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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.
The issue of a therapy of children with juvenile idiopathic arthritis (JIA) with intolerance or insufficient effectiveness of methotrexate remains actual.
Objective: Our aim was to study the efficacy and safety of tocilizumab in patients with polyarticular JIA.
Methods. In a retrospective study, we studied the results of the use of tocilizumab in patients with active polyarticular JIA ( 5 active joints) resistant to prior therapy with methotrexate or a combination of methotrexate with other nonbiologic disease-modifying antiinflammatory drugs.
Results. The data of 40 children (83% girls) with the onset median of polyarticular JIA of 4.8 (2.9, 8.1) years and the interval between the disease onset and the initiation of tocilizumab therapy of 5.7 (1.8, 8.5) years was analyzed. Tocilizumab was used as an intravenous infusion of 8 mg/kg (with a weight 30 kg) or 10 mg/kg (with a weight < 30 kg) every 4 weeks. The duration of tocilizumab monotherapy in 5 (13%) children was 1,109 days (452; 1,542). The stages of inactive disease (according to the criteria of C. Wallace, 2004) in 6 months of tocilizumab therapy reached 6 (15%) patients, in 42 months — 32 (80%) patients. In 3 patients, tocilizumab was canceled due to persistent remission. After 6 months of treatment, there was a marked decrease in erythrocyte sedimentation rate, C-reactive protein concentration, number of leukocytes and platelets (in all cases, p < 0.001) to normal values, which persisted throughout the whole period of drug administration. Predictors for achieving inactive disease were the initial (at the onset of tocilizumab therapy) number of peripheral blood leukocytes < 9.0X109/l [relative risk (RR) 1.92; 95% confidence interval (CI) 0.9–4.6)] and the absence of prior biological therapy (RR 1.92, 95% CI 0.9–4.6). The most frequent side effects of tocilizumab therapy were transient hypercholesterolemia (in 13), hypertriglyceridemia (in 4), transient grade II neutropenia (in 1).
Conclusion. The long-term efficacy and relative safety of tocilizumab in children with polyarticular JIA have been showed.
Meningococcal infection is an acute disease caused by Neisseria meningitidis, which proceeds with a diverse clinical aspect from nasopharyngitis to meningococcal meningitis and meningococcemia. Since 2014, a tetravalent meningococcal conjugate vaccine has been registered in Russia. This vaccine creates protection against serogroups A, C, W-135, Y and can be used from the age of nine months to 55 years. The actual issue is a vaccine tolerability, including when combined with other vaccine preparations.
Objective: Our aim was to evaluate the safety of a tetravalent meningococcal conjugate vaccine against serogroups A, C, Y and W-135 when it is combined with other vaccine preparations.
Methods. A prospective full-design study assessed the tolerability of immunization with a meningococcal conjugate vaccine, both in case of monovaccination and in combination with a pneumococcal 13-valent conjugate vaccine, measles-mumps-rubella, viral hepatitis A, influenza, and chicken pox vaccines.
Results. 97 children aged from 9 months to 18 years were vaccinated, 20 of them were healthy and 77 had medical issues (with allergic pathology, ENT diseases, cardiovascular and nervous system diseases, lung diseases as well as orphan diseases). Among vaccinated children, general reactions were observed in 3/97 (3.1%) children, local reactions — in 5 (5.2%). The post-vaccination period passed asymptomatically and uneventfully in the prevailing majority of children vaccinated with a tetravalent meningococcal conjugate vaccine (in 91, 93.8%).
Conclusion. The immunization with a tetravalent meningococcal conjugate vaccine against serogroups A, C, Y, W-135 is well tolerated, both in case of monovaccination and in combination with other vaccine preparations, in healthy children of different age groups and in patients with different health status.
The brain activity of a newborn affects postnatal adaptation, the disorder of which can cause dysfunction of organs and systems of the immature organism and the development of diseases in more distant periods of maturation.
Objective: Our aim was to study the effect of levocarnitine on dynamics of the brain bioelectrical activity formation in term infants delivered by cesarean section.
Methods. The study included term infants (gestation period 38–40 weeks) delivered by cesarean section, with perinatal hypoxic lesion of the central nervous system (cerebral ischemia). Children were randomized into groups of standard (recommended) treatment and standard treatment enhanced with levocarnitine (plus levocarnitine) — 30% oral solution at a dose of 100 mg/kg per day for 3 weeks starting from the 7th day of life. The brain bioelectrical activity was assessed with electroencephalography (EEG) of the natural sleep period on the 3rd–6th day and then at 3, 6, and 12 months.
Results. 45 children were randomized into groups of standard treatment and standard treatment plus levocarnitine, of which 44 and 40 children completed the study, respectively. Initially, the delayed formation of age-related brain activity was detected in 16/40 (40%) children receiving levocarnitine and in 19/44 (43%) in the experimental group (p = 0.767), disturbances in the EEG sleep pattern with generation of background anomalies — in 17 (43%) and 16 (36%) (p = 0.565), pathological graph elements — in 1 (3%) and 2 (5%) children (p = 0.536), respectively. According to the dynamic EEG control results, it was found that after 1 year the cerebral dysfunction was registered less frequently in children receiving levocarnitine — in 32 (80%) vs. 42 (96%) children in the group of standard treatment (p = 0.028).
Conclusion. Adminisration of levocarnitine in the neonatal period reduces the risk of developing cerebral dysfunction by the end of the first year of life.
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