Prisma Health-Upstate, Greenville, SC, USA.
Prisma Health-Upstate, Greenville, SC, USA.
Respir Med. 2020 Dec;175:106188. doi: 10.1016/j.rmed.2020.106188. Epub 2020 Nov 7.
Cytokine release syndrome (CRS) is a potentially severe complication of COVID-19 most commonly resulting in respiratory failure. This ten-patient study was designed to determine the efficacy of therapeutic plasma exchange (TPE) in improving oxygenation and in reducing the cytokine load in a critically ill subset of patients.
Five single volume plasma exchanges over eight days within a 14-day study period. In mechanically ventilated patients, oxygenation was measured via the PaO2/FiO2 (P/F) ratio and the oxygenation index (OI) daily for 14 days. Supplemental oxygen requirements were tracked daily for non-ventilated patients.
Non-ventilated patients were liberated from supplemental oxygen after TPE. The response was rapid with an 87% average reduction in oxygenation requirements following and average time to return to room air of 5.25 days. All mechanically ventilated patients demonstrated improvement in oxygenation with a 78% average improvement in the P/F ratio and a 43% improvement in OI. C-reactive protein (CRP) and serum levels of IL-6, IL-8, IL-10, TNFα, IFNγ and GM-CSF, were measured daily with immediate post TPE levels drawn on days 1, 2, 4, 6 and 8. All patients demonstrated significant reductions in CRP, IL-6, IL-10 and TNFα.
In the majority of patients with Penn class 3 and 4 CRS complicating COVID-19, TPE demonstrated a prompt improvement in oxygenation and reduction in cytokine load without compromising patient safety. As this pilot study was envisioned to be hypothesis generating, expanded trials using TPE alone and in conjunction with novel pharmacologic agents are warranted.
ClinicalTrials.gov NCT04374149.
细胞因子释放综合征（CRS）是 COVID-19 的一种潜在严重并发症，最常见的表现为呼吸衰竭。本研究纳入了 10 名患者，旨在确定治疗性血浆置换（TPE）在改善氧合和降低危重症患者细胞因子负荷方面的疗效。
在 14 天的研究期间内，8 天内进行 5 次单容量血浆置换。对于机械通气患者，通过 PaO2/FiO2（P/F）比值和氧合指数（OI）每天测量 14 天的氧合情况。对于非机械通气患者，每天监测补充氧气的需求。
TPE 后，非机械通气患者可以脱离补充氧气。反应迅速，氧合需求平均降低 87%，平均恢复至室内空气的时间为 5.25 天。所有机械通气患者的氧合均得到改善，P/F 比值平均提高 78%，OI 提高 43%。每天测量 C 反应蛋白（CRP）和血清 IL-6、IL-8、IL-10、TNFα、IFNγ 和 GM-CSF 水平，TPE 后第 1、2、4、6 和 8 天立即抽取 TPE 后即刻的血清样本。所有患者的 CRP、IL-6、IL-10 和 TNFα 水平均显著降低。
在 COVID-19 并发 Penn 分级 3 和 4 CRS 的大多数患者中，TPE 可迅速改善氧合并降低细胞因子负荷，同时不影响患者安全性。由于本研究旨在产生假说，因此需要使用 TPE 单独或与新型药物联合进行更大规模的试验。
ClinicalTrials.gov NCT04374149。
