同情使用普利替膦治疗免疫功能低下的 COVID-19 成年患者的结局和临床特征。

Outcomes and clinical characteristics of the compassionate use of plitidepsin for immunocompromised adult patients with COVID-19.

机构信息

Internal Medicine Department. Hospital Universitario Quirónsalud Madrid, Madrid, Spain; Universidad Europea de Madrid, Madrid, Spain; Research and clinical trials unit, Hospital Universitario Quirónsalud Madrid, Madrid, Spain.

Internal Medicine Department. Hospital Universitario HM Sanchinarro, Madrid, Spain.

出版信息

Int J Infect Dis. 2023 Oct;135:12-17. doi: 10.1016/j.ijid.2023.07.011. Epub 2023 Jul 21.

DOI:10.1016/j.ijid.2023.07.011

PMID:37481109

Abstract

OBJECTIVES

To evaluate the compassionate use of plitidepsin as an antiviral treatment in hospitalized immunocompromised adult patients with moderate-to-severe COVID-19.

DESIGN

Retrospective observational study of data -collected from January 01, 2021 to April 30, 2022- from 35 immunocompromised adult patients with COVID-19 non-eligible for other available antiviral treatments. Main outcome measures were time to respiratory recovery (SpFi ≥ 315); COVID-19-related 30-day-cumulative mortality after first plitidepsin infusion; and time to undetectable levels of viral RNA.

RESULTS

Thirty-three patients receiving a full course of plitidepsin (2.5 mg [n = 29] or 1.5 mg [n = 4]) were included. Most (69.7%) had a malignant hematologic disease and 27.3% had solid tumors. A total of 111 infusions were administered with lack of relevant safety events. Median time from plitidepsin initiation to SpFi ≥315 was 8 days (95% confidence interval [CI], 7-19). Median time to first negative reverse transcription-polymerase chain reaction for SARS-CoV-2 (cycle threshold >36) was 17 days (95% CI 13-25). Mortality rate was 16.3% (95% CI 3-37.3).

CONCLUSION

These data support plitidepsin as a well-tolerated treatment that might have potential clinical and antiviral efficacy in COVID-19 immunocompromised patients.

摘要

目的

评估普利替膦作为一种抗病毒药物在住院免疫功能低下的成年 COVID-19 患者中的同情使用。

设计

回顾性观察性研究，数据收集自 2021 年 1 月 1 日至 2022 年 4 月 30 日，纳入 35 名 COVID-19 免疫功能低下且不符合其他可用抗病毒治疗条件的成年患者。主要结局指标为呼吸恢复时间（SpFi ≥315）；首次普利替膦输注后 30 天 COVID-19 相关累积死亡率；以及病毒 RNA 检测不到水平的时间。

结果

纳入 33 名接受普利替膦全疗程治疗的患者（2.5 mg[n=29]或 1.5 mg[n=4]）。大多数（69.7%）患有恶性血液病，27.3%患有实体瘤。共进行了 111 次输注，无相关安全事件。从普利替膦开始到 SpFi ≥315 的中位时间为 8 天（95%置信区间[CI]，7-19）。首次 SARS-CoV-2 逆转录-聚合酶链反应（循环阈值>36）为阴性的中位时间为 17 天（95%CI 13-25）。死亡率为 16.3%（95%CI 3-37.3）。