[Evaluation of the efficacy and safety of a complex antiviral drug based on antibodies in the treatment of adult patients with acute respiratory viral infection].
| Autor: | Khamitov RF; Kazan State Medical University., Nikiforov VV; Pirogov Russian National Research Medical University.; Federal Scientific and Clinical Center for Specialized Types of Medical Care and Medical Technologies., Zaytsev AA; Burdenko Main Military Clinical Hospital.; Moscow State University of Food Production., Tragira IN; National Medical Research Center of Phthisiopulmonology and Infectious Diseases. |
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| Jazyk: | ruština |
| Zdroj: | Terapevticheskii arkhiv [Ter Arkh] 2022 Jan 15; Vol. 94 (1), pp. 83-93. Date of Electronic Publication: 2022 Jan 15. |
| DOI: | 10.26442/00403660.2022.01.201345 |
| Abstrakt: | Aim: To evaluate the efficacy and safety of Raphamin, containing technologically processed affinity-purified antibodies to interferon , CD4 receptor, 1 domain of the major histocompatibility complex class II and 2 microglobulin major histocompatibility complex class I in the treatment of acute respiratory viral infection (ARVI), including influenza, in adults. Materials and Methods: 240 patients 1870 years old with ARVI were included in a phase III (20192020), randomized, double-blind, placebo-controlled trial. Pregnant women, patients with suspected bacterial infections were excluded from the study. Raphamin/placebo was prescribed for 5 days within 24 hours of the illness onset. Primary endpoint was a time to resolution of ARVI (Polymerase chain reaction PCR-confirmed). Additionally, the severity of ARVI, proportion of patients with ARVI resolution/worsening/complications, frequency of antipyretics prescription, and time to resolution of symptoms of ARVI (including PCR non confirmed) were assessed. Results: The average time to resolution of ARVI (PCR-confirmed) was 4.11.9 [4.01.9] and 5.02.5 [5.02.5] days in the Raphamin/placebo groups (ITT and [PP] analysis, р=0.0155 and [р=0.0114], respectively). The duration of ARVI decreased by 0.892.23 [0.932.25] days. Superiority of Raphamin was shown during therapy period according to the ARVI resolution criterion (р=0.0014 [р=0.0005]). There were no statistically significant difference in the severity of ARVI and frequency of antipyretics prescription. The proportion of patients with worsening/complications was 0 [0]% and 2.5 [2.8]% in the Raphamin and placebo groups, respectively. Favorable safety profile of Raphamin (including the incidence and severity of adverse events) and high compliance were shown. Conclusion: Raphamin promotes significant decrease, practically by a day, the duration of ARVI, including influenza. |
| Databáze: | MEDLINE |
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