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亚甲蓝处理对 COVID-19 恢复期血浆的临床疗效没有影响。

Pathogen reduction with methylene blue does not have an impact on the clinical effectiveness of COVID-19 convalescent plasma.

机构信息

Department of Hematology, Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Spain.

Instituto de Investigación Sanitaria Hospital Puerta de Hierro-Segovia de Arana, Madrid, Spain.

出版信息

Vox Sang. 2023 Apr;118(4):296-300. doi: 10.1111/vox.13406. Epub 2023 Feb 3.

Abstract

BACKGROUND AND OBJECTIVES

There is a concern about a possible deleterious effect of pathogen reduction (PR) with methylene blue (MB) on the function of immunoglobulins of COVID-19 convalescent plasma (CCP). We have evaluated whether MB-treated CCP is associated with a poorer clinical response compared to other inactivation systems at the ConPlas-19 clinical trial.

MATERIALS AND METHODS

This was an ad hoc sub-study of the ConPlas-19 clinical trial comparing the proportion of patients transfused with MB-treated CCP who had a worsening of respiration versus those treated with amotosalen (AM) or riboflavin (RB).

RESULTS

One-hundred and seventy-five inpatients with SARS-CoV-2 pneumonia were transfused with a single CCP unit. The inactivation system of the CCP units transfused was MB in 90 patients (51.4%), RB in 60 (34.3%) and AM in 25 (14.3%). Five out of 90 patients (5.6%) transfused with MB-treated CCP had worsening respiration compared to 9 out of 85 patients (10.6%) treated with alternative PR methods (p = 0.220). Of note, MB showed a trend towards a lower rate of respiratory progressions at 28 days (risk ratio, 0.52; 95% confidence interval, 0.18-1.50).

CONCLUSION

Our data suggest that MB-treated CCP does not provide a worse clinical outcome compared to the other PR methods for the treatment of COVID-19.

摘要

背景与目的

有人担心亚甲蓝(MB)对 COVID-19 恢复期血浆(CCP)中免疫球蛋白的功能可能产生有害影响。我们评估了在 ConPlas-19 临床试验中,与其他灭活系统相比,MB 处理的 CCP 是否与更差的临床反应相关。

材料与方法

这是 ConPlas-19 临床试验的一项特别子研究,比较了输注 MB 处理的 CCP 的患者中呼吸恶化的比例与接受氨甲脒(AM)或核黄素(RB)治疗的患者的比例。

结果

175 名 SARS-CoV-2 肺炎住院患者输注了单个 CCP 单位。输注的 CCP 单位的灭活系统为 MB 的患者 90 例(51.4%),RB 为 60 例(34.3%),AM 为 25 例(14.3%)。与接受其他 PR 方法治疗的 85 例患者(10.6%)相比,输注 MB 处理的 CCP 的 5 例患者(5.6%)出现呼吸恶化(p=0.220)。值得注意的是,MB 处理的 CCP 在 28 天时呼吸进展的风险比为 0.52(95%置信区间,0.18-1.50),这表明其发生率较低。

结论

我们的数据表明,与其他用于治疗 COVID-19 的 PR 方法相比,MB 处理的 CCP 不会提供更差的临床结局。

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