferably using a non-pathogenic virus, to find out which type and combination of PPE protects best, and what is the best way to remove PPE. We also need randomised controlled studies of the effects of one type of training versus another to find out which training works best in the long term. HCWs exposed to highly infectious diseases should have their use of PPE registered and should be prospectively followed for their risk of infection.

摘要

背景

在诸如埃博拉病毒病(EVD)或严重急性呼吸综合征(SARS)等高传染性疾病的流行期间,医护人员由于接触患者受污染的体液,比普通人群面临更高的感染风险。通过个人防护装备(PPE)采取接触预防措施可降低风险。目前尚不清楚哪种类型的个人防护装备防护效果最佳、脱下个人防护装备的最佳方法是什么,以及如何确保医护人员按指示使用个人防护装备。

目的

评估全身个人防护装备的哪种类型或组件,以及哪种穿戴或脱下(脱卸)个人防护装备的方法,对医护人员造成自我污染或感染的风险最低,以及哪种培训方法最能提高对个人防护装备使用规范的依从性。

检索方法

我们检索了MEDLINE(截至2016年1月8日的PubMed)、Cochrane对照试验中心注册库(CENTRAL,截至2016年1月20日)、EMBASE(截至2016年1月8日的embase.com)、CINAHL(截至2016年1月20日的EBSCOhost)以及截至2016年1月8日的职业安全与健康更新数据库。我们还筛选了纳入试验和相关综述的参考文献列表,并联系了非政府组织和个人防护装备制造商。

选择标准

我们纳入了所有符合条件的对照研究,这些研究比较了个人防护装备的类型或组件对接触埃博拉病毒病和严重急性呼吸综合征等高传染性疾病且后果严重的医护人员在感染、污染或不遵守规范风险方面的影响。这包括使用荧光标记物或非致病性病毒模拟污染的研究。我们还纳入了比较各种穿戴或脱卸个人防护装备方式的研究,以及各种个人防护装备使用培训类型对相同结果影响的研究。

数据收集与分析

两位作者独立选择研究、提取数据并评估纳入试验的偏倚风险。我们打算进行荟萃分析,但未找到足够相似的研究来合并结果。

主要结果

我们纳入了9项研究,共1200名参与者,评估了10项干预措施。其中,8项试验使用荧光标记物、病毒或含细菌的液体模拟暴露。5项研究相互比较了不同类型的个人防护装备,但有2项未报告足够的数据。另外2项研究比较了不同的穿戴和脱卸方式,3项研究评估了不同类型培训的效果。纳入的研究均未报告个人防护装备对病毒穿透防护性能的标准化分类,仅有1项报告了所使用个人防护装备的品牌。没有研究针对接触埃博拉病毒病的医护人员开展,但有1项研究的参与者接触了严重急性呼吸综合征。不同类型个人防护装备之间的比较在模拟研究中,所有类型个人防护装备的参与者污染率从25%到100%不等。在一项研究中,由透气性更好的材料制成的个人防护装备导致污染斑点数量在统计学上无显著差异,但用户满意度更高(平均差(MD)-0.46(95%置信区间(CI)-0.84至-0.08,范围1至5,极低质量证据)。在另一项研究中防护服比围裙防护效果更好。在又一项研究中,使用动力空气净化呼吸器比一种现已过时的个人防护装备形式防护效果更好。没有关于护目镜与面罩、长袖与短袖手套或个人防护装备部件粘贴使用的研究。不同穿戴和脱卸程序方法之间的比较两项交叉模拟研究(一项随机对照试验,一项半随机对照试验)相互比较了不同的穿戴和脱卸方法。在一项模拟研究中,与单层手套相比,双层手套导致的污染更少(相对风险(RR)0.36;95%CI 0.16至0.78,极低质量证据),但未导致更多不遵守指南的情况(RR 1.08;95%CI 0.70至1.67,极低质量证据)。在另一项研究中,遵循美国疾病控制与预防中心(CDC)的脱卸建议导致污染更少(极低质量证据)。没有关于脱卸时使用消毒剂的研究。不同类型培训之间的比较在一项研究中,使用额外的计算机模拟导致脱卸错误减少(MD -1.2,95%CI -1.6至-0.7),在另一项研究中额外的口头指导导致错误减少(MD -0.9,95%CI -1.4至-0.4)。一项回顾性队列研究评估了主动培训(定义为面对面指导)与被动培训(定义为文件夹或视频)对个人防护装备使用不依从和脱卸指导不依从的影响。主动培训并未显著降低个人防护装备使用的不依从性(优势比(OR)0.63;95%CI 0.31至1.30),但降低了脱卸程序的不依从性(OR 0.45;95%CI 0.21至0.98,极低质量证据)。没有关于如何长期保留培训结果或资源使用的研究。由于研究存在高偏倚风险、证据的间接性以及参与者数量较少,所有比较的证据质量都非常低。这意味着真实效果可能与本文所报告的有很大差异。

作者结论

我们发现极低质量的证据表明,透气性更好的个人防护装备类型可能不会导致更多污染,但可能具有更高的用户满意度。我们还发现极低质量的证据表明,双层手套以及美国疾病控制与预防中心的脱卸指导似乎可降低污染风险,并且与被动培训相比,更积极的个人防护装备使用培训可能更多地减少个人防护装备和脱卸错误。然而,所有数据均来自偏倚风险高的单一研究,我们对效应估计不确定。我们需要开展有几十名参与者的模拟研究,最好使用非致病性病毒,以找出哪种类型和组合的个人防护装备防护效果最佳,以及脱下个人防护装备的最佳方法是什么。我们还需要对一种培训类型与另一种培训类型效果进行随机对照研究,以找出哪种培训从长远来看效果最佳。接触高传染性疾病的医护人员应记录其个人防护装备的使用情况,并应前瞻性地跟踪其感染风险。

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