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.
No abstract
Aim: to assess the efficacy and safety of enisamium iodide (film-coated tablets, 250 mg) for outpatient treatment of moderate-to-severe COVID-19 infection. Patients and Methods: this adaptive, randomized, open-label controlled study on the efficacy and safety of enisamium iodide enrolled 194 patients. The study group included 97 patients, and the comparison group included 97 patients. Comparison group patients received standard therapy. Study group patients received orally 500 mg of enisamium iodide three times daily for seven days. In addition, pathogenic and symptomatic treatment was prescribed. The first component of the primary endpoint was composite efficiency parameter. The second component of the primary endpoint was the proportion of patients with respiratory failure. Registration of deaths, adverse events and serious adverse events was carried out by standard methods. Results: cohort enrollment into part 1 of the study and treatment of all patients were completed. The mean time of the relief of major COVID-19 symptoms (primary combination endpoint) and differences between the study and comparison groups (8 days and 9 days, respectively, p=0.028) were revealed. The rate of respiratory failure in the study group and comparison group was: 4 (4,12%) versus 8 (8,25%) cases respectively. In addition, the effect of this drug on mortality in the groups was compared (one death in the study group and five deaths in the comparison group). The statistical reliability of these differences will be determined during part 2 of this study that started in September 2021. Conclusions: the efficacy and safety of enisamium iodide (film-coated tablets, 250 mg) for the COVID-19 were evaluated. A significant reduction in the time to clinical recovery (by one day) was reported in patients who received enisamium iodide. In addition, the rate of severe respiratory failure and associated mortality also tends to reduce after therapy that includes enisamium iodide. KEYWORDS: enisamium iodide, antivirals, etiopathogenic treatment, SARS-CoV-2, COVID-19, viral lung damage, pneumonia, randomized controlled study, adaptive study, open-label study. FOR CITATION: N.Yu. Pshenichnaya, Zhdanov K.V. Preliminary results of an adaptive randomized open-label controlled study on the efficacy and safety of enisamium iodide for outpatient treatment of the COVID-19 infection. Russian Medical Inquiry. 2021;5(11):705–711 (in Russ.). DOI: 10.32364/2587-6821-2021-5-11-705-711.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
customersupport@researchsolutions.com
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.