新型鞘氨醇-1-磷酸受体配体奥扎莫德在需要吸氧的 COVID-19 患者中的心脏安全性

IF 2.5 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS CJC Open Pub Date : 2024-09-01 DOI:10.1016/j.cjco.2024.05.002
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引用次数: 0

摘要

背景奥扎莫德是一种新型免疫调节剂,可通过减轻肺部炎症来治疗病毒性肺部感染。它是一种 S1P 受体配体,已知会诱发心动过缓和更严重的心脏不良反应,如房室传导阻滞和 QT 间期延长。在这项随机开放标签试验中,需要氧气支持的 COVID-19 患者被随机分为两组:标准护理 + 奥扎莫德 (OZA) 与单独标准护理 (SOC)。所有患者在住院期间都接受了为期 14 天的心电图监测(CardioSTAT,Icentia 公司,魁北克省)。我们评估了奥扎莫德对心率(HR)、PR 间期长度和 QT 间期持续时间的影响。与 SOC 组相比,OZA 组在治疗的前 10 天内平均每小时心率下降(P < 0.0001)。心率的最大降幅出现在第 3 天。心率的最大降幅出现在第 3 天,组间差异不显著:OZA 组为每分钟 49 次(四分位间范围,42-59),SOC 组为每分钟 54 次(48-60),P = 0.45。没有记录到高度房室传导阻滞。两组的 QT 和 PR 间期中位值均在正常范围内,无显著差异。结论 COVID-19 住院患者在开始奥扎莫德治疗 3 天后心率下降达到最大值,但在 10 天的治疗期间心率下降并不显著。未观察到相关的心脏不良事件。
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Cardiac Safety of Ozanimod Use, a Novel Sphingosine-1-Phosphate Receptor Ligand, in COVID-19 Patients Requiring Oxygen: Secondary Analysis of the COZI Randomized Clinical Trial

Background

Ozanimod is a novel immune modulator that could be useful in viral pulmonary infections by reducing lung inflammation. It is an S1P receptor ligand known to induce bradycardia and more serious adverse cardiac effects, such as atrioventricular block and QT interval prolongation. We present a substudy of the COVID-19 Ozanimod Intervention (COZI) trial in which ozanimod was administered in acute pulmonary infection patients, to assess cardiac safety.

Methods

In this pilot randomized open-label trial, COVID-19 patients requiring oxygen support were randomized into 2 groups: standard-of-care + ozanimod (OZA) vs standard-of-care alone (SOC). All patients were monitored with a 14-day electrocardiogram monitor (CardioSTAT, Icentia, Quebec, QC) during their hospitalization. We evaluated the cardiac effects of ozanimod on heart rate (HR), PR interval length, and QT interval duration.

Results

A total of 42 patients were analyzed: 23 in the SOC group and 19 in the OZA group. Mean hourly HR over the first 10 days of treatment decreased in the OZA group, compared with that in the SOC group (P < 0.0001). The maximum decrease in HR occurred on day 3. The maximum decrease in HR occurred on day 3, without a significant difference between groups: 49 beats per minute (interquartile range, 42-59) in the OZA group, and 54 beats per minute (48–60) in the SOC group, P = 0.45. No high-degree atrioventricular block was recorded. QT and PR interval median values were within the normal range in both groups, without a significant difference.

Conclusions

The maximal reduction in HR occurred 3 days after the onset of ozanimod treatment in patients hospitalized for COVID-19, but it did not remain significant over the 10-day treatment period. No relevant cardiac adverse event was observed.

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来源期刊
CJC Open
CJC Open Medicine-Cardiology and Cardiovascular Medicine
CiteScore
3.30
自引率
0.00%
发文量
143
审稿时长
60 days
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