Цель. Изучить влияние поливалентного механического бактериального лизата (ПМБЛ) на снижение общего числа инфекционных обострений хронической обструктивной болезни легких (ХОБЛ) у пациентов с частыми обострениями в анамнезе. Материалы и методы. В исследование включены больные (n=60) с частыми обострениями ХОБЛ (в возрасте ≥40 лет, группы C и D по классификации GOLD). Все пациенты слепым методом разделены на две группы. Первая группа пациентов (n=30) получала ПМБЛ (курс включал 3 цикла по 10 дней с 20-дневными интервалами между ними). Вторая группа пациентов (контроль, n=30) получала комплексную терапию ХОБЛ без иммуностимуляторов. Наблюдение осуществлялось через 10 дней, 1, 3 и 6 мес от начала исследования. Оценивались выраженность симптомов, частота рецидивов обострений ХОБЛ, повторных госпитализаций, вызовов скорой медицинской помощи; изменения в базовой схеме терапии ХОБЛ. Результаты. Включение ПМБЛ в стандартную терапию ХОБЛ привело к статистически значимому уменьшению выраженности клинических проявлений, уровня маркеров системного воспаления, объема и степени гнойности мокроты во время обострений и в течение 6 мес после обострения по сравнению с группой контроля. Через 6 мес наблюдения в группе больных, получавших ПМБЛ, отмечались статистически значимое улучшение функции внешнего дыхания, снижение частоты повторных обострений, вызовов скорой медицинской помощи по поводу обострения ХОБЛ, изменений проводимой базисной терапии и госпитализаций по поводу обострения ХОБЛ. Препарат показал высокую степень безопасности и низкую частоту нежелательных явлений. Заключение. Результаты проведенного исследования свидетельствуют о целесообразности клинического применения ПМБЛ для профилактики тяжелых инфекционных обострений ХОБЛ.
Aim. To evaluate the efficacy of mechanical bacterial lysate on the prevention of infectious exacerbations of chronic obstructive pulmonary disease in patients with frequent exacerbations. Materials and methods. The study included patients (n=60) with frequent exacerbations of COPD (groups C and D according to the GOLD classification). All COPD patients were divided into two groups by blind method. The first group (n=30) received conventional therapy for COPD plus MBL (the course included 3 cycles of 10 days’ therapy with 20-day intervals between them). The second group of patients (control, n=30) received conventional therapy for COPD without MBL.We evaluated the severity of symptoms, frequency of recurrence of COPD exacerbations, readmissions, need for emergency care and changes in basic therapy of COPD. Evaluations were done on 10 days, 1, 3 and 6 months from the start of the study. Results. Adding of MBL to the therapy list of COPD resulted in a significant decrease of biomarkers of systemic inflammation and sputum purulence during compared to the control group. After 6 months of observation MBL group demonstrated statistically significant improvement of respiratory function, decrease in frequency of COPD exacerbations, needs for emergency medical service, reduced changes in basic therapy and hospitalization for exacerbation of COPD. Therapy with MBL showed a high degree of safety and low incidence of adverse events. Conclusion. The results of the study indicate that MBL may be used for the prevention of severe infectious exacerbations of COPD.
1. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global strategy for diagnosis, management, and prevention of chronic obstructive pulmonary disease. NHLBI/WHO workshop report. Last updated 2019. www.goldcopd.org/
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3. Авдеев С.Н., Трушенко Н.В., Гайнитдинова В.В. и др. Лечение обострений хронической обструктивной болезни легких. Терапевтический архив. 2018;90(12):68-75 [Avdeev SN, Trushenko NV, Gainitdinova VV, et al. Treatment of exacerbations of chronic obstructive pulmonary disease. Therapeutic Archive. 2018;90(12):68-75 (In Russ.)]. doi: 10.26442/00403660.2018.12.000011
4. Harper K, Armelagos G. The Changing Disease Scape in the Third Epidemiological Transition. Int J Environmental Res Public Health. 2010;7(2):675-97. doi: 10.3390/ijerph7020675
5. Кривопалов А.А., Рязанцев С.В., Шаталов В.А. Новые возможности терапии и профилактики осложнений инфекционно-воспалительных заболеваний верхних дыхательных путей. Медицинский совет. 2016;18:24-32 [Krivopalov AA, Ryazantsev SV, Shatalov VA. New possibilities of therapy and prevention of complications of infectious and inflammatory diseases of the upper respiratory tract. Medical advice. 2016;18:24-32 (In Russ.)]. doi: 10.21518/2079-701X-2016-18-34-37
6. Волков А.Г., Трофименко С.Л. Клинические проявления вторичного иммунодефицита при заболеваниях ЛОР-органов. М., 2008 [Volkov AG, Trofimenko SL. Clinical manifestations of secondary immunodeficiency in diseases of ENT organs. Moscow, 2008 (In Russ.)].
7. Coley W. Contribution to the knowledge of sarcoma. Ann Surg. 1991;14:199-220.
8. Seneca H. Urease activity of sonic lysates of pathogenic bacteria. Lancet. 1961;277(7187):1166-7.
9. Hoffmann J, Hetru C. Insect defensins: inducible antibacterial peptides. Immunology Today. 1992;13(10):411-5. doi: 10.1016/0167-5699(92)90092-L
10. Mahler DA, Rosiello RA, Harver A, et al. Comparison of clinical dyspnea ratings and psychophysical measurements on respiratory sensation in obstructive airway disease. Am Rev Respir Dis. 1987;135:1229-33. doi: 10.1164/arrd.1987.135.6.1229
11. Borg G. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14:377-81.
12. Jones PW, Harding G, Berry P, et al. Development and first validation of the COPD Assessment Test. Eur Respir J. 2009;34:648-54. doi: 10.1183/ 09031936.00102509
13. Leidy NK, Rennard S, Schmier J, et al. The breathlessness, cough, and sputum scale. The development of empirically based guidelines for interpretation. Chest. 2002;124:2182–91. doi: 10.1378/chest.124.6.2182
14. Logan JI. The TG system for bedside recording of sputum colour. Ulster Med J. 2006;75:228-30. doi: 10.1080 / 02813430902759663
15. Cazzola M, Capuano A, Rogliani P, Matera G. Bacterial lysates as a potentially effective approach in preventing acute exacerbation of COPD. Curr Opin Pharmacol. 2012;12:300-8. doi: 10.1016/j.coph.2012.01.019
16. Braido F, Tarantini F, Ghiglione V, et al. Bacterial lysate in the prevention of acute exacerbation of COPD and in respiratory recurrent infections. Int J COPD. 2007;2(3):335-45.
17. Debbas N, Derenne JP. Preventive effects of an immunostimulating product on recurrent infections of chronic bronchitis in the elderly. Lung. 1990;168(Suppl.):737-40. doi: 10,1007/bf02718202
18. Collet JP, Shapiro P, Ernst P, et al. Effects of an immunostimulating agent on acute exacerbations and hospitalizations in patients with chronic obstructive pulmonary disease. The PARI-IS Study Steering Committee and Research Group. Prevention of Acute Respiratory Infection by an Immunostimulant. Am J Respir Crit Care Med. 1997;156(6):1719-24. doi: 10,1164/ajrccm.156.6.9612096
19. Cogo R, Ramponi A, Scivoletto G, Rippoli R. Prophylaxis for acute exacerbations of chronic bronchitis using an antibacterial sublingual vaccine obtained through mechanical lysis: a clinical and pharmacoeconomic study. Acta BioMedica. 2003;74;81-7.
20. Cazzola M. A new bacterial lysate protects by reducing infectious exacerbations in moderate to very severe COPD. A double-blind, randomized, placebo-controlled trial. Trends Med. 2006;6(3):199-207.
21. Cazzola M, Noschese P, Di Perna F. Value of adding a polyvalent mechanical bacterial lysate to therapy of COPD patients under regular treatment with salmeterol/fluticasone. Ther Adv Respir Dis. 2009;3:59-63. doi: 10.1177/1753465809104677
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1. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global strategy for diagnosis, management, and prevention of chronic obstructive pulmonary disease. NHLBI/WHO workshop report. Last updated 2019. www.goldcopd.org/
2. Aysanov ZR, Avdeev SN, Arkhipov VV, et al. National clinical guidelines for the diagnosis and treatment of COPD: an algorithm for making clinical decisions. Pulmonology. 2017;27(1):13-20 (In Russ.) doi: 10.18093/0869-0189-2017-27-1-13-20
3. Avdeev SN, Trushenko NV, Gainitdinova VV, et al. Treatment of exacerbations of chronic obstructive pulmonary disease. Therapeutic Archive. 2018;90(12):68-75 (In Russ.) doi: 10.26442/00403660.2018.12.000011
4. Harper K, Armelagos G. The Changing Disease Scape in the Third Epidemiological Transition. Int J Environmental Res Public Health. 2010;7(2):675-97. doi: 10.3390/ijerph7020675
5. Krivopalov AA, Ryazantsev SV, Shatalov VA. New possibilities of therapy and prevention of complications of infectious and inflammatory diseases of the upper respiratory tract. Medical advice. 2016;18:24-32 (In Russ.) doi: 10.21518/2079-701X-2016-18-34-37
6. Volkov AG, Trofimenko SL. Clinical manifestations of secondary immunodeficiency in diseases of ENT organs. Moscow, 2008 (In Russ.)
7. Coley W. Contribution to the knowledge of sarcoma. Ann Surg. 1991;14:199-220.
8. Seneca H. Urease activity of sonic lysates of pathogenic bacteria. Lancet. 1961;277(7187):1166-7.
9. Hoffmann J, Hetru C. Insect defensins: inducible antibacterial peptides. Immunology Today. 1992;13(10):411-5. doi: 10.1016/0167-5699(92)90092-L
10. Mahler DA, Rosiello RA, Harver A, et al. Comparison of clinical dyspnea ratings and psychophysical measurements on respiratory sensation in obstructive airway disease. Am Rev Respir Dis. 1987;135:1229-33. doi: 10.1164/arrd.1987.135.6.1229
11. Borg G. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14:377-81.
12. Jones PW, Harding G, Berry P, et al. Development and first validation of the COPD Assessment Test. Eur Respir J. 2009;34:648-54. doi: 10.1183/ 09031936.00102509
13. Leidy NK, Rennard S, Schmier J, et al. The breathlessness, cough, and sputum scale. The development of empirically based guidelines for interpretation. Chest. 2002;124:2182–91. doi: 10.1378/chest.124.6.2182
14. Logan JI. The TG system for bedside recording of sputum colour. Ulster Med J. 2006;75:228-30. doi: 10.1080 / 02813430902759663
15. Cazzola M, Capuano A, Rogliani P, Matera G. Bacterial lysates as a potentially effective approach in preventing acute exacerbation of COPD. Curr Opin Pharmacol. 2012;12:300-8. doi: 10.1016/j.coph.2012.01.019
16. Braido F, Tarantini F, Ghiglione V, et al. Bacterial lysate in the prevention of acute exacerbation of COPD and in respiratory recurrent infections. Int J COPD. 2007;2(3):335-45.
17. Debbas N, Derenne JP. Preventive effects of an immunostimulating product on recurrent infections of chronic bronchitis in the elderly. Lung. 1990;168(Suppl.):737-40. doi: 10,1007/bf02718202
18. Collet JP, Shapiro P, Ernst P, et al. Effects of an immunostimulating agent on acute exacerbations and hospitalizations in patients with chronic obstructive pulmonary disease. The PARI-IS Study Steering Committee and Research Group. Prevention of Acute Respiratory Infection by an Immunostimulant. Am J Respir Crit Care Med. 1997;156(6):1719-24. doi: 10,1164/ajrccm.156.6.9612096
19. Cogo R, Ramponi A, Scivoletto G, Rippoli R. Prophylaxis for acute exacerbations of chronic bronchitis using an antibacterial sublingual vaccine obtained through mechanical lysis: a clinical and pharmacoeconomic study. Acta BioMedica. 2003;74;81-7.
20. Cazzola M. A new bacterial lysate protects by reducing infectious exacerbations in moderate to very severe COPD. A double-blind, randomized, placebo-controlled trial. Trends Med. 2006;6(3):199-207.
21. Cazzola M, Noschese P, Di Perna F. Value of adding a polyvalent mechanical bacterial lysate to therapy of COPD patients under regular treatment with salmeterol/fluticasone. Ther Adv Respir Dis. 2009;3:59-63. doi: 10.1177/1753465809104677
1 ФГАОУ ВО «Первый Московский государственный медицинский университет им. И.М. Сеченова» Минздрава России
(Сеченовский Университет), Москва, Россия;
2 ФГБУ «Научно-исследовательский институт пульмонологии» ФМБА России, Москва, Россия;
3 ГБУЗ «Московский клинический научный центр им. А.С. Логинова» Департамента здравоохранения г. Москвы, Москва, Россия;
4 Военно-медицинская академия, Мингладон, Мьянма
1 Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia;
2 Scientific Research Institute of Pulmonology, Moscow, Russia;
3 Loginov Moscow Clinical Scientific Center, Moscow, Russia;
4 Military Medical Academy, Mingladon, Myanma