pulmoПульмонологияPULMONOLOGIYA0869-01892541-9617Scientific and Practical Journal “PULMONOLOGIYA” LLC10.18093/0869-0189-2014-0-1-pulmo-200Research ArticleОБЗОРЫREVIEWЗНАЧЕНИЕ ЭПИДЕМИОЛОГИЧЕСКИХ ИССЛЕДОВАНИЙ В ПУЛЬМОНОЛОГИИA ROLE OF EPIDEMIOLOGICAL STUDIES IN PULMONOLOGYАрхиповВ. В.ArkhipovV. V.

д. м. н., профессор кафедры клинической фармакологии и пропедевтики внутренних болезней ГБОУВПО "Первый Московский государственный медицинский университет им. И.М.Сеченова" Минздрава России, ГКБ № 23; тел.: (495) 915-59-89

arkhipov@gmx.usАрхиповаД. Е.ArkhipovaD. E.

к. м. н., ассистент кафедры клинической фармакологии и пропедевтики внутренних болезней ГБОУ ВПО"Первый Московский государственный медицинский университет им. И.М.Сеченова" Минздрава России, ГКБ № 23; тел.: (495) 915-59-89

730323@gmail.comГБОУ ВПО "Первый Московский государственный медицинский университет им. И.М.Сеченова" Минздрава России: 109240, Москва, ул. Яузская 11, ГКБ № 23Russian Federation20142802201401200Copyright © Архипов В.В., Архипова Д.Е., 20142014Архипов В.В., Архипова Д.Е.Arkhipov V.V., Arkhipova D.E.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://journal.pulmonology.ru/pulm/article/view/200

О роли эпидемиологических исследований в пульмонологии.

A role of epidemiological studies in pulmonology.

клинические исследованияхроническая обструктивная болезнь легкихclinical trialschronic obstructive pulmonary diseaseReferencesTravers J., Marsh S., Caldwell B. et al. External validity of randomized controlled trials in COPD. Respir Med. 2007; 101 (6): 1313–1320.Travers J., Marsh S., Caldwell B. et al. External validity of randomized controlled trials in COPD. Respir Med. 2007; 101 (6): 1313–1320.Tashkin D.P., Celli B., Senn S. et al. A 4-year trial of tiotropium in chronic obstructive pulmonary disease. N. Engl. J. Med. 2008; 359 (15): 1543–1554.Tashkin D.P., Celli B., Senn S. et al. A 4-year trial of tiotropium in chronic obstructive pulmonary disease. N. Engl. J. Med. 2008; 359 (15): 1543–1554.Tonnel A.B., Perez T., Grosbois J.M. et al. Effect of tiotropium on health-related quality of life as a primary efficacy endpoint in COPD. Int. J. Chron. Obstruct. Pulmon. Dis. 2008; 3(2): 301–310.Tonnel A.B., Perez T., Grosbois J.M. et al. Effect of tiotropium on health-related quality of life as a primary efficacy endpoint in COPD. Int. J. Chron. Obstruct. Pulmon. Dis. 2008; 3(2): 301–310.Fležar M., Jahnz-Rózyk K., Enache G. et al. SOSPES: SPIRIVA® observational study measuring SGRQ score in routine medical practice in Central and Eastern Europe. Int. J. COPD 2013; 8: 483–492.Fležar M., Jahnz-Rózyk K., Enache G. et al. SOSPES: SPIRIVA® observational study measuring SGRQ score in routine medical practice in Central and Eastern Europe. Int. J. COPD 2013; 8: 483–492.Lisspers K., Larsson K., Ställberg B. et al. COPD in primary care in Sweden – an 11 years epidemiological register study. ERS 2012; Abs. 4339.Lisspers K., Larsson K., Ställberg B. et al. COPD in primary care in Sweden – an 11 years epidemiological register study. ERS 2012; Abs. 4339.Szafranski W., Cukier A., Ramirez A. et al. Efficacy and safety of budesonide / formoterol in the management of chronic obstructive pulmonary disease. Eur. Respir. J. 2003; 21: 74–81.Szafranski W., Cukier A., Ramirez A. et al. Efficacy and safety of budesonide / formoterol in the management of chronic obstructive pulmonary disease. Eur. Respir. J. 2003; 21: 74–81.Soriano J.B., Kiri V.A., Pride N.B., Vestbo J. Inhaled corticosteroids with / without long-acting beta-agonists reduce the risk of rehospitalization and death in COPD patients. Am. J. Respir. Med. 2003; 2 (1): 67–74.Soriano J.B., Kiri V.A., Pride N.B., Vestbo J. Inhaled corticosteroids with / without long-acting beta-agonists reduce the risk of rehospitalization and death in COPD patients. Am. J. Respir. Med. 2003; 2 (1): 67–74.Calverley P., Pauwels R., Vestbo J. et al. Combined salmeterol and fluticasone in the treatment of chronic obstructive pulmonary disease: a randomised controlled trial. Lancet 2003; 361: 449–456.Calverley P., Pauwels R., Vestbo J. et al. Combined salmeterol and fluticasone in the treatment of chronic obstructive pulmonary disease: a randomised controlled trial. Lancet 2003; 361: 449–456.Calverley P.M., Anderson J.A., Celli B. et al. Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease. N. Engl. J. Med. 2007; 356 (8):775–789.Calverley P.M., Anderson J.A., Celli B. et al. Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease. N. Engl. J. Med. 2007; 356 (8):775–789.Vestbo J., Anderson J. A., Calverley P. M. et al. Bias due to withdrawal in long-term randomized trials in COPD: evidence from the TORCH study. Clin. Respir. J. 2011; 5: 44–49.Vestbo J., Anderson J. A., Calverley P. M. et al. Bias due to withdrawal in long-term randomized trials in COPD: evidence from the TORCH study. Clin. Respir. J. 2011; 5: 44–49.Suissa S. Medications to modify lung function decline in chronic obstructive pulmonary disease: some hopeful signs. Am. J. Respir. Crit. Care Med. 2008; 178 (4): 322–323.Suissa S. Medications to modify lung function decline in chronic obstructive pulmonary disease: some hopeful signs. Am. J. Respir. Crit. Care Med. 2008; 178 (4): 322–323.Lachin J.M. Statistical considerations in the intent-to-treat principle. Control. Clin. Trials. 2000; 21 (3): 167–189.Lachin J.M. Statistical considerations in the intent-to-treat principle. Control. Clin. Trials. 2000; 21 (3): 167–189.Celli B.R., Thomas N.E., Anderson J.A. et al. Effect of pharmacotherapy on rate of decline of lung function in chronic obstructive pulmonary disease: results from the TORCH study. Am. J. Respir. Crit. Care Med. 2008; 178 (4): 332–338.Celli B.R., Thomas N.E., Anderson J.A. et al. Effect of pharmacotherapy on rate of decline of lung function in chronic obstructive pulmonary disease: results from the TORCH study. Am. J. Respir. Crit. Care Med. 2008; 178 (4): 332–338.Miles M.C., Donohue J.F., Ohar J.A. Combination therapy for COPD: emerging evidence from recent clinical trials. Clin. Invest. 2011; 1 (6): 879–890.Miles M.C., Donohue J.F., Ohar J.A. Combination therapy for COPD: emerging evidence from recent clinical trials. Clin. Invest. 2011; 1 (6): 879–890.Suissa S., Ernst P., Vandemheen K.L., Aaron S.D. Methodological issues in therapeutic trials of COPD. Eur. Respir. J. 2008; 31: 927–933.Suissa S., Ernst P., Vandemheen K.L., Aaron S.D. Methodological issues in therapeutic trials of COPD. Eur. Respir. J. 2008; 31: 927–933.Wedzicha J.A., Calverley P.M., Seemungal T.A. et al. The prevention of chronic obstructive pulmonary disease exacerbations by salmeterol / fluticasone propionate or tiotropium bromide. Am. J. Respir. Crit. Care Med. 2008; 177 (1): 19–26.Wedzicha J.A., Calverley P.M., Seemungal T.A. et al. The prevention of chronic obstructive pulmonary disease exacerbations by salmeterol / fluticasone propionate or tiotropium bromide. Am. J. Respir. Crit. Care Med. 2008; 177 (1): 19–26.Suissa S. Methodologic shortcomings of the INSPIRE randomized trial. Am. J. Respir. Crit. Care Med. 2008; 178 (10): 1090–1091.Suissa S. Methodologic shortcomings of the INSPIRE randomized trial. Am. J. Respir. Crit. Care Med. 2008; 178 (10): 1090–1091.Tonelli M.R., Curtis J.R., Guntupalli K.K. et al. An official multi-society statement: The role of clinical research results in the practice of critical care medicine. Am. J. Respir. Crit. Care Med. 2012; 185 (10): 1117–1124.Tonelli M.R., Curtis J.R., Guntupalli K.K. et al. An official multi-society statement: The role of clinical research results in the practice of critical care medicine. Am. J. Respir. Crit. Care Med. 2012; 185 (10): 1117–1124.MacPherson H. Pragmatic clinical trials. Complement Ther. Med. 2004; 12 (2–3): 136–140.MacPherson H. Pragmatic clinical trials. Complement Ther. Med. 2004; 12 (2–3): 136–140.Vogelmeier C., D'Urzo A., Pauwels R. et al. Budesonide / formoterol maintenance and reliever therapy: an effective asthma treatment option? Eur. Respir. J. 2005; 26: 819–828.Vogelmeier C., D'Urzo A., Pauwels R. et al. Budesonide / formoterol maintenance and reliever therapy: an effective asthma treatment option? Eur. Respir. J. 2005; 26: 819–828.Suissa S., Ernst P., Boivin J.F. et al. A cohort analysis of excess mortality in asthma and the use of inhaled beta-agonists. Am. J. Respir. Crit. Care Med. 1994; 149 (3, Pt 1): 604–610.Suissa S., Ernst P., Boivin J.F. et al. A cohort analysis of excess mortality in asthma and the use of inhaled beta-agonists. Am. J. Respir. Crit. Care Med. 1994; 149 (3, Pt 1): 604–610.Suissa S., Ernst P., Benayoun S. et al. Low-dose inhaled corticosteroids and the prevention of death from asthma. N. Engl. J. Med. 2000; 343 (5): 332–336.Suissa S., Ernst P., Benayoun S. et al. Low-dose inhaled corticosteroids and the prevention of death from asthma. N. Engl. J. Med. 2000; 343 (5): 332–336.Sears M.R., Taylor D.R. The beta 2-agonist controversy. Observations, explanations and relationship to asthma epidemiology. Drug Saf. 1994; 11 (4): 259–283.Sears M.R., Taylor D.R. The beta 2-agonist controversy. Observations, explanations and relationship to asthma epidemiology. Drug Saf. 1994; 11 (4): 259–283.Suissa S., Dell'Aniello S., Ernst P. Long-term natural history of chronic obstructive pulmonary disease: severe exacerbations and mortality. Thorax 2012; 67 (11): 957–963.Suissa S., Dell'Aniello S., Ernst P. Long-term natural history of chronic obstructive pulmonary disease: severe exacerbations and mortality. Thorax 2012; 67 (11): 957–963.http://www.cebm.net/index.aspx?o=8117 26. http://www.cebm.net/mod_product/design/files/CEBMLevels-of-Evidence-2.1.pdfhttp://www.cebm.net/index.aspx?o=8117 26. http://www.cebm.net/mod_product/design/files/CEBMLevels-of-Evidence-2.1.pdfLarsson K., Janson C., Lisspers K. et al. Combination of budesonide / formoterol more effective than fluticasone / salmeterol in preventing exacerbations in chronic obstructive pulmonary disease: the PATHOS study. J. Intern. Med. 2013; 273 (6): 584–594.Larsson K., Janson C., Lisspers K. et al. Combination of budesonide / formoterol more effective than fluticasone / salmeterol in preventing exacerbations in chronic obstructive pulmonary disease: the PATHOS study. J. Intern. Med. 2013; 273 (6): 584–594.Janson C., Larsson K., Lisspers K.H. et al. Pneumonia and pneumonia related mortality in patients with COPD treated with fixed combinations of inhaled corticosteroid and long acting b2-agonist: observational matched cohort study (PATHOS). Br. Med. J. 2013; 346: f3306. Doi: 10.1136/bmj.f3306.Janson C., Larsson K., Lisspers K.H. et al. Pneumonia and pneumonia related mortality in patients with COPD treated with fixed combinations of inhaled corticosteroid and long acting b2-agonist: observational matched cohort study (PATHOS). Br. Med. J. 2013; 346: f3306. Doi: 10.1136/bmj.f3306.Joffe M.M., Rosenbaum P.R. Invited commentary: propensity scores. Am. J. Epidemiol. 1999; 150: 327–233.Joffe M.M., Rosenbaum P.R. Invited commentary: propensity scores. Am. J. Epidemiol. 1999; 150: 327–233.Perkins S.M., Tu W., Underhill M.G. et al. The use of propensity scores in pharmacoepidemiologic research. Pharmacoepidemiol. Drug Saf. 2000; 9: 93–101.Perkins S.M., Tu W., Underhill M.G. et al. The use of propensity scores in pharmacoepidemiologic research. Pharmacoepidemiol. Drug Saf. 2000; 9: 93–101.Battram C., Charlton S.J., Cuenoud B. et al. In vitro and in vivo pharmacological characterization of 5-[(R)-2-(5,6-diethyl-indan-2-ylamino)-1-hydroxy-ethyl]-8-hydroxy-1H-quinolin-2-one (indacaterol), a novel inhaled beta(2) adrenoceptor agonist with a 24-h duration of action. J. Pharmacol. Exp. Ther. 2006; 317 (2): 762–770.Battram C., Charlton S.J., Cuenoud B. et al. In vitro and in vivo pharmacological characterization of 5-[(R)-2-(5,6-diethyl-indan-2-ylamino)-1-hydroxy-ethyl]-8-hydroxy-1H-quinolin-2-one (indacaterol), a novel inhaled beta(2) adrenoceptor agonist with a 24-h duration of action. J. Pharmacol. Exp. Ther. 2006; 317 (2): 762–770.Partridge M.R., Schuermann W., Beckman O. et al. Effect on lung function and morning activities of budesonide / formoterol versus salmeterol/fluticasone in patients with COPD. Ther. Adv. Respir. Dis. 2009; 3 (4): 1–11.Partridge M.R., Schuermann W., Beckman O. et al. Effect on lung function and morning activities of budesonide / formoterol versus salmeterol/fluticasone in patients with COPD. Ther. Adv. Respir. Dis. 2009; 3 (4): 1–11.Lindberg A., Szalai Z., Pullerits T., Radeczky E. Fast onset of effect of budesonide / formoterol versus salmeterol / fluticasone and salbutamol in patients with chronic obstructive pulmonary disease and reversible airway obstruction. Respirology 2007; 12 (5): 732–739.Lindberg A., Szalai Z., Pullerits T., Radeczky E. Fast onset of effect of budesonide / formoterol versus salmeterol / fluticasone and salbutamol in patients with chronic obstructive pulmonary disease and reversible airway obstruction. Respirology 2007; 12 (5): 732–739.Borgström L., Asking L., Thorsson L. Idealhalers or realhalers? A comparison of Diskus and Turbuhaler. Int. J. Clin. Pract. 2005; 59 (12): 1488–1495.Borgström L., Asking L., Thorsson L. Idealhalers or realhalers? A comparison of Diskus and Turbuhaler. Int. J. Clin. Pract. 2005; 59 (12): 1488–1495.Bisgaard H., ed. Drug delivery to the lung. New York: Marcel Dekker, Inc. 2001. 437–438.Bisgaard H., ed. Drug delivery to the lung. New York: Marcel Dekker, Inc. 2001. 437–438.Vogelmeier C., Hederer B., Glaab T. et al. Tiotropium versus salmeterol for the prevention of exacerbations of COPD. N. Engl. J. Med. 2011; 364 (12): 1093–1103.Vogelmeier C., Hederer B., Glaab T. et al. Tiotropium versus salmeterol for the prevention of exacerbations of COPD. N. Engl. J. Med. 2011; 364 (12): 1093–1103.Ek A., Larsson K., Siljerud S., Palmberg L. Fluticasone and budesonide inhibit cytokine release in human lung epithelial cells and alveolar macrophages. Allergy 1999; 54 (7): 691–699.Ek A., Larsson K., Siljerud S., Palmberg L. Fluticasone and budesonide inhibit cytokine release in human lung epithelial cells and alveolar macrophages. Allergy 1999; 54 (7): 691–699.Pedersen S., O'Byme I. A comparison of the efficacy and safety of inhaled corticosteroids in asthma. Allergy 1997: 52 (Suppl. 39): 1–34.Pedersen S., O'Byme I. A comparison of the efficacy and safety of inhaled corticosteroids in asthma. Allergy 1997: 52 (Suppl. 39): 1–34.Miller-Larsson A., Jansson P., Runström A., Brattsand R. Prolonged airway activity and improved selectivity of budesonide possibly due to esterification. Am. J. Respir. Crit. Care Med. 2000; 162 (4, Pt 1): 1455–1461.Miller-Larsson A., Jansson P., Runström A., Brattsand R. Prolonged airway activity and improved selectivity of budesonide possibly due to esterification. Am. J. Respir. Crit. Care Med. 2000; 162 (4, Pt 1): 1455–1461.Zalacain R., Sobradillo V., Amilibia J. et al. Predisposing factors to bacterial colonization in chronic obstructive pulmonary disease. Eur. Respir. J. 1999; 13 (2): 343–348.Zalacain R., Sobradillo V., Amilibia J. et al. Predisposing factors to bacterial colonization in chronic obstructive pulmonary disease. Eur. Respir. J. 1999; 13 (2): 343–348.Wedzicha J.A., Brill S.E., Allinson J.P., Donaldson G.C. Mechanisms and impact of the frequent exacerbator phenotype in chronic obstructive pulmonary disease. BMC Med. 2013; 11: 181.Wedzicha J.A., Brill S.E., Allinson J.P., Donaldson G.C. Mechanisms and impact of the frequent exacerbator phenotype in chronic obstructive pulmonary disease. BMC Med. 2013; 11: 181.Blais L., Forget A., Ramachandran S. Relative effectiveness of budesonide / formoterol and fluticasone propionate / salmeterol in a 1-year, population-based, matched cohort study of patients with chronic obstructive pulmonary disease (COPD): Effect on COPD-related exacerbations, emergency department visits and hospitalizations, medication utilization, and treatment adherence. Clin. Ther. 2010; 32 (7): 1320–1328.Blais L., Forget A., Ramachandran S. Relative effectiveness of budesonide / formoterol and fluticasone propionate / salmeterol in a 1-year, population-based, matched cohort study of patients with chronic obstructive pulmonary disease (COPD): Effect on COPD-related exacerbations, emergency department visits and hospitalizations, medication utilization, and treatment adherence. Clin. Ther. 2010; 32 (7): 1320–1328.Ferguson G.T., Anzueto A., Fei R. et al. Effect of fluticasone propionate / salmeterol (250 / 50 microg) or salmeterol (50 microg) on COPD exacerbations. Respir. Med. 2008; 102 (8): 1099–1108.Ferguson G.T., Anzueto A., Fei R. et al. Effect of fluticasone propionate / salmeterol (250 / 50 microg) or salmeterol (50 microg) on COPD exacerbations. Respir. Med. 2008; 102 (8): 1099–1108.Calverley P.M.A., Dransfield M.T., Bourbeau J. et al. Safety of fluticasone furoate (FF), an inhaled corticosteroid in combination with vilanterol (VI), a long-acting beta agonist in management of COPD exacerbations. ERS congress abstract 2012. Abs. 2113; http://www.ers-education.org/ersMade/abstract_print_12/main_frameset.htmCalverley P.M.A., Dransfield M.T., Bourbeau J. et al. Safety of fluticasone furoate (FF), an inhaled corticosteroid in combination with vilanterol (VI), a long-acting beta agonist in management of COPD exacerbations. ERS congress abstract 2012. Abs. 2113; http://www.ers-education.org/ersMade/abstract_print_12/main_frameset.htmHalpin D.M., Gray J., Edwards S.J. et al. Budesonide / formoterol vs salmeterol / fluticasone in COPD: a systematic review and adjusted indirect comparison of pneumonia in randomised controlled trials. Int. J. Clin. Pract. 2011; 65 (7): 764–774.Halpin D.M., Gray J., Edwards S.J. et al. Budesonide / formoterol vs salmeterol / fluticasone in COPD: a systematic review and adjusted indirect comparison of pneumonia in randomised controlled trials. Int. J. Clin. Pract. 2011; 65 (7): 764–774.Sin D.D., Tashkin D., Zhang X. et al. Budesonide and the risk of pneumonia: a meta-analysis of individual patient data. Lancet 2009; 374 (9691): 712–719.Sin D.D., Tashkin D., Zhang X. et al. Budesonide and the risk of pneumonia: a meta-analysis of individual patient data. Lancet 2009; 374 (9691): 712–719.Sin D., Tashkin D., Radner F. et al. Risk of pneumonia related to budesonide use in COPD: An updated pooled analysis. ERS congress abstract 2012. Abs. 2117; http://www.ers-education.org/ersMade/abstract_print_12/main_frameset.htmSin D., Tashkin D., Radner F. et al. Risk of pneumonia related to budesonide use in COPD: An updated pooled analysis. ERS congress abstract 2012. Abs. 2117; http://www.ers-education.org/ersMade/abstract_print_12/main_frameset.htmSuissa S., Patenaude V., Lapi F., Ernst P. Inhaled corticosteroids in COPD and the risk of serious pneumonia. Thorax 2013; 68: 1029–1036.Suissa S., Patenaude V., Lapi F., Ernst P. Inhaled corticosteroids in COPD and the risk of serious pneumonia. Thorax 2013; 68: 1029–1036.Aaron S.D., Vandemheen K.L., Fergusson D. et al. Tiotropium in combination with placebo, salmeterol, or fluticasone-Aaron S.D., Vandemheen K.L., Fergusson D. et al. Tiotropium in combination with placebo, salmeterol, or fluticasone-salmeterol for treatment of chronic obstructive pulmonary disease: a randomized trial. Ann. Intern. Med. 2007; 146 (8): 545–555.salmeterol for treatment of chronic obstructive pulmonary disease: a randomized trial. Ann. Intern. Med. 2007; 146 (8): 545–555.FitzGerald J.M., Boulet L.P., Follows R.M. The CONCEPT trial: A 1-year, multicenter, randomized, double-blind, double-dummy comparison of a stable dosing regimen of salmeterol / fluticasone propionate with an adjustable maintenance dosing regimen of formoterol / budesonide in adults with persistent asthma. Clin. Ther. 2005; 27 (4): 393–406.FitzGerald J.M., Boulet L.P., Follows R.M. The CONCEPT trial: A 1-year, multicenter, randomized, double-blind, double-dummy comparison of a stable dosing regimen of salmeterol / fluticasone propionate with an adjustable maintenance dosing regimen of formoterol / budesonide in adults with persistent asthma. Clin. Ther. 2005; 27 (4): 393–406.Guyatt G., Cairns J., Churchill D. et al. Evidence-based medicine. A new approach to teaching the practice of medicine. J.A.M.A. 1992; 268 (17): 2420–2425.Guyatt G., Cairns J., Churchill D. et al. Evidence-based medicine. A new approach to teaching the practice of medicine. J.A.M.A. 1992; 268 (17): 2420–2425.Sackett D.L., Rosenberg W.M., Gray J.A. et al. Evidence based medicine: what it is and what it isn't. Br. Med. J. 1996; 312 (7023): 71–72.Sackett D.L., Rosenberg W.M., Gray J.A. et al. Evidence based medicine: what it is and what it isn't. Br. Med. J. 1996; 312 (7023): 71–72.van der Valk P., Monninkhof E., van der Palen J. et al. Effect of discontinuation of inhaled corticosteroids in patients with chronic obstructive pulmonary disease: the COPE study. Am. J. Respir. Crit. Care Med. 2002; 166 (10):1358–1363.van der Valk P., Monninkhof E., van der Palen J. et al. Effect of discontinuation of inhaled corticosteroids in patients with chronic obstructive pulmonary disease: the COPE study. Am. J. Respir. Crit. Care Med. 2002; 166 (10):1358–1363.

The authors declare that there are no conflicts of interest present.