Aim: to evaluate the efficacy and safety of Anaferon and Anaferon for children for the prevention and treatment of of acute respiratory viral infections (ARVI)/influenza using meta-analysis. Patients and Methods: the meta-analysis included data from 11 randomized clinical trials (RCTs) involving 3079 patients aged 1 month to 69 years, of which: 1729 people were included in the meta-analysis of the preventive drugs efficacy, 1550 patients — in the meta-analysis of the therapeutic efficacy of Anaferon for children. The evaluation of the therapeutic efficacy was conducted according to the criteria "disease duration" and/or "fever duration", the evaluation of the preventive efficacy was conducted according to the criterion "the proportion of patients not falling ill with ARVI/influenza". The safety was evaluated taking into account the number of adverse events (AEs). Statistical methods included the exact Fisher criterion, the Student criterion, fixed and random effects models, the Z-test, the Cochrane-Mantel-Hensel criterion, Cochrane Q-statistics and the I2 coefficient, the Breslow-Day test, the calculation of relative risk (RR), odds ratios (OR) and their 95% confidence intervals (CI). Results: according to the criterion "the proportion of patients not falling ill with ARVI/influenza", the RR of Anaferon for children was 1.2 [95% CI 1.2; 1.3] with an OR of 2.2 [95% CI 1.7; 2.9], while for Anaferon, the RR was 6.7 [95% CI 3.8; 11.8] with an OR of 20.1 [95% CI 9.2; 44.0]. At the same time, the proportion of patients without ARVI/influenza during Anaferon intake exceeded that in the absence of preventive intervention by almost 8 times, and during Anaferon for children intake — 1.3 times vs. placebo. When evaluating the therapeutic effect of Anaferon for children, it was found that the average disease duration was 1.4 times shorter than during placebo intake, and was 4.71±2.53 days (p<0,001). The average fever duration was 2.19±1.21 days vs. 3.22±1.81 days during placebo intake (p<0,001). According to the criterion "disease duration", the weighted average effect value was 1.05 [95% CI 0.44; 1.67], according to the criterion "fever duration" — 0.97 [95% CI 0.61; 1.33] (p<0.001, p-value of the two-tailed Z-test; random effects model). The therapeutic efficacy of Anaferon for children did not depend on the etiology of ARVI, the symptoms, and the presence of comorbidity (asthma). The total number of AEs is similar to those in the comparison group. Conclusion: the conducted review and meta-analysis concerning the efficacy and safety of Anaferon and Anaferon for children for the treatment and prevention of ARVI/influenza allow us to conclude the following: 1) Anaferon for children is effective and safe for the treatment of influenza and other acute respiratory infections, regardless of the pathogen and the presence of comorbidity (asthma); 2) Anaferon and Anaferon for children are effective and safe for the prevention of acute respiratory infections/influenza, including patients with concomitant bronchopulmonary pathology and frequently ill children. KEYWORDS: ARVI, influenza, prevention, treatment, meta-analysis, Anaferon, Anaferon for children. FOR CITATION: Geppe N.A., Zaplatnikov A.L., Kondyurina E.G. et al. Efficacy and safety of Anaferon for children and Anaferon for the prevention and treatment of influenza and other acute respiratory viral infections: systematic review and meta-analysis. Russian Medical Inquiry. 2021;5(5):335–347 (in Russ.). DOI: 10.32364/2587-6821-2021-5-5-335-347.
The expansion and standardization of clinical trials, as well as the use of sensitive and specific molecular diagnostics methods, provide new information on the age-specific roles of influenza and other respiratory viruses in development of severe acute respiratory infections (SARI). Here, we present the results of the multicenter hospital-based study aimed to detect age-specific impact of influenza and other respiratory viruses (ORV). The 2018–2019 influenza season in Russia was characterized by co-circulation of influenza A(H1N1)pdm09 and A(H3N2) virus subtypes which were detected among hospitalized patients with SARI in 19.3% and 16.4%, respectively. RSV dominated among ORV (15.1% of total cases and 26.8% in infants aged ≤ 2 years). The most significant SARI agents in intensive care units were RSV and influenza A(H1N1)pdm09 virus, (37.3% and 25.4%, respectively, of PCR-positive cases). Hyperthermia was the most frequently registered symptom for influenza cases. In contrast, hypoxia, decreased blood O2 concentration, and dyspnea were registered more often in RSV, rhinovirus, and metapneumovirus infection in young children. Influenza vaccine effectiveness (IVE) against hospitalization of patients with PCR-confirmed influenza was evaluated using test-negative case–control design. IVE for children and adults was estimated to be 57.0% and 62.0%, respectively. Subtype specific IVE was higher against influenza A(H1N1)pdm09, compared to influenza A(H3N2) (60.3% and 45.8%, respectively). This correlates with delayed antigenic drift of the influenza A(H1N1)pdm09 virus and genetic heterogeneity of the influenza A(H3N2) population. These studies demonstrate the need to improve seasonal influenza prevention and control in all countries as states by the WHO Global Influenza Strategy for 2019–2030 initiative.
BACKGROUND:During the COVID-19 pandemic, the problem of coronavirus-associated coagulopathy was one of the most difficult and poorly studied. The detected hemostasis disorders in adults are extrapolated to children and adolescents without sufficient representation in the literature. Because of COVID-19 is generally told as a mild disease in children a detailed laboratory examination not required. As a result, thrombotic and hemorrhagic complications, as well as the childrens multisystem inflammatory syndrome (MIS-C) are unexpected. At the same time, the hemostasis assessment in children with COVID-19 is necessary for the coronavirus-associated coagulopathy timely diagnosis, adequate anticoagulant therapy prescribing, various convalescence thrombotic complications prevention, as well as determining the necessary period of dynamic monitoring of patients. AIM:To assess the hemostasis in children with COVID-19-related illness in the acute disease period and convalescence. MATERIALS AND METHODS:The results of the examination of 460 patients from 2 days to 18 years old hospitalized with confirmed SARS-CoV-2 infection and 110 outpatient children from 3 months to 17 years old at different periods of COVID-19 convalescence are presented. The study included platelet count measured using automated hematocytometers, the main coagulation laboratory parameters and D-dimer level. RESULTS:The observational study indicate that children hospitalized with acute COVID-19-related illness have adult like coagulation changes, which significantly depend on the disease severity, presents of pneumonia and in the intensive care need cases, and the most sensitive indicator was the D-dimer level. However, there were opposite changes: both hyper- and hypocoagulation, a high frequency of normal or elevated platelet counts, as well as the presence of coagulopathy in 1/5 of cases even with a mild COVID-19 and the absence in 1/4 of severe cases. During the convalescence, coagulation laboratory parameters were normal, with the exception of an increased D-dimer level in every sixth patient within 1 month after recovery. CONCLUSIONS:Hemostasis changes in children with COVID-19-related illness differ from the adults by opposite, duration and risk factors. The anticoagulant therapy selection and duration requires an individual approach with the hematologist assistance. Further studies are needed to clarify the causes and consequences of hemostasis changes in children with mild forms of novel coronavirus SARS-CoV-2 infection, to establish additional coronavirus-associated coagulopathy factors in children with moderate and severe COVID-19, to develop recommendations for anticoagulant therapy in childhood.
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