Department of Hematology, Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Spain.
Instituto de Investigación Sanitaria Hospital Puerta de Hierro-Segovia de Arana, Madrid, Spain.
Vox Sang. 2023 Apr;118(4):296-300. doi: 10.1111/vox.13406. Epub 2023 Feb 3.
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.
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).
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).
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.
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。
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。
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。
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。
