Arterial events, venous thromboembolism, thrombocytopenia, and bleeding after vaccination with Oxford-AstraZeneca ChAdOx1-S in Denmark and Norway: population based cohort study.
Arterial events, venous thromboembolism, thrombocytopenia, and bleeding after vaccination with Oxford-AstraZeneca ChAdOx1-S in Denmark and Norway: population based cohort study.
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DOI：
10.1136/bmj.n1114
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发表时间：
2021-05-05
期刊：
影响因子：
--
通讯作者：
Hviid A
中科院分区：
文献类型：
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作者：
Pottegård A;Lund LC;Karlstad Ø;Dahl J;Andersen M;Hallas J;Lidegaard Ø;Tapia G;Gulseth HL;Ruiz PL;Watle SV;Mikkelsen AP;Pedersen L;Sørensen HT;Thomsen RW;Hviid A
旨在评估丹麦和挪威接种牛津-阿斯利康疫苗 ChAdOx1-S 后头 28 天内心血管和止血事件的发生率，并将其与一般人群中观察到的发生率进行比较。基于人群的队列研究。丹麦和挪威的全国医疗保健登记册。 2021 年 2 月 9 日至 2021 年 3 月 11 日期间首次接种 ChAdOx1-S 疫苗的所有 18-65 岁人群。丹麦 (2016-18) 和挪威 (2018-19) 的一般人群作为比较队列。根据两国一般人群的国家年龄和性别特定背景率，观察接种疫苗人群中因动脉事件、静脉血栓栓塞、血小板减少/凝血障碍和出血而发生的 28 天医院接触率与预期发生率的比较。接种疫苗的人群包括丹麦的 148-792 人（中位年龄 45 岁，80% 女性）和挪威的 132-472 人（中位年龄 44 岁，78% 女性），他们接受了第一剂 ChAdOx1-S。在接受 ChAdOx1-S 的 281~264 名患者中，动脉事件的标准化发病率为 0.97（95% 置信区间为 0.77 至 1.20）。在接种疫苗的队列中观察到 59 例静脉血栓栓塞事件，而根据普通人群的发病率预期为 30 例，对应于每 100000 次疫苗接种的标准化发病率为 1.97（1.50 至 2.54）和 11 例（5.6 至 17.0）例超额事件。观察到脑静脉血栓形成率高于预期：标准化发病率 20.25（8.14 至 41.73）；每 100 000 次疫苗接种中超过 2.5 个（0.9 至 5.2）个事件。任何血小板减少/凝血障碍的标准化发病率为 1.52（0.97 至 2.25），任何出血的标准化发病率为 1.23（0.97 至 1.55）。疫苗组中观察到 15 人死亡，而预期死亡人数为 44 人。在 ChAdOx1-S 的接受者中，观察到静脉血栓栓塞事件（包括脑静脉血栓形成）的发生率增加。对于其余的安全结果，结果在很大程度上令人放心，血小板减少/凝血障碍和出血的发生率略高，这可能受到对疫苗接种者加强监测的影响。然而，静脉血栓栓塞事件的绝对风险很小，应根据疫苗已证明的有益效果、特定国家的背景以及研究结果的普遍性的局限性来解释研究结果。
To assess rates of cardiovascular and haemostatic events in the first 28 days after vaccination with the Oxford-AstraZeneca vaccine ChAdOx1-S in Denmark and Norway and to compare them with rates observed in the general populations. Population based cohort study. Nationwide healthcare registers in Denmark and Norway. All people aged 18-65 years who received a first vaccination with ChAdOx1-S from 9 February 2021 to 11 March 2021. The general populations of Denmark (2016-18) and Norway (2018-19) served as comparator cohorts. Observed 28 day rates of hospital contacts for incident arterial events, venous thromboembolism, thrombocytopenia/coagulation disorders, and bleeding among vaccinated people compared with expected rates, based on national age and sex specific background rates from the general populations of the two countries. The vaccinated cohorts comprised 148 792 people in Denmark (median age 45 years, 80% women) and 132 472 in Norway (median age 44 years, 78% women), who received their first dose of ChAdOx1-S. Among 281 264 people who received ChAdOx1-S, the standardised morbidity ratio for arterial events was 0.97 (95% confidence interval 0.77 to 1.20). 59 venous thromboembolic events were observed in the vaccinated cohort compared with 30 expected based on the incidence rates in the general population, corresponding to a standardised morbidity ratio of 1.97 (1.50 to 2.54) and 11 (5.6 to 17.0) excess events per 100 000 vaccinations. A higher than expected rate of cerebral venous thrombosis was observed: standardised morbidity ratio 20.25 (8.14 to 41.73); an excess of 2.5 (0.9 to 5.2) events per 100 000 vaccinations. The standardised morbidity ratio for any thrombocytopenia/coagulation disorders was 1.52 (0.97 to 2.25) and for any bleeding was 1.23 (0.97 to 1.55). 15 deaths were observed in the vaccine cohort compared with 44 expected. Among recipients of ChAdOx1-S, increased rates of venous thromboembolic events, including cerebral venous thrombosis, were observed. For the remaining safety outcomes, results were largely reassuring, with slightly higher rates of thrombocytopenia/coagulation disorders and bleeding, which could be influenced by increased surveillance of vaccine recipients. The absolute risks of venous thromboembolic events were, however, small, and the findings should be interpreted in the light of the proven beneficial effects of the vaccine, the context of the given country, and the limitations to the generalisability of the study findings.
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DOI：
10.1016/s0140-6736(20)32661-1
发表时间：
2021-01-09
期刊：
Lancet (London, England)
影响因子：
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2020-12-31
期刊：
The New England journal of medicine
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期刊：
Lancet (London, England)
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2021-06-03
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The New England journal of medicine
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2021-02-04
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