Department of Clinical Pharmacy, School of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran; and.
Department of Anesthesiology and Critical Care, School of Medicine, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran.
Am J Ther. 2022;29(5):e520-e533. doi: 10.1097/MJT.0000000000001543. Epub 2022 Jul 22.
BACKGROUND: Remdesivir (RDV) is the main antiviral for the treatment of moderate to severe forms of Coronavirus disease 2019 (COVID-19). Several studies revealed a shortening time to clinical improvement of COVID-19 and mortality benefits in patients receiving RDV. The patients with renal disease were excluded from large clinical trials of RDV, and the probable nephrotoxicity of the drug, its metabolites, and the vehicle (sulfobutylether-β-cyclodextrin) have led to the recommendation against using RDV in patients with an estimated glomerular filtration rate of <30 mL/min. AREAS OF UNCERTAINTY: This systematic review aimed to collect data about the necessity and safety administration of RDV in the setting of renal impairment. DATA SOURCES: Search through databases including MEDLINE, ScienceDirect, Cochrane Library, and PubMed was performed. The studies were carried out in adults and enrolled patients with different types of renal impairment (ie, acute kidney injury, chronic kidney disease, kidney transplant, and renal replacement therapy) were included. Eligible studies were assessed, and required data were extracted. RESULTS: Twenty-two cross-sectional studies, cohorts, case reports, and case series were included in this review. The mortality rate was between 7.3% and 50%, and various severity of COVID-19 was included in the studies. None of them reported an increase in adverse effects attributed to RDV administration. A decrease in inflammatory mediators and other benefits were obvious. CONCLUSIONS: Although the manufacturer's labeling does not recommend RDV administration in patients with severe renal impairment, it seems that nephrotoxicity is less concerning in the population of these patients. Moreover, RDV may be helpful in acute kidney injury induced by the viral invasion of COVID-19. To the best of our knowledge, this is the first systematic review of the use of RDV in kidney failure. Larger, well-designed, and pharmacokinetic studies are required to have a safe and logical recommendation about the use of RDV in patients with renal disorders.
背景：瑞德西韦（RDV）是治疗 2019 年冠状病毒病（COVID-19）中度至重度形式的主要抗病毒药物。几项研究表明，接受 RDV 治疗的患者的 COVID-19 临床改善时间和死亡率均有所提高。患有肾脏疾病的患者被排除在 RDV 的大型临床试验之外，并且该药物、其代谢产物和载体（磺丁基醚-β-环糊精）可能具有肾毒性，这导致建议在估计肾小球滤过率<30 mL/min 的患者中不使用 RDV。
不确定性领域：本系统评价旨在收集有关在肾功能受损情况下使用 RDV 的必要性和安全性的数据。
数据来源：通过 MEDLINE、ScienceDirect、Cochrane 图书馆和 PubMed 等数据库进行搜索。这些研究在成人中进行，纳入了患有不同类型肾功能不全（即急性肾损伤、慢性肾脏病、肾移植和肾脏替代治疗）的患者。评估了合格的研究，并提取了所需的数据。
结果：本综述纳入了 22 项横断面研究、队列研究、病例报告和病例系列研究。这些研究的死亡率在 7.3%至 50%之间，包括各种严重程度的 COVID-19。它们均未报告归因于 RDV 给药的不良反应增加。炎症介质减少和其他益处明显。
结论：尽管制造商的标签不建议在严重肾功能不全的患者中使用 RDV，但在这些患者人群中，肾毒性似乎不太令人担忧。此外，RDV 可能对 COVID-19 病毒侵袭引起的急性肾损伤有帮助。据我们所知，这是关于 RDV 在肾衰竭患者中应用的首次系统评价。需要更大、设计更好和药代动力学研究，以便对肾功能障碍患者使用 RDV 提出安全合理的建议。
Naunyn Schmiedebergs Arch Pharmacol. 2024-6
Clin Infect Dis. 2021-12-6
Mini Rev Med Chem. 2021
J Infect Chemother. 2024-4
Zotero 插件