Article: [Efficacy and safety of bacterial lysate OM-85 in the treatment of uncomplicated acute respiratory infections: a double-blind, placebo-controlled, multicenter, randomized trial].
2023 Volume 95, Issue 10, Page(s) 850–858
Abstract: Aim: To evaluate the efficacy and safety of OM-85 in the treatment of uncomplicated acute respiratory infections (ARI) in adults.: Materials and methods: A double-blind, placebo-controlled, multicenter, randomized trial included 556 patients (18-60 ... ...
Abstract | Aim: To evaluate the efficacy and safety of OM-85 in the treatment of uncomplicated acute respiratory infections (ARI) in adults. Materials and methods: A double-blind, placebo-controlled, multicenter, randomized trial included 556 patients (18-60 years old) with mild and moderate ARI and negative results of polymerase chain reaction analysis for SARS-CoV-2 RNA and rapid test for influenza A and B viruses. Patients were randomized into two groups: in the first group ( Results: The superiority of OM-85 over placebo by primary endpoint was observed on the 5th, 7th and 10th days of treatment. OM-85 efficacy has also been proven by secondary criteria. OM-85 shortened the time until the symptoms of ARI resolved according to the WURSS-21 and CCQ, increased the proportion of patients with body temperature below 37°C by 2-9 days. The time needed to resolve the symptoms of disease in 20% of patients according to WURSS-21 was 7 and 9 days in patients taking OM-85 and placebo, respectively. Bacterial lysate increased the probability of complete disappearance of symptoms according to CCQ by 45.7% compared to placebo. The analysis of the frequency and severity of adverse events, laboratory tests, physical and instrumental examination results during treatment confirmed the good tolerability and safety of OM-85. Conclusion: The study confirmed the efficacy and safety of OM-85 in the complex treatment of ARI in adults. |
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MeSH term(s) | Adult ; Humans ; Adolescent ; Young Adult ; Middle Aged ; Bacterial Lysates ; RNA, Viral/therapeutic use ; Respiratory Tract Infections/drug therapy ; Influenza, Human/drug therapy ; Common Cold ; Double-Blind Method ; Bacteria ; Treatment Outcome |
Chemical Substances | Bacterial Lysates ; RNA, Viral |
Language | Russian |
Publishing date | 2023-11-23 |
Publishing country | Russia (Federation) |
Document type | Randomized Controlled Trial ; Multicenter Study ; English Abstract ; Journal Article |
ZDB-ID | 40718-5 |
ISSN | 2309-5342 ; 0040-3660 |
ISSN (online) | 2309-5342 |
ISSN | 0040-3660 |
DOI | 10.26442/00403660.2023.10.202464 |
Database | MEDical Literature Analysis and Retrieval System OnLINE |
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