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疑似新生儿早发型败血症经验性抗生素治疗的停用:一项系统评价和荟萃分析。

Discontinuation of empirical antibiotics in suspected neonatal early-onset sepsis: a systematic review and meta-analysis.

作者信息

Feng Kun, Zhang Tingwei, Hua Ziyu

机构信息

Department of Neonatology, Children's Hospital of Chongqing Medical University, Chongqing, China.

National Clinical Research Center for Child Health and Disorders; Ministry of Education Key Laboratory of Child Development and Disorders; Chongqing Key Laboratory of Child Rare Diseases in Infection and Immunity, Children's Hospital of Chongqing Medical University, Chongqing, China.

出版信息

Pediatr Res. 2025 Jul 29. doi: 10.1038/s41390-025-04290-9.

Abstract

BACKGROUND

Given the inconsistencies in guideline recommendations on optimal timing of empirical antibiotic discontinuation, this study aimed to systematically review and assess the efficacy and safety of different discontinuation strategies for suspected early-onset sepsis (EOS).

METHODS

We included randomized controlled trials (RCTs) comparing different durations of empirical antibiotics for suspected neonatal EOS. The data sources included PubMed, Embase, Cochrane CENTRAL, Web of Science, CINAHL, CNKI, SinoMed, and clinical trial registration websites. Details of the discontinuation regimens and outcomes were extracted into a predefined form.

RESULTS

This review included 11 unique studies evaluating nine different antibiotic discontinuation regimens. Eight RCTs compared various discontinuation regimens and had heterogeneous clinical characteristics, allowing only descriptive analyses. Three other studies found procalcitonin-guided discontinuation can safely reduce the duration of antibiotics (very low certainty) compared with clinical judgement discontinuation, without increasing the 14-day reinitiation rate (moderate certainty). Notably, there is a paucity of studies comparing guideline-recommended short courses (36-48 h) with longer courses or biomarker-guided discontinuation regimens. Of the 11 RCTs, 10 were assessed as high risk of bias, with only one at low risk.

CONCLUSIONS

There is currently insufficient evidence to determine the optimal strategy for discontinuing empirical antibiotics in suspected neonatal EOS.

IMPACT

This review found insufficient evidence to determine the optimal strategy for discontinuing empirical antibiotics in suspected EOS. This study highlights the need for more robust evidence to support guideline recommendations for discontinuing antibiotics in suspected EOS, particularly in resource-limited settings. Future research should focus on large, well-designed RCTs comparing short-course and biomarker-guided strategies, as well as economic analyses.

摘要

背景

鉴于关于经验性抗生素停用的最佳时机,指南建议存在不一致之处,本研究旨在系统评价和评估针对疑似早发型败血症(EOS)的不同停药策略的疗效和安全性。

方法

我们纳入了比较疑似新生儿EOS经验性抗生素不同使用时长的随机对照试验(RCT)。数据来源包括PubMed、Embase、Cochrane CENTRAL、Web of Science、CINAHL、中国知网、中国生物医学文献数据库以及临床试验注册网站。停药方案和结局的详细信息被提取到一个预定义的表格中。

结果

本综述纳入了11项独特的研究,评估了9种不同的抗生素停药方案。8项RCT比较了各种停药方案,且具有异质性的临床特征,仅允许进行描述性分析。其他三项研究发现,与临床判断停药相比,降钙素原指导下的停药可安全缩短抗生素使用时长(确定性极低),且不会增加14天再次使用抗生素的比例(确定性中等)。值得注意的是,比较指南推荐的短疗程(36 - 48小时)与长疗程或生物标志物指导的停药方案的研究较少。在这11项RCT中,10项被评估为存在高偏倚风险,只有1项为低风险。

结论

目前尚无足够证据确定疑似新生儿EOS经验性抗生素停药的最佳策略。

影响

本综述发现,尚无足够证据确定疑似EOS经验性抗生素停药的最佳策略。本研究强调需要更有力的证据来支持疑似EOS抗生素停药的指南建议,尤其是在资源有限的环境中。未来的研究应聚焦于比较短疗程和生物标志物指导策略的大型、设计良好的RCT以及经济学分析。

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