青少年特发性关节炎肺炎球菌多糖疫苗免疫的有效性和安全性:开放研究的初步结果

Екатерина Иосифовна Алексеева, М. А. Солошенко, Т. М. Дворяковская, О. Л. Ломакина, Рина Валериановна Денисова, К. Б. Исаева, А. В. Карасёва
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引用次数: 1

摘要

青少年特发性关节炎(JIA)是儿童最常见、致残性最强的风湿性疾病之一。接受免疫抑制和基因工程生物药物治疗的JIA患儿属于细菌和病毒感染的高危人群,包括那些接种预防性疫苗的儿童。目的:评价13价肺炎球菌多糖疫苗(PPV)治疗小儿JIA的疗效和安全性。方法。在一项前瞻性开放标签比较研究中,通过JIA患者血清中针对肺炎链球菌的特异性抗肺炎球菌抗体(anti-SPP)IgG水平来确定疫苗接种的效果。通过测定高灵敏度c反应蛋白和S-100蛋白以及不良事件的数量、记录上呼吸道感染和肺炎的数量、活动性关节炎关节的数量来评估疫苗接种的安全性。在使用甲氨蝶呤或依那西普治疗主要疾病期间,或在使用甲氨蝶呤或依那西普前3周,皮下接种一剂0.5 ml的13价PPV疫苗。随访1年。结果。该研究纳入了42例JIA患儿:21例处于疾病活跃期,21例处于疾病缓解期。由于接种疫苗,JIA患儿的抗肺炎球菌抗体(antiSPP)IgG水平从26.1 (14.3;52.1)至73.0 (52.5;156.0) mg/l (p = 0.001), JIA从27.4 (18.2;59.1)至54.6 (35.3;96.0) mg/l (p = 0.029)接种后S-100蛋白高活性预测因子浓度未升高(p = 0.192)。所有患者的JIA加重发作均未固定。在试验期间未观察到严重的不良事件。结论。JIA患儿接种13价PPV疫苗非常有效,不伴有疾病活动性的恶化/增加和严重不良事件的发生。
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Эффективность и безопасность иммунизации пневмококковой полисахаридной вакциной детей с ювенильным идиопатическим артритом: предварительные результаты проспективного открытого исследования
Juvenile idiopathic arthritis (JIA) is one of the most frequent and most disabling rheumatic diseases in children. Children with JIA receiving immunosuppressive and genetically engineered biologic drugs belong to the high-risk group for the development of bacterial and viral infections, including those administered by preventive vaccines. Objective: Our aim was to evaluate the efficacy and safety of 13-valent pneumococcal polysaccharide vaccine (PPV) in children with JIA. Methods. In a prospective open-label comparative study, the efficacy of vaccination was determined by the level of specific anti-pneumococcal antibodies (anti-SPP)IgG to Streptococcus pneumonia in the blood serum in patients with JIA. The safety of vaccination was assessed by determining a high-sensitivity C-reactive protein and S-100 protein as well as by the number of adverse events, by recording the number of infections of the upper respiratory tract and pneumonias, by the number of joints with active arthritis. Vaccination with 13-valent PPV was performed subcutaneously with one dose of 0.5 ml during therapy of the main disease with methotrexate or etanercept or 3 weeks before the appointment of methotrexate or etanercept. Patients were followed up for 1 year. Results. The study included 42 children with JIA: 21 with JIA in the active phase of the disease, 21 in remission of the disease. As a result of vaccination, the level of anti-pneumococcal antibodies (antiSPP)IgG increased in the group of children with JIA in the active phase from 26.1 (14.3; 52.1) to 73.0 (52.5; 156.0) mg/l (p = 0.001), with JIA in remission — from 27.4 (18.2; 59.1) to 54.6 (35.3; 96.0) mg/l (p = 0.029). The concentration of the predictor of S-100 protein high activity after vaccination was not increased (p = 0.192). JIA aggravation episodes were not fixed in any patient. Serious adverse events were not observed during the trial. Conclusion. The vaccination of children with JIA with 13-valent PPV is highly effective, not accompanied by exacerbation/increase in the activity of the disease and the development of serious adverse events.
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