Бактериальный лизат ОМ-85: от механизмов действия к доказательствам клинической эффективности в педиатрической практике
Бактериальный лизат ОМ-85: от механизмов действия к доказательствам клинической эффективности в педиатрической практике
Овсянников Д.Ю. Бактериальный лизат ОМ-85: от механизмов действия к доказательствам клинической эффективности
в педиатрической практике. Педиатрия. Consilium Medicum. 2019; 3: 92–97.
DOI: 10.26442/26586630.2019.3.190645
Ovsyannikov D.Iu. Bacterial lysate OM-85: from the mechanisms of action to the evidence of clinical efficacy in a pediatric practice. Pediatrics. Consilium Medicum. 2019; 3: 92–97. DOI: 10.26442/26586630.2019.3.190645
в педиатрической практике. Педиатрия. Consilium Medicum. 2019; 3: 92–97.
DOI: 10.26442/26586630.2019.3.190645
________________________________________________
Ovsyannikov D.Iu. Bacterial lysate OM-85: from the mechanisms of action to the evidence of clinical efficacy in a pediatric practice. Pediatrics. Consilium Medicum. 2019; 3: 92–97. DOI: 10.26442/26586630.2019.3.190645
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Аннотация
В статье обсуждаются проблемы этиологии, эпидемиологии, профилактики и терапии респираторных инфекций у детей, применение бактериального лизата ОМ-85 в педиатрической практике. Подробно описаны многокомпонентные механизмы действия препарата ОМ-85 на антигенпрезентирующие клетки, систему врожденного и приобретенного иммунитета, противовирусная и антибактериальная активность препарата, влияние на патогенез заболеваний, протекающих с бронхиальной обструкцией и атопией за счет действия на баланс Т-хелперов 1 и 2-го типа, воспаление дыхательных путей, иммуноглобулины. На основании метаанализа, рандомизированных зарубежных исследований приведены доказательства клинической эффективности препарата при острых и рецидивирующих респираторных инфекциях, а также заболеваниях, протекающих с бронхиальной обструкцией (острый бронхиолит, обструктивный бронхит, бронхиальная астма) у детей. На фоне терапии препаратом ОМ-85 по сравнению с контрольной группой отмечены статистически значимое сокращение частоты и длительности острых респираторных инфекций, длительности лихорадки, кашля, бронхиальной обструкции, антибактериальной терапии, увеличение содержания сывороточных иммуноглобулинов G, A, M. При этом установлены хорошая переносимость препарата ОМ-85 и его безопасность. Обоснованы показания для профилактического и терапевтического применения бактериального лизата ОМ-85 в детском возрасте.
Ключевые слова: респираторная инфекция, обструктивный бронхит, бронхиальная астма, профилактика, дети, ОМ-85.
Key words: respiratory infection, obstructive bronchitis, bronchial asthma, prevention, children, OM-85.
Ключевые слова: респираторная инфекция, обструктивный бронхит, бронхиальная астма, профилактика, дети, ОМ-85.
________________________________________________
Key words: respiratory infection, obstructive bronchitis, bronchial asthma, prevention, children, OM-85.
Список литературы
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[Kaliuzhin OV. OM-85 v profilaktike/lechenii respiratornykh infektsii i obostrenii khronicheskikh zabolevanii legkikh: kriterii vybora, mekhanizmy i dokazatel'stva. Lechashchii vrach. 2018; 3:77–82 (in Russian).]
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[Dronov I.A., Denisova A.R. Bakterial'nyi lizat OM-85: voprosy effektivnosti u detei i potentsial'naia rol' v sderzhivanii rosta antimikrobnoi rezistentnosti. Vopr. prakticheskoi pediatrii. 2019; 14 (1): 76–83 (in Russian).]
14. Luan H, Zhang Q, Wang L et al. OM85-BV induced the productions of IL-1beta, IL-6, and TNF-alpha via TLR4- and TLR2-mediated ERK1/2/NF-kB pathway in RAW264.7 cells. J Interferon Cytokine Res 2014; 34: 526e–36.
15. Parola C, Salogni L, Vaira X et al. Selective activation of human dendritic cells by OM-85 through a NF-kB and MAPK dependent pathway. PLoS One 2013; 8: e82867.
16. Manolova V, Flace A, Jeandet P et al. Biomarkers induced by the immunomodulatory bacterial extract OM-85: unique roles for Peyer’s patches and intestinal epithelial cells. J Clin Cell Immunol 2017; 8: 494.
17. Liao JY, Zhang T. Influence of OM-85 BV on hBD-1 and immunoglobulin in children with asthma and recurrent respiratory tract infection. Zhongguo Dang Dai Er Ke Za Zhi 2014; 16: 508–12.
18. Roth M, Pasquali C, Stolz D, Tamm M. Broncho Vaxom (OM-85) modulates rhinovirus docking proteins on human airway epithelial cells via Erk1/2 mitogen activated protein kinase and cAMP. PLoS One 2017; 12: e0188010.
19. Dang AT, Pasquali C, Ludigs K, Guarda G. OM-85 is an immunomodulator of interferon-b production and inflammasome activity. Sci Rep 2017; 7: 43844.
20. Zelle-Rieser C, Ramoner R, Bartsch G, Thurnher M. A clinically approved oral vaccine against pneumotropic bacteria induces the terminal maturation of CD83(þ) immunostimulatory dendritic cells. Immunol Lett 2001; 76: 63–7.
21. Roth M, Block LH. Distinct effects of Broncho-Vaxom (OM-85 BV) on gp130 binding cytokines. Thorax 2000; 55: 678–84.
22. Pasquali C, Salami O, Taneja M et al. Enhanced mucosal antibody production and protection against respiratory infections following an orally administered bacterial extract. Front Med 2014; 1: 41.
23. Yin J, Xu B, Zeng X, Shen K. Broncho-Vaxom in pediatric recurrent respiratory tract infections: A systematic review and meta-analysis. Int Immunopharmacol 2018, 54: 98–209.
24. Byl B, Libin M, Ge´rard M et al. Bacterial extract OM85-BV induces interleukin-12-dependent IFN-gamma production by human CD4(þ) T cells. J Interfer Cytok Res 1998; 18: 817–21.
25. Triantafillou V, Workman AD, Patel NN et al. Broncho-Vaxom (OM-85 BV) soluble components stimulate sinonasal innate immunity. Int Forum Allergy Rhinol 2018; 00: 1–8.
26. Navarro S, Cossalter G, Chiavaroli C et al. The oral administration of bacterial extracts prevents asthma via the recruitment of regulatory T cells to the airways. Mucosal Immunol 2011; 4: 53–65.
27. Huber M, Mossmann H, Bessler WG. Th1-orientated immunological properties of the bacterial extract OM-85-BV. Eur J Med Res 2005; 10: 209–17.
28. Han L, Zheng CP, Sun YQ et al. A bacterial extract of OM-85 Broncho-Vaxom prevents allergic rhinitis in mice. Am J Rhinol Allergy 2014; 28: 110–6.
29. Rodrigues A, Gualdi LP, de Souza RG et al. Bacterial extract (OM-85) with human-equivalent doses does not inhibit the development of asthma in a murine model. Allergol Immunopathol 2016; 44: 504–11.
30. Chen ZG, Ji JZ, Li M et al. Effect and analysis of clinical efficacy of immunomodulator on serum levels of IL-4 and IFN-gamma in asthmatic children. J Sun Yat-sen Univ Med Sci 2009; 30: 100–3.
31. Lu Y, Li Y, Xu L et al. Bacterial lysate increases the percentage of natural killer T cells in peripheral blood and alleviates asthma in children. Pharmacology 2015; 95: 139–44.
32. Han RF, Li HY, Wang JW, Cong XJ. Study on clinical effect and immunologic mechanism of infants capillary bronchitis secondary bronchial asthma treated with bacterial lysates Broncho-Vaxom. Eur Rev Med Pharmacol Sci 2016; 20: 2151–5.
33. Strickland DH, Judd S, Thomas JA et al. Boosting airway T-regulatory cells by gastrointestinal stimulation as a strategy for asthma control. Mucosal Immunol 2011; 4: 43–52.
34. Zhong H, Wei J, Yao Y et al. A bacterial extract of OM-85 Broncho-Vaxom suppresses ovalbumin-induced airway inflammation and remodeling in a mouse chronic allergic asthma model. Int J Clin Exp Pathol 2017; 10: 1149–57.
35. Калюжин О.В. Топические бактериальные лизаты в профилактике и лечении респираторных инфекций. Практическая медицина. 2016; 2 (94): 69–74.
[Kaliuzhin O.V. Topicheskie bakterial'nye lizaty v profilaktike i lechenii respiratornykh infektsii. Prakticheskaia meditsina. 2016; 2 (94): 69–74 (in Russian).]
36. Gomez Barreto D, De la Torre C, Alvarez A et al. Safety and efficacy of OM-85-BV plus amoxicillin/clavulanate in the treatment of subacute sinusitis and the prevention of recurrent infections in children. Allergol Immunopathol 1998; 26: 17–22.
37. Zagar S, Löfler-Badzek D. Broncho-Vaxom in children with rhinosinusitis: a double-blind clinical trial. J Otorhinolaryngol Relat Spec 1988; 50 (6): 397–404.
38. Liu YW, Dong SH, Zhan GY et al. Analysis of the effect of bacterial lysate and the immunologic mechanism in treating infant bronchiolitis. Eur Rev Med Pharmacol Sci 2017; 21 (14): 3332–6.
39. Berber AC, Del-Rio-Navarro BE. Use of Broncho-Vaxom in private practice: phase IV trial in 587 children. Clin Ther 1996; 18 (6): 1068–79.
40. Рябова М.А., Галкина О.В., Пестакова Л.В., Пособило Е.Е. К вопросу о консервативном лечении острых воспалительных заболеваний верхних дыхательных путей. Педиатрия (Прил. к журн. Consilium Medicum.). 2016; 3: 51–4 (in Russian).]
[Ryabova M.A., Galkina O.V., Pestakova L.V., Posobilo E.E. The question of treatment of acute diseases of the upper respiratory tract. Pediatrics (Suppl. Consilium Medicum). 2016; 3: 51–4.
41. Razi CH, Harmancı K, Abaci A et al. The immunostimulant OM-85 BV prevents wheezing attacks in preschool children. J Allergy Clin Immunol 2010; 126: 763–9.
42. Chen ZG, Ji JZ, Li M et al. Immunoregulants improves the prognosis of infants with wheezing. Nan Fang Yi Ke Da Xue Xue Bao 2007; 27: 1612–3.
2. Acute respiratory diseases in children: treatment and prevention. Manual for doctors. Moscow: Union of pediatricians of Russia, 2002 (in Russian).
3. Lozano R, Naghavi M, Foreman K et al. Global and regional mortality from 235 causes of death for 20 age groups in 1990 and 2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet 2012; 380: 2095–128.
4. Furman E.G., Mazunina E.S., Boitsova E.V., Ovsiannikov D.Iu. Zatiazhnoi bakterial'nyi bronkhit – "novaia" "staraia" bolezn'. Pediatriia. 2017; 96 (2): 136–44 (in Russian).
5. Ovsiannikov D.Iu., Illarionova T.Iu., Pushko L.V., Kuz'menko L.G. Chasto boleiushchie deti: chto eshche krome infektsii? Vopr. sovremennoi pediatrii. 2013; 12 (1): 74–86 (in Russian).
6. Zaplatnikov A.L., Girina A.A., Lokshina E.E. et al. Chasto boleiushchie deti: vse li resheno? Med. sovet. 2018; 17: 206–14 (in Russian).
7. Feleszko W, Ruszczynski M, Zalewski BM. Non-specific immune stimulation in respiratory tract infections. Separating the wheat from the chaff. Paediatr Respir Rev 2014; 15: 200e–6.
8. Karnaushkina M.A., Strutynskaia A.D., Ovsiannikov D.Iu. Nedonoshennost' i perenesennaia v rannem detstve infektsiia nizhnikh dykhatel'nykh putei kak faktory riska razvitiia khronicheskoi obstruktivnoi bronkholegochnoi patologii u vzroslykh. Sovr. tekhnologii v meditsine. 2017; 9 (1): 129–34 (in Russian).
9. Rachina S.A., Kozlov R.S., Tatochenko V.K. et al. Praktika lecheniia ostrykh respiratornykh infektsii u detei v ambulatorno-poliklinicheskikh uchrezhdeniiakh RF: rezul'taty mnogotsentrovogo farmakoepidemiologicheskogo issledovaniia. Klin. farmakologiia i terapiia. 2016; 2: 20–7 (in Russian).
10. Esposito S, Soto-Martinezb ME, Feleszkoc W et al. Nonspecific immunomodulators for recurrent respiratory tract infections, wheezing and asthma in children: a systematic review of mechanistic and clinical evidence. Curr Opin Allergy Clin Immunol 2018, 18: 198–208.
11.Khaitov M.R., Il'ina N.I., Luss L.V., Babakhin A.A. Mukozal'nyi immunitet respiratornogo trakta i ego rol' pri professional'nykh patologiiakh. Meditsina ekstremal'nykh situatsii. 2017; 61 (3): 8–24 (in Russian).
12. Kaliuzhin OV. OM-85 v profilaktike/lechenii respiratornykh infektsii i obostrenii khronicheskikh zabolevanii legkikh: kriterii vybora, mekhanizmy i dokazatel'stva. Lechashchii vrach. 2018; 3:77–82 (in Russian).
13. Dronov I.A., Denisova A.R. Bakterial'nyi lizat OM-85: voprosy effektivnosti u detei i potentsial'naia rol' v sderzhivanii rosta antimikrobnoi rezistentnosti. Vopr. prakticheskoi pediatrii. 2019; 14 (1): 76–83 (in Russian).
14. Luan H, Zhang Q, Wang L et al. OM85-BV induced the productions of IL-1beta, IL-6, and TNF-alpha via TLR4- and TLR2-mediated ERK1/2/NF-kB pathway in RAW264.7 cells. J Interferon Cytokine Res 2014; 34: 526e–36.
15. Parola C, Salogni L, Vaira X et al. Selective activation of human dendritic cells by OM-85 through a NF-kB and MAPK dependent pathway. PLoS One 2013; 8: e82867.
16. Manolova V, Flace A, Jeandet P et al. Biomarkers induced by the immunomodulatory bacterial extract OM-85: unique roles for Peyer’s patches and intestinal epithelial cells. J Clin Cell Immunol 2017; 8: 494.
17. Liao JY, Zhang T. Influence of OM-85 BV on hBD-1 and immunoglobulin in children with asthma and recurrent respiratory tract infection. Zhongguo Dang Dai Er Ke Za Zhi 2014; 16: 508–12.
18. Roth M, Pasquali C, Stolz D, Tamm M. Broncho Vaxom (OM-85) modulates rhinovirus docking proteins on human airway epithelial cells via Erk1/2 mitogen activated protein kinase and cAMP. PLoS One 2017; 12: e0188010.
19. Dang AT, Pasquali C, Ludigs K, Guarda G. OM-85 is an immunomodulator of interferon-b production and inflammasome activity. Sci Rep 2017; 7: 43844.
20. Zelle-Rieser C, Ramoner R, Bartsch G, Thurnher M. A clinically approved oral vaccine against pneumotropic bacteria induces the terminal maturation of CD83(þ) immunostimulatory dendritic cells. Immunol Lett 2001; 76: 63–7.
21. Roth M, Block LH. Distinct effects of Broncho-Vaxom (OM-85 BV) on gp130 binding cytokines. Thorax 2000; 55: 678–84.
22. Pasquali C, Salami O, Taneja M et al. Enhanced mucosal antibody production and protection against respiratory infections following an orally administered bacterial extract. Front Med 2014; 1: 41.
23. Yin J, Xu B, Zeng X, Shen K. Broncho-Vaxom in pediatric recurrent respiratory tract infections: A systematic review and meta-analysis. Int Immunopharmacol 2018, 54: 98–209.
24. Byl B, Libin M, Ge´rard M et al. Bacterial extract OM85-BV induces interleukin-12-dependent IFN-gamma production by human CD4(þ) T cells. J Interfer Cytok Res 1998; 18: 817–21.
25. Triantafillou V, Workman AD, Patel NN et al. Broncho-Vaxom (OM-85 BV) soluble components stimulate sinonasal innate immunity. Int Forum Allergy Rhinol 2018; 00: 1–8.
26. Navarro S, Cossalter G, Chiavaroli C et al. The oral administration of bacterial extracts prevents asthma via the recruitment of regulatory T cells to the airways. Mucosal Immunol 2011; 4: 53–65.
27. Huber M, Mossmann H, Bessler WG. Th1-orientated immunological properties of the bacterial extract OM-85-BV. Eur J Med Res 2005; 10: 209–17.
28. Han L, Zheng CP, Sun YQ et al. A bacterial extract of OM-85 Broncho-Vaxom prevents allergic rhinitis in mice. Am J Rhinol Allergy 2014; 28: 110–6.
29. Rodrigues A, Gualdi LP, de Souza RG et al. Bacterial extract (OM-85) with human-equivalent doses does not inhibit the development of asthma in a murine model. Allergol Immunopathol 2016; 44: 504–11.
30. Chen ZG, Ji JZ, Li M et al. Effect and analysis of clinical efficacy of immunomodulator on serum levels of IL-4 and IFN-gamma in asthmatic children. J Sun Yat-sen Univ Med Sci 2009; 30: 100–3.
31. Lu Y, Li Y, Xu L et al. Bacterial lysate increases the percentage of natural killer T cells in peripheral blood and alleviates asthma in children. Pharmacology 2015; 95: 139–44.
32. Han RF, Li HY, Wang JW, Cong XJ. Study on clinical effect and immunologic mechanism of infants capillary bronchitis secondary bronchial asthma treated with bacterial lysates Broncho-Vaxom. Eur Rev Med Pharmacol Sci 2016; 20: 2151–5.
33. Strickland DH, Judd S, Thomas JA et al. Boosting airway T-regulatory cells by gastrointestinal stimulation as a strategy for asthma control. Mucosal Immunol 2011; 4: 43–52.
34. Zhong H, Wei J, Yao Y et al. A bacterial extract of OM-85 Broncho-Vaxom suppresses ovalbumin-induced airway inflammation and remodeling in a mouse chronic allergic asthma model. Int J Clin Exp Pathol 2017; 10: 1149–57.
35. Kaliuzhin O.V. Topicheskie bakterial'nye lizaty v profilaktike i lechenii respiratornykh infektsii. Prakticheskaia meditsina. 2016; 2 (94): 69–74 (in Russian).
36. Gomez Barreto D, De la Torre C, Alvarez A et al. Safety and efficacy of OM-85-BV plus amoxicillin/clavulanate in the treatment of subacute sinusitis and the prevention of recurrent infections in children. Allergol Immunopathol 1998; 26: 17–22.
37. Zagar S, Löfler-Badzek D. Broncho-Vaxom in children with rhinosinusitis: a double-blind clinical trial. J Otorhinolaryngol Relat Spec 1988; 50 (6): 397–404.
38. Liu YW, Dong SH, Zhan GY et al. Analysis of the effect of bacterial lysate and the immunologic mechanism in treating infant bronchiolitis. Eur Rev Med Pharmacol Sci 2017; 21 (14): 3332–6.
39. Berber AC, Del-Rio-Navarro BE. Use of Broncho-Vaxom in private practice: phase IV trial in 587 children. Clin Ther 1996; 18 (6): 1068–79.
40. Ryabova M.A., Galkina O.V., Pestakova L.V., Posobilo E.E. The question of treatment of acute diseases of the upper respiratory tract. Pediatrics (Suppl. Consilium Medicum). 2016; 3: 51–4.
41. Razi CH, Harmancı K, Abaci A et al. The immunostimulant OM-85 BV prevents wheezing attacks in preschool children. J Allergy Clin Immunol 2010; 126: 763–9.
42. Chen ZG, Ji JZ, Li M et al. Immunoregulants improves the prognosis of infants with wheezing. Nan Fang Yi Ke Da Xue Xue Bao 2007; 27: 1612–3.
[Brady M. Respiratory viral infections. Infectious disease. D.Murray ed. Moscow: Praktika, 2006; p. 604–30 (in Russian).]
2. Острые респираторные заболевания у детей: лечение и профилактика. Пособие для врачей. М.: Союз педиатров России, 2002.
[Acute respiratory diseases in children: treatment and prevention. Manual for doctors. Moscow: Union of pediatricians of Russia, 2002 (in Russian).]
3. Lozano R, Naghavi M, Foreman K et al. Global and regional mortality from 235 causes of death for 20 age groups in 1990 and 2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet 2012; 380: 2095–128.
4. Фурман Е.Г., Мазунина Е.С., Бойцова Е.В., Овсянников Д.Ю. Затяжной бактериальный бронхит – «новая» «старая» болезнь. Педиатрия. 2017; 96 (2): 136–44.
[Furman E.G., Mazunina E.S., Boitsova E.V., Ovsiannikov D.Iu. Zatiazhnoi bakterial'nyi bronkhit – "novaia" "staraia" bolezn'. Pediatriia. 2017; 96 (2): 136–44 (in Russian).]
5. Овсянников Д.Ю., Илларионова Т.Ю., Пушко Л.В., Кузьменко Л.Г. Часто болеющие дети: что еще кроме инфекций? Вопр. современной педиатрии. 2013; 12 (1): 74–86.
[Ovsiannikov D.Iu., Illarionova T.Iu., Pushko L.V., Kuz'menko L.G. Chasto boleiushchie deti: chto eshche krome infektsii? Vopr. sovremennoi pediatrii. 2013; 12 (1): 74–86 (in Russian).]
6. Заплатников А.Л., Гирина А.А., Локшина Э.Э. и др. Часто болеющие дети: все ли решено? Мед. совет. 2018; 17: 206–14.
[Zaplatnikov A.L., Girina A.A., Lokshina E.E. et al. Chasto boleiushchie deti: vse li resheno? Med. sovet. 2018; 17: 206–14 (in Russian).]
7. Feleszko W, Ruszczynski M, Zalewski BM. Non-specific immune stimulation in respiratory tract infections. Separating the wheat from the chaff. Paediatr Respir Rev 2014; 15: 200e–6.
8. Карнаушкина М.А., Струтынская А.Д., Овсянников Д.Ю. Недоношенность и перенесенная в раннем детстве инфекция нижних дыхательных путей как факторы риска развития хронической обструктивной бронхолегочной патологии у взрослых. Совр. технологии в медицине. 2017; 9 (1): 129–34.
[Karnaushkina M.A., Strutynskaia A.D., Ovsiannikov D.Iu. Nedonoshennost' i perenesennaia v rannem detstve infektsiia nizhnikh dykhatel'nykh putei kak faktory riska razvitiia khronicheskoi obstruktivnoi bronkholegochnoi patologii u vzroslykh. Sovr. tekhnologii v meditsine. 2017; 9 (1): 129–34 (in Russian).]
9. Рачина С.А., Козлов Р.С., Таточенко В.К. и др. Практика лечения острых респираторных инфекций у детей в амбулаторно-поликлинических учреждениях РФ: результаты многоцентрового фармакоэпидемиологического исследования. Клин. фармакология и терапия. 2016; 2: 20–7.
[Rachina S.A., Kozlov R.S., Tatochenko V.K. et al. Praktika lecheniia ostrykh respiratornykh infektsii u detei v ambulatorno-poliklinicheskikh uchrezhdeniiakh RF: rezul'taty mnogotsentrovogo farmakoepidemiologicheskogo issledovaniia. Klin. farmakologiia i terapiia. 2016; 2: 20–7 (in Russian).]
10. Esposito S, Soto-Martinezb ME, Feleszkoc W et al. Nonspecific immunomodulators for recurrent respiratory tract infections, wheezing and asthma in children: a systematic review of mechanistic and clinical evidence. Curr Opin Allergy Clin Immunol 2018, 18: 198–208.
11. Хаитов М.Р., Ильина Н.И., Лусс Л.В., Бабахин А.А. Мукозальный иммунитет респираторного тракта и его роль при профессиональных патологиях. Медицина экстремальных ситуаций. 2017; 61 (3): 8–24.
[Khaitov M.R., Il'ina N.I., Luss L.V., Babakhin A.A. Mukozal'nyi immunitet respiratornogo trakta i ego rol' pri professional'nykh patologiiakh. Meditsina ekstremal'nykh situatsii. 2017; 61 (3): 8–24 (in Russian).]
12. Калюжин ОВ. ОМ-85 в профилактике/лечении респираторных инфекций и обострений хронических заболеваний легких: критерии выбора, механизмы и доказательства. Лечащий врач. 2018; 3:77–82.
[Kaliuzhin OV. OM-85 v profilaktike/lechenii respiratornykh infektsii i obostrenii khronicheskikh zabolevanii legkikh: kriterii vybora, mekhanizmy i dokazatel'stva. Lechashchii vrach. 2018; 3:77–82 (in Russian).]
13. Дронов И.А., Денисова А.Р. Бактериальный лизат ОМ-85: вопросы эффективности у детей и потенциальная роль в сдерживании роста антимикробной резистентности. Вопр. практической педиатрии. 2019; 14 (1): 76–83.
[Dronov I.A., Denisova A.R. Bakterial'nyi lizat OM-85: voprosy effektivnosti u detei i potentsial'naia rol' v sderzhivanii rosta antimikrobnoi rezistentnosti. Vopr. prakticheskoi pediatrii. 2019; 14 (1): 76–83 (in Russian).]
14. Luan H, Zhang Q, Wang L et al. OM85-BV induced the productions of IL-1beta, IL-6, and TNF-alpha via TLR4- and TLR2-mediated ERK1/2/NF-kB pathway in RAW264.7 cells. J Interferon Cytokine Res 2014; 34: 526e–36.
15. Parola C, Salogni L, Vaira X et al. Selective activation of human dendritic cells by OM-85 through a NF-kB and MAPK dependent pathway. PLoS One 2013; 8: e82867.
16. Manolova V, Flace A, Jeandet P et al. Biomarkers induced by the immunomodulatory bacterial extract OM-85: unique roles for Peyer’s patches and intestinal epithelial cells. J Clin Cell Immunol 2017; 8: 494.
17. Liao JY, Zhang T. Influence of OM-85 BV on hBD-1 and immunoglobulin in children with asthma and recurrent respiratory tract infection. Zhongguo Dang Dai Er Ke Za Zhi 2014; 16: 508–12.
18. Roth M, Pasquali C, Stolz D, Tamm M. Broncho Vaxom (OM-85) modulates rhinovirus docking proteins on human airway epithelial cells via Erk1/2 mitogen activated protein kinase and cAMP. PLoS One 2017; 12: e0188010.
19. Dang AT, Pasquali C, Ludigs K, Guarda G. OM-85 is an immunomodulator of interferon-b production and inflammasome activity. Sci Rep 2017; 7: 43844.
20. Zelle-Rieser C, Ramoner R, Bartsch G, Thurnher M. A clinically approved oral vaccine against pneumotropic bacteria induces the terminal maturation of CD83(þ) immunostimulatory dendritic cells. Immunol Lett 2001; 76: 63–7.
21. Roth M, Block LH. Distinct effects of Broncho-Vaxom (OM-85 BV) on gp130 binding cytokines. Thorax 2000; 55: 678–84.
22. Pasquali C, Salami O, Taneja M et al. Enhanced mucosal antibody production and protection against respiratory infections following an orally administered bacterial extract. Front Med 2014; 1: 41.
23. Yin J, Xu B, Zeng X, Shen K. Broncho-Vaxom in pediatric recurrent respiratory tract infections: A systematic review and meta-analysis. Int Immunopharmacol 2018, 54: 98–209.
24. Byl B, Libin M, Ge´rard M et al. Bacterial extract OM85-BV induces interleukin-12-dependent IFN-gamma production by human CD4(þ) T cells. J Interfer Cytok Res 1998; 18: 817–21.
25. Triantafillou V, Workman AD, Patel NN et al. Broncho-Vaxom (OM-85 BV) soluble components stimulate sinonasal innate immunity. Int Forum Allergy Rhinol 2018; 00: 1–8.
26. Navarro S, Cossalter G, Chiavaroli C et al. The oral administration of bacterial extracts prevents asthma via the recruitment of regulatory T cells to the airways. Mucosal Immunol 2011; 4: 53–65.
27. Huber M, Mossmann H, Bessler WG. Th1-orientated immunological properties of the bacterial extract OM-85-BV. Eur J Med Res 2005; 10: 209–17.
28. Han L, Zheng CP, Sun YQ et al. A bacterial extract of OM-85 Broncho-Vaxom prevents allergic rhinitis in mice. Am J Rhinol Allergy 2014; 28: 110–6.
29. Rodrigues A, Gualdi LP, de Souza RG et al. Bacterial extract (OM-85) with human-equivalent doses does not inhibit the development of asthma in a murine model. Allergol Immunopathol 2016; 44: 504–11.
30. Chen ZG, Ji JZ, Li M et al. Effect and analysis of clinical efficacy of immunomodulator on serum levels of IL-4 and IFN-gamma in asthmatic children. J Sun Yat-sen Univ Med Sci 2009; 30: 100–3.
31. Lu Y, Li Y, Xu L et al. Bacterial lysate increases the percentage of natural killer T cells in peripheral blood and alleviates asthma in children. Pharmacology 2015; 95: 139–44.
32. Han RF, Li HY, Wang JW, Cong XJ. Study on clinical effect and immunologic mechanism of infants capillary bronchitis secondary bronchial asthma treated with bacterial lysates Broncho-Vaxom. Eur Rev Med Pharmacol Sci 2016; 20: 2151–5.
33. Strickland DH, Judd S, Thomas JA et al. Boosting airway T-regulatory cells by gastrointestinal stimulation as a strategy for asthma control. Mucosal Immunol 2011; 4: 43–52.
34. Zhong H, Wei J, Yao Y et al. A bacterial extract of OM-85 Broncho-Vaxom suppresses ovalbumin-induced airway inflammation and remodeling in a mouse chronic allergic asthma model. Int J Clin Exp Pathol 2017; 10: 1149–57.
35. Калюжин О.В. Топические бактериальные лизаты в профилактике и лечении респираторных инфекций. Практическая медицина. 2016; 2 (94): 69–74.
[Kaliuzhin O.V. Topicheskie bakterial'nye lizaty v profilaktike i lechenii respiratornykh infektsii. Prakticheskaia meditsina. 2016; 2 (94): 69–74 (in Russian).]
36. Gomez Barreto D, De la Torre C, Alvarez A et al. Safety and efficacy of OM-85-BV plus amoxicillin/clavulanate in the treatment of subacute sinusitis and the prevention of recurrent infections in children. Allergol Immunopathol 1998; 26: 17–22.
37. Zagar S, Löfler-Badzek D. Broncho-Vaxom in children with rhinosinusitis: a double-blind clinical trial. J Otorhinolaryngol Relat Spec 1988; 50 (6): 397–404.
38. Liu YW, Dong SH, Zhan GY et al. Analysis of the effect of bacterial lysate and the immunologic mechanism in treating infant bronchiolitis. Eur Rev Med Pharmacol Sci 2017; 21 (14): 3332–6.
39. Berber AC, Del-Rio-Navarro BE. Use of Broncho-Vaxom in private practice: phase IV trial in 587 children. Clin Ther 1996; 18 (6): 1068–79.
40. Рябова М.А., Галкина О.В., Пестакова Л.В., Пособило Е.Е. К вопросу о консервативном лечении острых воспалительных заболеваний верхних дыхательных путей. Педиатрия (Прил. к журн. Consilium Medicum.). 2016; 3: 51–4 (in Russian).]
[Ryabova M.A., Galkina O.V., Pestakova L.V., Posobilo E.E. The question of treatment of acute diseases of the upper respiratory tract. Pediatrics (Suppl. Consilium Medicum). 2016; 3: 51–4.
41. Razi CH, Harmancı K, Abaci A et al. The immunostimulant OM-85 BV prevents wheezing attacks in preschool children. J Allergy Clin Immunol 2010; 126: 763–9.
42. Chen ZG, Ji JZ, Li M et al. Immunoregulants improves the prognosis of infants with wheezing. Nan Fang Yi Ke Da Xue Xue Bao 2007; 27: 1612–3.
________________________________________________
2. Acute respiratory diseases in children: treatment and prevention. Manual for doctors. Moscow: Union of pediatricians of Russia, 2002 (in Russian).
3. Lozano R, Naghavi M, Foreman K et al. Global and regional mortality from 235 causes of death for 20 age groups in 1990 and 2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet 2012; 380: 2095–128.
4. Furman E.G., Mazunina E.S., Boitsova E.V., Ovsiannikov D.Iu. Zatiazhnoi bakterial'nyi bronkhit – "novaia" "staraia" bolezn'. Pediatriia. 2017; 96 (2): 136–44 (in Russian).
5. Ovsiannikov D.Iu., Illarionova T.Iu., Pushko L.V., Kuz'menko L.G. Chasto boleiushchie deti: chto eshche krome infektsii? Vopr. sovremennoi pediatrii. 2013; 12 (1): 74–86 (in Russian).
6. Zaplatnikov A.L., Girina A.A., Lokshina E.E. et al. Chasto boleiushchie deti: vse li resheno? Med. sovet. 2018; 17: 206–14 (in Russian).
7. Feleszko W, Ruszczynski M, Zalewski BM. Non-specific immune stimulation in respiratory tract infections. Separating the wheat from the chaff. Paediatr Respir Rev 2014; 15: 200e–6.
8. Karnaushkina M.A., Strutynskaia A.D., Ovsiannikov D.Iu. Nedonoshennost' i perenesennaia v rannem detstve infektsiia nizhnikh dykhatel'nykh putei kak faktory riska razvitiia khronicheskoi obstruktivnoi bronkholegochnoi patologii u vzroslykh. Sovr. tekhnologii v meditsine. 2017; 9 (1): 129–34 (in Russian).
9. Rachina S.A., Kozlov R.S., Tatochenko V.K. et al. Praktika lecheniia ostrykh respiratornykh infektsii u detei v ambulatorno-poliklinicheskikh uchrezhdeniiakh RF: rezul'taty mnogotsentrovogo farmakoepidemiologicheskogo issledovaniia. Klin. farmakologiia i terapiia. 2016; 2: 20–7 (in Russian).
10. Esposito S, Soto-Martinezb ME, Feleszkoc W et al. Nonspecific immunomodulators for recurrent respiratory tract infections, wheezing and asthma in children: a systematic review of mechanistic and clinical evidence. Curr Opin Allergy Clin Immunol 2018, 18: 198–208.
11.Khaitov M.R., Il'ina N.I., Luss L.V., Babakhin A.A. Mukozal'nyi immunitet respiratornogo trakta i ego rol' pri professional'nykh patologiiakh. Meditsina ekstremal'nykh situatsii. 2017; 61 (3): 8–24 (in Russian).
12. Kaliuzhin OV. OM-85 v profilaktike/lechenii respiratornykh infektsii i obostrenii khronicheskikh zabolevanii legkikh: kriterii vybora, mekhanizmy i dokazatel'stva. Lechashchii vrach. 2018; 3:77–82 (in Russian).
13. Dronov I.A., Denisova A.R. Bakterial'nyi lizat OM-85: voprosy effektivnosti u detei i potentsial'naia rol' v sderzhivanii rosta antimikrobnoi rezistentnosti. Vopr. prakticheskoi pediatrii. 2019; 14 (1): 76–83 (in Russian).
14. Luan H, Zhang Q, Wang L et al. OM85-BV induced the productions of IL-1beta, IL-6, and TNF-alpha via TLR4- and TLR2-mediated ERK1/2/NF-kB pathway in RAW264.7 cells. J Interferon Cytokine Res 2014; 34: 526e–36.
15. Parola C, Salogni L, Vaira X et al. Selective activation of human dendritic cells by OM-85 through a NF-kB and MAPK dependent pathway. PLoS One 2013; 8: e82867.
16. Manolova V, Flace A, Jeandet P et al. Biomarkers induced by the immunomodulatory bacterial extract OM-85: unique roles for Peyer’s patches and intestinal epithelial cells. J Clin Cell Immunol 2017; 8: 494.
17. Liao JY, Zhang T. Influence of OM-85 BV on hBD-1 and immunoglobulin in children with asthma and recurrent respiratory tract infection. Zhongguo Dang Dai Er Ke Za Zhi 2014; 16: 508–12.
18. Roth M, Pasquali C, Stolz D, Tamm M. Broncho Vaxom (OM-85) modulates rhinovirus docking proteins on human airway epithelial cells via Erk1/2 mitogen activated protein kinase and cAMP. PLoS One 2017; 12: e0188010.
19. Dang AT, Pasquali C, Ludigs K, Guarda G. OM-85 is an immunomodulator of interferon-b production and inflammasome activity. Sci Rep 2017; 7: 43844.
20. Zelle-Rieser C, Ramoner R, Bartsch G, Thurnher M. A clinically approved oral vaccine against pneumotropic bacteria induces the terminal maturation of CD83(þ) immunostimulatory dendritic cells. Immunol Lett 2001; 76: 63–7.
21. Roth M, Block LH. Distinct effects of Broncho-Vaxom (OM-85 BV) on gp130 binding cytokines. Thorax 2000; 55: 678–84.
22. Pasquali C, Salami O, Taneja M et al. Enhanced mucosal antibody production and protection against respiratory infections following an orally administered bacterial extract. Front Med 2014; 1: 41.
23. Yin J, Xu B, Zeng X, Shen K. Broncho-Vaxom in pediatric recurrent respiratory tract infections: A systematic review and meta-analysis. Int Immunopharmacol 2018, 54: 98–209.
24. Byl B, Libin M, Ge´rard M et al. Bacterial extract OM85-BV induces interleukin-12-dependent IFN-gamma production by human CD4(þ) T cells. J Interfer Cytok Res 1998; 18: 817–21.
25. Triantafillou V, Workman AD, Patel NN et al. Broncho-Vaxom (OM-85 BV) soluble components stimulate sinonasal innate immunity. Int Forum Allergy Rhinol 2018; 00: 1–8.
26. Navarro S, Cossalter G, Chiavaroli C et al. The oral administration of bacterial extracts prevents asthma via the recruitment of regulatory T cells to the airways. Mucosal Immunol 2011; 4: 53–65.
27. Huber M, Mossmann H, Bessler WG. Th1-orientated immunological properties of the bacterial extract OM-85-BV. Eur J Med Res 2005; 10: 209–17.
28. Han L, Zheng CP, Sun YQ et al. A bacterial extract of OM-85 Broncho-Vaxom prevents allergic rhinitis in mice. Am J Rhinol Allergy 2014; 28: 110–6.
29. Rodrigues A, Gualdi LP, de Souza RG et al. Bacterial extract (OM-85) with human-equivalent doses does not inhibit the development of asthma in a murine model. Allergol Immunopathol 2016; 44: 504–11.
30. Chen ZG, Ji JZ, Li M et al. Effect and analysis of clinical efficacy of immunomodulator on serum levels of IL-4 and IFN-gamma in asthmatic children. J Sun Yat-sen Univ Med Sci 2009; 30: 100–3.
31. Lu Y, Li Y, Xu L et al. Bacterial lysate increases the percentage of natural killer T cells in peripheral blood and alleviates asthma in children. Pharmacology 2015; 95: 139–44.
32. Han RF, Li HY, Wang JW, Cong XJ. Study on clinical effect and immunologic mechanism of infants capillary bronchitis secondary bronchial asthma treated with bacterial lysates Broncho-Vaxom. Eur Rev Med Pharmacol Sci 2016; 20: 2151–5.
33. Strickland DH, Judd S, Thomas JA et al. Boosting airway T-regulatory cells by gastrointestinal stimulation as a strategy for asthma control. Mucosal Immunol 2011; 4: 43–52.
34. Zhong H, Wei J, Yao Y et al. A bacterial extract of OM-85 Broncho-Vaxom suppresses ovalbumin-induced airway inflammation and remodeling in a mouse chronic allergic asthma model. Int J Clin Exp Pathol 2017; 10: 1149–57.
35. Kaliuzhin O.V. Topicheskie bakterial'nye lizaty v profilaktike i lechenii respiratornykh infektsii. Prakticheskaia meditsina. 2016; 2 (94): 69–74 (in Russian).
36. Gomez Barreto D, De la Torre C, Alvarez A et al. Safety and efficacy of OM-85-BV plus amoxicillin/clavulanate in the treatment of subacute sinusitis and the prevention of recurrent infections in children. Allergol Immunopathol 1998; 26: 17–22.
37. Zagar S, Löfler-Badzek D. Broncho-Vaxom in children with rhinosinusitis: a double-blind clinical trial. J Otorhinolaryngol Relat Spec 1988; 50 (6): 397–404.
38. Liu YW, Dong SH, Zhan GY et al. Analysis of the effect of bacterial lysate and the immunologic mechanism in treating infant bronchiolitis. Eur Rev Med Pharmacol Sci 2017; 21 (14): 3332–6.
39. Berber AC, Del-Rio-Navarro BE. Use of Broncho-Vaxom in private practice: phase IV trial in 587 children. Clin Ther 1996; 18 (6): 1068–79.
40. Ryabova M.A., Galkina O.V., Pestakova L.V., Posobilo E.E. The question of treatment of acute diseases of the upper respiratory tract. Pediatrics (Suppl. Consilium Medicum). 2016; 3: 51–4.
41. Razi CH, Harmancı K, Abaci A et al. The immunostimulant OM-85 BV prevents wheezing attacks in preschool children. J Allergy Clin Immunol 2010; 126: 763–9.
42. Chen ZG, Ji JZ, Li M et al. Immunoregulants improves the prognosis of infants with wheezing. Nan Fang Yi Ke Da Xue Xue Bao 2007; 27: 1612–3.
Авторы
Д.Ю. Овсянников*
ФГАОУ ВО «Российский университет дружбы народов» Министерства науки и высшего образования,
Москва, Россия
*mdovsyannikov@yahoo.com
People’s Friendship University of Russia, Moscow, Russia
*mdovsyannikov@yahoo.com
ФГАОУ ВО «Российский университет дружбы народов» Министерства науки и высшего образования,
Москва, Россия
*mdovsyannikov@yahoo.com
________________________________________________
People’s Friendship University of Russia, Moscow, Russia
*mdovsyannikov@yahoo.com
Цель портала OmniDoctor – предоставление профессиональной информации врачам, провизорам и фармацевтам.