Voss Erica A, Shoaibi Azza, Yin Hui Lai Lana, Blacketer Clair, Alshammari Thamir, Makadia Rupa, Haynes Kevin, Sena Anthony G, Rao Gowtham, van Sandijk Sebastiaan, Fraboulet Clement, Boyer Laurent, Le Carrour Tanguy, Horban Scott, Morales Daniel R, Martínez Roldán Jordi, Ramírez-Anguita Juan Manuel, Mayer Miguel A, de Wilde Marcel, John Luis H, Duarte-Salles Talita, Roel Elena, Pistillo Andrea, Kolde Raivo, Maljković Filip, Denaxas Spiros, Papez Vaclav, Kahn Michael G, Natarajan Karthik, Reich Christian, Secora Alex, Minty Evan P, Shah Nigam H, Posada Jose D, Garcia Morales Maria Teresa, Bosca Diego, Cadenas Juanino Honorio, Diaz Holgado Antonio, Pedrera Jiménez Miguel, Serrano Balazote Pablo, García Barrio Noelia, Şen Selçuk, Üresin Ali Yağız, Erdogan Baris, Belmans Luc, Byttebier Geert, Malbrain Manu L N G, Dedman Daniel J, Cuccu Zara, Vashisht Rohit, Butte Atul J, Patel Ayan, Dahm Lisa, Han Cora, Bu Fan, Arshad Faaizah, Ostropolets Anna, Nyberg Fredrik, Hripcsak George, Suchard Marc A, Prieto-Alhambra Dani, Rijnbeek Peter R, Schuemie Martijn J, Ryan Patrick B
OHDSI Collaborators, Observational Health Data Sciences and Informatics (OHDSI), New York, NY, USA.
Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, the Netherlands.
EClinicalMedicine. 2023 Apr;58:101932. doi: 10.1016/j.eclinm.2023.101932. Epub 2023 Apr 4.
Adverse events of special interest (AESIs) were pre-specified to be monitored for the COVID-19 vaccines. Some AESIs are not only associated with the vaccines, but with COVID-19. Our aim was to characterise the incidence rates of AESIs following SARS-CoV-2 infection in patients and compare these to historical rates in the general population.
A multi-national cohort study with data from primary care, electronic health records, and insurance claims mapped to a common data model. This study's evidence was collected between Jan 1, 2017 and the conclusion of each database (which ranged from Jul 2020 to May 2022). The 16 pre-specified prevalent AESIs were: acute myocardial infarction, anaphylaxis, appendicitis, Bell's palsy, deep vein thrombosis, disseminated intravascular coagulation, encephalomyelitis, Guillain- Barré syndrome, haemorrhagic stroke, non-haemorrhagic stroke, immune thrombocytopenia, myocarditis/pericarditis, narcolepsy, pulmonary embolism, transverse myelitis, and thrombosis with thrombocytopenia. Age-sex standardised incidence rate ratios (SIR) were estimated to compare post-COVID-19 to pre-pandemic rates in each of the databases.
Substantial heterogeneity by age was seen for AESI rates, with some clearly increasing with age but others following the opposite trend. Similarly, differences were also observed across databases for same health outcome and age-sex strata. All studied AESIs appeared consistently more common in the post-COVID-19 compared to the historical cohorts, with related meta-analytic SIRs ranging from 1.32 (1.05 to 1.66) for narcolepsy to 11.70 (10.10 to 13.70) for pulmonary embolism.
Our findings suggest all AESIs are more common after COVID-19 than in the general population. Thromboembolic events were particularly common, and over 10-fold more so. More research is needed to contextualise post-COVID-19 complications in the longer term.
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针对新型冠状病毒肺炎（COVID-19）疫苗，预先指定了特殊关注的不良事件（AESIs）进行监测。一些AESIs不仅与疫苗有关，还与COVID-19有关。我们的目的是描述患者感染严重急性呼吸综合征冠状病毒2（SARS-CoV-2）后AESIs的发病率，并将这些发病率与普通人群的历史发病率进行比较。
一项多国队列研究，数据来自初级保健、电子健康记录以及映射到通用数据模型的保险理赔。本研究的证据收集于2017年1月1日至每个数据库结束（时间范围从2020年7月至2022年5月）。预先指定的16种常见AESIs为：急性心肌梗死、过敏反应、阑尾炎、贝尔麻痹、深静脉血栓形成、弥散性血管内凝血、脑脊髓炎、吉兰-巴雷综合征、出血性卒中、非出血性卒中、免疫性血小板减少症、心肌炎/心包炎、发作性睡病、肺栓塞、横贯性脊髓炎以及血小板减少伴血栓形成。估计年龄-性别标准化发病率比（SIR），以比较每个数据库中COVID-19感染后与大流行前的发病率。
观察到AESIs发病率在年龄方面存在显著异质性，一些发病率随年龄明显增加，而另一些则呈相反趋势。同样，在相同健康结局和年龄-性别分层的不同数据库之间也观察到差异。与历史队列相比，所有研究的AESIs在COVID-19感染后似乎始终更为常见，相关的荟萃分析SIR范围从发作性睡病的1.32（1.05至1.66）到肺栓塞的11.70（10.10至13.70）。
我们的研究结果表明，所有AESIs在COVID-19感染后都比普通人群中更为常见。血栓栓塞事件尤为常见，其发生率高出10倍以上。需要更多研究以长期了解COVID-19感染后的并发症情况。
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