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[JAMA在线发表]:机械通气患者的去污染策略与耐药细菌引起的血行性感染
2018年10月26日 时讯速递, 进展交流 暂无评论

Original Investigation

October 22, 2018

Decontamination Strategies and Bloodstream Infections With Antibiotic-Resistant Microorganisms in Ventilated Patients: A Randomized Clinical Trial

Bastiaan H. Wittekamp, Nienke L. Plantinga, Ben S. Cooper, et al

JAMA. Published online October 22, 2018.

doi:10.1001/jama.2018.13765

Abstract

Importance 背景

The effects of chlorhexidine (CHX) mouthwash, selective oropharyngeal decontamination (SOD), and selective digestive tract decontamination (SDD) on patient outcomes in ICUs with moderate to high levels of antibiotic resistance are unknown.

氯已定(CHX)漱口、选择性口咽部去污染(SOD)及选择性胃肠道去污染(SDD)对中高程度抗生素耐药ICU中患者预后的影响尚不明确。

Objective 目的

To determine associations between CHX 2%, SOD, and SDD and the occurrence of ICU-acquired bloodstream infections with multidrug-resistant gram-negative bacteria (MDRGNB) and 28-day mortality in ICUs with moderate to high levels of antibiotic resistance.

在中高程度抗生素耐药的ICU中,明确2%CHX,SOD和SDD与多重耐药(MDRGNB)革兰阴性杆菌引起的ICU获得性血行性感染及28天病死率的关系。

Design, Setting, and Participants 设计,场景及研究人群

Randomized trial conducted from December 1, 2013, to May 31, 2017, in 13 European ICUs where at least 5% of bloodstream infections are caused by extended-spectrum β-lactamase–producing Enterobacteriaceae. Patients with anticipated mechanical ventilation of more than 24 hours were eligible. The final date of follow-up was September 20, 2017.

2013年12月1日至2017年12月31日间,在欧洲13个ICU中(至少5%的血行性感染由产ESBL肠杆菌科细菌引起)进行的随机临床试验。预期机械通气时间超过24小时的患者入选。最后随访日期为2017年9月20日。

Interventions 干预措施

Standard care was daily CHX 2% body washings and a hand hygiene improvement program. Following a baseline period from 6 to 14 months, each ICU was assigned in random order to 3 separate 6-month intervention periods with either CHX 2% mouthwash, SOD (mouthpaste with colistin, tobramycin, and nystatin), or SDD (the same mouthpaste and gastrointestinal suspension with the same antibiotics), all applied 4 times daily.

标准治疗包括每日使用2%CHX擦拭身体以及手卫生改进计划。在为期6-14个月的基线阶段后,每个ICU根据随机顺序实施3个为期6个月的干预阶段,期间患者接受CHX 2%漱口,SOD(含有粘菌素、妥布霉素及制霉菌素的口腔软膏),或SDD(含有相同抗生素的口腔及胃肠道制剂),所有措施均为每日4次。

Main Outcomes and Measures 主要预后指标

The occurrence of ICU-acquired bloodstream infection with MDRGNB (primary outcome) and 28-day mortality (secondary outcome) during each intervention period compared with the baseline period.

与基线阶段相比,每个干预阶段MDRGNB引起的ICU获得性血行性感染发生率(主要预后指标)及28天病死率(次要预后指标)。

Results 结果

A total of 8665 patients (median age, 64.1 years; 5561 men [64.2%]) were included in the study (2251, 2108, 2224, and 2082 in the baseline, CHX, SOD, and SDD periods, respectively). ICU-acquired bloodstream infection with MDRGNB occurred among 144 patients (154 episodes) in 2.1%, 1.8%, 1.5%, and 1.2% of included patients during the baseline, CHX, SOD, and SDD periods, respectively. Absolute risk reductions were 0.3% (95% CI, −0.6% to 1.1%), 0.6% (95% CI, −0.2% to 1.4%), and 0.8% (95% CI, 0.1% to 1.6%) for CHX, SOD, and SDD, respectively, compared with baseline. Adjusted hazard ratios were 1.13 (95% CI, 0.68-1.88), 0.89 (95% CI, 0.55-1.45), and 0.70 (95% CI, 0.43-1.14) during the CHX, SOD, and SDD periods, respectively, vs baseline. Crude mortality risks on day 28 were 31.9%, 32.9%, 32.4%, and 34.1% during the baseline, CHX, SOD, and SDD periods, respectively. Adjusted odds ratios for 28-day mortality were 1.07 (95% CI, 0.86-1.32), 1.05 (95% CI, 0.85-1.29), and 1.03 (95% CI, 0.80-1.32) for CHX, SOD, and SDD, respectively, vs baseline.

共有 8665 名患者(中位年龄,64.1 岁;5561 名男性 [64.2%])纳入此项研究(基线、CHX、SOD和SDD阶段分别为2251,2108,2224 和 2082名患者)。共有144名患者(154次)发生MDRGNB引起的ICU获得性血行性感染, 基线、CHX、SOD和SDD阶段发生率分别为2.1%,1.8%,1.5% 和 1.2%。与基线阶段相比,CHX、SOD和SDD阶段绝对危险度下降分别为 0.3% (95% CI, −0.6% to 1.1%), 0.6% (95% CI, −0.2% to 1.4%), 和 0.8% (95% CI, 0.1% to 1.6%)。与基线阶段相比,CHX、SOD和SDD阶段校正后风险比分别为 1.13 (95% CI, 0.68-1.88),0.89 (95% CI, 0.55-1.45)和0.70 (95% CI, 0.43-1.14)。基线、CHX、SOD和SDD阶段28天病死率分别为31.9%, 32.9%, 32.4%, 和 34.1%。与基线阶段相比,CHX、SOD和SDD阶段28天死亡的校正后比数比分别为 1.07 (95% CI, 0.86-1.32), 1.05 (95% CI, 0.85-1.29), 和1.03 (95% CI, 0.80-1.32) 。

Conclusions and Relevance 结论与意义

Among patients receiving mechanical ventilation in ICUs with moderate to high antibiotic resistance prevalence, use of CHX mouthwash, SOD, or SDD was not associated with reductions in ICU-acquired bloodstream infections caused by MDRGNB compared with standard care.

对于在中高水平抗生素耐药的ICU中接受机械通气的患者,与标准治疗相比,CHX漱口、SOD或SDD并不降低MDRGNB引起的ICU获得性血行性感染发生率。

Trial Registration 试验注册

ClinicalTrials.gov NCT02208154

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