23价肺炎球菌多糖疫苗对脊柱炎患者的免疫原性、安全性和临床疗效(初步数据)

M. Baranova, N. Muravyeva, B. Belov, M. Cherkasova, Z. Verizhnikova, T. Korotaeva
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引用次数: 2

摘要

背景。免疫抑制药物被广泛用于治疗脊柱炎(SpA)患者,以有效控制疾病的活动性。与此同时,这些药物的使用与发生上呼吸道和下呼吸道感染的风险增加有关,这可以通过接种疫苗来预防。本研究的目的是评估23价肺炎球菌多糖疫苗(PPV-23)在SpA患者中的免疫原性、安全性和临床疗效。材料和方法。该研究包括54例SpA患者:39例强直性脊柱炎患者,15例银屑病关节炎患者。大多数患者有2例或2例以上下呼吸道感染史,2例患者报告慢性鼻窦炎每月加重,1例患者报告每2 - 3个月出现中耳炎。在纳入研究时,72%的患者接受了免疫抑制治疗。PPV-23在持续抗风湿病治疗的背景下以1剂(0.5 ml)的剂量给药。使用EIA PCP IgG试剂盒(TestLine Clinical Diagnostics s.r.o,捷克共和国)在基线、接种疫苗后1、3和12个月检测肺炎球菌荚膜多糖抗体水平。评估PPV-23的耐受性、疫苗接种对SpA活性的影响(根据BASDAI指数的动态)以及上呼吸道和下呼吸道感染的发生率。结果。与基线相比,接种疫苗后1、3和12个月的肺炎球菌荚膜多糖抗体浓度显著升高。接种疫苗对SpA活性和“新的”自身免疫性疾病的出现没有负面影响。76%的患者对疫苗耐受良好。观察期间仅有1例患者出现肺炎。经常患有鼻窦炎和中耳炎的患者在接种疫苗后报告没有这些感染。结论。研究的初步结果表明PPV-23在SpA患者中具有足够的免疫原性、安全性和临床疗效。
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Immunogenicity, Safety, and Clinical Effectiveness of the 23-Valent Pneumococcal Polysaccharide Vaccine in Patients With Spondyloarthritis (Preliminary Data)
Background. Immunosuppressive drugs are widely used for the treatment of patients with spondyloarthritis (SpA) to effectively control the activity of the disease. At the same time, the use of these drugs is associated with an increased risk of developing infections of the upper and lower respiratory tract, which can be prevented by vaccination. The aim of the study was to evaluate the immunogenicity, safety, and clinical efficacy of the 23-valent pneumococcal  polysaccharide vaccine (PPV-23) in patients with SpA. Material and methods. The study included 54 patients with SpA: 39 with ankylosing spondylitis, and 15 with psoriatic arthritis. Most patients had a history of two or more cases of lower respiratory tract infections, 2 patients reported a monthly exacerbation of chronic sinusitis, one patient reported the development of otitis every 2–3 months. 72% of patients received immunosuppressive therapy at the time of inclusion in the study. PPV-23 was administered in the amount of 1 dose (0.5 ml) against the background of ongoing antirheumatic therapy. The level of antibodies to pneumococcal capsular polysaccharide was determined using the EIA PCP IgG kit (TestLine Clinical Diagnostics s.r.o., Czech Republic) at baseline, after 1, 3, and 12 months after vaccination. The tolerability of PPV-23, the effect of vaccination on SpA activity (according to the dynamics of the BASDAI index), and the incidence of upper and lower respiratory tract infections were assessed. Results. The concentration of antibodies to pneumococcal capsular polysaccharide was significantly higher 1, 3, and 12 months after vaccination compared to baseline. There was no negative effect of vaccination on the activity of SpA and the emergence of «new» autoimmune disorders. The vaccine was well tolerated by 76% of patients., Only one patient developed pneumonia during the observation period. Patients suffering from frequent sinusitis and otitis reported the absence of these infections after vaccination. Conclusions. Preliminary results of the study indicate sufficient immunogenicity, safety, and clinical efficacy of PPV-23 in patients with SpA.
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