Особенности легкой бронхиальной астмы в России: результаты исследования SYGMA2
Особенности легкой бронхиальной астмы в России: результаты исследования SYGMA2
Айсанов З.Р., Авдеев С.Н., Архипов В.В., Белевский А.С., Вознесенский Н.А. от имени российских исследователей SYGMA2. Особенности легкой бронхиальной астмы в России: результаты исследования SYGMA2. Терапевтический архив. 2021; 93 (4): 449–455. DOI: 10.26442/00403660.2021.04.200812
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Aisanov ZR, Avdeev SN, Arkhipov VV, Belevsky AS, Voznesenskiy NA on behalf of SYGMA2 Russian investigators. Peculiarities of Mild Asthma in Russia: the Results of SYGMA2 Study. Terapevticheskii Arkhiv (Ter. Arkh.). 2021; 93 (4): 449–455. DOI: 10.26442/00403660.2021.04.200812
Особенности легкой бронхиальной астмы в России: результаты исследования SYGMA2
Айсанов З.Р., Авдеев С.Н., Архипов В.В., Белевский А.С., Вознесенский Н.А. от имени российских исследователей SYGMA2. Особенности легкой бронхиальной астмы в России: результаты исследования SYGMA2. Терапевтический архив. 2021; 93 (4): 449–455. DOI: 10.26442/00403660.2021.04.200812
________________________________________________
Aisanov ZR, Avdeev SN, Arkhipov VV, Belevsky AS, Voznesenskiy NA on behalf of SYGMA2 Russian investigators. Peculiarities of Mild Asthma in Russia: the Results of SYGMA2 Study. Terapevticheskii Arkhiv (Ter. Arkh.). 2021; 93 (4): 449–455. DOI: 10.26442/00403660.2021.04.200812
Цель. Региональные особенности легкой бронхиальной астмы (БА) в целом изучены недостаточно. Данный ретроспективный анализ проводился для изучения региональных особенностей российской популяции пациентов с легкой БА, в том числе статуса контроля, фармакотерапии и частоты тяжелых обострений. Материалы и методы. Исследование SYGMA2 – двойное слепое международное исследование у взрослых пациентов с легкой БА (n=4176). Нами проведен открытый ретроспективный анализ исходных характеристик российской группы исследования SYGMA2 (n=579) по сравнению с пациентами из других стран. Данный анализ был описательным по своей сути и не тестировал каких-либо гипотез. Результаты. Российская группа практически не отличалась от популяции остальных стран по демографическим параметрам, статусу курения и длительности заболевания. Показатели спирометрии в российской группе оказались несколько хуже, чем у пациентов из других стран. При включении в исследование 48% пациентов из России получали регулярное базисное лечение и имели контроль БА, а 52% использовали только короткодействующие бронходилататоры и не достигали контроля БА. В остальной популяции распределение было обратным – 55/45%. В России также была больше доля пациентов, перенесших хотя бы 1 тяжелое обострение БА за предшествующий год (30,1%), по сравнению с 20,7% в других странах. Заключение. У пациентов с легкой БА в России наблюдается более позднее назначение базисной терапии и избыточное применение короткодействующих бронходилататоров. Это может приводить к недостаточному контролю симптомов и повышать риск тяжелых обострений БА.
Ключевые слова: бронхиальная астма, легкая бронхиальная астма, базисная терапия, контроль астмы, тяжелое обострение
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Aim. Patients with mild asthma may experience severe exacerbations. This analysis was conducted to investigate regional peculiarities of mild asthma population in Russia. Materials and methods. The SYGMA2 is a double-blind multinational study involving adult patients with mild asthma (n=4176). We conducted an open-label descriptive analysis of the baseline characteristics of the Russian group (n=579) of SYGMA2 trial comparing to SYGMA2 population from other countries. The subanalysis was descriptive only, and no hypothesis were tested. Results. The Russian population of patients with mild asthma was comparable to the rest of countries in terms of demographic characteristics, smoking status and duration of asthma. The spirometric parameters in the Russian group was slightly worse than in the other population. At the study entry 48% of Russian patients had symptom control on maintenance therapy, but 52% were uncontrolled on short-acting bronchodilators. While in other countries this ratio was inverse (55/45%). More patients with mild asthma in the Russian group had at least one severe exacerbation in the previous year (30.1% vs 20.7% in other countries). Conclusion. We revealed a delayed prescription of controller therapy and overuse of short-acting bronchodilators in the Russian group of mild asthma patients, that may increase risk of asthma non-control and severe exacerbation.
Keywords: asthma, mild asthma, maintenance therapy, symptom control, severe exacerbation
Список литературы
1. 2019 GINA Main Report – Global Initiative for Asthma – GINA. Available at: https://ginasthma.org/gina-reports. Accessed: 08.03.2021.
2. Dusser D, Montani D, Chanez P, et al. Mild asthma: An expert review on epidemiology, clinical characteristics and treatment recommendations. Allergy. 2007;62(6):591-604. doi: 10.1111/j.1398-9995.2007.01394.x
3. Rabe KF, Adachi M, Lai CKW, et al. Worldwide severity and control of asthma in children and adults: The global asthma insights and reality surveys. J Allergy Clin Immunol. 2004;114(1):40-7. doi: 10.1016/j.jaci.2004.04.042
4. Zureik M, Neukirch C, Leynaert B, et al. Sensitisation to airborne moulds and severity of asthma: Cross sectional study from European Community respiratory health survey. Br Med J. 2002;325(7361):411-4. doi: 10.1136/bmj.325.7361.411
5. Liard R, Leynaert B, Zureik M, et al. Using Global Initiative for Asthma guidelines to assess asthma severity in populations. Eur Respir J. 2000;16(4):615-20. doi: 10.1034/j.1399-3003.2000.16d08.x
6. Com-Ruelle L, Crestin B, Dumesnil S. L’asthme En France Selon Les Stades de Sévérité, 2000. Available at: https://www.researchgate.net/publication/268413581. Accessed: 08.06.2020.
7. Bloom CI, Nissen F, Douglas IJ, et al. Exacerbation risk and characterisation of the UK’s asthma population from infants to old age. Thorax. 2018;73(4):313-20. doi: 10.1136/thoraxjnl-2017-210650
8. Архипов В.В., Григорьева Е.В., Гавришина Е.В. Контроль над бронхиальной астмой в России: результаты многоцентрового наблюдательного исследования НИКА. Пульмонология. 2011;6:87-93 [Arkhipov VV, Grigoryeva EV, Gavrishina EV. Control of bronchial asthma in Russia: results of NIKA multi-center observational study. Pulmonologiya. 2011;6:87-93 (In Russ.)]. doi: 10.18093/0869-0189-2011-0-6-87-93
9. Suruki RY, Daugherty JB, Boudiaf N, Albers FC. The frequency of asthma exacerbations and healthcare utilization in patients with asthma from the UK and USA. BMC Pulm Med. 2017;17(1). doi: 10.1186/s12890-017-0409-3
10. Wells KE, Peterson EL, Ahmedani BK, et al. The relationship between combination inhaled corticosteroid and long-acting β-agonist use and severe asthma exacerbations in a diverse population. J Allergy Clin Immunol. 2012;129(5):1274. doi: 10.1016/j.jaci.2011.12.974
11. Bårnes CB, Ulrik CS. Asthma and adherence to inhaled corticosteroids: Current status and future perspectives. Respir Care. 2015;60(3):455-68. doi: 10.4187/respcare.03200
12. Suissa S, Ernst P, Kezouh A. Regular use of inhaled corticosteroids and the long term prevention of hospitalisation for asthma. Thorax. 2002;57(10):880-4. doi: 10.1136/thorax.57.10.880
13. 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):332-6. doi: 10.1056/NEJM200008033430504
14. O’Byrne PM, FitzGerald JM, Zhong N, et al. The SYGMA programme of phase 3 trials to evaluate the efficacy and safety of budesonide/formoterol given “as needed” in mild asthma: Study protocols for two randomised controlled trials. Trials. 2017;18(1). doi: 10.1186/s13063-016-1731-4
15. Lipworth B, Chan R, Chris, Kuo R. Anti-inflammatory reliever therapy for asthma. Ann Allergy Asthma Immunol. 2020;124:13-5. doi: 10.1016/j.anai.2019.10.002
16. Rabe KF, Atienza T, Magyar P, et al. Effect of budesonide in combination with formoterol for reliever therapy in asthma exacerbations: a randomised controlled, double-blind study. Lancet. 2006;368(9537): 744-53. doi: 10.1016/S0140-6736(06)69284-2
17. O’Byrne PM, Bisgaard H, Godard PP, et al. Budesonide/formoterol combination therapy as both maintenance and reliever medication in asthma. Am J Respir Crit Care Med. 2005;171(2):129-36. doi: 10.1164/rccm.200407-884OC
18. Patel M, Pilcher J, Pritchard A, et al. Efficacy and safety of maintenance and reliever combination budesonide-formoterol inhaler in patients with asthma at risk of severe exacerbations: A randomised controlled trial. Lancet Respir Med. 2013;1(1):32-42.
doi: 10.1016/S2213-2600(13)70007-9
19. Beasley R, Weatherall M, Shirtcliffe P, et al. Combination corticosteroid/β-agonist inhaler as reliever therapy: A solution for intermittent and mild asthma? J Allergy Clin Immunol. 2014;133(1):39-41. doi: 10.1016/j.jaci.2013.10.053
20. Haahtela T, Tamminen K, Malmberg LP, et al. Formoterol as needed with or without budesonide in patients with intermittent asthma and raised NO levels in exhaled air: A SOMA study. Eur Respir J. 2006;28(4):748-55. doi: 10.1183/09031936.06.00128005
21. O’Byrne PM, FitzGerald JM, Bateman ED, et al. Inhaled Combined Budesonide-Formoterol as Needed in Mild Asthma. N Engl J Med. 2018;378(20):1865-76. doi: 10.1056/NEJMoa1715274
22. Bateman ED, Reddel HK, O’Byrne PM, et al. As-Needed Budesonide-Formoterol versus Maintenance Budesonide in Mild Asthma. N Engl
J Med. 2018;378(20):1877-87. doi: 10.1056/NEJMoa1715275
23. Quanjer PH, Stanojevic S, Cole TJ, et al. Multi-ethnic reference values for spirometry for the 3-95-yr age range: The global lung function 2012 equations. Eur Respir J. 2012;40(6):1324-43. doi: 10.1183/09031936.00080312
24. Cooper BG, Stocks J, Hall GL, et al. The global lung function initiative (GLI) network: Bringing the world’s respiratory reference values together. Breathe. 2017;13(3):e56-e64. doi: 10.1183/20734735.012717
25. Nwaru BI, Ekström M, Hasvold P, et al. Overuse of short-acting β2-agonists in asthma is associated with increased risk of exacerbation and mortality: A nationwide cohort study of the global SABINA programme. Eur Respir J. 2020;55(4). doi: 10.1183/13993003.01872-2019
26. Janson C, Menzies-Gow A, Nan C, et al. SABINA: An Overview of Short-Acting β2-Agonist Use in Asthma in European Countries. Adv Ther. 2020;37(3):1124-35. doi: 10.1007/s12325-020-01233-0
27. Muneswarao J, Hassali MA, Ibrahim B, et al. It is time to change the way we manage mild asthma: An update in GINA 2019. Respir Res. 2019;20(1). doi: 10.1186/s12931-019-1159-y
________________________________________________
1. 2019 GINA Main Report – Global Initiative for Asthma – GINA. Available at: https://ginasthma.org/gina-reports. Accessed: 08.03.2021.
2. Dusser D, Montani D, Chanez P, et al. Mild asthma: An expert review on epidemiology, clinical characteristics and treatment recommendations. Allergy. 2007;62(6):591-604. doi: 10.1111/j.1398-9995.2007.01394.x
3. Rabe KF, Adachi M, Lai CKW, et al. Worldwide severity and control of asthma in children and adults: The global asthma insights and reality surveys. J Allergy Clin Immunol. 2004;114(1):40-7. doi: 10.1016/j.jaci.2004.04.042
4. Zureik M, Neukirch C, Leynaert B, et al. Sensitisation to airborne moulds and severity of asthma: Cross sectional study from European Community respiratory health survey. Br Med J. 2002;325(7361):411-4. doi: 10.1136/bmj.325.7361.411
5. Liard R, Leynaert B, Zureik M, et al. Using Global Initiative for Asthma guidelines to assess asthma severity in populations. Eur Respir J. 2000;16(4):615-20. doi: 10.1034/j.1399-3003.2000.16d08.x
6. Com-Ruelle L, Crestin B, Dumesnil S. L’asthme En France Selon Les Stades de Sévérité, 2000. Available at: https://www.researchgate.net/publication/268413581. Accessed: 08.06.2020.
7. Bloom CI, Nissen F, Douglas IJ, et al. Exacerbation risk and characterisation of the UK’s asthma population from infants to old age. Thorax. 2018;73(4):313-20. doi: 10.1136/thoraxjnl-2017-210650
8. Arkhipov VV, Grigoryeva EV, Gavrishina EV. Control of bronchial asthma in Russia: results of NIKA multi-center observational study. Pulmonologiya. 2011;6:87-93 (In Russ.)
doi: 10.18093/0869-0189-2011-0-6-87-93
9. Suruki RY, Daugherty JB, Boudiaf N, Albers FC. The frequency of asthma exacerbations and healthcare utilization in patients with asthma from the UK and USA. BMC Pulm Med. 2017;17(1). doi: 10.1186/s12890-017-0409-3
10. Wells KE, Peterson EL, Ahmedani BK, et al. The relationship between combination inhaled corticosteroid and long-acting β-agonist use and severe asthma exacerbations in a diverse population. J Allergy Clin Immunol. 2012;129(5):1274. doi: 10.1016/j.jaci.2011.12.974
11. Bårnes CB, Ulrik CS. Asthma and adherence to inhaled corticosteroids: Current status and future perspectives. Respir Care. 2015;60(3):455-68. doi: 10.4187/respcare.03200
12. Suissa S, Ernst P, Kezouh A. Regular use of inhaled corticosteroids and the long term prevention of hospitalisation for asthma. Thorax. 2002;57(10):880-4. doi: 10.1136/thorax.57.10.880
13. 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):332-6. doi: 10.1056/NEJM200008033430504
14. O’Byrne PM, FitzGerald JM, Zhong N, et al. The SYGMA programme of phase 3 trials to evaluate the efficacy and safety of budesonide/formoterol given “as needed” in mild asthma: Study protocols for two randomised controlled trials. Trials. 2017;18(1). doi: 10.1186/s13063-016-1731-4
15. Lipworth B, Chan R, Chris, Kuo R. Anti-inflammatory reliever therapy for asthma. Ann Allergy Asthma Immunol. 2020;124:13-5. doi: 10.1016/j.anai.2019.10.002
16. Rabe KF, Atienza T, Magyar P, et al. Effect of budesonide in combination with formoterol for reliever therapy in asthma exacerbations: a randomised controlled, double-blind study. Lancet. 2006;368(9537): 744-53. doi: 10.1016/S0140-6736(06)69284-2
17. O’Byrne PM, Bisgaard H, Godard PP, et al. Budesonide/formoterol combination therapy as both maintenance and reliever medication in asthma. Am J Respir Crit Care Med. 2005;171(2):129-36. doi: 10.1164/rccm.200407-884OC
18. Patel M, Pilcher J, Pritchard A, et al. Efficacy and safety of maintenance and reliever combination budesonide-formoterol inhaler in patients with asthma at risk of severe exacerbations: A randomised controlled trial. Lancet Respir Med. 2013;1(1):32-42.
doi: 10.1016/S2213-2600(13)70007-9
19. Beasley R, Weatherall M, Shirtcliffe P, et al. Combination corticosteroid/β-agonist inhaler as reliever therapy: A solution for intermittent and mild asthma? J Allergy Clin Immunol. 2014;133(1):39-41. doi: 10.1016/j.jaci.2013.10.053
20. Haahtela T, Tamminen K, Malmberg LP, et al. Formoterol as needed with or without budesonide in patients with intermittent asthma and raised NO levels in exhaled air: A SOMA study. Eur Respir J. 2006;28(4):748-55. doi: 10.1183/09031936.06.00128005
21. O’Byrne PM, FitzGerald JM, Bateman ED, et al. Inhaled Combined Budesonide-Formoterol as Needed in Mild Asthma. N Engl J Med. 2018;378(20):1865-76. doi: 10.1056/NEJMoa1715274
22. Bateman ED, Reddel HK, O’Byrne PM, et al. As-Needed Budesonide-Formoterol versus Maintenance Budesonide in Mild Asthma. N Engl
J Med. 2018;378(20):1877-87. doi: 10.1056/NEJMoa1715275
23. Quanjer PH, Stanojevic S, Cole TJ, et al. Multi-ethnic reference values for spirometry for the 3-95-yr age range: The global lung function 2012 equations. Eur Respir J. 2012;40(6):1324-43. doi: 10.1183/09031936.00080312
24. Cooper BG, Stocks J, Hall GL, et al. The global lung function initiative (GLI) network: Bringing the world’s respiratory reference values together. Breathe. 2017;13(3):e56-e64. doi: 10.1183/20734735.012717
25. Nwaru BI, Ekström M, Hasvold P, et al. Overuse of short-acting β2-agonists in asthma is associated with increased risk of exacerbation and mortality: A nationwide cohort study of the global SABINA programme. Eur Respir J. 2020;55(4). doi: 10.1183/13993003.01872-2019
26. Janson C, Menzies-Gow A, Nan C, et al. SABINA: An Overview of Short-Acting β2-Agonist Use in Asthma in European Countries. Adv Ther. 2020;37(3):1124-35. doi: 10.1007/s12325-020-01233-0
27. Muneswarao J, Hassali MA, Ibrahim B, et al. It is time to change the way we manage mild asthma: An update in GINA 2019. Respir Res. 2019;20(1). doi: 10.1186/s12931-019-1159-y
Авторы
З.Р. Айсанов*1, С.Н. Авдеев2, В.В. Архипов3, А.С. Белевский1, Н.А. Вознесенский4 от имени российских исследователей* SYGMA2
1 ФГАОУ ВО «Российский национальный исследовательский медицинский университет им. Н.И. Пирогова» Минздрава России, Москва, Россия;
2 ФГАОУ ВО «Первый Московский государственный медицинский университет им. И.М. Сеченова» Минздрава России (Сеченовский Университет), Москва, Россия;
3 ФГБОУ ДПО «Российская медицинская академия непрерывного профессионального образования» Минздрава России, Москва, Россия;
4 ФГБУН «Институт проблем экологии и эволюции им. А.Н. Северцова» РАН, Москва, Россия
*aisanov@mail.ru
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Zaurbek R. Aisanov*1, Sergey N. Avdeev2, Vladimir V. Arkhipov3, Andrey S. Belevsky1, Nikolay A. Voznesenskiy4 on behalf of SYGMA2 Russian investigators**
1 Pirogov Russian National Research Medical University, Moscow, Russia;
2 Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia;
3 Russian Medical Academy of Continuous Professional Education, Moscow, Russia
4 Severtsov Institute of Ecology and Evolution, Moscow, Russia
*aisanov@mail.ru