临床与病理杂志2025，Vol.45Issue(10)：1318-1324,7.DOI:10.11817/j.issn.2095-6959.2025.241088
2019版《新生儿败血症诊断及治疗专家共识》发布前后抗生素使用变化:一项单中心回顾性队列研究
Antibiotic use changes before and after the release of the Expert Consensus on the Diagnosis and Management of Neonatal Sepsis(version 2019):A single-center retrospective cohort study
摘要
Abstract
Objective:Neonatal sepsis is one of the central causes of neonatal morbidity worldwide.In China,neonatal sepsis care continues to face multiple clinical challenges.The Expert Consensus on the Diagnosis and Management of Neonatal Sepsis(version 2019)(hereinafter referred to as"Consensus")updated the principles of diagnosis and treatment and standardized clinical practices.However,evidence describing its post-release impact on real-world clinical behavior,especially antibiotic-use patterns,remains limited.This study aims to evaluate the influence of the Consensus on the management of early-onset sepsis(EOS),objectively assess its clinical implementation effects,identify ongoing issues in antibiotic utilization,and provide clinical evidence for optimizing neonatal sepsis strategies and improving antimicrobial-management systems. Methods:Clinical data were retrospectively collected for children admitted to the neonatal ward of the Department of Pediatrics(Xuhui Campus),Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine,from July 1,2017,to June 30,2021,with a diagnosis of suspected early-onset neonatal sepsis who received antibiotic therapy.Variables included length of stay,hospitalization cost,antibiotic doses,duration and categories,and outcomes including combined neonatal necrotizing enterocolitis(NEC)grade≥II,death within 28 d,readmission for infection within 30 d after discharge.Patients were grouped into pre-Consensus and post-Consensus cohorts based on the release date,and classified into confirmed EOS and suspected EOS according to the Consensus diagnostic criteria.Multivariate Logistic regression was used to analyze risk factors for EOS.Changes in treatment patterns and short-term adverse-prognosis risk were compared between pre-and post-Consensus EOS and suspected-EOS subgroups. Results:A total of 353 patients were included 208 in the pre-Consensus group(confirmed EOS n=27,suspected EOS n=181)and 145 in the post-Consensus group(confirmed EOS n=66,suspected EOS n=79).In the post-Consensus suspected-EOS subgroup,both length of stay[6(5 to 7)d vs 7(6 to 9)d,P<0.001]and antibiotic-treatment duration[4(3 to 5)d vs 6(4 to 7)d,P<0.001]were significantly shorter than pre-Consensus,and antibiotic doses were markedly reduced[6(5 to 9)doses vs 11(7 to 15)doses,P=0.003].Generalized linear model analysis showed that mean hospitalization-cost ratio post-vs pre-Consensus was 0.81 in suspected EOS[95%confidence interval(CI)0.34 to 1.90,Pfalse discovery rate=0.626]and 2.11 in confirmed EOS(95%CI 0.49 to 9.06,Pfalse discovery rate=0.626),with no statistically significant difference.Across both periods,the number of patients with NEC grade≥II,28-day mortality,and infection-related readmission 30 days after discharge was 0 in the suspected-EOS subgroup.Fisher's exact tests with Bonferroni-corrected α'≈0.017 showed no significant differences between groups(all P>0.999). Conclusion:After Consensus release,suspected-EOS patients receive fewer antibiotic doses and shorter antibiotic courses,with shorter hospital stays,no clear increase in hospitalization costs,and no increase in serious adverse events after reduced antibiotic exposure.关键词
新生儿/早发型败血症/抗生素/回顾性队列研究/用药模式Key words
neonate/early-onset sepsis/antibiotic/retrospective cohort study/medication-use pattern引用本文复制引用
许玉子,刘芬..2019版《新生儿败血症诊断及治疗专家共识》发布前后抗生素使用变化:一项单中心回顾性队列研究[J].临床与病理杂志,2025,45(10):1318-1324,7.基金项目
上海交通大学医学院附属第六人民医院院级课题(LY33.x-4553).This work was supported by the Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine,Institutional-Level Project,China(LY33.X-4553). （LY33.x-4553）
