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接种新冠病毒疫苗的健康受试者的参数及凝血激活均无变化。

No changes of parameters nor coagulation activation in healthy subjects vaccinated for SARS-Cov-2.

作者信息

Peyvandi Flora, Scalambrino Erica, Clerici Marigrazia, Lecchi Anna, Revelli Nicoletta, Palla Roberta, Gualtierotti Roberta, Prati Daniele, Tripodi Armando

机构信息

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Angelo Bianchi Bonomi Hemophilia and Thrombosis Center, Fondazione Luigi Villa, Milan, Italy.

Università degli Studi di Milano, Department of Pathophysiology and Transplantation, Milan, Italy.

出版信息

Thromb Update. 2021 Aug;4:100059. doi: 10.1016/j.tru.2021.100059. Epub 2021 Jun 25.

Abstract

BACKGROUND

Recent reports of thrombotic events after SARS-Cov-2 vaccination raised concern. However, modifications of the most common coagulation parameters after vaccination are unknown.

AIMS

We measured parameters of coagulation including (i) basic coagulation tests, (ii) procedures aimed to assess the ex-vivo potential capacity to generate thrombin and (iii) in vivo thrombin activity. We also assessed anti-platelet factor 4 (aPF4) with two methods.

DESIGN

Laboratory measurements were performed for a cohort of subjects (n = 30) before (baseline) and after (7 and 21days after first dose, and 14days after second dose) SARS-Cov-2 vaccination.

RESULTS

All subjects received the Pfizer-BioNTech vaccine, and none developed symptomatic thrombotic events during the study period. None of the parameters showed clinically relevant variations at different time-points before and after vaccination. Only platelet count showed a slight increase, and F1.2 and the thrombin generation parameters ETP and ETP-TM ratio, showed a small decline, at the last time-point after vaccination when compared to baseline. aPF4 was negative in all the subjects, except two, who were positive (one with the chemiluminescent and the other with the ELISA assay).

CONCLUSIONS

The study shows no modifications of the coagulation parameters nor the presence of biochemical signs of coagulation activation following the administration of the Pfizer-BioNTech vaccine.

摘要

背景

近期关于新型冠状病毒2型(SARS-CoV-2)疫苗接种后血栓形成事件的报道引发了关注。然而,接种疫苗后最常见凝血参数的变化尚不清楚。

目的

我们测量了凝血参数,包括(i)基本凝血试验,(ii)旨在评估体外凝血酶生成潜在能力的检测方法,以及(iii)体内凝血酶活性。我们还使用两种方法评估了抗血小板因子4(aPF4)。

设计

对一组受试者(n = 30)在接种SARS-CoV-2疫苗前(基线)以及接种后(首剂后7天和21天,以及第二剂后14天)进行实验室检测。

结果

所有受试者均接种了辉瑞-BioNTech疫苗,且在研究期间均未发生有症状的血栓形成事件。接种前后不同时间点,所有参数均未显示出具有临床意义的变化。与基线相比,仅血小板计数在接种后的最后一个时间点略有增加,而F1.2以及凝血酶生成参数ETP和ETP-TM比值略有下降。除两名受试者aPF4呈阳性(一名采用化学发光法,另一名采用酶联免疫吸附测定法)外,所有受试者的aPF4均为阴性。

结论

该研究表明,接种辉瑞-BioNTech疫苗后,凝血参数无变化,也不存在凝血激活的生化迹象。

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