Results of a randomized, double-blind, placebo-controlled clinical trial in adult patients with acute respiratory viral infection [Лечение острых...
Сел’кова Е. П., Костинов М. П., Барт Б. Y., Авер’янов А. В., Петров Д. В.
Пульмонология
Т. 29, Вып. 3, С. 302-310
Опубликовано: 2019
Тип ресурса: Статья
DOI:10.18093/0869-0189-2019-29-3-302-310
Аннотация:
The aim of this study was to investigate efficacy and safety of released-active antibodies against interferon-gamma, CD4-receptor, and histamine in adult patients with acute respiratory viral infection (ARVI). Methods. This multicenter, randomized, double-blind, placebo-controlled clinical trial in parallel groups was carried out in 2011 – 2012. Data of 161 ambulatory patients from 4 centers at Russian Federation were included in the analysis. The patients' age was 18 to 60 years. Patients with ARVI signs duration ≤ 48 hours were enrolled in the study. The patients were randomly assigned for the treatment with released-active antibodies against IFN-γ, CD4-receptor, and histamine (the active treatment group; n = 76), or placebo (placebo group; n = 85) for 5 days at 1:1 ratio. The randomization was made using the block randomization method. The treatment efficacy was evaluated according to number of patients with normal body temperature (≤ 37.0 °C) over 5 days of the treatment. Additiona
Ключевые слова:
Acute respiratory viral infection; CD4-receptor; Histamine; Placebo-controlled study; Released-active antibodies against interferon-γ
antibody; antipyretic agent; CD4 antibody; CD4 antigen; gamma interferon; gamma interferon antibody; histamine; histamine antibody; unclassified drug; acute disease; adult; Article; body temperature; controlled study; disease duration; disease severity; double blind procedure; drug efficacy; drug safety; human; major clinical study; multicenter study; randomized controlled trial; viral respiratory tract infection
Язык текста: Русский
ISSN: 0869-0189
Сел’кова Е. П.
Костинов М. П. Михаил Петрович 1956-
Барт Б. Y. Б.Я.
Авер’янов А. В.
Петров Д. В.
Sel’kova E. P.
Kostinov M. P. Mikhail Petrovich 1956-
Bart B. Y. B.Ya.
Aver’yanov A. V.
Petrov D. V.
Results of a randomized, double-blind, placebo-controlled clinical trial in adult patients with acute respiratory viral infection [Лечение острых респираторных вирусных инфекций у взрослых: результаты рандомизированного двойного слепого плацебо-контролируемого клинического исследования]
Results of a randomized, double-blind, placebo-controlled clinical trial in adult patients with acute respiratory viral infection [Лечение острых...
Текст визуальный непосредственный
Пульмонология
Научно-практический журнал "Пульмонология"
Т. 29, Вып. 3 С. 302-310
2019
Статья
Acute respiratory viral infection CD4-receptor Histamine Placebo-controlled study Released-active antibodies against interferon-γ
antibody antipyretic agent CD4 antibody CD4 antigen gamma interferon gamma interferon antibody histamine histamine antibody unclassified drug acute disease adult Article body temperature controlled study disease duration disease severity double blind procedure drug efficacy drug safety human major clinical study multicenter study randomized controlled trial viral respiratory tract infection
The aim of this study was to investigate efficacy and safety of released-active antibodies against interferon-gamma, CD4-receptor, and histamine in adult patients with acute respiratory viral infection (ARVI). Methods. This multicenter, randomized, double-blind, placebo-controlled clinical trial in parallel groups was carried out in 2011 – 2012. Data of 161 ambulatory patients from 4 centers at Russian Federation were included in the analysis. The patients' age was 18 to 60 years. Patients with ARVI signs duration ≤ 48 hours were enrolled in the study. The patients were randomly assigned for the treatment with released-active antibodies against IFN-γ, CD4-receptor, and histamine (the active treatment group; n = 76), or placebo (placebo group; n = 85) for 5 days at 1:1 ratio. The randomization was made using the block randomization method. The treatment efficacy was evaluated according to number of patients with normal body temperature (≤ 37.0 °C) over 5 days of the treatment. Additiona