新型冠状病毒疫苗接种后大脑静脉窦血栓形成的年龄分层风险。
Age-Stratified Risk of Cerebral Venous Sinus Thrombosis After SARS-CoV-2 Vaccination.
机构信息
From the Departments of Neurology (K.K., A.v.d.M., M.S.v.K., J.M.C.) and Vascular Medicine (M.M.L.), Amsterdam University Medical Centers, University of Amsterdam, the Netherlands; Departments of Neurology (M.R.H., M.A.) and Hematology (J.A.K.H.), Inselspital, Bern University Hospital, University of Bern; Department of Neurology (K.J., E.L., T.T.), Sahlgrenska University Hospital; Department of Clinical Neuroscience (K.J., E.L., T.T.), Institute of Neuroscience and Physiology, Sahlgrenska Academy at University of Gothenburg, Sweden; Department of Neurology (J.P.), Helsinki University Hospital and University of Helsinki, Finland; Department of Internal Medicine (S.M.) and Radboud Institute of Health Sciences (S.M.), Radboud University Medical Center, Nijmegen, the Netherlands; National Institute for Health Research University College London Hospitals Biomedical Research Centre (M.M.L.), UK; University of Lille (C.C.), Inserm, CHU Lille, U1172-Lille Neuroscience and Cognition, France; Department of Clinical Epidemiology and Biostatistics (A.H.Z.), Amsterdam University Medical Centers, University of Amsterdam, the Netherlands; and Department of Neurosciences and Mental Health (J.M.F., D.A.d.S.), Neurology Service, Hospital de Santa Maria/Centro Hospitalar Universitário Lisboa Norte (CHULN), University of Lisbon, Portugal.
出版信息
Neurology. 2022 Feb 15;98(7):e759-e768. doi: 10.1212/WNL.0000000000013148. Epub 2021 Dec 17.
BACKGROUND AND OBJECTIVES
Cerebral venous sinus thrombosis (CVST) as a part of the thrombosis and thrombocytopenia syndrome is a rare adverse drug reaction of severe acute respiratory syndrome coronavirus disease 2 (SARS-CoV-2) vaccination. Estimated background rate of CVST with thrombocytopenia is 0.1 per million per month. We assessed the age-stratified risk of CVST with and without thrombocytopenia after SARS-CoV-2 vaccination.
METHODS
We estimated the absolute risk of CVST with and without thrombocytopenia within 28 days of a first dose of 4 SARS-CoV-2 vaccinations using data from the European Medicines Agency's EudraVigilance database (until June 13, 2021). As a denominator, we used data on vaccine delivery from 31 European countries. For 22.8 million adults from 25 countries, we estimated the absolute risk of CVST after the first dose of ChAdOx1 nCov-19 per age category.
RESULTS
The absolute risk of CVST within 28 days of first-dose vaccination was 7.5 (95% confidence interval [CI] 6.9-8.3), 0.7 (95% CI 0.2-2.4), 0.6 (95% CI 0.5-0.7), and 0.6 (95% CI 0.3-1.1) per million of first doses of ChAdOx1 nCov-19, Ad26.COV2.S, BNT162b2, and mRNA-1273, respectively. The absolute risk of CVST with thrombocytopenia within 28 days of first dose vaccination was 4.4 (95% CI 3.9-4.9), 0.7 (95% CI 0.2-2.4), 0.0 (95% CI 0.0-0.1), and 0.0 (95% CI 0.0-0.2) per million of first doses of ChAdOx1 nCov-19, Ad26.COV2.S, BNT162b2, and mRNA-1273, respectively. In recipients of ChAdOx1 nCov-19, the absolute risk of CVST, both with and without thrombocytopenia, was the highest in the 18- to 24-year-old group (7.3 per million, 95% CI 2.8-18.8 and 3.7 per million, 95% CI 1.0-13.3, respectively). The risk of CVST with thrombocytopenia in ChAdOx1 nCov-19 recipients was the lowest in the age group ≥70 years (0.2, 95% CI 0.0-1.3). Age <60 years compared to ≥60 years was a predictor for CVST with thrombocytopenia (incidence rate ratio 5.79, 95% CI 2.98-11.24, < 0.001).
DISCUSSION
The risk of CVST with thrombocytopenia within 28 days of first-dose vaccination with ChAdOx1 nCov-19 was higher in younger age groups. The risk of CVST with thrombocytopenia was slightly increased in patients receiving Ad26.COV2.S compared with the estimated background risk. The risk of CVST with thrombocytopenia was not increased in recipients of SARS-CoV-2 mRNA vaccines.
背景和目的
作为严重急性呼吸综合征冠状病毒病 2 （SARS-CoV-2）疫苗接种后血栓和血小板减少症综合征的一部分，脑静脉窦血栓形成（CVST）是一种罕见的药物不良反应。伴有血小板减少的 CVST 的估计背景发生率为每月每百万人 0.1 例。我们评估了接种 SARS-CoV-2 疫苗后 28 天内有无血小板减少的 CVST 的年龄分层风险。
方法
我们使用欧洲药品管理局 EudraVigilance 数据库的数据（截至 2021 年 6 月 13 日），评估了 4 种 SARS-CoV-2 疫苗首剂后 28 天内有无血小板减少的 CVST 的绝对风险。作为分母，我们使用了来自 31 个欧洲国家的疫苗接种数据。对于来自 25 个国家的 2280 万成年人，我们估计了每剂 ChAdOx1 nCov-19 接种后的第 1 天的 CVST 绝对风险。
结果
接种首剂后 28 天内的 CVST 绝对风险分别为接种 ChAdOx1 nCov-19、Ad26.COV2.S、BNT162b2 和 mRNA-1273 的第 1 剂的每百万剂量中 7.5（95%置信区间 [CI] 6.9-8.3）、0.7（95% CI 0.2-2.4）、0.6（95% CI 0.5-0.7）和 0.6（95% CI 0.3-1.1）；接种首剂后 28 天内伴有血小板减少的 CVST 的绝对风险分别为接种 ChAdOx1 nCov-19、Ad26.COV2.S、BNT162b2 和 mRNA-1273 的第 1 剂的每百万剂量中 4.4（95% CI 3.9-4.9）、0.7（95% CI 0.2-2.4）、0.0（95% CI 0.0-0.1）和 0.0（95% CI 0.0-0.2）。在接种 ChAdOx1 nCov-19 的受种者中，伴有或不伴有血小板减少的 CVST 的绝对风险在 18-24 岁年龄组最高（分别为每百万 7.3 例，95% CI 2.8-18.8 和每百万 3.7 例，95% CI 1.0-13.3）。接种 ChAdOx1 nCov-19 的受种者中伴有血小板减少的 CVST 的风险在年龄≥70 岁的年龄组最低（0.2，95% CI 0.0-1.3）。与年龄≥60 岁相比，年龄<60 岁是伴有血小板减少的 CVST 的预测因素（发病率比 5.79，95% CI 2.98-11.24，<0.001）。
讨论
接种 ChAdOx1 nCov-19 后 28 天内伴有血小板减少的 CVST 的风险在年轻年龄组中更高。与估计的背景风险相比，接受 Ad26.COV2.S 的患者伴有血小板减少的 CVST 的风险略有增加。接受 SARS-CoV-2 mRNA 疫苗的患者伴有血小板减少的 CVST 的风险没有增加。
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