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洗必泰凝胶与水溶液在预防脐部残端的应用:一项随机非劣效性试验。

Chlorhexidine gel versus aqueous for preventive use on umbilical stump: a randomized noninferiority trial.

机构信息

Maternal Child Health Integrated Program/John Snow Inc., Washington, DC, USA.

出版信息

Pediatr Infect Dis J. 2010 Nov;29(11):999-1003. doi: 10.1097/INF.0b013e3181e70c59.

DOI:10.1097/INF.0b013e3181e70c59
PMID:20555293
Abstract

BACKGROUND

Recent trials of chlorhexidine cord cleansing have employed aqueous solution applied with cotton swabs. Care-takers may prefer gel, resulting in better compliance when implemented at large scale. We examined whether a guar-gum-thickened formulation was at least as efficacious as aqueous in reducing periumbilical flora.

METHODS

Newborns (n = 694) from normal deliveries at a hospital in Kathmandu were randomly allocated to cord cleansing with either gel or aqueous chlorhexidine, applied by finger. Immediately before and 24 hours after cleansing, periumbilical swabs were collected and cultured. The primary outcome was periumbilical colonization at 24 hours. Household-level acceptability and ease of use in a rural setting where most deliveries are not attended by health workers were assessed by providing 61 women with either gel or aqueous formulations and following up on their experience using the products.

RESULTS

Babies allocated to gel and aqueous chlorhexidine were comparable on a range of variables measured at baseline. At 24 hours postapplication, 4.6% (15 of 327) of cultures were positive in the gel group and 10.7% (35 of 326) in the aqueous group. The absolute difference in rates (gel minus aqueous) was -6.1% (95% CI: -10.2%, -2.1%). The acceptability study found that satisfaction and compliance were high for both; use of either largely displaced the traditional use of oil-based mixtures. Overall, there was a preference for gel.

CONCLUSIONS

The gel formulation was not inferior to aqueous and gel reduced bacterial colonization to a greater degree. A gel formulation might be considered in future research or program settings where chlorhexidine cleansing of the cord is being evaluated or promoted.

摘要

背景

最近的氯己定脐带清洁试验采用棉签涂抹水溶液。护理人员可能更喜欢凝胶,因此在大规模实施时依从性更好。我们研究了瓜尔胶增稠配方是否至少与水溶液一样有效,以减少脐部菌群。

方法

在加德满都一家医院的正常分娩中,将 694 名新生儿随机分配到用凝胶或水溶液氯己定清洁脐带,用手指涂抹。在清洁前和 24 小时后立即采集脐部拭子进行培养。主要结局是 24 小时时脐部定植。在大多数分娩都没有卫生工作者参与的农村环境中,通过向 61 名妇女提供凝胶或水溶液制剂,并跟踪她们使用产品的经验,评估家庭层面的可接受性和易用性。

结果

在基线测量的一系列变量上,分配到凝胶和水溶液氯己定的婴儿具有可比性。在应用后 24 小时,凝胶组有 4.6%(327 例中的 15 例)的培养物阳性,水溶液组有 10.7%(326 例中的 35 例)。(凝胶-水溶液)的绝对差异为-6.1%(95%CI:-10.2%,-2.1%)。可接受性研究发现,两者的满意度和依从性都很高;使用任何一种产品都在很大程度上取代了传统的油性混合物。总的来说,凝胶更受欢迎。

结论

凝胶配方并不逊于水溶液,并且凝胶降低了细菌定植的程度更大。在正在评估或推广氯己定清洁脐带的未来研究或项目环境中,可以考虑凝胶配方。

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