在免疫炎症性风湿病患者中使用联合载体疫苗GamCOVID-Vac (Sputnik V):安全性问题-新闻

А. Н. Куликов, Н.В. Муравьева, Б. С. Белов, С. И. Глухова, A. Kulikov, N. Muravyeva, B. Belov, S. Glukhova, V. A. N. Research, Белов Борис Сергеевич
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摘要

该研究的目的是评估Gam-COVID-Vac (Sputnik V)联合载体疫苗的安全性,并确定免疫炎症性风湿病(IIRD)患者发生不良事件的危险因素。患者和方法。对正在住院治疗或向va Nasonova风湿病研究所咨询和诊断中心申请的IIRD患者进行了单阶段研究,这些患者接受了Sputnik V疫苗的两种成分。对照组为无IIRD的免疫者。一名研究医生对所有参与者进行了访谈,并填写了一份统一的问卷,从医疗文件中获得了额外的信息。结果。该研究包括325名IIRD患者和138名健康对照者。接种第一种成分后,发生局部和全身不良事件(ae)的IIRD患者数量显著低于对照组(分别为20.3%和38.4%;p < 0.001)。这些差异在第二组分免疫后仍然存在(分别为12.3%和28.3%,p<0.001)。完全接种疫苗后,40.3%的患者和22.5%的对照组未发生不良反应(p<0.001)。女性以及可能的甲氨蝶呤治疗增加了在疫苗的第一个组成部分(美罗华单抗治疗)上发生局部和全身不良反应的风险。老年患者、病程超过10年的患者和肥胖患者的ae发生率较低。IIRD加重1例(0.3%),未出现新的自身免疫现象。结论。根据获得的数据,在IIRD患者中使用Gam-COVID-Vac (Sputnik V)是安全的。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
The use of the combined vector vaccine GamCOVID-Vac (Sputnik V) in patients with immuno-inflammatory rheumatic diseases: safety issues-news
The aim of the study was to assess the safety of the combined vector vaccine Gam-COVID-Vac (Sputnik V) and to determine the risk factors for the development of adverse events in patients with immuno-inflammatory rheumatic diseases (IIRD). Patients and methods. A single-stage study of patients with IIRD who were on inpatient treatment or who applied to the consultative and diagnostic center of the V.A. Nasonova Research Institute of Rheumatology was conducted, who received both components of the Sputnik V vaccine. The control group included immunized persons without IIRD. All participants were interviewed by a research doctor with filling out a unified questionnaire, additional information was obtained from medical documentation. Results. The study included 325 patients with IIRD and 138 healthy controls. After vaccination with the first component, the number of patients with IIRD, in whom the development of local and systemic adverse events (AEs) was noted, was significantly lower compared to the control (20.3% and 38.4% respectively; p<0.001). These differences also persisted after immunization with the second component (12.3% and 28.3% respectively, p<0.001). After complete vaccination, no AEs were documented in 40.3% of patients and 22.5% of the control group (p<0.001). Female sex and, possibly, methotrexate therapy increases the risk of developing local and systemic AEs on the first component of the vaccine, rituximab therapy - on the second. A lower incidence of AEs is typical for elderly patients, patients with a disease duration of more than 10 years and obesity. Exacerbation of IIRD was registered in 1 (0.3%) case, the occurrence of new autoimmune phenomena was not observed. Conclusions. According to the data obtained, the use of Gam-COVID-Vac (Sputnik V) in patients with IIRD is safe.
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