[Burden and management of severe asthma in Russia: results from international observational study].

AIM: To assess clinical and demographic characteristics of severe asthma (SA) patients and their management in Russian Federation. MATERIALS AND METHODS: This publication provides data for Russian part of population of the international observational study. In Phase I, retrospective analysis of medical records of patients with SA was performed with assessment of clinical and demographic data, medical history, comorbidities, treatment approaches and healthcare utilization. Phase II was a cross-sectional collection of patient-reported outcomes: level of asthma control assessed by ACT (Asthma Control Test) and health-related quality of life (HRQoL) measured using the EQ-5D-5L questionnaire. Phase I patients were enrolled into Phase II if they signed a written consent form. RESULTS: A total of 315 patients were included in Phase I of the study, 106 (33.6%) of them entered Phase II. Majority of study participants were either obese (n=103; 39.8%) or overweight (n=94; 36.3%). The most common comorbidities were cardiovascular diseases (n=217; 71.4%), followed by chronic respiratory diseases (n=198; 68.8%). There were 268 (85.1%) patients who had at least one exacerbation during last 12 months. Data for blood eosinophil count were available in 176 patients; 81.3% of them (n=143) had only one test in the last 12 months. The mean (SD) last available blood eosinophil count was 161.2 (181.2) cells/mm3. Serum Immunoglobulin E (IgE) value was known for 88 patients, and the mean (SD) last measured IgE value was 254.3 (249.7) ng/mL. Only 4.7% of Phase II participants had ACT scores indicative of controlled asthma (>20). As much as 74.5% had scores ≤15 suggesting uncontrolled disease. Most patients also had impaired HRQoL. CONCLUSION: Most SA patients had poor disease control with frequent exacerbations and high number of comorbidities. Blood eosinophils and IgE level measurements were not evaluated routinely which might be a barrier for appropriate phenotyping and treatment selection.

[Efficacy and safety of patients immunization with chronic obstructive pulmonary disease with monoclonal antibodies].

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is characterized by a high level of morbidity and mortality and is associated with significant social and economic damage to the health system and society. COPD and COVID-19 have many potentially negative relationships that can lead to worse outcomes of COVID-19, including impaired lung function, old age and the presence of concomitant diseases Aim. To assess efficacy and safety of the drug Tixagevimab + Cilgavimab for the pre-contact prevention of COVID-19 infection in patients with COPD. MATERIAL AND METHODS: A total of 324 male patients were included in the study, who were treated or monitored at the Regional Clinic Hospital №3 and the Regional Pulmonological Center of Chelyabinsk in April-May 2022. The main endpoints of observation, for 3 and 6 months, to assess the effectiveness were the dynamics of shortness of breath according to The Modified Medical Research Council Dyspnea Scale - mMRC, the The forced expiratory volume in 1 second, the number of exacerbations, emergency calls, hospitalizations, polymerase chain reaction for SARS-CoV-2. Local and general reactions after immunization were evaluated. The drug Evusheld (150 mg Tixsagevimab +150 mg Cilgavimab, AstraZeneca) was used for immunization. RESULTS AND CONCLUSION: The effectiveness of pre-contact prevention of COVID-19 was 88.8%. The administration of the drug does not provoke an exacerbation of the underlying disease. The main clinical and functional indicators have positive dynamics by the 6th month of follow-up. The drug is well tolerated and has no significant both early and late complications.

[Risk of community acquired pneumonia in patients with diabetes mellitus: Review].

The article for the first time provides a relatively comprehensive overview of the main aspects of the epidemiology and clinical features of infectious pathology, i.e., community-acquired pneumonia, as comorbid and aggravating conditions in patients with type 1 and type 2 diabetes mellitus. Risk factors and pathogenetic patterns of infectious processes development, as well as the special etiological role of pneumococcal infection in this group of patients, are considered. Particular attention is paid to the possibilities of and approaches to the primary prevention of vaccine-preventable infections as the causes of the development of community-acquired pneumonia and invasive diseases in patients with diabetes mellitus with a review of international studies, guidelines, and local experience data in pneumococcal infection immunization.

[Analysis of the clinical efficacy of vaccination against pneumococcal infection in patients with chronic obstructive pulmonary disease in combination with type 2 diabetes mellitus].

The article presents data on the analysis of the clinical efficacy of vaccination against pneumococcal infection in patients with chronic obstructive pulmonary disease (COPD) in combination with type 2 diabetes mellitus during a 5 years follow-up period. MATERIALS AND METHODS: The study included patients (n=103) with COPD in combination with type 2 diabetes. Primary endpoints were changes dyspnea mMRC score, FEV1, number of exacerbations of COPD, hospitalizations, and a rate of pneumonia. The prognostic indices BODE, DOSE, ADO were also calculated. 13-valent conjugate pneumococcal vaccine PCV-13 and 23-valent polysaccharide vaccine PPV-23 were used for vaccination. RESULTS: It has been established that when vaccination is included in the management plan for patients with COPD in combination with diabetes, the severity of dyspnea decreases, the lung function stabilize both for short-term and 5-years follow-up. Vaccination with PCV-13 and PPV-23 reduce number of exacerbations, a rate of pneumonia and hospitalizations, but long-term efficacy has been demonstrated only for PCV-13. Vaccination with PCV-13 can improve the quality of life and prognosis for patients with COPD in combination with type 2 diabetes. CONCLUSION: Vaccination of pneumococcal infection in patients with COPD and type 2 diabetes mellitus can reduce the number of exacerbations, incidence of pneumonia and the number of hospitalizations, improve the prognosis and survival of patients using PCV-13 by maintaining efficacy for 5 years of follow-up.

[Impact of vaccination with pneumococcal vaccines on recurrent pneumonia in patients with chronic obstructive pulmonary disease].

BACKGROUND: Community-acquired pneumonia (САР) and chronic obstructive pulmonary disease (COPD) are among the main causes of mortality worldwide, and, in addition, they also lead to great economic losses for the health system of all countries. Currently, there is an increase in cases of recurrent pneumonia, both in the general population and, in particular, in patients with COPD. One of the most important risk factors for the development of pneumonia is the previous episode of САР. Potential risk factors for recurrent pneumonia are concomitant diseases such as heart failure, COPD, diabetes mellitus, neurological disorders, swallowing dysfunction, immune deficiency. AIM: To conduct a retrospective analysis of the effect of vaccine prophylaxis with conjugated pneumococcal vaccine (PCV13) and polysaccharide pneumococcal vaccine (PPV23) on the risk of recurrent pneumonia in patients with COPD. MATERIALS AND METHODS: A total of 302 male patients were included in the retrospective study. When analyzing the data, the fact of the development of pneumonia of any etiology during the 5th observation period was taken into account. For the recurrence of pneumonia, more than two episodes of CAP were taken during the year. 13-valent conjugated pneumococcal vaccine Prevenar-13 and 23-valent polysaccharide vaccine Pneumo23 were used for vaccine prophylaxis. The relative risk of the event was calculated. A 95% confidence interval was used. RESULTS AND CONCLUSION: A retrospective analysis showed that, firstly, CAP is a fairly frequent complication of COPD: initially, the average percentage of cases of САР was 19.3%. Secondly, the risk of developing repeated episodes of pneumonia remains quite high in unvaccinated patients and tends to increase within 5 years: from 17 to 22%. Thirdly, the pneumococcal vaccines used have different effects on the risk of recurrent pneumonia in patients with COPD, a significant decrease in the number of recurrent pneumonia is observed only with the use of conjugated vaccines.

[Experience of using dupilumab in the treatment of severe asthma].

The article provides data on modern approaches to the treatment of patients with severe uncontrolled bronchial asthma with an emphasis on the use of dupilumab, a human recombinant monoclonal antibody to the alpha subunit of the interleukin (IL)-4 receptor, which inhibits signal transmission from both IL-4 and IL-13. The results of dupilumab pivotal randomized clinical trials DRI12544, QUEST and VENTURE are summarized. Indications for use of this medicinal product are listed in Federal Clinical Guidelines on the management of asthma (year of revision 2019). Clinical cases with various clinical course of bronchial asthma are described, including cases with frequent exacerbations. In conclusion, dupilumab could be a treatment of choice for the patients with severe bronchial asthma and it is reasonable from an economic, clinical and pathogenetic point of view.

[The concept of chronic obstructive pulmonary disease clinical control as a decision - making tool in real clinical practice for optimizing of basic pharmacotherapy].

The main goals of COPD therapy are to achieve clinical stability with minimal clinical manifestations and low risk of relapse. The proposed COPD control concept by analogy with asthma has not been quite well characterized yet. COPD control is defined as "the long - term maintenance of a clinical situation with a low impact of symptoms on the patient's life and absence of exacerbations." The situation of clinical control in COPD is considered desirable and potentially achievable for most patients with COPD. Pharmacotherapeutic options for COPD are constantly expanding. The control concept may be useful when the decision on treatment of COPD is made for dynamic adjustment of the therapy volume.

[Severe bronchial asthma patient care organization in various regions of the Russian Federation. From endotypes and phenotypes of bronchial asthma to personalized choice of therapy].

The meeting of the Expert board was held in Moscow on June 24, 2019, at which the following issues were considered: the applicability of a new terminology characterizing asthma endotypes and phenotypes in real clinical practice, the effect of phenotypes and biomarkers in patients with bronchial asthma on the choice of biological drug, as well as the optimal clinical profiles of patients for whom dupilumab is most effective, taking into account the data of the III phase clinical trials, regional features of medical care and changes in updated international clinical guidelines for the diagnosis and treatment of asthma. The Expert board included members of leading Russian scientific and educational medical institutions: S.N. Avdeev, corresponding member of the Russian Academy of Sciences, prof., MD; O.A. Volkova, Ph.D.; I.V. Demko, prof., MD; G.L. Ignatova, prof., MD; I.V. Leshchenko, prof., MD; Kanukova N.A.; Kudelya L.M., prof., MD; V.A. Nevzorova, prof., MD; N.G. Nedashkovskaya; O.P. Ukhanova, prof., MD; L.V. Shulzhenko, prof., MD; R.S. Fassakhov, prof., MD.

[Experience of olokizumab use in COVID-19 patients].

Most subjects with the COVID-19 experience mild to moderate symptoms, but approximately 10% of cases suffer from severe course of disease. IL-6 inhibitors are actively used to neutralize and prevent the cytokine storm. Olokizumab is a humanized monoclonal antibody belonging to the G4/Kappa immunoglobulin isotype that selectively binds to human IL-6 and effectively neutralizes it. AIM: To evaluate the efficacy and safety of Artlegia (olokizumab) for the treatment of subjects with a disease caused by the SARS-COV-2 virus in a real-world clinical setting. MATERIALS AND METHODS: The analysis included data of 610 subjects aged 55.0812.68 years who received olokizumab at a single dose of 160 mg/mL 0.4 mL subcutaneously as a preemptive anti-inflammatory therapy. The comparison group included 511 subjects aged 55.2311.23 years who received standard therapy without IL-6 inhibitors. Control Endpoints: 1. Positive clinical changes on Day 7. 2. Changes in the CRP levels on Days 1, 2, and 7. 3. Duration of oxygen therapy. 4. Number of days in hospital. 5. Number of adverse events. 6. Disease outcome. RESULTS: If a cytokine storm occurs, immune regulatory events will trigger the development of either a protective immune response or an exacerbated inflammatory response. The use of preemptive anti-inflammatory therapy has both a short-term and, most importantly, a long-term effect on the T and B parts of the immune process. These aspects definitely require further research and observation. CONCLUSION: The use of olokizumab to treat the new COVID-19 coronavirus disease has demonstrated a positive effect on clinical and laboratory parameters. Primarily, it affects the severity of clinical parameters by improving the general condition already on the first day of observation, and decreasing body temperature to normal values. The changes in the C-reactive protein levels show a significant effect of the IL-6 inhibitor on the systemic inflammatory response.

[Analysis of the impact of vaccination of pneumococcal infection in patients with chronic obstructive pulmonary disease in combination with diabetes].

AIM: The article presents data on the evaluation of the clinical efficacy of using a conjugated pneumococcal vaccine in patients with COPD in combination with 2-type diabetes during a 3-year follow - up period. MATERIALS AND METHODS: The study included 309 patients with an isolated course of COPD and in combination with diabetes. The main parameters for evaluating the effectiveness were: the dynamics of clinical symptoms - shortness of breath on the mMRC scale, CAT test, FEV1, the number of exacerbations, hospitalizations, the number of pneumonia, the state of carbohydrate metabolism (HbA1c) and the lipid profile. For vaccine prevention 13-valent conjugated pneumococcal vaccine Prevenar-13 was used. RESULTS AND CONCLUSIONS: The use of PСV13 helps to reduce the severity of respiratory symptoms, reduce the number and duration of exacerbations of COPD, reduce the number of pneumonia. Both in isolated course of COPD and in combination with diabetes. Vaccination PCV13 in patients with comorbid course contributes to the compensation of carbohydrate metabolism and improve the lipid profile.

[Analysis of the effectiveness of joint or sequential vaccination with pneumococcal and influenza vaccines in patients with chronic obstructive pulmonary disease].

One of the extremely important problems of managing patients with chronic obstructive pulmonary disease (COPD) is to prevent exacerbations. The article presents data on the clinical and economic efficiency of joint vaccine prevention of conjugate pneumococcal vaccine Prevenar 13 (PCV13) and SOVIGRIPP flu vaccine in patients with COPD. MATERIAL AND METHODS: 153 patients were included in the study. They were divided into three groups. The first group (n=53) - consisted of patients who were vaccinated with PCV13. The second group (n=51) included patients who were vaccinated with PCV13 and influenza vaccine simultaneously or with an interval of not more than 2 weeks. The third group (n=49) included not vaccinated patients. The observation period is 1 year. RESULTS AND DISCUSSION: Combined vaccine prevention of pneumococcal conjugate and influenza vaccines reduces the degree of clinical impairment and stabilizes the main functional parameters of the respiratory system at a significantly lower level compared to monovaccination with only pneumococcal vaccine. Single - stage vaccination with PCV13 and influenza vaccine reduces the risk of adverse events in COPD, reduces the number of exacerbations associated with this hospitalization of patients and the incidence of pneumonia. CONCLUSION: Combined vaccination with the use of two vaccines minimizes the costs of the health care system. The budget savings can reach an average of 80-83% per year or up to 26 967 - 28 001 rubles per patient with COPD.

Efficiency of vaccine prophylaxis concentrated pneumococcal vaccine in patients with chronic obstructive lung disease and chronic heart failure.

AIM: The article uses the analysis of clinical and pharmacoeconomic effectiveness of 13-valent conjugated pneumococcal vaccine in patients with combined course of chronic obstructive pulmonary disease (COPD), ischemic heart disease (IHD) and chronic heart failure (CHF). MATERIALS AND METHODS: 429 male patients with diagnoses of COPD, IHD, CHF were included in the study. The main endpoints of observation, for 5 years, for evaluation of effectiveness were dynamic assessment for class CHF, the number of exacerbations, hospitalizations, the number of pneumonias. The 13-valent conjugated pneumococcal vaccine (PCV13) Prevenar-13 was used for vaccine prophylaxis. RESULTS: The increase in age with the combined course of COPD and cardiovascular pathology leads to a deterioration in the basic clinical and functional indicators. With the increase in the clinical symptoms of the defeat of the respiratory system. There is an increase in the functional class of heart failure. Inclusion of vaccine prophylaxis PCV13 in the management plan of patients with combined pathology. Reduce the degree of dyspnea and stabilize the main functional indicators. CONCLUSION: Vaccination of patients with COPD using PCV13 combined with CHF and IHD made it possible to manage the health system expenses by 74-84%.

[New opportunities for inhaled therapy for inflammatory diseases of the respiratory system]. / Novye vozmozhnosti ingaliatsionnoi terapii pri vospalitel'nykh zabolevaniiakh respiratornoi sistemy.

The paper considers current approaches to mucoregulatory therapy for various inflammatory diseases of the respiratory system. It gives the advantages and disadvantages of common drugs used in their treatment. Emphasis is laid on the use of inhaled hypertonic saline of NaCl in combination with hyaluronic acid (Hyaneb). Clinical examples of its use in chronic obstructive pulmonary disease, acute and chronic bronchitis, and severe asthma are considered.

[Impact of vaccination on the course of bronchial and systemic inflammation in patients with COPD and CHD]. / Vliyanie vaktsinatsii na dinamiku bronkhial'nogo i sistemnogo vospaleniya u patsientov s khronicheskoi obstruktivnoi bolezn'yu legkikh i ishemicheskoi bolezn'yu serdtsa.

AIM: To investigate the effect of 13-valent pneumococcal conjugate vaccine (PCV-13) on the clinical and functional manifestations of systemic inflammation in patients with chronic obstructive pulmonary disease (COPD) and coronary heart disease (CHD). SUBJECTS AND METHODS: The protocol included 36 patients with COPD and 36 patients with COPD concurrent with CHD. The number of COPD exacerbations, hospital admissions, pneumonia cases, degree of dyspnea, and functional indicators were analyzed. The levels of markers for inflammation, such as C-reactive protein (CRP), fibrinogen, and procalcitonin (PCT), were investigated. RESULTS: A year after vaccination, the COPD group showed decreases in the level of CRP, fibrinogen, and PCT by 11, 6, and 2%, respectively; the COPD + CHD group did by 12, 24, and 19%. PCT levels demonstrated the closest correlation with clinical and functional parameters; the other indicators showed moderate (CRP) and low (fibrinogen) correlations. CONCLUSION: PCV-13 vaccination can reduce systemic inflammation just a year later.

[Experience of Pneumo 23 vaccine in patients with combination of COLD with pneumoconiosis].

The most well-studied, but not single factor of COLD development is smoking. Occupational hazards as organic and inorganic dust are underevaluated risk factor of COLD. Smoking increased unfavorable effects of occupational hazards. Interesting for the study are the patients with combination of pneumoconiosis and COLD, severe concomitant diseases and decompensated complications--chronic cardiac failure and chronic lung failure. These patients have lower life quality, more frequent infectious exacerbations of COLD and pneumonias--that remains a significant medical and social problem. At present, pneumonia occupies 4-5th place in lethal outcomes structure. Pneumo 23--polysaccharide 23-valent vaccine--covers main serotypes of pneumococcus causing diseases of severe clinical course. In the study, the patients were injected with Pneumo 23 along with basic COLD therapy, were observed over 5 years and demonstrated reliable decrease of acute respiratory infections, COLD exacerbations and pneumonias. Those exacerbations and pneumonias had less severe course. Number of the exacerbations requiring hospitalization also decreased.

[Efficacy of nebulizer therapy with acetylcystein in outpatients with chronic obstructive lung disease].

Chronic obstructive lung disease (COLD) is a widespread illness with constantly growing mortality. Mucolytic therapy plays a significant role in treatment of patients with COLD. The paper contains the results of nebulization with acetyl-cystein as part of rehabilitation program in outpatients with stable clinical course of I-II stage of COLD. The results demonstrated significant clinical improvement, as well as positive changes in external respiration parameters (1 sforced expiratory volume), increase of physical activity tolerance, and disappearance of acute inflammation phase reactants in saliva.

[Lipid peroxidation processes in chronic bronchitis]. / Sostoianie protsessov perekisnogo okisleniia lipidov pri khronicheskom bronkhite.

AIM: Comparison of the levels of lipid peroxidation (LPO) products in condensate of the exhaled air (CEA) and in the biopsy samples from the inflammation focus. MATERIALS AND METHODS: Extraction spectrophotometry was used to measure LPO products in CEA and biopsies from 30 males aged 30-60 years suffering from chronic bronchitis and 30 healthy controls of the same age. RESULTS: There was activation of local accumulation of isopropanol-soluble LPO products in the bronchopulmonary system accompanied by lowered content of lipoperoxides and high antioxidant activity in CEA. CONCLUSION: Chronic bronchitis is characterized by multidirectional shifts in LPO in the inflammation focus and CEA.