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阿根廷多发性硬化症患者接种疫苗后的 COVID-19 发病率:来自全国登记处 RelevarEM 的数据。

Incidence of COVID-19 after vaccination in people with multiple sclerosis in Argentina: Data from the nationwide registry RelevarEM.

机构信息

Centro de esclerosis múltiple de Buenos Aires, Billinghurst 1611, Buenos Aires CP 1181, Argentina; Servicio de Neurología, Unidad de EM y Enfermedades Desmielinizantes, Hospital Universitario de CEMIC, Buenos Aires, Argentina.

Instituto de Neurociencias de Rosario, San Lorenzo, Rosario, Santa Fé, Argentina.

出版信息

Mult Scler Relat Disord. 2022 Dec;68:104104. doi: 10.1016/j.msard.2022.104104. Epub 2022 Aug 12.

Abstract

UNLABELLED

The objective of the study was to evaluate the incidence of COVID-19 after complete vaccination in people with multiple sclerosis (PwMS) included in the Argentinean MS and NMOSD registry (RelevarEM, NCT03375177).

METHODS

cohort study conducted between May 2021 and December 2021. The primary outcome was the appearance of infection during the follow-up time (at least three months after complete vaccination (second dose)). Data was collected through the contact between the treating physician and the patient. Specific information was requested (date, symptoms, need for hospitalization, ventilatory assistance, treatment, and evolution). The contact was made every 30 days during the period of 3 months after the full dose vaccination. A positive COVID-19 case was defined according to the definition established by the Ministry of Health in Argentina. Cumulative incidence was reported by Kaplan Meier survival curves as well as incidence density.

RESULTS

A total of 576 PwMS were included, mean age 45.2 ± 13 years, 432 (75%) RRMS, 403 (70%) were female. The mean and median time of follow-up after the second dose was 91 ± 17 and 94 ± 21 days respectively. Most frequent first and second dose received was Astra-Zeneca vaccine, followed by Sputnik V vaccine. During follow-up a total of twenty COVID-19 cases were observed for a total exposure time of 39,557 days. The overall cumulative incidence for the observed period was 3.4% (SE 0.4%) with an overall incidence density of 5 × 10.000 patients/day (95%CI 0.7-12). We observed more cases in woman than men with an incidence density of 6 × 10.000 patients/day (95%CI 0.9-9) vs. 3 × 10.000 patients/day (95%CI 0.2-6) respectively, but not significantly different (IRR 1.7 95% CI 0.56-7.37 p = 0.15).

CONCLUSION

we found an incidence density of breakthrough COVID-19 infection of 5 × 10.000 patients/day (95%CI 0.7-12) after vaccination in Argentina.

摘要

目的

评估纳入阿根廷多发性硬化症和 NMOSD 登记处(RelevarEM,NCT03375177)的多发性硬化症患者(PwMS)完全接种疫苗后的 COVID-19 发病率。

方法

这是一项在 2021 年 5 月至 2021 年 12 月期间进行的队列研究。主要结局是在随访期间(至少在完全接种疫苗(第二剂)后三个月)出现感染。通过治疗医生与患者之间的联系收集数据。要求提供具体信息(日期、症状、住院需求、通气支持、治疗和进展)。在完全接种剂量后 3 个月的期间内,每 30 天进行一次联系。根据阿根廷卫生部规定的定义,将 COVID-19 阳性病例定义为阳性病例。通过 Kaplan-Meier 生存曲线和发病率密度报告累积发病率。

结果

共纳入 576 名 PwMS,平均年龄为 45.2±13 岁,432 名(75%)为 RRMS,403 名(70%)为女性。第二剂后随访的平均和中位数时间分别为 91±17 和 94±21 天。最常接种的第一和第二剂疫苗分别是阿斯利康疫苗和 Sputnik V 疫苗。在随访期间,共观察到 20 例 COVID-19 病例,总暴露时间为 39557 天。观察期间的总累积发病率为 3.4%(SE 0.4%),总发病率密度为 5×10.000 例/患者/天(95%CI 0.7-12)。我们观察到女性的病例多于男性,发病率密度分别为 6×10.000 例/患者/天(95%CI 0.9-9)和 3×10.000 例/患者/天(95%CI 0.2-6),但差异无统计学意义(IRR 1.7,95%CI 0.56-7.37,p=0.15)。

结论

我们发现,在阿根廷,接种疫苗后突破性 COVID-19 感染的发病率密度为 5×10.000 例/患者/天(95%CI 0.7-12)。

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