新型冠状病毒疫苗接种后诱导的免疫性血栓性血小板减少症：巴西 39 例系列病例描述。
Vaccine-induced immune thrombotic thrombocytopenia after COVID-19 vaccination: Description of a series of 39 cases in Brazil.
机构信息
Institute of Technology in Immunobiologicals/Bio-Manguinhos/Fiocruz, Rio de Janeiro, Brazil.
Department of Hematology, Instituto Nacional de Infectologia Evandro Chagas, Fundação Oswaldo Cruz (Fiocruz), Rio de Janeiro, Brazil; Division of Molecular Carcinogenesis, Research Center, Instituto Nacional de Câncer (INCA), Rio de Janeiro, Brazil; Division of Epidemiology, Department of Pediatrics, University of Minnesota, Minneapolis, United States of America.
出版信息
Vaccine. 2022 Aug 5;40(33):4788-4795. doi: 10.1016/j.vaccine.2022.06.014. Epub 2022 Jun 16.
OBJECTIVE
Describe a case series of vaccine-induced immune thrombotic thrombocytopenia (VITT) after COVID-19 vaccination in Brazil that included ChAdOx1 nCoV-19, Ad26.COV2.S and BNT162b2 vaccines, describing their clinical and laboratory characteristics.
METHODOLOGY
Descriptive case series study using Bio-Manguinhos/Fiocruz/AstraZeneca Brazil and National Immunization Program/Ministry of Health (NIP/MoH) data on COVID-19 AEFI surveillance. We obtained patient-level data from pharmacovigilance for AEFI surveillance and used both the NIP/MoH and Bio-Manguinhos/Fiocruz pharmacovigilance databases to create the study database. Thirty-nine cases of suspect VITT were included, 36 after ChAdOx1 nCoV-19, one after BNT162b2 and two after Ad26.COV2.S vaccine. All cases were based on meeting the Brighton Collaboration criteria for VITT. The primary outcomes were clinical and laboratory features, site of thrombosis, and anti-PF4 ELISA, when available.
RESULTS
Thirty-nine cases met the criteria, 38 of which were classified as level 1 and one as level 3 according to Brighton Collaboration. Most cases had the central nervous system (CNS) as the main site of thrombosis (21/39) and happened after the vaccine first dose (34/39). The median age of the cases was 41 years old (23 to 86 yo). Most of the cases (61.5%) occurred in women. The median interval between vaccination and onset of symptoms was 8 days (0-37 days). The platelet count and D-dimer count had median values of 34,000/µL and 19,235 µg FEU/L, respectively. The ELISA anti-PF4 antibody was positive in 18 samples. The overall mortality rate was 51% and was higher in cases of CNS thrombosis with intracerebral bleeding.
CONCLUSION
Our case series shows that Brazilian VITT cases have similar clinical and laboratory profiles as demonstrated in the literature. Brazil has administered more than 300 million doses of COVID-19 vaccines (more than 110 million from ChAdOx1 nCoV-19). VITT seems to be a very rare but serious adverse event following COVID-19 immunization, especially adenoviral vector immunization.
目的
描述巴西发生的一系列与 COVID-19 疫苗接种相关的免疫性血栓性血小板减少症（VITT）病例，这些病例涉及 ChAdOx1 nCoV-19、Ad26.COV2.S 和 BNT162b2 疫苗，描述其临床和实验室特征。
方法
本研究采用巴西布坦坦研究所/Fiocruz/阿斯利康的生物制品和免疫制剂国家中心和国家免疫计划/卫生部（NIP/MoH）的 COVID-19 疫苗不良反应监测数据进行描述性病例系列研究。我们从疫苗不良反应监测的药物警戒中获取患者水平数据，并使用 NIP/MoH 和生物制品和免疫制剂国家中心药物警戒数据库创建研究数据库。纳入了 39 例疑似 VITT 病例，其中 36 例与 ChAdOx1 nCoV-19 相关，1 例与 BNT162b2 相关，2 例与 Ad26.COV2.S 疫苗相关。所有病例均基于符合布莱顿协作组 VITT 标准。主要结局指标包括临床和实验室特征、血栓形成部位和 PF4 ELISA（如果有）。
结果
39 例病例符合标准，其中 38 例根据布莱顿协作组标准分类为 1 级，1 例为 3 级。大多数病例（21/39）的血栓形成主要部位为中枢神经系统（CNS），且均发生在首剂疫苗接种后（34/39）。病例的中位年龄为 41 岁（23-86 岁）。大多数病例（61.5%）发生在女性。从接种疫苗到出现症状的中位间隔为 8 天（0-37 天）。血小板计数和 D-二聚体的中位数分别为 34,000/µL 和 19,235µg FEU/L。18 份样本的 ELISA 抗 PF4 抗体阳性。总死亡率为 51%，CNS 血栓伴颅内出血的死亡率更高。
结论
本病例系列研究表明，巴西 VITT 病例具有与文献报道相似的临床和实验室特征。巴西已接种超过 3 亿剂 COVID-19 疫苗（其中超过 1.1 亿剂来自 ChAdOx1 nCoV-19）。VITT 似乎是 COVID-19 免疫接种后一种非常罕见但严重的不良事件，尤其是腺病毒载体免疫接种。
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