January 27, 2017 The new Global Strategy for Diagnosis, Treatment and Prevention of COPD (GOLD) Working Group Report 2017 has been released, the result of a collaboration of 22 experts in the field of chronic obstructive pulmonary disease (COPD). This report is based on scientific publications on this issue that were published before October 2016. It was simultaneously published online in the American Journal of Respiratory and Critical Care Medicine and posted on the GOLD website. The updated guidelines address recent developments in diagnostics, de-escalation strategies, nonpharmacologic treatment options, and the role of comorbidities in the management of patients with COPD.
As before, the new report recommends screening for COPD in patients with a history of risk factors for COPD, as well as shortness of breath, chronic cough or sputum production. In this case, it is recommended to use as a diagnostic criterion the value of the ratio of forced expiratory volume in 1 second (FEV1) to forced vital capacity (FVC) after inhalation of a bronchodilator, equal to< 0,70. Факторами риска развития ХОБЛ считаются отягощенный семейный анамнез, низкая масса тела при рождении, частые респираторные инфекции в детстве, а также воздействие табачного дыма, дыма от сгорания топлива, которое используется для обогрева или приготовления пищи, а также ряд профессиональных воздействий, например, пыли, паров, копоти и прочих химических факторов.
One of the key changes in the new document is the separation of symptom assessment from spirometric assessment. Although respiratory function testing remains necessary to make a diagnosis, the main goals of the examination are to assess symptoms, the risk of exacerbations, and the degree of impact of the disease on the general health of patients. Based on these parameters, patients can then be classified into groups A, B, C and D, according to which treatment is prescribed. Thus, spirometry remains a diagnostic tool and a marker of the severity of obstruction, but it is no longer needed to make decisions about pharmacotherapy, with the exception of the administration of roflumilast. Also, threshold values determined using spirometry remain important for non-pharmacological treatments, in particular for lung volume reduction and lung transplantation.
Another change concerns the definition of exacerbation, which is now formulated in a simpler and more practical manner. The evidence base for treatment and prevention of exacerbations was also expanded.
Another new aspect of the GOLD Report is its detailed discussion of treatment intensification and de-escalation strategies, whereas earlier reports focused primarily on recommendations for initial treatment. Along with the inclusion of treatment intensification and de-intensification algorithms, the experts modified the discussion of treatment options and removed first-line treatment alternatives. The document now includes additional rationale for recommended initial therapy and possible alternative options for all patient populations (ABCD). The guidelines also place considerable emphasis on the use of combination bronchodilators as first-line treatment.
The updated guidance also provides detailed analysis of nonpharmacologic treatment options beyond influenza and pneumococcal vaccinations to reduce the risk of lower respiratory tract infections. Smoking cessation remains the most important aspect of any treatment plan, and pulmonary rehabilitation is also highly beneficial. The latter refers to a comprehensive intervention based on a thorough assessment of the patient's condition and adapted to his needs. It may include components such as physical training, education (including self-help), interventions aimed at achieving behavioral changes to improve physical and psychological well-being, and increasing adherence to treatment. Pulmonary rehabilitation has the potential to reduce the risk of readmission and mortality in patients following a recent exacerbation, but there is evidence that starting it before the patient is discharged may result in increased mortality.
Inhaled oxygen may improve survival in patients with severe resting hypoxemia, but long-term oxygen therapy in people with stable COPD and moderate or exercise-only hypoxemia does not prolong their life expectancy or reduce the risk of hospitalization. The usefulness of assisted ventilation remains unclear, although patients with proven obstructive sleep apnea should use continuous positive airway pressure machines to improve survival and reduce the risk of hospitalization.
As mentioned above, an important part of the new document is devoted to the diagnosis and treatment of concomitant pathologies in patients with COPD. In addition to the importance of identifying and treating obstructive sleep apnea discussed above, the GOLD Report addresses the importance of awareness of, and appropriate treatment for, comorbidities such as cardiovascular disease, osteoporosis, anxiety and depression, and gastroesophageal reflux.
Proven surgical techniques such as lung volume reduction surgery, bullectomy, lung transplantation, and some bronchoscopic procedures are discussed in more detail than previous reports. All should be considered in selected patients with appropriate indications.
The section on palliative care has also become more detailed. Hospice care and other end-of-life issues are discussed, as well as optimal strategies for managing symptoms such as shortness of breath, pain, anxiety, depression, fatigue, and eating disorders.
In principle, new GOLD reports are published annually when necessary, but the text undergoes significant changes only every few years as a significant amount of new information accumulates that must be taken into account in clinical practice. This update is the result of another planned major revision, and the authors hope that as a result of their work the guideline will be more practical and easier to use in a variety of clinical situations.
1
Russian Respiratory Society
Federal clinical
recommendations for diagnosis and
treatment
chronic obstructive disease
lungs
2014
2
Team of authors
Chuchalin Alexander Grigorievich Director of the Federal State Budgetary Institution "Research Institute of Pulmonology" FMBA
Russia, Chairman of the Board of the Russian Respiratory Society, chief freelance specialist pulmonologist
Ministry of Health of the Russian Federation, academician of the Russian Academy of Medical Sciences, professor, doctor of medical sciences.
Aisanov Zaurbek Ramazanovich
Head of the Department of Clinical Physiology and Clinical Research, Federal State Budgetary Institution "Research Institute of Pulmonology" FMBA of Russia, Professor, Doctor of Medical Sciences.
Avdeev Sergey Nikolaevich
Deputy Director for Scientific Work, Head of the Clinical Department of the Federal State Budgetary Institution "Research Institute of Pulmonology" FMBA of Russia, Professor, Doctor of Medical Sciences.
Belevsky Andrey
Stanislavovich
Professor of the Department of Pulmonology, State Budgetary Educational Institution of Higher Professional Education
RNRMU named after N.I. Pirogova, head of the rehabilitation laboratory
FSBI "Research Institute of Pulmonology" FMBA of Russia
, professor, doctor of medical sciences
Leshchenko Igor Viktorovich
Professor of the Department of Phthisiology and Pulmonology of the State Budgetary Educational Institution of Higher Professional Education of the USMU, chief freelance pulmonologist of the Ministry of Health
Sverdlovsk region and the Health Department of Yekaterinburg, scientific director of the clinic “Medical Association “New Hospital”, professor, doctor of medical sciences, honored doctor of Russia,
Meshcheryakova Natalya Nikolaevna
Associate Professor of the Department of Pulmonology, State Budgetary Educational Institution of Higher Professional Education, Russian National Research Medical University named after N.I. Pirogova, leading researcher at the rehabilitation laboratory
FSBI "Research Institute of Pulmonology" FMBA of Russia, Ph.D.
Ovcharenko Svetlana Ivanovna
Professor, Department of Faculty Therapy No. 1, Faculty of Medicine, State Budgetary Educational Institution of Higher Professional Education First
MSMU im. THEM. Sechenova, professor, doctor of medical sciences,
Honored Doctor of the Russian Federation
Shmelev Evgeniy Ivanovich
Head of the Department of Differential Diagnosis of Tuberculosis, Central Research Institute of Infectious Diseases of the Russian Academy of Medical Sciences, Doctor of Medical Sciences. Sciences, Professor, Doctor of Medical Sciences, Honored Scientist of the Russian Federation.
3
TABLE OF CONTENTS
1.
Methodology
4
2.
COPD Definition and Epidemiology
6
3.
Clinical picture of COPD
8
4.
Diagnostic principles
11
5.
Functional tests in diagnostics and monitoring
14
COPD course
6.
Differential diagnosis of COPD
18
7.
Modern classification of COPD. Comprehensive
20
assessment of severity.
8.
Therapy for stable COPD
24
9.
Exacerbation of COPD
29
10.
Treatment for exacerbation of COPD
31
11.
COPD and related diseases
34
12.
Rehabilitation and patient education
36
4
1. Methodology
Methods used to collect/select evidence:
search in electronic databases.
Description of methods used to collect/select evidence: the evidence base for recommendations is the publications included in
Cochrane Library, EMBASE and MEDLINE databases. The search depth was 5 years.
Methods used to assess the quality and strength of evidence:
Expert consensus;
Assessment of significance in accordance with the rating scheme (see Table 1).
Table 1. Rating scheme for assessing the strength of recommendations.
Levels
evidence
Description
1++
High quality meta-analyses, systematic reviews of randomized controlled trials (RCTs) or
RCT with very low risk of bias
1+
Qualitatively conducted meta-analyses, systematic, or
RCTs with low risk of bias
1-
Meta-analyses, systematic, or RCTs with a high risk of bias
2++
High-quality systematic reviews of case-control or cohort studies.
High-quality reviews of case-control or cohort studies with very low risk of confounding effects or bias and moderate probability of causality
2+
Well-conducted case-control or cohort studies with moderate risk of confounding effects or bias and moderate probability of causality
2-
Case-control or cohort studies with a high risk of confounding effects or bias and a moderate probability of causality
3
Non-analytical studies (eg case reports, case series)
4
Expert opinion
Methods used to analyze evidence:
Reviews of published meta-analyses;
Systematic reviews with evidence tables.
Description of methods used to analyze evidence:
When selecting publications as potential sources of evidence, the methodology used in each study is examined to ensure its validity. The outcome of the study influences the level of evidence assigned to the publication, which in turn influences the strength of the resulting recommendations.
5
Methodological examination is based on several key questions that focus on those features of the study design that have a significant impact on the validity of the results and conclusions. These key questions may vary depending on the types of studies and questionnaires used to standardize the publication assessment process. The recommendations used the MERGE questionnaire developed by
New South Wales Department of Health. This questionnaire is designed for detailed assessment and adaptation according to requirements
Russian Respiratory Society (RRO) in order to maintain an optimal balance between methodological rigor and the possibility of practical application.
The assessment process, of course, can also be affected by a subjective factor.
To minimize potential bias, each study was assessed independently, i.e. at least two independent members of the working group.
Any differences in assessments were discussed by the whole group as a whole.
If it was impossible to reach consensus, an independent expert was involved.
Evidence tables:
Evidence tables were completed by members of the working group.
Methods used to formulate recommendations:
Expert consensus.
Table 2. Rating scheme for assessing the strength of recommendations
Force
Description
A
At least one meta-analysis, systematic review or RCT rated 1++, directly applicable to the target population and demonstrating robustness of the results, or a body of evidence including results from studies rated 1+, directly applicable to the target population and demonstrating overall robustness results
IN
A body of evidence that includes results from studies rated 2++ that are directly applicable to the target population and demonstrate general robustness of the results, or evidence extrapolated from studies rated 1++ or 1+
WITH
A body of evidence that includes findings from studies rated 2+, directly applicable to the target population, and demonstrating overall robustness of the results; or extrapolated evidence from studies rated 2++
D
Level 3 or 4 evidence; or extrapolated evidence from studies rated 2+
Good Practice Points (GPPs):
Recommended good practice is based on the clinical experience of the guideline working group members.
Economic analysis:
6
No cost analysis was performed and pharmacoeconomics publications were not reviewed.
Recommendation validation method:
External expert assessment;
Internal expert assessment.
Description of the method for validating recommendations:
These draft recommendations were reviewed by independent experts who were asked to comment primarily on the extent to which the interpretation of the evidence underlying the recommendations is understandable.
Comments were received from primary care physicians and local therapists regarding the clarity of the recommendations and their assessment of the importance of the recommendations as a working tool in daily practice.
A preliminary version was also sent to a non-medical reviewer for comments from patient perspectives.
The comments received from the experts were carefully systematized and discussed by the chairman and members of the working group. Each point was discussed and the resulting changes to the recommendations were recorded. If changes were not made, then the reasons for refusing to make changes were recorded.
Consultation and expert assessment:
A preliminary version was posted for wide discussion on the website
RPO to ensure that persons not participating in the congress have the opportunity to participate in the discussion and improvement of the recommendations.
The draft guidelines were also peer-reviewed by independent experts, who were asked to comment primarily on the clarity and accuracy of the interpretation of the evidence base underlying the recommendations.
Working group:
For final revision and quality control, the recommendations were re-analyzed by members of the working group, who concluded that all comments and comments from experts were taken into account, and the risk of systematic errors in the development of recommendations was minimized.
Basic recommendations:
Strength of recommendations (A – D), levels of evidence (1++, 1+, 1-, 2++, 2+, 2-, 3, 4) and good practice points (GPPs) are given in the text. recommendations.
2. Definition of COPD and epidemiology
Definition
COPD is a preventable and treatable disease
characterized by persistent air speed limitation
flow, which is usually progressive and associated with severe chronic
inflammatory response of the lungs to the action of pathogenic particles or gases.
In some patients, exacerbations and concomitant diseases may affect
overall severity of COPD (GOLD 2014).
Traditionally, COPD combines chronic bronchitis and emphysema
Chronic bronchitis is usually defined clinically as the presence of a cough producing sputum for at least 3 months over the next 2 years.
7
Emphysema is defined morphologically as the presence of persistent dilation of the airways distal to the terminal bronchioles, associated with destruction of the alveolar walls, not associated with fibrosis.
In patients with COPD, both conditions are most often present, and in some cases it is quite difficult to clinically distinguish between them in the early stages of the disease.
The concept of COPD does not include bronchial asthma and other diseases associated with poorly reversible bronchial obstruction (cystic fibrosis, bronchiectasis, bronchiolitis obliterans).
Epidemiology
Prevalence
COPD is currently a global problem. In some countries around the world, the prevalence of COPD is very high (over 20% in Chile), in others it is lower (about 6% in Mexico). The reasons for this variability are differences in people's lifestyles, behavior and exposure to a variety of damaging agents.
One of the Global Studies (BOLD Project) provided a unique opportunity to estimate the prevalence of COPD using standardized questionnaires and pulmonary function tests in populations of adults over 40 years of age in both developed and developing countries. Prevalence
COPD stage II and higher (GOLD 2008), according to the BOLD study, among people over 40 years old was 10.1±4.8%; including for men – 11.8±7.9% and for women – 8.5±5.8%. According to an epidemiological study on the prevalence of COPD in the Samara region (residents 30 years of age and older), the prevalence of COPD in the total sample was 14.5% (men - 18.7%, women - 11.2%). According to the results of another Russian study conducted in the Irkutsk region, the prevalence of COPD in people over 18 years of age among the urban population was 3.1%, among the rural
6,6 %.
The prevalence of COPD increased with age: in the age group from 50 to
69 years old, 10.1% of men in the city and 22.6% suffered from the disease
in the countryside. Almost every second man over 70 years of age living in rural areas was diagnosed with COPD.
Mortality
According to WHO, COPD is currently the 4th leading cause of death in the world. About 2.75 million people die from COPD every year, which is
4.8% of all causes of death. In Europe, mortality from COPD varies significantly, from
0.20 per 100,000 population in Greece, Sweden, Iceland and Norway, up to 80 per 100,000 in Ukraine and Romania.
In the period from 1990 to 2000. mortality from cardiovascular diseases in general and from stroke decreased by 19.9% and 6.9%, respectively, while mortality from COPD increased by 25.5%. A particularly pronounced increase in mortality from
COPD occurs among women.
Predictors of mortality in patients with COPD are factors such as the severity of bronchial obstruction, nutritional status (body mass index), physical endurance according to the 6-minute walk test and severity of shortness of breath, frequency and severity of exacerbations, pulmonary hypertension.
The main causes of death in patients with COPD are respiratory failure (RF), lung cancer, cardiovascular diseases and tumors of other localizations.
Socio-economic significance of COPD
In developed countries, the total economic costs associated with COPD in the structure of pulmonary diseases occupy 2nd place after lung cancer and 1st place
8 in terms of direct costs, exceeding the direct costs of bronchial asthma by 1.9 times.
The economic costs per patient associated with COPD are three times higher than for a patient with bronchial asthma. The few reports on direct medical costs for COPD indicate that more than 80% of costs are spent on inpatient care and less than 20% on outpatient care. It was found that 73% of costs are for 10% of patients with severe disease. The greatest economic damage comes from treating exacerbations of COPD. In Russia, the economic burden of COPD, taking into account indirect costs, including absenteeism (absenteeism) and presenteeism (less effective work due to poor health), amounts to 24.1 billion rubles.
3. Clinical picture of COPD
Under conditions of exposure to risk factors (smoking, both active and passive, exogenous pollutants, bioorganic fuel, etc.), COPD usually develops slowly and progresses gradually. The peculiarity of the clinical picture is that for a long time the disease proceeds without pronounced clinical manifestations (3, 4; D).
The first signs with which patients consult a doctor are a cough, often with sputum production, and/or shortness of breath. These symptoms are most pronounced in the morning. During cold seasons, “frequent colds” occur.
This is the clinical picture of the onset of the disease,
which the doctor regards as a manifestation of smoker’s bronchitis, and the diagnosis of COPD at this stage is practically not made.
Chronic cough, usually the first symptom of COPD, is often underestimated by patients, as it is considered an expected consequence of smoking and/or exposure to adverse environmental factors. Typically, patients produce a small amount of viscous sputum. An increase in cough and sputum production occurs most often in the winter months, during infectious exacerbations.
Dyspnea is the most important symptom of COPD (4; D). It is often the reason for seeking medical help and the main reason limiting the patient’s work activity. The health impact of breathlessness is assessed using the British Medical Council questionnaire.
(MRC). Initially, shortness of breath occurs with relatively high levels of physical activity, such as running on level ground or walking up stairs. As the disease progresses, shortness of breath intensifies and can limit even daily activity, and later occurs at rest, forcing the patient to stay at home (Table 3). In addition, the assessment of dyspnea using the MRC scale is a sensitive tool for predicting the survival of patients with COPD.
Table 3. Dyspnea rating according to the Medical Research Council Scale (MRC)
Dyspnea Scale.
Degree Severity
Description
0 no
I feel short of breath only during intense physical activity
1 light
I get out of breath when walking quickly on level ground or climbing a gentle hill
2 medium
Shortness of breath causes me to walk on level ground slower than people of the same age, or I stop breathing when I walk on level ground at my normal pace
9 3 heavy
I get out of breath after walking about 100 m, or after walking for a few minutes on level ground
4 very heavy
I am too short of breath to leave the house or feel out of breath when getting dressed or undressed
When describing the clinical picture of COPD, it is necessary to take into account the features characteristic of this particular disease: its subclinical onset, the absence of specific symptoms, and the steady progression of the disease.
The severity of symptoms varies depending on the phase of the disease (stable course or exacerbation). A condition in which the severity of symptoms does not change significantly over weeks or even months should be considered stable, and in this case, disease progression can only be detected with long-term (6-12 months) follow-up of the patient.
Exacerbations of the disease have a significant impact on the clinical picture - periodically occurring deterioration of the condition (lasting at least 2-3 days), accompanied by an increase in the intensity of symptoms and functional disorders. During an exacerbation, there is an increase in the severity of hyperinflation and the so-called. air traps in combination with a reduced expiratory flow, which leads to increased shortness of breath, which is usually accompanied by the appearance or intensification of distant wheezing, a feeling of constriction in the chest, and a decrease in exercise tolerance.
In addition, the cough intensity increases, changes
(increases or sharply decreases) the amount of sputum, the nature of its separation, color and viscosity. At the same time, indicators of external respiration function and blood gases deteriorate: speed indicators (FEV) decrease
1
etc.), hypoxemia and even hypercapnia may occur.
The course of COPD is an alternation of a stable phase and exacerbation of the disease, but it varies from person to person. However, progression of COPD is common, especially if the patient continues to be exposed to inhaled pathogenic particles or gases.
The clinical picture of the disease also seriously depends on the phenotype of the disease, and vice versa, the phenotype determines the characteristics of the clinical manifestations
COPD For many years, there has been a division of patients into emphysematous and bronchitis phenotypes.
Bronchitic type is characterized by a predominance of signs of bronchitis
(cough, sputum production). Emphysema in this case is less pronounced. In the emphysematous type, on the contrary, emphysema is the leading pathological manifestation, shortness of breath prevails over cough. However, in clinical practice it is very rarely possible to distinguish the emphysematous or bronchitis phenotype of COPD in the so-called. “pure” form (it would be more correct to talk about a predominantly bronchitis or predominantly emphysematous phenotype of the disease).
The features of the phenotypes are presented in more detail in Table 4.
Russian Respiratory Society
chronic obstructive pulmonary disease
Chuchalin Alexander Grigorievich |
Director of the Federal State Budgetary Institution "Research Institute of Pulmonology" FMBA |
Russia, Chairman of the Board of the Russian |
|
Respiratory Society, Chief |
|
freelance specialist pulmonologist |
|
Ministry of Health of the Russian Federation, academician of the Russian Academy of Medical Sciences, professor, |
|
Aisanov Zaurbek Ramazanovich |
Head of the Department of Clinical Physiology |
and clinical studies of the Federal State Budgetary Institution "Research Institute |
|
Avdeev Sergey Nikolaevich |
Deputy Director for Research, |
Head of the Clinical Department of the Federal State Budgetary Institution "Research Institute |
|
pulmonology" FMBA of Russia, professor, doctor of medical sciences. |
|
Belevsky Andrey |
Professor of the Department of Pulmonology, State Budgetary Educational Institution of Higher Professional Education |
Stanislavovich |
RNRMU named after N.I. Pirogova, head |
rehabilitation laboratory of the Federal State Budgetary Institution "Research Institute |
|
Pulmonology" FMBA of Russia , professor, doctor of medical sciences |
|
Leshchenko Igor Viktorovich |
Professor of the Department of Phthisiology and |
pulmonology GBOU VPO USMU, chief |
|
freelance specialist pulmonologist of the Ministry of Health |
|
Sverdlovsk Region and Administration |
|
health care of Yekaterinburg, scientific |
|
Head of the Medical Clinic |
|
association "New Hospital", professor, |
|
Doctor of Medical Sciences, Honored Doctor of Russia, |
|
Meshcheryakova Natalya Nikolaevna |
Associate Professor, Department of Pulmonology, State Budgetary Educational Institution of Higher Professional Education, Russian National Research Medical University |
named after N.I. Pirogova, leading researcher |
|
rehabilitation laboratory of the Federal State Budgetary Institution "Research Institute |
|
Pulmonology" FMBA of Russia, Ph.D. |
|
Ovcharenko Svetlana Ivanovna |
Professor of the Department of Faculty Therapy No. |
1st Faculty of Medicine, State Budgetary Educational Institution of Higher Professional Education First |
|
MSMU im. THEM. Sechenova, professor, doctor of medical sciences, |
|
Honored Doctor of the Russian Federation |
|
Shmelev Evgeniy Ivanovich |
Head of the Department of Differential |
diagnostics of tuberculosis Central Research Institute of the Russian Academy of Medical Sciences, doctor |
|
honey. Sciences, Professor, Doctor of Medical Sciences, Honored |
|
scientist of the Russian Federation. |
Methodology |
||
COPD Definition and Epidemiology |
||
Clinical picture of COPD |
||
Diagnostic principles |
||
Functional tests in diagnostics and monitoring |
||
COPD course |
||
Differential diagnosis of COPD |
||
Modern classification of COPD. Comprehensive |
||
assessment of severity. |
||
Therapy for stable COPD |
||
Exacerbation of COPD |
||
Treatment for exacerbation of COPD |
||
COPD and related diseases |
||
Rehabilitation and patient education |
||
1. Methodology
Methods used to collect/select evidence:
search in electronic databases.
Description of methods used to collect/select evidence:
Methods used to assess the quality and strength of evidence:
Expert consensus;
Description |
||||||
evidence |
||||||
High quality meta-analyses, systematic reviews |
||||||
randomized controlled trials (RCTs) or |
||||||
RCT with very low risk of bias |
||||||
Qualitatively conducted meta-analyses, systematic, or |
||||||
RCTs with low risk of bias |
||||||
Meta-analyses, systematic, or high-risk RCTs |
||||||
systematic errors |
||||||
High quality |
systematic reviews |
research |
||||
case-control |
cohort |
research. |
||||
High-quality reviews of case-control studies or |
||||||
cohort studies with very low risk of effects |
||||||
confounding or systematic errors and average probability |
||||||
causal relationship |
||||||
Well-conducted case-control studies or |
||||||
cohort studies with moderate risk of confounding effects |
||||||
or systematic errors and the average probability of causality |
||||||
relationships |
||||||
Case-control or cohort studies with |
||||||
high risk of mixing effects or systematic |
||||||
errors and average probability of causal relationship |
||||||
Non-analytical studies (e.g. case reports, |
||||||
case series) |
||||||
Expert opinion |
||||||
Methods used to analyze evidence:
Systematic reviews with evidence tables.
Description of methods used to analyze evidence:
When selecting publications as potential sources of evidence, the methodology used in each study is examined to ensure its validity. The outcome of the study influences the level of evidence assigned to the publication, which in turn influences the strength of the resulting recommendations.
Methodological examination is based on several key questions that focus on those features of the study design that have a significant impact on the validity of the results and conclusions. These key questions may vary depending on the types of studies and questionnaires used to standardize the publication assessment process. The recommendations used the MERGE questionnaire developed by the New South Wales Department of Health. This questionnaire is designed to be assessed in detail and adapted to meet the requirements of the Russian Respiratory Society (RRS) in order to maintain an optimal balance between methodological rigor and practical applicability.
The assessment process, of course, can also be affected by a subjective factor. To minimize potential bias, each study was assessed independently, i.e. at least two independent members of the working group. Any differences in assessments were discussed by the whole group as a whole. If it was impossible to reach consensus, an independent expert was involved.
Evidence tables:
Evidence tables were completed by members of the working group.
Methods used to formulate recommendations:
Description |
|
At least one meta-analysis, systematic review or RCT, |
|
demonstrating sustainability of results |
|
A body of evidence including the results of studies assessed |
|
overall sustainability of results |
|
extrapolated evidence from studies rated 1++ |
|
A body of evidence including the results of studies assessed |
|
overall sustainability of results; |
|
extrapolated evidence from studies rated 2++ |
|
Level 3 or 4 evidence; |
|
extrapolated evidence from studies rated 2+ |
Good Practice Points (GPPs):
Economic analysis:
No cost analysis was performed and pharmacoeconomics publications were not reviewed.
External expert assessment;
Internal expert assessment.
These draft recommendations were reviewed by independent experts who were asked to comment primarily on the extent to which the interpretation of the evidence underlying the recommendations is understandable.
Comments were received from primary care physicians and local therapists regarding the clarity of the recommendations and their assessment of the importance of the recommendations as a working tool in daily practice.
A preliminary version was also sent to a non-medical reviewer for comments from patient perspectives.
The comments received from the experts were carefully systematized and discussed by the chairman and members of the working group. Each point was discussed and the resulting changes to the recommendations were recorded. If changes were not made, then the reasons for refusing to make changes were recorded.
Consultation and expert assessment:
The preliminary version was posted for wide discussion on the RPO website so that persons not participating in the congress had the opportunity to participate in the discussion and improvement of the recommendations.
Working group:
For final revision and quality control, the recommendations were re-analyzed by members of the working group, who concluded that all comments and comments from experts were taken into account, and the risk of systematic errors in the development of recommendations was minimized.
2. Definition of COPD and epidemiology
Definition
COPD is a preventable and treatable disease characterized by persistent airflow limitation that is usually progressive and associated with a significant chronic inflammatory response of the lungs to pathogenic particles or gases. In some patients, exacerbations and comorbidities may influence the overall severity of COPD (GOLD 2014).
Traditionally, COPD combines chronic bronchitis and emphysema. Chronic bronchitis is usually defined clinically as the presence of a cough with
sputum production for at least 3 months over the next 2 years.
Emphysema is defined morphologically as the presence of persistent dilation of the airways distal to the terminal bronchioles, associated with destruction of the alveolar walls, not associated with fibrosis.
In patients with COPD, both conditions are most often present, and in some cases it is quite difficult to clinically distinguish between them in the early stages of the disease.
The concept of COPD does not include bronchial asthma and other diseases associated with poorly reversible bronchial obstruction (cystic fibrosis, bronchiectasis, bronchiolitis obliterans).
Epidemiology
Prevalence
COPD is currently a global problem. In some countries around the world, the prevalence of COPD is very high (over 20% in Chile), in others it is lower (about 6% in Mexico). The reasons for this variability are differences in people's lifestyles, behavior and exposure to a variety of damaging agents.
One of the Global Studies (BOLD Project) provided a unique opportunity to estimate the prevalence of COPD using standardized questionnaires and pulmonary function tests in populations of adults over 40 years of age in both developed and developing countries. The prevalence of COPD stage II and higher (GOLD 2008), according to the BOLD study, among people over 40 years of age was 10.1 ± 4.8%; including for men – 11.8±7.9% and for women – 8.5±5.8%. According to an epidemiological study on the prevalence of COPD in the Samara region (residents 30 years of age and older), the prevalence of COPD in the total sample was 14.5% (men - 18.7%, women - 11.2%). According to the results of another Russian study conducted in the Irkutsk region, the prevalence of COPD in people over 18 years of age among the urban population was 3.1%, among the rural population 6.6%. The prevalence of COPD increased with age: in the age group from 50 to 69 years, 10.1% of men in the city and 22.6% in rural areas suffered from the disease. Almost every second man over 70 years of age living in rural areas was diagnosed with COPD.
Mortality
According to WHO, COPD is currently the 4th leading cause of death in the world. About 2.75 million people die from COPD each year, accounting for 4.8% of all causes of death. In Europe, mortality from COPD varies significantly: from 0.20 per 100,000 population in Greece, Sweden, Iceland and Norway, to 80 per 100,000
V Ukraine and Romania.
IN period from 1990 to 2000 mortality from cardiovascular diseases
V overall and from stroke decreased by 19.9% and 6.9%, respectively, while mortality from COPD increased by 25.5%. A particularly pronounced increase in mortality from COPD is observed among women.
Predictors of mortality in patients with COPD are factors such as the severity of bronchial obstruction, nutritional status (body mass index), physical endurance according to the 6-minute walk test and severity of shortness of breath, frequency and severity of exacerbations, pulmonary hypertension.
The main causes of death in patients with COPD are respiratory failure (RF), lung cancer, cardiovascular diseases and tumors of other localizations.
Socio-economic significance of COPD
IN In developed countries, the total economic costs associated with COPD in the structure of pulmonary diseases occupy 2nd place after lung cancer and 1st place
in terms of direct costs, exceeding the direct costs of bronchial asthma by 1.9 times. The economic costs per patient associated with COPD are three times higher than for a patient with bronchial asthma. The few reports on direct medical costs for COPD indicate that more than 80% of costs are spent on inpatient care and less than 20% on outpatient care. It was found that 73% of costs are for 10% of patients with severe disease. The greatest economic damage comes from treating exacerbations of COPD. In Russia, the economic burden of COPD, taking into account indirect costs, including absenteeism (absenteeism) and presenteeism (less effective work due to poor health), amounts to 24.1 billion rubles.
3. Clinical picture of COPD
Under conditions of exposure to risk factors (smoking, both active and passive, exogenous pollutants, bioorganic fuel, etc.), COPD usually develops slowly and progresses gradually. The peculiarity of the clinical picture is that for a long time the disease proceeds without pronounced clinical manifestations (3, 4; D).
The first signs with which patients consult a doctor are a cough, often with sputum production, and/or shortness of breath. These symptoms are most pronounced in the morning. During cold seasons, “frequent colds” occur. This is the clinical picture of the onset of the disease, which the doctor regards as a manifestation of smoker’s bronchitis, and the diagnosis of COPD at this stage is practically not made.
Chronic cough, usually the first symptom of COPD, is often underestimated by patients, as it is considered an expected consequence of smoking and/or exposure to adverse environmental factors. Typically, patients produce a small amount of viscous sputum. An increase in cough and sputum production occurs most often in the winter months, during infectious exacerbations.
Dyspnea is the most important symptom of COPD (4; D). It is often the reason for seeking medical help and the main reason limiting the patient’s work activity. The health impact of breathlessness is assessed using the British Medical Council (MRC) questionnaire. Initially, shortness of breath occurs with relatively high levels of physical activity, such as running on level ground or walking up stairs. As the disease progresses, shortness of breath intensifies and can limit even daily activity, and later occurs at rest, forcing the patient to stay at home (Table 3). In addition, the assessment of dyspnea using the MRC scale is a sensitive tool for predicting the survival of patients with COPD.
Table 3. Dyspnea score using the Medical Research Council Scale (MRC) Dyspnea Scale.
Description |
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I only feel short of breath during intense physical activity. |
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load |
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I get out of breath when I walk quickly on level ground or |
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walking up a gentle hill |
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Shortness of breath makes me walk slower on level ground, |
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than people of the same age, or stops at me |
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breathing when I walk on level ground in the usual |
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tempo for me |
When describing the clinical picture of COPD, it is necessary to take into account the features characteristic of this particular disease: its subclinical onset, the absence of specific symptoms, and the steady progression of the disease.
The severity of symptoms varies depending on the phase of the disease (stable course or exacerbation). A condition in which the severity of symptoms does not change significantly over weeks or even months should be considered stable, and in this case, disease progression can only be detected with long-term (6-12 months) follow-up of the patient.
Exacerbations of the disease have a significant impact on the clinical picture - periodically occurring deterioration of the condition (lasting at least 2-3 days), accompanied by an increase in the intensity of symptoms and functional disorders. During an exacerbation, there is an increase in the severity of hyperinflation and the so-called. air traps in combination with a reduced expiratory flow, which leads to increased shortness of breath, which is usually accompanied by the appearance or intensification of distant wheezing, a feeling of constriction in the chest, and a decrease in exercise tolerance. In addition, the intensity of the cough increases, the amount of sputum, the nature of its separation, color and viscosity changes (increases or sharply decreases). At the same time, indicators of the function of external respiration and blood gases deteriorate: speed indicators (FEV1, etc.) decrease, hypoxemia and even hypercapnia may occur.
The course of COPD is an alternation of a stable phase and exacerbation of the disease, but it varies from person to person. However, progression of COPD is common, especially if the patient continues to be exposed to inhaled pathogenic particles or gases.
The clinical picture of the disease also seriously depends on the phenotype of the disease, and vice versa, the phenotype determines the characteristics of the clinical manifestations of COPD. For many years, there has been a division of patients into emphysematous and bronchitis phenotypes.
The bronchitis type is characterized by a predominance of signs of bronchitis (cough, sputum production). Emphysema in this case is less pronounced. In the emphysematous type, on the contrary, emphysema is the leading pathological manifestation, shortness of breath prevails over cough. However, in clinical practice it is very rarely possible to distinguish the emphysematous or bronchitis phenotype of COPD in the so-called. “pure” form (it would be more correct to talk about a predominantly bronchitis or predominantly emphysematous phenotype of the disease). The features of the phenotypes are presented in more detail in Table 4.
Table 4. Clinical and laboratory features of the two main phenotypes of COPD.
Peculiarities |
external |
Reduced nutrition |
Increased nutrition |
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Pink complexion |
Diffuse cyanosis |
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Extremities are cold |
Limbs are warm |
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Predominant symptom |
||||||
Scanty – often mucous |
Abundant – often mucous- |
|||||
Bronchial infection |
||||||
Pulmonary heart |
||||||
terminal stage |
||||||
Radiography |
Hyperinflation, |
Gain |
pulmonary |
|||
chest |
bullous |
changes, |
increase |
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"vertical" heart |
heart size |
|||||
Hematocrit, % |
||||||
PaO2 |
||||||
PaCO2 |
||||||
Diffusion |
small |
|||||
ability |
decline |
|||||
If it is impossible to distinguish the predominance of one phenotype or another, one should speak of a mixed phenotype. In clinical settings, patients with a mixed type of disease are more common.
In addition to the above, other phenotypes of the disease are currently identified. First of all, this applies to the so-called overlap phenotype (a combination of COPD and asthma). Although it is necessary to carefully differentiate between patients with COPD and asthma and the significant difference in chronic inflammation in these diseases, in some patients COPD and asthma may be present simultaneously. This phenotype can develop in smoking patients suffering from bronchial asthma. Along with this, as a result of large-scale studies it has been shown that about 20–30% of patients with COPD may have reversible bronchial obstruction, and eosinophils appear in the cellular composition during inflammation. Some of these patients can also be attributed to the “COPD + BA” phenotype. Such patients respond well to corticosteroid therapy.
Another phenotype that has been reported recently is that of patients with frequent exacerbations (2 or more exacerbations per year, or 1 or more exacerbations leading to hospitalization). The importance of this phenotype is determined by the fact that the patient emerges from an exacerbation with reduced functional indicators of the lungs, and the frequency of exacerbations directly affects the life expectancy of patients and requires an individual approach to treatment. The identification of numerous other phenotypes requires further clarification. Several recent studies have drawn attention to differences in the clinical presentation of COPD between men and women. As it turned out, women are characterized by more pronounced hyperreactivity of the respiratory tract, they report more pronounced shortness of breath at the same levels of bronchial obstruction as in men, etc. With the same functional indicators, oxygenation occurs better in women than in men. However, women are more likely to develop exacerbations, they show less effect from physical training in rehabilitation programs, and they rate their quality of life lower according to standard questionnaires.
It is well known that patients with COPD have numerous extrapulmonary manifestations of the disease due to the systemic effect of chronic
The main goal of treatment is to prevent the progression of the disease. Treatment goals are as follows (Table 12)
Table 12. Main goals of treatment
Main areas of treatment:
I. Non-pharmacological effects
- · Reducing the influence of risk factors.
- · Educational programs.
II. Drug treatment
Non-pharmacological methods of exposure are presented in Table 13.
Table 13. Non-pharmacological methods of influence
In patients with severe disease (GOLD 2 - 4), pulmonary rehabilitation should be used as a necessary measure.
II. Drug treatment
The choice of the volume of pharmacological therapy is based on the severity of clinical symptoms, the value of post-bronchodilator FEV1, and the frequency of exacerbations of the disease.
Table 14. Principles of drug therapy for stable COPD patients according to levels of evidence
|
Drug class |
Use of drugs (with level of evidence) |
|
Bronchodilators |
Bronchodilators are the mainstay of treatment for COPD. (A, 1+) Inhalation therapy is preferable. Drugs are prescribed either “as needed” or systematically. (A,1++) Preference is given to long-acting bronchodilators. (A, 1+) Tiotropium bromide, having a 24-hour effect, reduces the frequency of exacerbations and hospitalizations, improves symptoms and quality of life (A, 1++), improves the effectiveness of pulmonary rehabilitation (B, 2++) Formoterol and salmeterol significantly improve FEV1 and other lung volumes, quality of life, reduce the severity of symptoms and the frequency of exacerbations, without affecting mortality and decline in pulmonary function. (A, 1+) Ultra long-acting bronchodilator indacaterol allows you to significantly increase FEV1, reduce the severity of shortness of breath, the frequency of exacerbations and improve quality of life. (A, 1+) |
|
Combinations of bronchodilators |
Combinations of long-acting bronchodilators increase the effectiveness of treatment, reduce the risk of side effects and have a greater effect on FEV1 than either drug alone. (B, 2++) |
|
Inhaled glucocorticosteroids (ICS) |
They have a positive effect on the symptoms of the disease, pulmonary function, quality of life, reduce the frequency of exacerbations without affecting the gradual decrease in FEV1, and do not reduce overall mortality. (A, 1+) |
|
Combinations of inhaled corticosteroids with long-acting bronchodilators |
Combination therapy with ICS and long-acting β2-agonists may reduce mortality in patients with COPD. (B, 2++) Combination therapy with ICS and long-acting β2-agonists increases the risk of developing pneumonia, but has no other side effects. (A, 1+) Adding a long-acting β2-agonist to the combination with an inhaled corticosteroid tiotropium bromide improves lung function, quality of life and can prevent recurrent exacerbations. (B, 2++) |
|
Phosphodiesterase type 4 inhibitors |
Roflumilast reduces the frequency of moderate and severe exacerbations in patients with the bronchitis variant of severe and extremely severe COPD and a history of exacerbations. (A, 1++) |
|
Methylxanthines |
For COPD theophylline has a moderate bronchodilator effect compared to placebo. (A, 1+) Theophylline in low doses reduces the number of exacerbations in patients with COPD, but does not increase post-bronchodilator pulmonary function. (B, 2++) |
Table 15. List of essential drugs registered in Russia and used for basic therapy of patients with COPD
|
Drugs |
Single doses |
Duration of action |
||
|
For inhalation (device, mcg) |
For nebulizer therapy, mg/ml |
orally, mg |
||
|
b2-Agonists |
||||
|
Meek-acting |
||||
|
Fenoterol |
100-200 (DAI1) |
|||
|
Salbutamol |
||||
|
Long-acting |
||||
|
Formoterol |
4.5-12 (DAI, DPI2) |
|||
|
Indacaterol |
150-300 (DPI) |
|||
|
Anticholinergic drugs |
||||
|
Meek-acting |
||||
|
Ipratropium bromide |
||||
|
Long-acting |
||||
|
Tiotropium bromide |
|
|||
|
Glycopyrronium bromide |
||||
|
Combination of short-acting β2-agonists + anticholinergic drugs |
||||
|
Fenoterol/ Ipratropium |
100/40-200/80 (DAI) |
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|
Salbutamol/ Ipratropium |
||||
|
Methylxanthines |
||||
|
Theophylline (SR)*** |
Various, up to 24 |
|||
|
Inhaled glucocorticosteroids |
||||
|
Beclomethasone |
||||
|
Budesonide |
100, 200, 400 (DPI) |
|||
|
Fluticasone propionate |
||||
|
Combination of long-acting β2-agonists + glucocorticosteroids in one inhaler |
||||
|
Formoterol/ Budesonide |
|
|||
|
Salmeterol/ Fluticasone |
|
|||
|
4-phosphodiesterase inhibitors |
||||
|
Roflumilast |
1DAI - metered dose aerosol inhaler; 2DPI - metered dose powder inhaler
Schemes of pharmacological therapy for patients with COPD, compiled taking into account a comprehensive assessment of the severity of COPD (frequency of exacerbations of the disease, severity of clinical symptoms, stage of COPD, determined by the degree of bronchial obstruction) are given in Table 16.
Table 16. Pharmacological treatment regimens for COPD (GOLD 2013)
|
patients with COPD |
Drugs of choice |
Alternative drugs |
Other drugs |
|
COPD, mild, (post-bronchodilator FEV1 ≤ 50% predicted) with a low risk of exacerbations and rare symptoms (group A) |
1st scheme: KDAKH "on demand" 2nd scheme: CDBA “on demand” |
1st scheme: 2nd scheme: 3rd scheme: in combination with KDAH |
1) Theophylline |
|
COPD, non-severe (post-bronchodilator FEV1 ≤ 50% predicted) with a low risk of exacerbations and frequent symptoms (group B) |
1st scheme: 2nd scheme: |
1st scheme: in combination with DDBA |
and/or 2) Theophylline |
|
< 50% от должной) с высоким риском обострений и редкими симптомами (group C) |
1st scheme: LABA/ICS 2nd scheme: |
1st scheme: in combination with DDBA 2nd scheme: in combination with PDE-4 inhibitor 3rd scheme: in combination with PDE-4 inhibitor |
and/or 2) Theophylline |
|
COPD, severe (post-bronchodilator FEV1< 50% от должной) с высоким риском обострений и частыми симптомами (group D) |
1st scheme: LABA/ICS 2nd scheme: In addition to drugs of the 1st scheme: 3rd scheme: |
1st scheme: LABA/ICS in combination with DDAH 2nd scheme: LABA/ICS in combination with PDE-4 inhibitor 3rd scheme: in combination with DDBA 4th scheme : in combination with PDE-4 inhibitor |
and/or 3) Theophylline |
*- KDAH - short-acting anticholinergics; CDBA - short-acting β2-agonists; LABAs are long-acting β2-agonists; DDAC - long-acting anticholinergics; ICS - inhaled glucocorticosteroids; PDE-4 - phosphodiesterase inhibitors - 4.
Other treatments: oxygen therapy, ventilation support and surgical treatment.
Oxygen therapy
It was found that long-term administration of oxygen (> 15 hours per day) increases survival in patients with chronic respiratory failure and severe hypoxemia at rest (B, 2++).
Ventilation support
Non-invasive ventilation is widely used in patients with extremely severe and stable COPD.
The combination of NIV with long-term oxygen therapy may be effective in selected patients, especially in the presence of obvious daytime hypercapnia.
Surgery:
Lung volume reduction surgery (LVR) and lung transplantation.
The OPUL operation is performed by removing part of the lung to reduce hyperinflation and achieve more efficient pumping of the respiratory muscles. Its use is carried out in patients with upper lobe emphysema and low exercise tolerance.
Lung transplantation can improve quality of life and functional outcomes in carefully selected patients with very severe COPD. The selection criteria are FEV1<25% от должной величины, РаО2 <55 мм рт.ст., РаСО2 >50 mmHg when breathing room air and pulmonary hypertension (Ppa > 40 mm Hg).
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