This study provided experimental and clinical evidence of the efficacy of oseltamivir and umifenovir against influenza viruses, representatives of which have continued to circulate in post-pandemic seasons.
In spite of vaccination was recommended by the World Health Organization, the main strategy of influenza is antiviral drugs treatment, one of which is umifenovir. Aim. The aim of the study is to obtain additional data on safety and therapeutic efficacy of the antiviral drug Arbidol (umifenovir) in patients with a diagnosis of influenza and common cold. Materials and methods. Double-blind, randomized, placebo-controlled clinical study investigating efficacy and safety of Arbidol (umifenovir) in Treatment and Prophylaxis of Influenza and Common Cold (ARBITR) IV phase started in November 2011 and completed in April 2016 on the basis of 15 research centers in various regions of the Russian Federation. A total of 359 patients, aged 18 to 65 years with influenza or acute respiratory tract infection, of no more than 36 hours' duration were enrolled in the study. Patients were randomized into two groups: a group of patients (therapy group) treated by Arbidol (umifenovir) at a dosage of 800 mg/day (2 capsules) for 5 days (n=181), and a group of patients receiving placebo 4 times a day for 5 days (n=178). The primary outcome measures of the study were the duration of clinical illness among patients with common cold and influenza/ARVI, the duration and severity of the main symptoms. Number of clinical complications associated with influenza and common cold was assessed as a secondary outcome. Safety was assessed by analyzing number of adverse events that are probably or definitely related to Arbidol, assessing vital signs, examining the physical condition of patients and general clinical laboratory parameters. Results. In the group treated by umifenovir, the number of full recover patients on the 4th day from the disease onset were significantly differed from the number of such cases in the placebo group. The number of cases of complete recovery after 96 hours was 98 patients (54.1%) and 77 (43.3%), p
The FRs for influenza and ARVI complications are patient's age (children under 3 years of age and adults older than 65 years), the presence of chronic somatic diseases, and pregnancy. Patients with endocrine, eating, metabolic (including obesity), circulatory, and respiratory disorders are at high risk for influenza and ARVI complications. Umifenovir therapy substantially reduces the duration of fever and risk of complications, especially in patients with laboratory-confirmed influenza infection.
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