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COVID-19 血液透析患者早期使用瑞德西韦的疗效和安全性:病例报告及文献复习。

Efficacy and safety of early administration of remdesivir in hemodialysis patients with COVID-19: A case report and literature review.

机构信息

Department of Cardiovascular, University of the Ryukyus Graduate School of Medicine, Nephrology, and Neurology, Okinawa, Japan.

Dialysis Unit, University of the Ryukyus Hospital, Okinawa, Japan.

出版信息

Medicine (Baltimore). 2024 Nov 29;103(48):e40650. doi: 10.1097/MD.0000000000040650.

DOI:10.1097/MD.0000000000040650
PMID:39612460
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11608740/
Abstract

RATIONALE

Although the mortality of severe coronavirus disease 2019 (COVID-19) has decreased after the emergence of the Omicron variant, it remains high in patients on hemodialysis (HD). Remdesivir (RDV) is considered as the first line drug for hospitalized COVID-19 patients, however the evidence regarding the usage in HD patients is lacking because clinical trials of RDV have excluded HD patients for safety reasons. Thus, accumulation of knowledge on the regimen, efficacy, and tolerability of RDV in HD patients is important.

PATIENT CONCERNS

A nosocomial COVID-19 cluster was occurred from August 31 to October 12 in 2021 when the Delta variant was predominant. During the cluster, 11 health-care workers and 20 inpatients including 7 HD patients were infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

DIAGNOSES

The diagnosis of COVID-19 was confirmed by the real-time polymerase chain reaction (PCR) for SARS-CoV-2.

INTERVENTIONS

RDV was initiated within 16 hours after the onset of fever (≥ 37.4°C) or positive PCR result in all HD patients, and continued at 100 mg/day intravenously once daily for either consecutive 5 or 10 days.

OUTCOMES

All patients fully recovered within 2 weeks and did not develop severe COVID-19. Two patients experienced mild liver dysfunction, but it was temporary and remitted spontaneously even continuing RDV treatment. Discontinuation of RDV therapy due to adverse events was not required in any patients.

LESSONS

Present cases indicated early intervention with RDV may contribute the favorable outcome and daily administration of RDV for up to 10 days was well tolerated even in HD patients. Literature review showed no previous article reported the efficacy and safety of such earlier and longer administration of remdesivir as in the present cases, therefore this report is informative for clinicians to consider the usage of RDV in HD patients.

摘要

背景

尽管奥密克戎变异株出现后,严重 2019 冠状病毒病(COVID-19)的死亡率有所下降,但在接受血液透析(HD)的患者中仍然很高。瑞德西韦(RDV)被认为是住院 COVID-19 患者的一线药物,然而,由于 RDV 的临床试验出于安全原因排除了 HD 患者,因此缺乏关于 RDV 在 HD 患者中使用的证据。因此,积累关于 RDV 在 HD 患者中的方案、疗效和耐受性的知识非常重要。

患者关注

德尔塔变异株占主导地位期间,2021 年 8 月 31 日至 10 月 12 日发生了一起医院内 COVID-19 聚集性疫情。在此期间,共有 11 名医护人员和 20 名住院患者(包括 7 名 HD 患者)感染了严重急性呼吸综合征冠状病毒 2(SARS-CoV-2)。

诊断

COVID-19 的诊断通过实时聚合酶链反应(PCR)检测 SARS-CoV-2 阳性结果确定。

干预措施

所有 HD 患者均在发热(≥37.4°C)或 PCR 阳性结果出现后 16 小时内开始使用 RDV,连续 5 或 10 天,每天 100mg 静脉内给药 1 次。

结果

所有患者在 2 周内完全康复,未发生严重 COVID-19。2 名患者出现轻度肝功能障碍,但为一过性,即使继续 RDV 治疗也可自行缓解。在任何患者中,均无需因不良事件而停止 RDV 治疗。

经验教训

本病例表明,早期使用 RDV 干预可能有助于获得良好的结果,并且即使在 HD 患者中,连续 10 天每天给予 RDV 也可耐受。文献复习未发现以前有文章报道过如此早期和更长时间使用 RDV 的疗效和安全性,因此本报告为临床医生考虑在 HD 患者中使用 RDV 提供了信息。

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本文引用的文献

1
Comparative outcomes of hemodialysis patients facing pre-Omicron and Omicron COVID-19 epidemics.奥密克戎(Omicron)前和奥密克戎(Omicron)新冠疫情期间行血液透析患者的比较结局。
Ther Apher Dial. 2024 Feb;28(1):51-60. doi: 10.1111/1744-9987.14067. Epub 2023 Sep 19.
2
Reduced COVID-19 morbidity and mortality in hemodialysis patients across the various Omicron sublineages-A retrospective analysis.奥密克戎各亚谱系中降低血液透析患者的 COVID-19 发病率和死亡率:一项回顾性分析。
Front Public Health. 2023 Aug 10;11:1218188. doi: 10.3389/fpubh.2023.1218188. eCollection 2023.
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Treatment of patients with COVID-19 on hemodialysis: Efficacy of remdesivir.接受血液透析的COVID-19患者的治疗:瑞德西韦的疗效。
Nefrologia (Engl Ed). 2023 Dec;43 Suppl 2:112-113. doi: 10.1016/j.nefroe.2022.07.008. Epub 2023 Jan 25.
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Comparison of safety and outcomes related to remdesivir treatment among dialysis patients hospitalized with COVID-19.新冠病毒肺炎住院透析患者中与瑞德西韦治疗相关的安全性及治疗结果比较
Clin Kidney J. 2022 Aug 23;15(11):2056-2062. doi: 10.1093/ckj/sfac185. eCollection 2022 Nov.
5
Clinical Effectiveness and Safety of Remdesivir in Hemodialysis Patients with COVID-19.瑞德西韦在新冠肺炎血液透析患者中的临床疗效与安全性
Kidney Int Rep. 2022 Nov;7(11):2522-2525. doi: 10.1016/j.ekir.2022.08.031. Epub 2022 Sep 10.
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Infectious Diseases Society of America Guidelines on the Treatment and Management of Patients With COVID-19 (September 2022).美国传染病学会关于 COVID-19 患者治疗和管理的指南(2022 年 9 月)。
Clin Infect Dis. 2024 Jun 27;78(7):e250-e349. doi: 10.1093/cid/ciac724.
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Differences in incidence and fatality of COVID-19 by SARS-CoV-2 Omicron variant versus Delta variant in relation to vaccine coverage: A world-wide review.奥密克戎变异株与德尔塔变异株相关的 COVID-19 发病率和病死率的差异与疫苗覆盖率有关:一项全球性综述。
J Med Virol. 2023 Jan;95(1):e28118. doi: 10.1002/jmv.28118. Epub 2022 Sep 20.
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Safety and Tolerability of Remdesivir in Patients with End-stage Renal Disease on Maintenance Hemodialysis.接受维持性血液透析的终末期肾病患者使用瑞德西韦的安全性和耐受性
Indian J Crit Care Med. 2022 May;26(5):619-625. doi: 10.5005/jp-journals-10071-24168.
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Safety profile and clinical results of Remdesivir in Hemodialysis patients infected with SARS-CoV-2. A single-center Spanish cohort study.瑞德西韦在感染新型冠状病毒的血液透析患者中的安全性和临床结果。一项西班牙单中心队列研究。
J Nephrol. 2023 Jan;36(1):171-172. doi: 10.1007/s40620-022-01364-3. Epub 2022 Jun 18.
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Risk factors associated with COVID-19 severity among patients on maintenance haemodialysis: a retrospective multicentre cross-sectional study in the UK.维持性血液透析患者 COVID-19 严重程度相关的危险因素:英国一项回顾性多中心横断面研究。
BMJ Open. 2022 May 30;12(5):e054869. doi: 10.1136/bmjopen-2021-054869.