Clinical efficacy of mechanical bacterial lysate in the prevention of infectious exacerbations of chronic obstructive pulmonary disease

Avdeev, S. N.; Нуралиева, Г. С.; Гайнитдинова, В. В.; Баймаканова, Г. Е.; Со, А. К.; Merzhoeva, Zamira M.

doi:10.26442/00403660.2020.04.000590

Cited by 6 publications

(7 citation statements)

References 15 publications

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“…Administration of bacteria-based immunomodulatory agents induces polarization of immune response, mainly type Th1, and is associated with an increase in NK cytotoxicity and an enhanced expression of TLR2, TLR4, and TLR9 [9]. So far, a large number of papers have been published focusing on the use of bacteria-based vaccines in the treatment of obstructive pulmonary disease and asthma [10,11,12,13]. The results of the studies investigating the e cacy of immunomodulatory agents in COVID-19 infection are, however, scarce, anecdotal, and sometimes not evidence-based.…”

Section: Introductionmentioning

confidence: 99%

`Secretory IgA and course of COVID-19 in patients receiving a bacteria-based immunostimulant agent in addition to background therapy

Kostinov

Свитич

Chuchalin

et al. 2022

Preprint

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Scientific Relevance: Mucosal immunity plays a major role not only in the prevention but probably also in the outcome of COVID-19. An enhanced production of secretory immunoglobulin A (sIgA) might contribute to the activation of the immune response mechanisms. Study Objective: To assess the levels of sIgA produced by epithelial cells in the nasal and pharyngeal mucosa and those measured in salivary gland secretions and to study the course of COVID-19 following the intranasal or subcutaneous administration of a bacteria-based immunostimulant agent. Materials and Methods: This study included 69 patients, aged between 18 and 60, who had moderate COVID-19 infection. They were divided into two groups: Group 1 (control group) included 39 patients who received only background therapy, and Group 2 was made up of 30 patients who received background therapy in combination with the Immunovac VP4 vaccine, a bacteria-based immunostimulant agent, which was given for 11 days starting from the day of admission to hospital. The levels of sIgA were measured by ELISA in nasal epithelial swabs, pharyngeal swabs, and salivary gland secretions at baseline and on days 14 and 30. Results: The convalescence phase of moderate COVID-19 was associated with a decrease in sIgA levels in nasal swabs, persistently high sIgA levels in salivary gland secretions, and no changes in pharyngeal swabs with the levels similar to those in healthy subjects. The addition of an immunostimulant agent to combination therapy for patients with COVID-19 stimulates the production of sIgA in the nasal and pharyngeal compartments, reduces C-reactive protein (CRP) levels and shortens the duration of fever and the length of hospital stay. Conclusion: Using an immunomodulatory agent containing bacterial ligands in therapy for COVID-19 patients enhances the production of sIgA in the nasal and pharyngeal compartments and improves the course of the disease.

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Section: Introductionmentioning

confidence: 99%

`Secretory IgA and course of COVID-19 in patients receiving a bacteria-based immunostimulant agent in addition to background therapy

Kostinov

Свитич

Chuchalin

et al. 2022

Preprint

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“…На сегодняшний день опубликовано достаточное количество работ по применению бактериальных вакцин в лечении хронической обструктивной болезни легких и бронхиальной астмы [1,7,9,11]. Однако исследования эффективности применения иммуномодуляторов при ВП разрозненны и не всегда доказательны.…”

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The effect of immunomodulators on various markers of the acute inflammation phase in patients with mild community-acquired pneumonia

Костинов

Гайнитдинова

Кажарова

et al. 2021

Tuberk. bolezni lëgk.

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The objective: to study the effect of immunomodulators on markers of the acute inflammation phase in patients with mild community-acquired pneumonia (CAP).Subjects and methods. Patients (n = 64) with mild CAP (39.62 ± 9.82 years, CRB – 650.15 ± 0.04 scores) were enrolled in the study. The patients were divided into 2 groups: Group 1 (control) received only standard CAP therapy; in the other two groups, immunomodulators were prescribed simultaneously with standard therapy: in Group 2 – bacterial lysate (BL), in Group 3 – azoximer bromide (AB). In the patients, the blood levels of IL-6, TNF-α, C-reactive protein (CRP), lactoferrin were tested before treatment (day 1), and on days 13 and 60 of observation.Results. The initial levels of TNF-α, IL-6, CRP and lactoferrin in the patients were statistically significantly higher above normal ones. A significant decrease in the levels of TNF-α, IL-6, CRP was found in all patients on the 13th and 60th days of observation compared to the 1st day, the maximum reduction was observed in the patients receiving immunomodulators. The biggest decrease in the level of lactoferrin on the 60th day of observation was noted in the group of patients taking BL. The changes in the rate of TNF-α and IL-6 levels decrease on the 13th and 60th days were also statistically significantly more pronounced (compared to the control group). The changes in the rate of decreasing from the baseline on the 13th and 60th days in TNF-α in the BL Group made 44 [-64; -32]% and 85 [-89; -82]%; in the AB Group – 28 [-40; -20]% and 82 [-86; -80]%; in IL-6 in the BL group – 32 [-40; -18]% and 86 [-90; -85]%, in the AB group – 45 [-53; -38]% and 86 [-88; -84]%. In the control group, this parameter for TNF-α was 18 [-32; -8]% and 64 [-78; -56]%, for IL-6 – 11 [-20; -1]% and 75 [-81; -74]%.Conclusion. The addition of immunomodulators (BL, AB) to the therapy of patients with mild CAP results in statistically significant decrease in the blood levels of biomarkers of the acute inflammation phase on the 13th and 60th days.

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“…During the process, we found that the study by Ricci et al ( 13 ) was ancillary to the AIACE study ( 2 ), but retained it because it reported complementary data. Ultimately, this meta-analysis included 12 studies, namely, nine randomized controlled trials and three abstracts of randomized controlled trials with sufficient data ( 8 – 10 , 13 – 21 ). Figure 1 summarizes the study selection process.…”

Section: Resultsmentioning

confidence: 99%

“…First, we conducted a subgroup analysis. The forest and radial plots ( Figure 7 ) analyzing the effect on the exacerbation rate showed obvious heterogeneity for mechanical bacterial lysates; Avdeev et al ( 8 ) included patients with a lower FEV 1 /predicted and found a higher RR, and might be the source of heterogeneity. After removing this study, the heterogeneity decreased (overall: RR = 0.88, 95% CI 0.79–0.97, P = 0.009; heterogeneity: P = 0.24, I 2 = 25%; mechanical bacterial lysate subgroup: RR = 0.92, 95% CI 0.71–1.21, P = 0.57; heterogeneity: P = 0.42, I 2 = 0).…”

Section: Resultsmentioning

confidence: 99%

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A Meta-Analysis on the Efficacy and Safety of Bacterial Lysates in Chronic Obstructive Pulmonary Disease

et al. 2022

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BackgroundChronic obstructive pulmonary disease (COPD) is a common and frequently encountered disease of respiratory apparatus and is vulnerable to infection. Increasing studies reveal that bacterial lysates play an encouraging role in preventing exacerbations in these patients. We here investigated the efficacy and safety of bacterial lysates in COPD.MethodsWe performed systematic research on PubMed, EMBASE, the Cochrane Library (CENTRAL), and Web of Science by using the keywords and their synonyms for studies published before January 11, 2022. Two researchers screened the studies of literature independently according to the inclusion and exclusion criteria and extracted data from the included studies. Another two researchers assessed the risk of bias of each included using the Cochrane risk-of-bias tool. Meta-analysis was conducted using R (version 4.1.1, The R Foundation for Statistical Computing) and Review Manager (version 5.4.0, The Cochrane Collaboration).ResultsA total of 12 studies were included in this meta-analysis, and the pooled results showed that bacterial lysates were effective to reduce exacerbation rate (overall: relative risk [RR] = 0.83, 95% confidence interval [CI] 0.72–0.96; alkaline bacterial lysate subgroup [OM-85]: RR = 0.87, 95% CI 0.77–0.98; mechanical bacterial lysate subgroup [Ismigen]: RR = 0.70, 95% CI 0.41–1.20) and mean number of exacerbations (overall: MD = −0.42, 95% CI −0.75 to −0.08; alkaline bacterial lysate subgroup [OM-85]: MD = −0.72, 95% CI −1.35 to −0.09; mechanical bacterial lysate subgroup [Ismigen]: MD = −0.02, 95% CI −0.21 to 0.17). Bacterial lysates were also found beneficial in alleviating symptoms. The side effects were acceptable and slight.ConclusionBacterial lysates can benefit patients with COPD by reducing exacerbations and alleviating symptoms. OM-85 is the preferable product based on the existing evidence. Further studies are needed to validate these findings.Systematic Review Registration[www.crd.york.ac.uk/prospero/], identifier [CRD42022299420].

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Clinical efficacy of mechanical bacterial lysate in the prevention of infectious exacerbations of chronic obstructive pulmonary disease

Cited by 6 publications

References 15 publications

`Secretory IgA and course of COVID-19 in patients receiving a bacteria-based immunostimulant agent in addition to background therapy

`Secretory IgA and course of COVID-19 in patients receiving a bacteria-based immunostimulant agent in addition to background therapy

The effect of immunomodulators on various markers of the acute inflammation phase in patients with mild community-acquired pneumonia

A Meta-Analysis on the Efficacy and Safety of Bacterial Lysates in Chronic Obstructive Pulmonary Disease

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