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[Lancet Infect Dis在线发表]:携带产ESBL肠杆菌科细菌患者的接触隔离
2019年09月16日 时讯速递, 进展交流 暂无评论

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Contact precautions in single-bed or multiple-bed rooms for patients with extended-spectrum β-lactamase-producing Enterobacteriaceae in Dutch hospitals: a cluster-randomised, crossover, non-inferiority study

Marjolein F Q Kluytmans-van den Bergh, Patricia C J Bruijning-Verhagen, Prof Christina M J E Vandenbroucke-Grauls, et al.

Lancet Infect Dis Published:August 23, 2019 DOI:https://doi.org/10.1016/S1473-3099(19)30262-2

Summary

Background 背景

Use of single-bed rooms for control of extended-spectrum β-lactamase (ESBL)-producing Enterobacteriaceae is under debate; the added value when applying contact precautions has not been shown. We aimed to assess whether an isolation strategy of contact precautions in a multiple-bed room was non-inferior to a strategy of contact precautions in a single-bed room for preventing transmission of ESBL-producing Enterobacteriaceae.

采用单人房间控制产ESBL肠杆菌科细菌存在争议;在此基础上采取接触隔离措施的意义也未被阐明。对于预防产ESBL肠杆菌科细菌,我们评估多人房间内采取隔离策略,是否不劣于单人房间内的隔离措施。

Methods 方法

We did a cluster-randomised, crossover, non-inferiority study on medical and surgical wards of 16 Dutch hospitals. During two consecutive study periods, either contact precautions in a single-bed room or contact precautions in a multiple-bed room were applied as the preferred isolation strategy for patients with ESBL-producing Enterobacteriaceae cultured from a routine clinical sample (index patients). Eligible index patients were aged 18 years or older, had no strict indication for barrier precautions in a single-bed room, had a culture result reported within 7 days of culture and before discharge, and had no wardmate known to be colonised or infected with an ESBL-producing Enterobacteriaceae isolate of the same bacterial species with a similar antibiogram. Hospitals were randomly assigned in a 1:1 ratio by computer to one of two sequences of isolation strategies, stratified by university or non-university hospital. Allocation was masked for laboratory technicians who assessed the outcomes but not for patients, treating doctors, and infection-control practitioners enrolling index patients. The primary outcome was transmission of ESBL-producing Enterobacteriaceae to wardmates, which was defined as rectal carriage of an ESBL-producing Enterobacteriaceae isolate that was clonally related to the index patient's isolate in at least one wardmate. The primary analysis was done in the per-protocol population, which included patients who were adherent to the assigned room type. A 10% non-inferiority margin for the risk difference was used to assess non-inferiority. This study is registered with Nederlands Trialregister, NTR2799.

我们在荷兰16所医院的内科和外科病房进行了一项群组随机,交叉,非劣效研究。在2个连续研究阶段,对于常规临床标本分离到产ESBL肠杆菌科细菌的患者(指示病例),我们采取了单人房间内隔离措施,或多人房间内的隔离措施作为主要隔离策略。指示病例的入选标准包括年龄超过18岁,没有在单人房间进行屏障防护的严格适应症,留取培养7天内且在出院前培养结果回报,病区病友没有产ESBL肠杆菌科细菌(种属相同,抗菌谱相似)定植或感染。我们将医院根据是否为大学附属医院分层,并按照1:1的比例随机分为隔离策略的两种顺序之一。对评估预后(并非患者预后)的实验室技术员、主治医生及纳入指示患者的感染控制人员进行分配隐藏。主要预后指标为产ESBL肠杆菌科细菌传播到同病区病友,定义为同病区至少一名病友直肠携带与指示病例分离株相关克隆的产ESBL肠杆菌科细菌。针对符合方案人群(符合分配房间类型的患者)进行主要分析。采用风险差异10%非劣效界值进行评估。研究在荷兰临床试验网站注册,注册号NTR2799。

Findings 结果

16 hospitals were randomised, eight to each sequence of isolation strategies. All hospitals randomised to the sequence single-bed room then multiple-bed room and five of eight hospitals randomised to the sequence multiple-bed room then single-bed room completed both study periods and were analysed. From April 24, 2011, to Feb 27, 2014, 1652 index patients and 12 875 wardmates were assessed for eligibility. Of those, 693 index patients and 9527 wardmates were enrolled and 463 index patients and 7093 wardmates were included in the per-protocol population. Transmission of ESBL-producing Enterobacteriaceae to at least one wardmate was identified for 11 (4%) of 275 index patients during the single-bed room strategy period and for 14 (7%) of 188 index patients during the multiple-bed room strategy period (crude risk difference 3·4%, 90% CI −0·3 to 7·1).

16所医院接受随机分组,每种隔离策略顺序各有8所医院。随机分至先单人房间然后多人房间的所有医院,以及分至先多人房间然后单人房间的8所医院中的5所完成了所有阶段的研究并纳入分析。从2011年4月24日至2014年2月27日,共对1652名指示病例及12875名病区病友进行入选筛查。其中,693名指示病例及9527名同病区病友入选,463名指示病例及7093名同病区病友纳入符合方案人群。在单人房间阶段,275名指示病例中11名(4%)发生产ESBL肠杆菌科细菌传播给至少一名同病区病友,多人房间阶段,188名指示病例中14名(7%)发生传播(粗风险差异, 3·4%, 90% CI −0·3 to 7·1)。

Interpretation 结论

For patients with ESBL-producing Enterobacteriaceae cultured from a routine clinical sample, an isolation strategy of contact precautions in a multiple-bed room was non-inferior to a strategy of contact precautions in a single-bed room for preventing transmission of ESBL-producing Enterobacteriaceae. Non-inferiority of the multiple-bed room strategy might change the current single-bed room preference for isolation of patients with ESBL-producing Enterobacteriaceae and, thus, broaden infection-control options for ESBL-producing Enterobacteriaceae in daily clinical practice.

对于常规临床标本分离到产ESBL肠杆菌科细菌的患者,采取多人房间内接触隔离措施,在预防产ESBL肠杆菌科细菌传播方面并不劣于单人房间内的接触隔离措施。多人房间策略非劣效结果可能改变目前主张采用单人房间用于隔离产ESBL肠杆菌科细菌患者的做法,从而在临床实践中增加了感染控制的选择。

Funding

Netherlands Organisation for Health Research and Development.

评论[仅代表个人意见]

  • 耐药菌筛查必须与隔离措施相结合,才能得到控制耐药菌传播的明显效果。这一点众所周知。
  • 然而,上述措施能否成功的第一个关键问题在于,应当根据常规临床标本对可疑的耐药菌感染患者进行筛查(即本研究的做法),抑或通过常规监测标本对所有患者进行耐药菌定植或感染的筛查?显然,第二个答案应该是正确的。
  • 上述措施能否成功的第二个关键问题在于,如何看待尚未接受筛查的患者?或者说,当得到培养结果前,应当对患者采取何种感控措施?一种做法是,认为这些患者没有耐药菌定植或感染,可与其他患者同住多人房间(即本研究的做法);另一种做法是,假设这些患者可能存在耐药菌定植或感染,先在单人房间隔离,待筛查培养结果阴性后方可入住多人房间(此后定期进行常规筛查)。显然,第二种做法应该是正确的。

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