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Aim. To assess the clinical and immunological features in patients with chronic opisthorchiasis, depending on the duration of the infection. Methods. The first group consisted of 19 patients with the duration of the infection up to 1 year, the second group consisted of 21 patients with the duration of the infection between 1 and 5 years, the third group was formed of 23 patients with the duration of the disease more than 5 years, the control group 20 healthy individuals. Immunological research was carried out at the Clinical Diagnostic Center. Statistical processing was performed using Microsoft Excel 2010 and Statistica 6.0 software. The statistical significance of differences was determined by using the MannWhitney test (U-test) at the level of significance of p 0.05. The correlations were assessed by calculating Spearman's rank correlation coefficients.Results Clinical features of chronic opisthorchiasis were revealed in the disease duration groups of up to 1 year, from 1 year to 5 years, more than 5 years: the subclinical course was most common in the group of up to 1 year; cholangiohepatitis prevailed in the group of between 1 to 5 years, allergic skin syndrome, cholangiocholecystitis and pancreatitis dominated in the group of more than 5 years. The immune response in chronic opisthorchiasis was characterized by: up to 1 year lymphocytosis, increased levels of immunoglobulins M (IgM) and circulating immune complexes (CIC), a decrease in the number of T-lymphocytes (CD3+), as well as an increase in bactericidal activity of leukocytes (BAL); between 1 and 5 years monocytosis, increased levels of immunoglobulins M, immunoglobulins G and circulating immune complexes, a decrease in T-cytotoxic lymphocytes (CD8+) and nitro blue tetrazolium (NBT test), as well as an increase in NK cells and phagocytic activity of monocytes, more than 5 years eosinophilia. Conclusion. Common features of rearrangement of the immune system in opisthorchiasis: inflammatory changes in the hemogram, activation of humoral immunity with parallel suppression of the cellular component of the immune system, and increased phagocytosis.

Background. The Hemoblastoses are one of the urgent problems of oncohematology. Modern methods for the treatment of hemoblastoses have improved the prognosis significantly. However, the use of chemotherapy is accompanied by a high frequency of drug complications, including those associated with neurotoxicity. The addition of neurological symptoms to the main clinical picture of the disease significantly aggravates the patients condition, affects the prognosis and quality to life. Aim. Compare clinical picture and neurophysiological signs of chemo-induced polyneuropathy in children with acute lymphoblastic leukemia. Materials and methods. Neurological examination and electromyography (EMG), were conducted in 21 children aged 3 to 17 years in Regional Children Clinical Hospital of Yekaterinburg from 2019 to 2020. Results. In the study group, the signs of peripheral polyneuropathy, were revealed in almost all patients receiving induction chemotherapy (95.2%) while clinical neurological symptoms were found in 25% patients. During a 4-month follow-up, all children with subclinical signs of peripheral nerve damage developed corresponding neurological symptoms. According to EMG, the number of patients with mixed polyneuropathy increased by 1.7 times. In every third child, the amplitude of the M-response and nerve conduction velocity, were decreased. Conclusions. Therefore, neurophysiological examination should be performed at an early stage to identify high-risk groups for neurotoxic complications in children with acute lymphoblastic leukemia receiving chemotherapy as timely administration of therapeutic treatment is required.

The aim of the study was to carry out a meta-analysis of randomized clinical trials in order to combine the results of clinical trials on Triazavirin® (Riamilovir) efficacy in etiotropic therapy of influenza.Materials and methods. The analysis was carried out in accordance with the PRISMA principles regarding the quality of information presentation on the results of systematic reviews and meta-analyzes of works assessing medical interventions. The study included 471 patients with a confirmed diagnosis of influenza (with laboratory confirmed presence of influenza virus antigens).Results. The conducted meta-analysis showed that the use of Triazavirin® (Riamilovir) has a statistically significant effect on the severity of clinical symptoms in patients with influenza, therefore Riamilovir can be used in the initial therapy of adult patients with influenza.Conclusion. Clinical studies have shown that the use of Triazavirin® (Riamilovir) is effective both in the initial and late stages of the disease, and therefore Riamilovir can be used in the treatment of adult patients with respiratory diseases of viral etiology, in particular, those diagnosed with influenza. The meta-analysis of the collected data showed that therapy with Triazavirin® (Riamilovir) has statistically significant advantages in various aspects both in comparison with the placebo group and with the Tamiflu® (Oseltamivir) group.

The aimof the study was to carry out meta-analysis of randomized controlled trials in order to combine the results of clinical trials on Triazavirin®(Riamilovir) efficacy in the etiotropic therapy of acute respiratory viral infection.Materials and methods.The studies included 435 patients with a confirmed diagnosis of acute respiratory viral infection or ARVI (with laboratory confirmed absence of influenza virus antigens). The research was carried out in 27 centers. In studies, patients were divided into 3 groups in a 1:1:1 ratio (a total of 145 people per group). Each study included a group taking 100 mg of the medication 5 times a day, a group taking 250 mg of the medication 3 times a day and a placebo 2 times a day, as well as a group taking a placebo 5 times a day. The analysis was carried out in accordance with the PRISMA principles regarding the quality of information presentation on the results of systematic reviews and meta-analyzes of works evaluating the effects of medical interventions.Results. The conducted meta-analysis showed that the use of Triazavirin®(Riamilovir) has a statistically significantly effects on the severity of clinical symptoms in patients with ARVI. The performed meta-analysis confirmed reliable associations between the use of Triazavirin®(Riamilovir) in both doses and the chance of a persistent improvement in clinical symptoms on the 5thday of therapy. The meta-analysis also confirmed the statistical significance of the clinical effects of Riamilovir by such indicators as the area under the curve «point on the scale showing the severity of the condition in a patient with ARVI in relation to time», the proportion of patients with complete alleviation of all symptoms by the end of the 5th day from the start of therapy.Conclusion.The clinical trials proved that the use of Triazavirin®(Riamilovir) is effective both in the initial and in the late stages of the disease, therefore, the drug can be used in the initial therapy of adult patients with respiratory diseases of viral etiology.

The assessment of the effectiveness, safety and tolerance of the drug Riamilovir for emergency drug prevention in the foci of a new coronavirus infection (COVID-19).The trial included 113 persons aged 18 years and older who had level 1 contacts with patients with a new coronavirus infection (COVID-19), who had not previously been ill, with negative PCR results for COVID-19.The high effectiveness, safety and good tolerance of the preventive use of the drug Riamilovir for the period of 20 days of taking a prophylactic dose of 1 capsule (250 mg) per day in the foci of COVID-19 has been established.The effectiveness and safety of the preventive use of the drug Riamilovir allow to recommend it for emergency drug prophylaxis in contact persons in the foci of a new coronavirus infection (COVID-19).Цель. Оценить эффективность, безопасность и переносимость препарата Риамиловир в качестве средства экстренной медикаментозной профилактики в очагах новой коронавирусной инфекции (COVID-19). Материалы и методы. В исследование включены 113 человек в возрасте 18 лет и старше, имевших контакты 1-го уровня с больными новой коронавирусной инфекцией (COVID-19), ранее не болевших, при наличии отрицательных результатов полимеразной цепной реакции на SARS-CoV-2. Результаты. Установлена высокая эффективность, безопасность и хорошая переносимость препарата Риамиловир на протяжении 20 дней приема профилактической дозы 1 капсула (250 мг) в день в очагах COVID-19. Заключение. Эффективность и безопасность профилактического приема препарата Риамиловир позволяют рекомендовать его для экстренной медикаментозной профилактики у контактных лиц в очагах новой коронавирусной инфекции (COVID-19).

Aim. Evaluation of the efficacy, safety, and tolerability of Riamilovir (trade name «Triazavirin®») in patients with mild COVID-19.Materials and methods. The randomized open-label study included 120 patients with clinical and epidemiological manifestations of coronavirus infection and its laboratory (PCR) confirmation.Results. The efficacy, safety, as well as good tolerability of Riamilovir in the treatment of new coronavirus infection (COVID-19) have been established.Conclusion. The results of the study on the efficacy, safety, and tolerability of Riamilovir allow us to recommend it as a means of etiotropic therapy of the new coronavirus infection (COVID-19).

Background. Tolerance to immunization with conjugate tetravalent vaccine against meningococcal infection (serotypes A, C, Y, W) for vulnerable categories of children has not been studied before. The aim of the study is to estimate the safety of the conjugate tetravalent vaccine against meningococcal disease serotypes A, C, Y, W in children who deprived of parental care. Methods. Our cohort prospective study included 1-4 years old children with distresses and chronic diseases (neurological disorders, congenital defects, genetic diseases, allergy) in closed healthcare facility. The safety of tetravalent conjugate meningococcal vaccine (serotypes A, C, Y, W) was measured in 24-hour hospital during 7 days after vaccination in two ways: mono-vaccination and combined vaccination (with other vaccines from National vaccination calendar). General and local adverse effects (AE) were registered. Results. 105 children were immunized. 94 children (89.5 %) had asymptomatic postvaccinal period after using monoand co-vaccination. General AEs such as fever, long-lasting crying, vomiting, diarrhea and drowsiness were not registered at all. Local AEs such as pain, hyperemia and edema in injection site were registered in 11 (10,5 %) children. All local AEs were mild and recovered fast both in mono-vaccination and combined vaccination. No aggravations of primary disease were mentioned. Conclusion. We can notice good immunization’s tolerance in children with diseases and parental deprevation using the conjugate tetravalent vaccination against meningococcal disease (serotypes A, C, Y, W) in mono-vaccination and combined vaccination.

Rengalin liquid formulation on the basis of antibodies to bradikinin histamine and morphine was specially designed for the treatment of cough in children. The three-component combination in therapeutically active against both dry and wet cough due to effect on diverse pathogenetic aspects of the cough reflex. The aim of the multicenter, comparative, randomized clinical trial was to estimate the efficacy and safety of rengalin in the treatment of cough in patients with acute respiratory infection (ARI) of the upper respiratory tract.One hundred forty six patients at the age of 3 to 17 years (the average age of 8.2 ± 3.6 years) from 14 medical centres of Russia were observed. The patients suffered from dry/nonproductive, frequent, sore cough preventing from day-time activity and/or night sleep (≥ 4 by the Cough Severity Scale). The cough duration ranged from 12 hours to 3 days. For 3 days the patients of group 1 (n = 71) and group 2 (n = 75) were treated with rengalin and sinekod (butamirate) respectively. For the following 4 days the patients (in case of viscid expectoration were treated with ambroxole in the age doses. The results of the Per Protokol Analysis (n = 67 rengalin group and n = 73 sinekod group) with an account of the Non-Infectiority Design are presented.In 3 days the number of the group 1 patients with significant improvement/recovery by the day and night estimates amounted to 90% and 88% respectively (vs. 81% and 88% in the group 2 patients, no night opisodes of cough after 3-days rengalin use being recorded in 52% of the patients vs. 34% in the sinekod group patients (p = 0.0003). On the 7th day of the treatment with rengalin the number of the children with significant improvement of or recovery from day-time cought amounted to 99%and that of the patients with significant improvement of or recovery from night-time cough amounted to 93%, in 90% of them no night-time cough being recorded (p = 0.0008). As for the patients of the reference group, the respective values were 93% and 90%, no night-time cough being recorded in 81% of the patients. The time required for development of productive/moist cough during the 3-day treatment course in the patients of both the group was the same (2.9 ± 0.3 days in the patients of group 1 and 2.9 ± 0.4 days in the group 2 patients. Moreover, in 34% of the rengalin dry cough became residual (as rare episode of tussiculation with scantly exudation). After 3-day course of the rengalin therapy, 66% of the patients was treated with ambroxole (versus 95% in sinecod group (p0.0001) based on comparative analysis and χ2 = 17.7, p0.0001 by the results of the frequency analysis). The total duration of cough in the patients of groups 1 and 2 was 6.5 ± 0.8 and 6.7 ± 0.7 days respectively (the comparability truth, p = 0.0001). The severity of the day-time cough by the area under the curve estimates for 7 days of the treatment in the rengalin group patients was equel to 14.3 ± 5.6 numbers--days and that of the patients of the sinekod? group was equal to 15.9?6.1 numbers - days. The severity of the night-time cough was equal to 4.2 ± 2.7 number--days respectively. In 2 patients (3%) treated with sinekod signs of ARI generalization was observed after the 3-day treatment (p0.0001). The research physicians-investigators (CGI-EL Scale) the combination of the anti- and protussive activities in one drug to be efficient and absolutely safe for the chilgren. The therapeutic efficacy in the patients of the rengalin group was higher in 3 days (2.1 ± 0.5 numbers) and even in 7 days (2.7 ± 0.5 numbers). The results value in the patients of the sinekod group being 1.8 ± 0.4 and 2.5 ± 0.6 numbers (one-wayANOVA for repeated estimates ANOVA: Visit - F(1/138) = 146, p0.0001, TREATMENT--F(1/138) = 9.0, p = 0.003). The factor of the side effects in the patients of the rengalin group was zero (no side effects due to the treatment were recorded in the patients), whereas in the patients treated with sinekod for 3 days the respective value was 0.1 ± 0.3 (true superiority of rengalin by the ANOVA data. TREATMENT--F(1/138) = 4.7, p = 0.03). The efficacy factor of the rengalin was also in its favour (ANOVA: Visit--F(1/138) = 182, p0.0001, TREATMENT--F(1y138) = 7.3, p = 0.008). In the patients treated with rengalin there were defected no deviations in the biochemical and general clinical analyses of blood and urine, no adverse reactions characteristic of antitussive drugs of the action. 100-percent adherence to the therapy was stated.He antitussive effect of rengalin in the treatment of frequent dry day-time and night-time cough was observed earlier and proved to be comparable with that of butamirate (sinekod). Rengalin prevented significant exudation and viscid expectoration in many patients, promoted rapid residual in the patients with dry cough and the patients recovery. The use of rengalin for 3 days significantly lowered the percentage of the patients requiring treatment with mucolytics at the subsequent stages of ARI.

The pediatric dosage form of Egroferon--a drug indicated for the treatment of influenza and acute respiratory infections (ARIs)--is developed taking in account the broad range of pathogens (most of which are viruses), and age-dependent features of immune system reactions (absence of specific immunity and immunological memory, relative "immaturity" of immune reactions, reduced interferon production by immunocompetent cells, etc.). Ergoferon interferes with the non-specific mechanisms of antiviral defence that ensure eliciting of an immune response, regardless of the virus type (the interferon system and CD4+cells), and influences virus-induced histamine release and histamine-mediated inflammatory reactions. Used over four years in clinical practice, the drug has shown a high efficacy and safety profile for the treatment of influenza and ARIs in adult patients. The purpose of the multi-center, randomized, double-blind, placebo-controlled study was to evaluate the clinical efficacy and safety of a new ergoferon liquid dosage form in the treatment of ARIs in children. The publication contains the results of the fist study stage completed as per the study plan and data from the interim analysis. METHODS. The screening involved a total of 162 subjects, aged 3 to 17 years (average, 8.2 ± 3.9 years), that had presented to 13 research centers based in Russia with common signs and symptoms of ARI (body temperature ≥ 38.0 degrees C, as measured with a digital infrared temporal artery thermometer; symptom severity score ≥ 4) during seasonal morbidity. Ergoferon was administered in 82 subjects receiving the therapeutic regimen of the drug for 5 days; 80 children received placebo. The subjects were monitored for 6 days. Treatment efficacy was assessed on the basis of morning, evening and total daily ARI symptom scores, including scoring estimates of fever, general symptoms and symptoms affecting the nose, throat and chest. Along with this, calculations were performed to obtain the Total Index (TI) of ARI; illness severity was evaluated using a mathematical "area under the curve" model. RESULTS. Starting from Day 2, the percentage of convalescents was observed to increase--from 6% (morning) and 14% (evening) to 20% and 29% on Day 3, respectively, and 58% and 61% on Day 4. The results suggested a substantially higher efficacy of Ergoferon as compared to placebo treatment (the Cochran-Mantel-Haenszel χ2 test: χ2 = 21.7; p0.0001). Ergoferon had a marked effect on fever and other signs of intoxication. In Ergoferon group, the percentage of non-fever subjects, with the endpoint defined at ≤ 37.2 degrees C, was 43% on Day 2, as estimated in the morning and the evening (vs 25% and 19% in the placebo group, respectively; χ2 = 10.6; p = 0.012), and 83% in the morning and 84% in the evening on Day 3 (vs 60% and 54% in the placebo group, respectively; χ2 = 16.7; p = 0.001). The Generalized Linear Model (GENMOD) procedure confirmed the significance of differences between the Ergoferon and placebo groups according to the following parameters: 1) Ergoferon was significantly more effective in reducing body temperature (to lower values) than the placebo; 2) Ergoferon had an earlier effect on fever (main marker of viremia), as compared to placebo; 3) The significant Ergoferon's superiority over placebo was also evident by the morning and evening measurements throughout the five-day therapy. The TI was observed to significantly decrease starting from Day 2 of Ergoferon administration: from 13.0 ± 4.5 to 7.9 ± 4.8 on Day 2 and 4.5 ± 2.9 on Day 3 (based on the patient's diary data); from 14.3 ± 4.2 to 4.9 ± 3.0 on Day 3 (based on the doctor's assessment). The severity of ARI-related intoxication signs was reduced most significantly, in particular as indicated by the results of doctor's objective examination on Day 3 (GENMOD: factor "Treatment"--χ2 = 147.8; p0.0001; factor "Day of administration"--X=6.1; p = 0.013; Tukey-Kramer post hoc analysis: z = -3.09; p = 0.024). The average fever duration in ergoferon-treated subjects was 1.9 ± 0.8 days (p0.0001). The overall duration of ARI was much shorter in Ergoferon group than in the group of placebo (p = 0.021). The "area under the curve" measure of TI in Ergoferon group was significantly lower as compared to Placebo group, both according to the patient's diary records (21.9 ± 10.9 TI x Days vs 28.0 ± 13.0 TI x Days; p0.002) and the doctor's examination (12.4 ± 4.7 vs 14.2 ± 5.2 TI x Days; p = 0.023). Ergoferon treatment was associated with a lower frequency of using antipyretics (χ2 = 4.1; p = 0.043), particularly on the first day of illness. The monitoring of adverse events as well as the haematology, biochemistry and urinalysis findings were indicative of Ergoferon's safety. No signs of drug incompatibility were observed as a result of ergoferon administration in combination with antipyretics, decongestants, expectorants, inhaled corticosteroids, cromoglicic acid derivatives, leukotriene receptor antagonists, short-acting beta2 agonists and topical anti-septics. There were also no cases of bacterial complications, worsening of illness severity, or acute exacerbations of coexisting allergy or chronic ENT pathology. The children demonstrated good drug tolerance and 100% treatment compliance. CONCLUSIONS. Ergoferon liquid dosage form is an efficacious and safe treatment for ARIs in children. The study results demonstrated the drug's efficacy against the major syndromes associated and caused by viremia--fever and general intoxication. The early onset of the drug's effect was shown to result in a shorter time to convalescence and reduced ARI severity, particularly during the initial days of illness.