In most cases, acute diarrhoea will become selflimiting during the first few days after onset. For young children, however, health risks may develop when the disease lasts longer than 3 days. The purpose of the present trial was to determine whether the stool frequency of infants and toddlers suffering from acute diarrhoea could be normalised more quickly by administering the probiotic Escherichia coli Nissle 1917 (EcN) solution than by administering a placebo. The safety of EcN were also assessed. A total of 113 children (aged 2-47 months) with acute diarrhoea (> three watery or loose stools in 24 h) were randomised to either a group receiving the probiotic EcN suspension (n =55) or a group receiving the placebo suspension (n=58) in a confirmative, double-blind clinical trial. Depending on the age of patients, 1-3 ml per day of verum suspension (10 8 viable EcN cells per millilitre) or placebo were administered orally. The causes of the diarrhoea were viral rather than bacterial, but they were mainly unspecific infections. The median onset of treatment response (reduction of daily stool frequency to ≤ three watery or loose stools over at least 2 consecutive days) occurred more rapidly in the children receiving the EcN solution (2.5 days) than in those receiving the placebo (4.8 days), a significant difference (2.3 days; p=0.0007). The number of patients showing a response was clearly higher (p<0.0001) in the EcN group (52/55; 94.5%) than in the placebo group (39/58; 67.2%). EcN was found to be safe and well-tolerated, and it showed a significant superiority compared to the placebo in the treatment of acute diarrhoea in infants and toddlers.

In the conditions of this trial EcN was a suitable remedy for diarrhea >4 days in young children.

No abstract

To evaluate the efficacy and safety of Ergoferon in combination with symptomatic therapy in children from 6 months to 6 years old with acute respiratory infections (ARI) in contemporary outpatient practice, an international, multicenter, double-blind, placebo-controlled, randomized, parallel-group clinical trial was performed. Derived by technological treatment of antibodies to interferon gamma, histamine, and CD4, Ergoferon was previously proved to modulate its molecular targets promoting effective antiviral protection. The data of 282 patients with oral temperature ≥38.0°C plus mild to moderate severity of flu-like nonspecific and nasal/throat/chest symptoms were included in intention-to-treat analysis (n = 140, Ergoferon group; n = 142, placebo group). Time to alleviation of all ARI symptoms was the primary endpoint, and 8 outcome measures were estimated as the secondary endpoints. Respiratory viruses were confirmed in 57.1% (Ergoferon) and 54.9% (Placebo) of patients. Compared to placebo, Ergoferon reduced time to alleviation of all ARI symptoms (4.5 ± 1.7 versus 5.2 ± 2.2 days in placebo; p = 0.026 ) including fever (2.8 ± 1.5 vs 3.4 ± 2.0; p = 0.031 ), flu-like nonspecific (4.0 ± 1.8 vs 4.7 ± 2.2, p = 0.022 ), and nasal/throat/chest (4.3 ± 2.0 versus 5.0 ± 2.3; p = 0.024 ) symptoms. Ergoferon add-on therapy decreased the mean total symptom severity score (according to 4-point scale for each symptom), ARI severity, frequency of antipyretic use, and percentage of complication requiring antibiotics and increased the percentage of recovered patients. The incidence of adverse events (AEs) in the Ergoferon group was significantly lower compared to the placebo group (7.0% versus 18.8%; p = 0.004 ) including infectious diseases (3.5% vs 12.5%; p = 0.008 ). In the Ergoferon group, AEs were mild or moderate. In 8 (57.1%) cases, AEs were unrelated to Ergoferon, in 5 (35.7%), the relationship was uncertain, and in 1 (7.1%), it was possible (mild rash on the face). Ergoferon treatment is beneficial for infants and young children with ARI in contemporary outpatient practice. Being well-tolerated, Ergoferon increases the symptomatic therapy effectiveness and improves the patient condition and disease outcomes.

Rotavirus accounted for 31% of all AGE-related outpatient visits. The major rotavirus genotypes were G1P[8] and G4P[8]. Rotavirus gastroenteritis was associated with significantly more severe clinical symptoms than non-rotavirus gastroenteritis. The average costs of rotavirus cases for parents of children were elevated against the same indications for non-rotavirus. These findings underscore the need for a safe and effective rotavirus vaccine in Russia.

No abstract

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.

Objective. To evaluate the efficacy and safety of Ergoferon in children and adults with acute respiratory viral infections (ARVIs). Material and methods. We have analyzed the results of 10 randomized controlled trials involving 1732 patients. The outcome measures included duration of fever, disease severity, frequency of deteriorations, number of adverse events (AEs), and assessment of drug interaction. We have conducted statistical analysis of pooled data and meta-analysis using logistic regression. Results. Patients receiving Ergoferon were 1.5 times more likely to have shorter period of fever than those receiving placebo (ОR = 1.499, р = 0.0002). Patients in the Ergoferon group had milder ARVI and influenza than patients in the placebo group (according to the AUC analysis: 32.83 ± 18.12 vs 36.94 ± 19.08 units in the placebo group, p = 0.0083). The frequency of deterioration in the Ergoferon group was 7 times lower than that in the placebo group (0.6% vs 4.4% of cases). Treatment safety was confirmed by fewer patients having AEs in the experimental group (0.6% vs 10.8%, p = 0.0006.) and no drug interactions. Conclusion. Our findings suggest that Ergoferon significantly reduced duration of fever in patients with ARVI and influenza compared to placebo. Ergoferon alleviated the disease and reduced the incidence of bacterial complications. Moreover, this drug demonstrated good tolerability and compatibility with other drugs. Key words: ARVI, influenza, meta-analysis, ARVI treatment, influenza treatment, Ergoferon