Immunological mechanisms of the drug Cytovir®-3 action as the basis of the prevention of acute respiratory viral infections and influenza
Introduction. Influenza viruses and other acute respiratory viral infections (ARVI) cause massive outbreaks of infectious diseases quite often becoming epidemic nature. The economic and social damage done to the health of the population by these infections and related complications is enormous. It is quite naturally, many research teams are persistently looking for ways and means of solving this serious problem. The complex preparation Cytovir®-3 in the form of capsules has been used for 20 years for the prevention and early pathogenetic treatment of influenza and ARVI. The study of the mechanism of anti-infectious protection is one of the main tasks in the development of a antiviral medicinal product with both direct and indirect effects.
The article presents the results of an open non-randomized clinical study of the safety and tolerability of the drug Cytovir®-3 capsules in healthy volunteers aged 18 to 30 years with a prolonged course of taking the drug with the study of immunological mechanisms of action
Aim of the study - to investigate the immunological mechanisms of action and safety of Cytovir®-3 capsules in healthy volunteers with a prolonged course of administration.
Material and methods. The article presents the results of an open, non-randomized clinical study of the safety and tolerability of Cytovif®-3 capsules in 21 healthy volunteers aged 18 to 30 years. The duration of the course of taking Cytovir®-3 was 14 days, 1 capsule 3 times a day. An in-depth examination of the volunteers was carried out at the screening stage, on the 5th day of taking the drug and after the 14-day course. Safety and tolerance were assessed according to the data of clinical examination with fixation of vital signs, as well as by studying the dynamics of clinical and biochemical blood tests, general urine analysis and indicators of the body’s immunological reactivity.
Results. In the course of the clinical study the activating effect of the drug on the indicators of stimulated oxidative NBT activity and the level of lysosomal cationic proteins, the phagocytic index, as well as the dynamics of secretory IgA (sIgA) was noted. 4 Cases of adverse events (headache and itching) were registered in 3 (14.3 %) participants, they were regarded as mild and unlikely to be related to the drug intake.
Conclusion. The studied scheme of the prolonged course of taking the drug Cytovir®-3 capsules showed the activity of the drug in relation to the microbicidal parameters of the cells of innate immunity (functional activity of monocytes, neutrophils, as well as the level of sIgA), the fluctuations of which were significant and localized within the limits of the adaptive response norm, which indicates an increase in the body’s immunoresistance after the course and reveals the mechanisms of the preventive action of the drug was shown a high level of safety and good tolerance in assessing the effect on the vital functions of the body, instrumental, laboratory general clinical and immunological indicators.
Keywords:antiviral activity; Cytovir-3®; healthy volunteers; prophylactic action; innate immunity; safety
For citation: Ruleva A.A., Popova V.V., Lyovina A.V., Krasnov A.A., Petlenko S.V. Immunological mechanisms of the drug Cytovir®-3 action as the basis of the prevention of acute respiratory viral infections and influenza. Immu-nologiya. 2021; 42 (2): 148-58. DOI: https://doi.org/10.33029/0206-4952-2021-42-2-148-158 (in Russian)
Funding. The study had no sponsor support.
Conflict of interests. The authors declare no conflict of interests.
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