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[JAMA在线发表]: 治疗金黄色葡萄球菌定植父母对传播给ICU中新生儿的影响
2020年01月21日 时讯速递, 进展交流 暂无评论

Preliminary Communication | December 30, 2019

Effect of Treating Parents Colonized With Staphylococcus aureus on Transmission to Neonates in the Intensive Care Unit: A Randomized Clinical Trial

Aaron M. Milstone, Annie Voskertchian, Danielle W. Koontz, et al

JAMA. Published online December 30, 2019. doi:https://doi.org/10.1001/jama.2019.20785

Abstract

Importance 背景

Staphylococcus aureus is a leading cause of health care–associated infections in the neonatal intensive care unit (NICU). Parents may expose neonates to S aureus colonization, a well-established predisposing factor to invasive S aureus disease.

金黄色葡萄球菌是新生儿ICU (NICU)中医院获得性感染最常见的病原微生物。父母可能使新生儿暴露于金黄色葡萄球菌定植的风险中,这是侵袭性金黄色葡萄球菌感染的易感因素。

Objective 目的

To test whether treating parents with intranasal mupirocin and topical chlorhexidine compared with placebo would reduce transmission of S aureus from parents to neonates.

验证与安慰剂相比,鼻前庭莫匹罗星及局部洗必泰治疗父母,能否减少从金黄色葡萄球菌从父母向新生儿的传播。

Design, Setting, and Participants 试验设计、场景及研究对象 

Double-blinded randomized clinical trial in 2 tertiary NICUs in Baltimore, Maryland. Neonates (n = 236) with S aureus–colonized parent(s) were enrolled. The study period was November 7, 2014, through December 13, 2018.

马里兰州巴尔的摩市的2个三级ICU进行的双盲随机临床试验,入选父母有金黄色葡萄球菌定植的新生儿(n = 236)。研究从2014年11月7日至2018年12月13日进行。

Interventions 干预措施 

Parents were assigned to intranasal mupirocin and 2% chlorhexidine–impregnated cloths (active treatment, n = 117) or petrolatum intranasal ointment and nonmedicated soap cloths (placebo, n = 119) for 5 days.

将父母随机分组,分别使用鼻前庭莫匹罗星及2%洗必泰浸润布(活性治疗组, n = 117) 或凡士林鼻膏及无药物肥皂布 (安慰剂, n = 119)。

Main Outcomes and Measures 主要预后指标

The primary end point was concordant S aureus colonization by 90 days, defined as neonatal acquisition of an S aureus strain that was the same strain as a parental strain at time of screening. Secondary outcomes included neonatal acquisition of any S aureus strain and neonatal S aureus infections.

主要预后终点为90天内金黄色葡萄球菌的一致性定植,定义为新生儿获得的金黄色葡萄球菌菌株与筛查时父母的菌株相同。次要预后终点包括新生儿获得任何金黄色葡萄球菌菌株及新生儿金黄色葡萄球菌感染。

Results 结果

Among 236 randomized neonates, 208 were included in the analytic sample (55% male; 76% singleton births; mean birth weight, 1985 g [SD, 958 g]; 76% vaginal birth; mean parent age, 31 [SD, 7] years), of whom 18 were lost to follow-up. Among 190 neonates included in the analysis, 74 (38.9%) acquired S aureuscolonization by 90 days, of which 42 (56.8%) had a strain concordant with a parental baseline strain. In the intervention and placebo groups, 13 of 89 neonates (14.6%) and 29 of 101 neonates (28.7%), respectively, acquired concordant S aureus colonization (risk difference, –14.1% [95% CI, –30.8% to –3.9%]; hazard ratio [HR], 0.43 [95.2% CI, 0.16 to 0.79]). A total of 28 of 89 neonates (31.4%) in the intervention group and 46 of 101 (45.5%) in the control group acquired any S aureus strain (HR, 0.57 [95% CI, 0.31 to 0.88]), and 1 neonate (1.1%) in the intervention group and 1 neonate (1.0%) in the control group developed an S aureus infection before colonization. Skin reactions in parents were common (4.8% intervention, 6.2% placebo).

在 236 名接受随机分组的新生儿中,208名纳入分析样本 (55% 男性; 76% 单产儿; 平均出生体重, 1985 g [SD, 958 g]; 76% 阴道生产; 父母平均年龄, 31 [SD, 7] 岁), 其中18 名失访。在纳入分析的190 名新生儿中,90天内74 名 (38.9%) 发生金黄色葡萄球菌定植,其中 42 名 (56.8%) 与父母基线菌株相一致。在干预组及安慰剂组,分别有 89 名新生儿中的13 名 (14.6%) 及 101 名新生儿中的29 名 (28.7%) 发生金黄色葡萄球菌一致性定植 (风险差异, –14.1% [95% CI, –30.8% to –3.9%]; 风险比 [HR], 0.43 [95.2% CI, 0.16 to 0.79])。干预组 89 名新生儿中 28 名 (31.4%) 及对照组 101 名新生儿中 46 名 (45.5%) 获得任何金黄色葡萄球菌 (HR, 0.57 [95% CI, 0.31 to 0.88]),干预组和治疗组分别有1名新生儿 (1.1% vs. 1.0%) 在定植钱发生金黄色葡萄球菌感染。父母皮肤反应常见 (干预组4.8%, 安慰剂组 6.2%)。

Conclusions and Relevance 结论与意义

In this preliminary trial of parents colonized with S aureus, treatment with intranasal mupirocin and chlorhexidine-impregnated cloths compared with placebo significantly reduced neonatal colonization with an S aureus strain concordant with a parental baseline strain. However, further research is needed to replicate these findings and to assess their generalizability.

在这项针对金黄色葡萄球菌定植的父母初步试验中,与安慰剂相比,使用鼻前庭莫匹罗星及洗必泰浸润布能够显著减少与父母基线菌株一致的金黄色葡萄球菌菌株在新生儿的定植。然而,需要进一步研究验证这一结果并评估其可推广性。

Trial Registration 试验注册

ClinicalTrials.gov Identifier: NCT02223520

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