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瑞德西韦治疗儿童急性 SARS-CoV-2 感染的安全性。

Safety of remdesivir in the treatment of acute SARS-CoV-2 infection in pediatric patients.

机构信息

Department of Pediatrics, Section of Infectious Diseases, Medical College of Wisconsin, Milwaukee, WI, USA.

, PO Box 1997, Suite C450 Pediatric Infectious Diseases, Milwaukee, WI, USA.

出版信息

BMC Infect Dis. 2024 Sep 17;24(1):987. doi: 10.1186/s12879-024-09833-9.

DOI:10.1186/s12879-024-09833-9
PMID:39289614
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11406769/
Abstract

BACKGROUND

Transaminase and creatinine elevations have been well described in adults treated with remdesivir for COVID-19. It is hypothesized that a similar safety profile exists in children with COVID-19 treated with remdesivir, but available data are limited, especially in children < 12 months. The primary aim of this study was to determine the prevalence and timing of elevations in transaminases and creatinine in children with COVID-19 who were treated with remdesivir.

METHODS

This was a retrospective, observational cohort study including all pediatric patients admitted to a single, freestanding children's hospital who were positive for COVID-19 and received at least 1 dose of remdesivir between 1/1/2020 and 5/31/2022. Available baseline and peak transaminase and creatinine concentrations were evaluated. Multivariable logistic regression analysis was performed to identify risk factors for transaminase elevation.

RESULTS

A total of 180 patients met inclusion criteria. Creatinine elevation of any grade was noted in 16% and remained elevated only in those with underlying chronic kidney disease. Transaminase elevation of any grade was noted in 58% of patients and remained elevated in only 1%. Older age and critical respiratory disease were associated with higher risk of significant transaminase elevation, whereas non-Hispanic ethnicity was strongly associated with protection against significant transaminase elevation.

CONCLUSIONS

In our cohort of hospitalized children with COVID-19 who were treated with remdesivir, most patients experienced only mild transaminitis and normal creatinine concentrations. A limited number of patients experienced laboratory abnormalities which were transient, suggesting a favorable safety profile for remdesivir use in pediatrics.

摘要

背景

接受瑞德西韦治疗 COVID-19 的成年人的转氨酶和肌酐升高已得到充分描述。据推测,接受瑞德西韦治疗的 COVID-19 儿童也存在类似的安全性特征,但现有数据有限,尤其是在<12 个月的儿童中。本研究的主要目的是确定接受瑞德西韦治疗的 COVID-19 儿童中转氨酶和肌酐升高的发生率和时间。

方法

这是一项回顾性观察队列研究,纳入了 2020 年 1 月 1 日至 2022 年 5 月 31 日期间在一家独立的儿童医院住院且 COVID-19 检测阳性并至少接受一剂瑞德西韦治疗的所有儿科患者。评估了可用的基线和峰值转氨酶和肌酐浓度。采用多变量逻辑回归分析来确定转氨酶升高的危险因素。

结果

共纳入 180 例患者符合纳入标准。任何等级的肌酐升高的发生率为 16%,仅在有基础慢性肾脏病的患者中持续升高。任何等级的转氨酶升高的发生率为 58%,仅在 1%的患者中持续升高。年龄较大和严重呼吸疾病与较高的显著转氨酶升高风险相关,而非西班牙裔种族与显著转氨酶升高的保护作用相关。

结论

在我们接受瑞德西韦治疗的 COVID-19 住院儿童队列中,大多数患者仅经历轻微的肝酶升高和正常的肌酐浓度。少数患者出现短暂的实验室异常,表明瑞德西韦在儿科使用的安全性良好。

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World J Clin Pediatr. 2023 Jun 9;12(3):57-67. doi: 10.5409/wjcp.v12.i3.57.
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Liver transaminase concentrations in children with acute SARS-CoV-2 infection.儿童急性严重急性呼吸综合征冠状病毒 2 感染的肝转氨酶浓度。
Clin Biochem. 2023 Aug;118:110588. doi: 10.1016/j.clinbiochem.2023.110588. Epub 2023 May 30.
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Remdesivir Use in Pediatric Patients for SARS-CoV-2 Treatment: Single Academic Center Study.瑞德西韦治疗 SARS-CoV-2 儿童患者的应用:单中心研究。
Pediatr Infect Dis J. 2023 Apr 1;42(4):310-314. doi: 10.1097/INF.0000000000003814. Epub 2022 Dec 29.
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A Description of COVID-19-Directed Therapy in Children Admitted to US Intensive Care Units 2020.2020 年美国重症监护病房收治儿童的 COVID-19 定向治疗描述。
J Pediatric Infect Dis Soc. 2022 May 30;11(5):191-198. doi: 10.1093/jpids/piab123.
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