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用于预防新生儿败血症和死亡的脐带防腐剂。

Umbilical cord antiseptics for preventing sepsis and death among newborns.

作者信息

Imdad Aamer, Bautista Resti Ma M, Senen Kathlynne Anne A, Uy Ma Esterlita V, Mantaring Jacinto Blas, Bhutta Zulfiqar A

机构信息

Department of Pediatrics, SUNY Upstate Medical University, Syracuse, USA.

出版信息

Cochrane Database Syst Rev. 2013 May 31;2013(5):CD008635. doi: 10.1002/14651858.CD008635.pub2.

Abstract

BACKGROUND

The umbilical cord is a structure made of blood vessels and connective tissue that connects the baby and placenta in utero. The umbilical cord is cut after birth, which separates the mother and her baby both physically and symbolically. Omphalitis is defined as infection of the umbilical cord stump. Tracking of bacteria along the umbilical vessels may lead to septicaemia that can result in neonatal morbidity and mortality, especially in developing countries.

OBJECTIVES

To determine the effect of application of antimicrobials on newborn's umbilical cord versus routine care for prevention of morbidity and mortality in hospital and community settings.

SEARCH METHODS

We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (1 October 2012). In addition, we also searched LILACS (1982 to 11 October 2012) and HERDIN NeON (October 2012)

SELECTION CRITERIA

We included randomized, cluster-randomized and quasi-randomized controlled trials of topical cord care compared with no topical care, and comparisons between different forms of care.

DATA COLLECTION AND ANALYSIS

Two review authors independently assessed trials for inclusion, trial quality and subsequently extracted data. Data were checked for accuracy.

MAIN RESULTS

The search identified 77 trials. We included 34 trials in the review involving 69,338 babies, five studies are awaiting classification and there are two ongoing community trials. Included studies were conducted in both developed and developing countries. Among the 34 included trials, three were large, cluster-randomized trials conducted in community settings in developing countries and 31 studies were conducted in hospital settings mostly in developed countries. Data for community and hospital studies were analyzed separately. The three trials conducted in community settings contributed 78% of the total number of children included in this review. Of the trials conducted in hospital settings, the majority had small sample sizes. There were 22 different interventions studied across the included trials and the most commonly studied antiseptics were 70% alcohol, triple dye and chlorhexidine.Only one antiseptic, chlorhexidine was studied in community settings for umbilical cord care. Three community trials reported data on all-cause mortality that comprised 1325 deaths in 54,624 participants and combined results showed a reduction of 23% (average risk ratio (RR) 0.77, 95% confidence interval (CI) 0.63 to 0.94, random-effects, T² = 0.02, I² = 50%) in the chlorhexidine group compared with control. The reduction in omphalitis ranged from 27% to 56% depending on the severity of infection. Cord separation time was increased by 1.7 days in the chlorhexidine group compared with dry cord care (mean difference (MD) 1.75 days, 95% CI 0.44 to 3.05, random-effects, T² = 0.88, I² = 100%). Washing of umbilical cord with soap and water was not advantageous compared with dry cord care in community settings.Among studies conducted in hospital settings, no study reported data for mortality or tetanus. No antiseptic was advantageous to reduce the incidence of omphalitis compared with dry cord care in hospital settings. Topical triple dye application reduced bacterial colonization with Staphylococcus aureus compared with dry cord care (average RR 0.15, 95% CI 0.10 to 0.22, four studies, n = 1319, random-effects, T² = 0.04, I² = 24%) or alcohol application (average RR 0.45, 95% CI 0.25 to 0.80, two studies, n = 487, random-effects, T² = 0.00, I² = 0%). There was no advantage of application of alcohol and triple dye for reduction of colonization with streptococcus. Topical alcohol application was advantageous in reduction of colonization with Enterococcus coli compared with dry cord care (average RR 0.73, 95% CI 0.58 to 0.92, two studies, n = 432, random-effects, T² = 0.00, I² = 0%) and in a separate analysis, triple dye increased the risk of colonization compared with alcohol (RR 3.44, 95% CI 2.10 to 5.64, one study, n = 373). Cord separation time was significantly increased with topical application of alcohol (MD 1.76 days, 95% CI 0.03 to 3.48, nine studies, n = 2921, random-effects, T² = 6.54, I² = 97%) and triple dye (MD 4.10 days, 95% CI 3.07 to 5.13, one study, n = 372) compared with dry cord care in hospital settings. The number of studies was insufficient to make any inference about the efficacy of other antiseptics.

AUTHORS' CONCLUSIONS: There is significant evidence to suggest that topical application of chlorhexidine to umbilical cord reduces neonatal mortality and omphalitis in community and primary care settings in developing countries. It may increase cord separation time however, there is no evidence that it increases risk of subsequent morbidity or infection.There is insufficient evidence to support the application of an antiseptic to umbilical cord in hospital settings compared with dry cord care in developed countries.

摘要

背景

脐带是由血管和结缔组织构成的结构,在子宫内连接胎儿与胎盘。出生后脐带被剪断,这在生理和象征意义上使母亲和婴儿分离。脐炎被定义为脐带残端的感染。细菌沿脐血管蔓延可能导致败血症,进而引发新生儿发病和死亡,在发展中国家尤其如此。

目的

确定使用抗菌药物处理新生儿脐带相较于常规护理,在医院和社区环境中预防发病和死亡的效果。

检索方法

我们检索了Cochrane妊娠与分娩组试验注册库(2012年10月1日)。此外,我们还检索了拉丁美洲和加勒比地区卫生科学数据库(1982年至2012年10月11日)以及HERDIN NeON(2012年10月)。

选择标准

我们纳入了将局部脐带护理与不进行局部护理相比较的随机、整群随机和半随机对照试验,以及不同护理形式之间的比较。

数据收集与分析

两位综述作者独立评估试验是否纳入、试验质量,并随后提取数据。对数据进行准确性检查。

主要结果

检索到77项试验。我们在综述中纳入了34项试验,涉及69338名婴儿,5项研究等待分类,还有2项社区试验正在进行。纳入的研究在发达国家和发展中国家均有开展。在34项纳入试验中,3项是在发展中国家社区环境中进行的大型整群随机试验,31项研究主要在发达国家的医院环境中进行。分别对社区和医院研究的数据进行分析。在社区环境中进行的3项试验占本综述纳入儿童总数的78%。在医院环境中进行的试验,多数样本量较小。纳入试验共研究了22种不同干预措施,最常研究的防腐剂为70%酒精、三联染料和氯己定。在社区环境中,仅对一种防腐剂氯己定进行了脐带护理研究。3项社区试验报告了全因死亡率数据,54624名参与者中有1325例死亡,合并结果显示,与对照组相比,氯己定组死亡率降低了23%(平均风险比(RR)0.77,95%置信区间(CI)0.63至0.94,随机效应模型,T² = 0.02,I² = 50%)。根据感染严重程度,脐炎的降低幅度在27%至56%之间。与脐带干燥护理相比,氯己定组脐带脱落时间延长了1.7天(平均差值(MD)1.75天,95% CI 0.44至3.05,随机效应模型,T² = 0.88,I² = 100%)。在社区环境中,与脐带干燥护理相比,用肥皂和水清洗脐带并无优势。在医院环境中进行的研究,没有一项报告死亡率或破伤风的数据。在医院环境中,与脐带干燥护理相比,没有一种防腐剂在降低脐炎发病率方面具有优势。与脐带干燥护理相比,局部应用三联染料可降低金黄色葡萄球菌的定植率(平均RR 0.15,95% CI 0.10至0.22,4项研究,n = 1319,随机效应模型,T² = 0.04,I² = 24%)或酒精应用(平均RR 0.45,95% CI 0.25至0.80,2项研究,n = 487,随机效应模型,T² = 0.00,I² = 0%)。酒精和三联染料在降低链球菌定植方面没有优势。与脐带干燥护理相比,局部应用酒精在降低大肠杆菌定植方面具有优势(平均RR 0.73,95% CI 0.58至0.92,2项研究,n = 432,随机效应模型,T² = 0.00,I² = 0%),在一项单独分析中,与酒精相比,三联染料增加了定植风险(RR 3.44,95% CI 2.10至5.64,1项研究,n = 373)。在医院环境中,与脐带干燥护理相比,局部应用酒精(MD 1.76天,95% CI 0.03至3.48,9项研究,n = 2921,随机效应模型,T² = 6.54,I² = 97%)和三联染料(MD 4.10天,95% CI 3.07至5.13,1项研究,n = 372)均显著延长了脐带脱落时间。研究数量不足以对其他防腐剂的疗效进行任何推断。

作者结论

有充分证据表明,在发展中国家的社区和初级保健环境中,局部应用氯己定处理脐带可降低新生儿死亡率和脐炎发生率。然而,这可能会延长脐带脱落时间,且没有证据表明会增加后续发病或感染风险。在发达国家的医院环境中,与脐带干燥护理相比,没有足够证据支持对脐带应用防腐剂。

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