Results of an open multicenter non-interventional observational prospective study of the effect on quality of life of the drug Kipferon® used in children 0–7 years old with acute respiratory viral infections in the conditions of routine outpatient practice
Authors: Gorelov A.V. ,   Central Research Institute of Epidemiology of Rospotrebnadzor, Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing, Moscow, Russian Federation, Omarova H.G. , Belikova E.E. , Eremina O.L. , Dombayan S.H. , Zaitseva N.S. , Zolotova T.V. , Kotlova V.B. , Manchenkova I.I. , Tkhakushinova N.H. , Lukashevich M.G. , Nezabudkina A.S. , Khanilo T.V. , Panova I.V. , Parfenova I.V. , Petukhova M.V. , Ploskireva A.A. , Pogorelova O.O. , Razuvaev O.A. , Sorokina T.A. , Tolstoy O.V. , Chemyakina O.V. , Shaturina T.T. , Yakovleva L.V. , Khanilo T.V. , Gracheva E.V. ,   I.M.Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russian Federation,   Russian University of Medicine, Moscow, Russian Federation,   Central Research Institute of Epidemiology of Rospotrebnadzor, Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing, Moscow, Russian Federation,   Children City Polyclinic No 8, Rostov-on-Don, Russian Federation,   Rostov State Medical University, Rostov-on-Don, Russian Federation,   LLC “Open Medicine”, Tolyatti, Russian Federation,   Children City Polyclinic No 8, Rostov on Don, Russian Federation,   Rostov State Medical University, Rostov-on-Don, Russian Federation,   Rostov State Medical University, Rostov-on-Don, Russian Federation,   LLC "ENT Counseling Center", Rostov-on-Don, Russian Federation,   Rostov State Medical University, Rostov-on-Don, Russian Federation,   LLC "ENT Counseling Center", Rostov-on-Don, Russian Federation,   LLC “Healthy Child”, Voronezh, Russian Federation,   Burdenko Voronezh State Medical University, Voronezh, Russian Federation,   Rostov State Medical University, Rostov-on-Don, Russian Federation,   LLC "ENT Counseling Center", Rostov-on-Don, Russian Federation,   Kuban State Medical University, Krasnodar, Russian Federation,   Specialized Clinical Children's Infectious Diseases Hospital, Krasnodar, Russian Federation,   2Children City Polyclinic of the Zheleznodorozhny District, Rostov on Don, Russian Federation,   Children City Polyclinic No 45, Saint Petersburg, Russian Federation,   Bashkir State Medical University, Ufa, Russian Federation,   Children City Polyclinic No 8, Rostov on Don, Russian Federation,   Rostov State Medical University, Rostov-on-Don, Russian Federation,   Central Research Institute of Epidemiology of Rospotrebnadzor, Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing, Moscow, Russian Federation,   Children City Polyclinic No 8, Rostov on Don, Russian Federation,   Central Research Institute of Epidemiology of Rospotrebnadzor, Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing, Moscow, Russian Federation,   Central Research Institute of Epidemiology of Rospotrebnadzor, Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing, Moscow, Russian Federation,   LLC “Healthy Child”, Voronezh, Russian Federation,   Burdenko Voronezh State Medical University, Voronezh, Russian Federation,   Central Research Institute of Epidemiology of Rospotrebnadzor, Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing, Moscow, Russian Federation,   Children City Polyclinic No 8, Rostov on Don, Russian Federation,   LLC “Open Medicine”, Tolyatti, Russian Federation,   Kuban State Medical University, Krasnodar, Russian Federation,   Bashkir State Medical University, Ufa, Russian Federation,   City Children Clinical Hospital No 17, Ufa, Russian Federation,   City Polyclinic No 12, Rostov on Don, Russian Federation
Published: July 2024

Objective. To evaluate the dynamics of the quality of life of children aged 0 to 7 years with acute respiratory viral infections (ARVI) of mild and moderate severity when adding the drug Kipferon® (a mixture of normal human immunoglobulin and recombinant interferon α-2b) to standard therapy, as well as to determine the effect of this drug on the infectious morbidity of patients during 3 months following the course of treatment. Patients and Methods. A multicenter observational clinical study conducted at 19 clinical centers in Russia in routine outpatient and polyclinic practice included 855 children aged 0 to 7 years; the mean age was 3.5 ± 1.7 years. There were 460 (53.8%) boys and 395 (46.2%) girls. There were 89 children aged 0 to 1 year; older children were 766. Patients were divided into 2 groups: the main group (n = 656), children from which received Kipferon® (rectal suppositories, according to the instructions for use) for 7 days in addition to standard symptomatic therapy, and the control group (n = 199). The children were examined on admission, on the 3–5th and 6-8th day from the beginning of treatment; 1 and 3 months after the end of the course of therapy. The severity of the main clinical symptoms was evaluated using a 10-point system. The legal representatives of all patients signed informed consent. Statistical analysis of the results was performed using the methods of descriptive and variation statistics, Student and Mann–Whitney criteria; differences were considered reliable at p < 0.05. Results. The initial general level of discomfort, as well as the degree of severity of 11 main symptoms of acute respiratory infection were comparable in both groups and significantly improved by the end of the treatment course. On the 3-5th day from the beginning of treatment in patients receiving Kipferon® preparation, statistically significant (p < 0.05) improvement in all leading manifestations of ARVI was revealed, while in the control group improvement was registered only in 8 symptoms out of 11. In infants of the main group by the 3–5th day of treatment, difficulties in feeding and falling asleep significantly (p < 0.05) decreased; older patients significantly better ate and slept, and were more physically active. Bacterial complications of ARVI in the main group developed 2 times less frequently: 36 (5.7%) cases vs. 20 (10.3%); the differences are reliable (p = 0.026) according to the χ2 criterion. Repeated acute respiratory viral infections during 3 months of follow-up were significantly (p < 0.05) more frequent in children who did not receive Kipferon® (47.5% vs. 20.3%). No serious adverse events were detected during the use of Kipferon® preparation. Adverse events were recorded in 2 patients, none of them was classified as related to the use of the study drug; serious adverse events were absent during the entire observation period. Conclusion. The efficacy and safety of the immunomodulating drug Kipferon® allows us to recommend it as an important addition to symptomatic agents in the treatment of acute respiratory infections in pediatrics. Key words: children, interferons, Kipferon®, acute respiratory viral infections