标准治疗方案加和不加地塞米松对3-7岁儿童脓胸结局的影响:一项随机双盲临床试验

IF 3.1 3区 医学 Q1 PEDIATRICS
Alireza Eshghi, Nasrin Hoseiny Nejad, Azar Mohammadzadeh, Farhad Mansouri, Shabnam Aghajani
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引用次数: 0

摘要

背景:糖皮质激素对炎症因子有有效的抑制作用,被用作病毒性肺炎的辅助治疗。我们进行了这项研究,以比较标准治疗方案与不使用地塞米松对3-7岁脓胸儿童结局的影响。方法:该随机对照试验于2023年6月至2024年11月在伊朗一所大学医院进行。研究对象为3-7岁的患脓胸的儿童。所有患者均接受标准抗生素治疗(万古霉素和美罗培南)和纤溶剂(阿替普酶)。地塞米松组在胸膜内注射地塞米松。采用块大小为4的块随机化进行随机化。儿童和结局评估者对地塞米松治疗均采用盲法。主要终点是住院时间(LOS),次要终点包括发烧持续时间、胸管放置、血氧饱和度和CRP水平。结果:47例患者(地塞米松组23例)中,女生占48.9% (n = 23)。地塞米松组的LOS中位数为9.5天,范围为7-17天,明显低于对照组的中位数为16天,范围为10-24天。地塞米松组发热持续时间(中位数5天vs 11天)和CRP水平(中位数12.5天vs 21天)均显著低于对照组。两组患者在COVID-19和流感PCR检测、胸膜液涂片培养、血培养、血氧饱和度、胸腔置管时间等方面均无显著差异。结论:我们的研究结果表明,使用地塞米松可减少住院时间、发烧时间和CRP水平,从而使脓胸患儿恢复更快。地塞米松是一种安全有效的儿童脓胸辅助治疗方法。试验注册:IRCT20240705062336N1,回顾性注册(20241116)。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Standard treatment regimen with and without dexamethasone on outcome of children aged 3-7 years with empyema: a randomized double blind clinical trial.

Background: Corticosteroids have an effective inhibitory effect on inflammatory factors and are used as adjunctive therapy for viral pneumonia. We conducted this study to compare the effects of a standard treatment regimen with and without dexamethasone on the outcomes of 3-7-year-old children with empyema.

Methods: This randomized controlled trial was conducted at a university hospital in Iran from June 2023 to November 2024. Children aged 3-7 years with empyema were enrolled. All patients received standard antibiotic treatment (Vancomycin and Meropenem) and a fibrinolytic agent (alteplase). The dexamethasone group received additional intrapleural dexamethasone injections. Randomization was performed using block randomization with a block size of 4. Both children and outcome assessors were blinded to dexamethasone administration. The primary outcome was length of stay (LOS), with secondary outcomes including duration of fever, chest tube placement, oxygen saturation, and CRP levels.

Results: Out of 47 patients (dexamethasone group = 23), 48.9% of the subjects (n = 23) were girls. The LOS in the dexamethasone group, with a median of 9.5 days and a range of 7-17 days, was significantly less than in the control group, with a median of 16 days and a range of 10-24 days. The duration of fever (median 5 vs. 11 days) and CRP level (median 12.5 vs. 21) in the dexamethasone group were significantly lower than in the control group. No significant difference was observed between the two groups in terms of PCR for COVID-19 and influenza, pleural fluid smear culture, blood culture, oxygen saturation, and duration of chest tube placement.

Conclusions: Our findings showed that the use of dexamethasone decreases the duration of hospitalization, duration of fever, and CRP levels, leading to faster recovery in children with empyema. Dexamethasone can be a safe and effective adjunctive therapy for empyema in children.

Trial registration: IRCT20240705062336N1, Retrospectively Registered (20241116).

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来源期刊
CiteScore
6.10
自引率
13.90%
发文量
192
审稿时长
6-12 weeks
期刊介绍: Italian Journal of Pediatrics is an open access peer-reviewed journal that includes all aspects of pediatric medicine. The journal also covers health service and public health research that addresses primary care issues. The journal provides a high-quality forum for pediatricians and other healthcare professionals to report and discuss up-to-the-minute research and expert reviews in the field of pediatric medicine. The journal will continue to develop the range of articles published to enable this invaluable resource to stay at the forefront of the field. Italian Journal of Pediatrics, which commenced in 1975 as Rivista Italiana di Pediatria, provides a high-quality forum for pediatricians and other healthcare professionals to report and discuss up-to-the-minute research and expert reviews in the field of pediatric medicine. The journal will continue to develop the range of articles published to enable this invaluable resource to stay at the forefront of the field.
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