Хроническая обструктивная болезнь легких

Objectives

This Russian clinical guideline provides an evidence-based framework for the diagnosis, classification, treatment, prevention and follow-up of chronic obstructive pulmonary disease (COPD), coded under International Classification of Diseases, 10th Revision category J44.[1]Its overarching clinical aims are to relieve symptoms, improve quality of life and exercise tolerance, prevent exacerbations, slow functional deterioration where possible, reduce complications and mortality, and support long-term self-management.[2][3]

• Reduce exposure to tobacco smoke, passive smoking, occupational dusts, gases and fumes, and polluted air, while recognising smoking as the principal risk factor for COPD.[4][5]
• Identify COPD accurately through clinical assessment, spirometry and differential diagnosis, including distinction from asthma, respiratory infection, lung cancer, cardiovascular disease and other conditions that may mimic or complicate COPD.[6][7]
• Classify severity and future risk using airflow limitation, symptoms, exacerbation history, complications, phenotype and coexisting diseases, including the Global Initiative for Chronic Obstructive Lung Disease assessment framework.[8][9]
• Control symptoms and reduce future exacerbation risk through individualised pharmacological and non-pharmacological treatment.[10][11]
• Prevent progression and avoidable harm through smoking cessation, vaccination against influenza and pneumococcal infection, pulmonary rehabilitation, physical activity, patient education and written self-management plans.[2][12][13]
• Manage acute exacerbations promptly, including assessment for respiratory failure, bacterial infection and alternative diagnoses, and escalation to hospital, ventilatory support or intensive care where clinically required.[14][15][16]
• Support patients with severe disease through long-term oxygen therapy, home non-invasive ventilation, lung-volume reduction procedures, lung transplantation and multidisciplinary assessment where indicated.[17][18][19][20]

The guideline does not set out a broader health-system mission, population targets, budgeted national strategy or quantified implementation objectives. Its strategic content is principally expressed through clinical recommendations, quality criteria and evidence-graded treatment pathways.[21][22]

Implementation

The approach is a continuum of evidence-based, patient-centred COPD care spanning risk reduction, diagnosis, routine review, stable-disease management, rehabilitation, exacerbation treatment and advanced respiratory support. Recommendations were developed through literature searches including the Cochrane Library, EMBASE and MEDLINE, expert consensus, independent assessment by at least two working-group members, external review and consultation with primary-care clinicians and the wider public through the Russian Respiratory Society website.[23][24][25][26]

• Assess suspected COPD using clinical history, smoking exposure, symptom and exacerbation history, physical examination, spirometry with bronchodilator testing, pulse oximetry, chest radiography and selected blood testing.[21]Confirm persistent expiratory airflow limitation using a forced expiratory volume in one second to forced vital capacity ratio below 0.7.[6]
• Use spirometric severity, symptom burden measured by the COPD Assessment Test or modified Medical Research Council Dyspnoea Scale, exacerbations in the previous year, exercise tolerance, body mass index and comorbidities to tailor treatment and prognosis assessment.[8][27]
• Deliver smoking-cessation support through brief advice, behavioural and psychological interventions, group or self-help support, and pharmacological treatment where there are no contraindications.[28]
• Provide bronchodilators as the foundation of pharmacotherapy, escalating from short-acting medicines as needed to long-acting monotherapy or combinations where symptoms, exercise limitation or exacerbation risk persist.[29][30][31]
• Select inhaled corticosteroids selectively for people with recurrent exacerbations, asthma features or raised blood eosinophils, and consider withdrawal where benefits are limited or adverse-effect risks outweigh expected benefit.[32][33][34]
• Consider phenotype-specific adjuncts, including roflumilast, mucolytics, theophylline or long-term macrolides, while monitoring medicine-specific risks such as adverse effects, antimicrobial resistance and serum theophylline concentrations.[35][36][37][38][39]
• Train patients to use inhalers correctly at treatment initiation and follow-up, matching device choice to coordination and inspiratory-flow capacity and using spacers, nebulisers or soft-mist inhalers where appropriate.[39][11][40]
• Provide pulmonary rehabilitation as a multicomponent programme incorporating physical training, education, nutritional and psychosocial support, with adaptation to disease severity, comorbidity and patient motivation.[3][41]
• Implement written action and self-management plans, patient education and multidisciplinary programmes to improve quality of life and reduce treatment delays during exacerbations.[12]
• Manage exacerbations according to severity through short-acting bronchodilators, systemic or inhaled corticosteroids, targeted antibiotic treatment when bacterial infection is likely, controlled oxygen therapy and timely respiratory support.[15][42][43][44]
• Use non-invasive ventilation for acute hypercapnic respiratory failure when indicated, monitor arterial blood gases during initial treatment, and proceed to invasive ventilation when drug treatment and non-invasive ventilation fail or urgent intubation is required.[16][45]
• Deliver long-term oxygen therapy following assessment during clinical stability, generally at home, and provide home non-invasive ventilation after hospital-based parameter selection with outpatient monitoring and specialist equipment servicing.[19][46][47]

Quality assurance relies on evidence grades, recommendation strengths, clinical quality criteria and scheduled review. Stable COPD follow-up includes reassessment of symptoms and exacerbations after three months and repeat spirometry after three months; acute-care quality criteria include review by a pulmonologist or physician and pulse oximetry within 30 minutes of hospital admission.[21][48]The source does not specify formal organisational accountability, financing arrangements, workforce plans or a national reporting system.[25][49]

Monitoring & Evaluation

The guideline primarily sets out clinical assessment, evidence grading and care-quality criteria rather than a population-level monitoring or accountability framework. It supports monitoring chronic obstructive pulmonary disease through repeated assessment of symptoms, airflow limitation, exacerbations, oxygenation, treatment response, complications and comorbidities.[8][9][21]Formal surveillance systems, reporting schedules, responsible institutions, programme targets and accountability arrangements are not specified in the supplied material.[23][22][24]

• Assess disease severity and future risk using spirometry, including the ratio of forced expiratory volume in one second to forced vital capacity and forced expiratory volume in one second as a percentage of its predicted value.[8]Classify risk alongside annual exacerbation history and symptom burden measured using the modified Medical Research Council Dyspnoea Scale and COPD Assessment Test.[8][9]
• Record symptom burden, exercise limitation, exacerbation frequency, complications and coexisting conditions as part of clinical review.[9][14][50]Prognostic assessment may also incorporate dyspnoea, six-minute walk distance and body mass index.[27]
• Use diagnostic quality controls for spirometry by obtaining at least three technically correct forced expiratory manoeuvres and applying reproducibility criteria to the highest forced vital capacity and forced expiratory volume in one second values.[51]Report non-reproducible but technically acceptable results explicitly as non-reproducible, with the best attempts and direction of change described where required.[52]
• Monitor treatment response through symptom control, exacerbation risk, inhaler technique, medicine adherence and adverse effects.[10][29]Follow-up should include checking inhaler use because errors are common.[39]
• Review stable disease after three months by reassessing symptoms and exacerbation frequency and repeating spirometry.[21]Use documented quality criteria for physical examination, smoking exposure, symptoms, exacerbations, pulse oximetry, spirometry, chest radiography and selected blood tests.[21]
• Monitor acute exacerbation care through timely clinical review and pulse oximetry, including assessment by a pulmonologist or physician within 30 minutes and pulse oximetry within 30 minutes of hospital admission.[48]When oxygen saturation is below 75%, the material specifies intensive-care physician review within 30 minutes.[48]
• Assess exacerbation-treatment outcomes using clinical and laboratory measures, including a 50% reduction in C-reactive protein from baseline during antibacterial treatment and symptom improvement equivalent to a one-point reduction on the Medical Research Council scale or a two-point reduction on the COPD Assessment Test.[53]
• Monitor arterial carbon dioxide tension and pH by arterial blood-gas analysis during the first 30 to 60 minutes of non-invasive ventilation.[16]Assess respiratory rate, dyspnoea, accessory-muscle use, consciousness, haemodynamic stability, airway protection and gas exchange to determine whether non-invasive ventilation should continue or invasive ventilation is required.[16][45]
• Provide specialist follow-up and equipment servicing for home non-invasive ventilation after ventilation parameters have been selected in hospital.[47]Assess long-term oxygen therapy eligibility using blood-gas values during a clinically stable phase, preferably three to four weeks after an exacerbation.[19]
• Apply evidence levels and recommendation grades to communicate the confidence and strength of clinical recommendations.[22][24]Base guideline development on systematic evidence review, independent assessment by at least two working-group members, full-group resolution of disagreements and consultation of an independent expert where consensus is not reached.[22][24]
• Use external and internal expert review, consultation with primary-care clinicians and public discussion to quality-assure draft recommendations.[25][26]Review comments systematically, document amendments or reasons for rejecting changes, and complete final working-group editing and quality control.[25][26]

Costing & Financing

No cost analysis or pharmacoeconomic analysis was conducted, and the supplied material does not specify budgets, allocations, medicine prices, funding sources, resource-mobilisation arrangements, funding gaps or economic assumptions.[25]The guideline identifies resource-intensive components of care, including diagnostic testing, inhaled medicines, oxygen equipment, home ventilation, specialist servicing, hospital treatment, pulmonary rehabilitation and selected surgery, but provides no monetary values or financing plan.[54][19][47][3]

• Recognise that frequent exacerbations are associated with higher treatment costs, although no monetary estimate is provided.[55]
• Note that portable home ventilators are described as relatively inexpensive and that oxygen concentrators and cylinders may be required for some patients, without prices or funding arrangements.[47]
• Consider medicine availability as one factor in selecting triple inhaled therapy, while noting that the material does not quantify affordability, procurement requirements or patient access.[56]
• Recognise that potentially unjustified inhaled corticosteroid use may incur unnecessary costs, but no estimate of these costs is supplied.[56][17]