Бронхиальная астма является одним из наиболее часто встречающихся хронических заболеваний детского возраста и чаще манифестирует в раннем детстве. Несмотря на то что на сегодняшний день сведения об эффективности и безопасности фармакотерапии бронхиальной астмы у детей ограничены, имеющиеся данные позволяют рекомендовать у пациентов в возрасте 5 лет и младше поэтапный подход, подразумевающий в том числе назначение ингаляционных глюкокортикостероидов и антагонистов лейкотриеновых рецепторов. В данной статье авторами на примере будесонида и монтелукаста рассмотрены особенности фармакодинамики и фармакокинетики данных групп лекарственных средств, а также проведено сравнение эффективности и безопасности их применения в педиатрической практике.
Bronchial asthma is one of the most common chronic diseases of childhood and more often manifests in early childhood. Despite the fact that to date, available findings about efficacy and safety of bronchial asthma pharmacotherapy in children are limited, available data allow us to recommend a step-wise approach in patients aged 5 years and younger, including administration of inhaled glucocorticosteroids and leukotriene receptor antagonists. In this article, authors discuss the pharmacodynamics and pharmacokinetics properties of these classes of drugs onthe example of budesonide and montelukast, and compare the efficacy and safety of their use in pediatric practice.
1. Masoli M, Fabian D, Holt S, Beasley R. The global burden of asthma: executive summary of the GINA Dissemination Committee report. Allergy 2004; 59: 469–78.
2. Simpson CR, Sheikh A. Trends in the epidemiology of asthma in England: a national study of 333,294 patients. J R Soc Med 2010; 103: 98–106.
3. Bisgaard H, Szefler S. Prevalence of asthma-like symptoms in young children. Pediatr Pulmonol 2007; 42: 723–8.
4. Kuehni CE, Strippoli MP, Low N et al. Wheeze and asthma prevalence and related health- service use in white and south Asian pre-schoolchildren in the United Kingdom. Clin Exp Allergy 2007; 37: 1738–46.
5. Martinez FD, Wright AL, Taussig LM et al. Asthma and wheezing in the first six years of life. The Group Health Medical Associates. N Engl J Med 1995; 332: 133–8.
6. Sly PD, Boner AL, Bjorksten B et al. Early identification of atopy in the prediction of persistent asthma in children. Lancet 2008; 372: 1100–6.
7. Doherty G, Bush A. Diagnosing respiratory problems in young children. Practitioner 2007; 251: 20, 2–5.
8. Pedersen S. Preschool asthma – not so easy to diagnose. Prim Care Respir J 2007; 16: 4–6.
9. Brand PL, Caudri D, Eber E et al. Classification and pharmacological treatment of preschool wheezing: changes since 2008. Eur Respir J 2014; 43: 1172–7.
10. Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention, 2017. 06.02.2018. URL: www.ginasthma.org
11. Castro-Rodriguez JA, Holberg CJ, Wright AL, Martinez FD. A clinical index to define risk of asthma in young children with recurrent wheezing. Am J Respir Crit Care Med 2000; 162: 1403–6.
12. Bisgaard H, Allen D, Milanowski J et al. Twelve-month safety and efficacy of inhaled fluticasone propionate in children aged 1 to 3 years with recurrent wheezing. Pediatrics 2004; 113: e87–94.
13. Guilbert TW, Morgan WJ, Zeiger RS et al. Long-term inhaled corticosteroids in preschool children at high risk for asthma. N Engl J Med 2006; 354: 1985–97.
14. Nielsen KG, Bisgaard H. The effect of inhaled budesonide on symptoms, lung function, and cold air and methacholine responsiveness in 2- to 5-year-old asthmatic children. Am J Respir Crit Care Med 2000; 162: 1500–6.
15. Szefler SJ, Baker JW, Uryniak T et al. Comparative study of budesonide inhalation suspension and montelukast in young children with mild persistent asthma. J Allergy Clin Immunol 2007; 120: 1043–50.
16. Инструкция по медицинскому применению лекарственного препарата Сингуляр®. Государственный реестр лекарственных средств. 06.02.2018 URL: http://grls.rosminzdrav.ru/Grls_View_v2.aspx?routingGuid=a148e32c-aedc-4936-b984-aa7ea5c111b0&am.... / Instruktsiia po meditsinskomu primeneniiu lekarstvennogo preparata Singuliar®. Gosudarstvennyi reestr lekarstvennykh sredstv. 06.02.2018 URL: http://grls.rosminzdrav.ru/Grls_View_v2.aspx?routingGuid=a148e32c-aedc-4936-b984-aa7ea5c111b0&am.... [in Russian]
17. Hvizdos KM, Jarvis B. Budesonide inhalation suspension: a review of its use in infants, children and adults with inflammatory respiratory disorders. Drugs 2000; 60 (5): 1141–78.
18. Knorr B, Franchi LM, Bisgaard H et al. Montelukast, a leukotriene receptor antagonist, for the treatment of persistent asthma in children aged 2 to 5 years. Pediatrics 2001; 108: E48.
19. Shah MB, Gohil J, Khapekar S, Dave J. Montelukast versus budesonide as a first line preventive therapy in mild persistent asthma in 2 to 18 y. Indian J Pediatr 2014; 81 (7): 655–9.
20. Szefler SJ, Carlsson LG, Uryniak T, Baker JW. Budesonide inhalation suspension versus montelukast in children aged 2 to 4 years with mild persistent asthma. J Allergy Clin Immunol Pract 2013; 1 (1): 58–64.
21. Edsbäcker S, Wollmer P, Selroos O et al. Do airway clearance mechanisms influence the local and systemic effects of inhaled corticosteroids? Pulm Pharmacol Ther 2008; 21: 247–2582.
22. Bhupendrasinh F Chauhan, Francine M Ducharme. Anti-leukotriene agents compared to inhaled corticosteroids in the management of recurrent and/or chronic asthma in adults and children. Cochraine library 06.02.2018 URL: http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD002314.pub3/full
23. Loke YK, Blanco P, Thavarajah M, Wilson AM. Impact of inhaled corticosteroids on growth in children with asthma: Systematic review and meta-analysis. PLoS One 2015; 10.
24. Kelly HW, Sternberg AL, Lescher R et al. Effect of inhaled glucocorticoids in childhood on adult height. N Engl J Med 2012; 367: 904–12.
25. Pedersen S. Do inhaled corticosteroids inhibit growth in children? Am J Respir Crit Care Med 2001; 164: 521–35.
26. Wallerstedt SM, Brunlöf G, Sundström A, Eriksson AL. Montelukast and psychiatric disorders in children. Pharmacoepidemiol Drug Saf 2009; 18 (9): 858–64.
27. Calapai G, Casciaro M, Miroddi M et al. Montelukast-induced adverse drug reactions: a review of case reports in the literature. Pharmacology 2014; 94 (1–2): 60–70.
28. Инструкция по медицинскому применению лекарственного препарата Пульмикорт® (суспензия для ингаляций дозированная 0,25 и 0,5 мг/мл) с учетом изменений №1, 2, 3. Регистрационное удостоверение П N013826/01 от 14.09.2007, дата переоформления 24.11.2016. / Instruktsiya po meditsinskomu primeneniiu lekarstvennogo preparata Pulmikort® (suspenziya dlya ingalyatsii dozirovannaya 0,25 i 0,5 mg/ml) s uchetom izmenenii №1, 2, 3. Registratsionnoe udostoverenie P N013826/01 ot 14.09.2007, data pereoformleniya 24.11.2016. [in Russian]
29. Philip G et al. Analysis of behavior-related adverse experiences in clinical trials of montelukast. J Allergy Clin Immunol 2009; 124: 699–706.
30. Philip G et al. Reports of suicidality in clinical trials of montelukast. J Allergy Clin Immunol 2009; 124: 691–6.
31. Kelsay K. Assessing risk: data from montelukast clinical trials. J Allergy Clin Immunol 2009; 124: 697–8.
32. Marchand MS et al. Troubles psychiatriques associés au montélukast: données de la base nationale de pharmacovigilance. [Psychiatric disorders associated with montelukast: data from the National Pharmacovigilance Database]. Arch Pediatr 2013; 20: 269–73.
33. Aldea Perona A et al. Psychiatric disorders and montelukast in children: a disproportionality analysis of the VigiBase®. Drug Saf 2016; 39: 69–78.
34. Bygdell M et al. Psychiatric adverse drug reactions reported during a 10-year period in the Swedish pediatric population. Pharmacoepidemiol Drug Saf 2012; 21: 79–86.
35. Benard B et al. Neuropsychiatric adverse drug reactions in children initiated on montelukast in real-life practice. Eur Respir J 2017; 50 (2): 1700148.
________________________________________________
1. Masoli M, Fabian D, Holt S, Beasley R. The global burden of asthma: executive summary of the GINA Dissemination Committee report. Allergy 2004; 59: 469–78.
2. Simpson CR, Sheikh A. Trends in the epidemiology of asthma in England: a national study of 333,294 patients. J R Soc Med 2010; 103: 98–106.
3. Bisgaard H, Szefler S. Prevalence of asthma-like symptoms in young children. Pediatr Pulmonol 2007; 42: 723–8.
4. Kuehni CE, Strippoli MP, Low N et al. Wheeze and asthma prevalence and related health- service use in white and south Asian pre-schoolchildren in the United Kingdom. Clin Exp Allergy 2007; 37: 1738–46.
5. Martinez FD, Wright AL, Taussig LM et al. Asthma and wheezing in the first six years of life. The Group Health Medical Associates. N Engl J Med 1995; 332: 133–8.
6. Sly PD, Boner AL, Bjorksten B et al. Early identification of atopy in the prediction of persistent asthma in children. Lancet 2008; 372: 1100–6.
7. Doherty G, Bush A. Diagnosing respiratory problems in young children. Practitioner 2007; 251: 20, 2–5.
8. Pedersen S. Preschool asthma – not so easy to diagnose. Prim Care Respir J 2007; 16: 4–6.
9. Brand PL, Caudri D, Eber E et al. Classification and pharmacological treatment of preschool wheezing: changes since 2008. Eur Respir J 2014; 43: 1172–7.
10. Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention, 2017. 06.02.2018. URL: www.ginasthma.org
11. Castro-Rodriguez JA, Holberg CJ, Wright AL, Martinez FD. A clinical index to define risk of asthma in young children with recurrent wheezing. Am J Respir Crit Care Med 2000; 162: 1403–6.
12. Bisgaard H, Allen D, Milanowski J et al. Twelve-month safety and efficacy of inhaled fluticasone propionate in children aged 1 to 3 years with recurrent wheezing. Pediatrics 2004; 113: e87–94.
13. Guilbert TW, Morgan WJ, Zeiger RS et al. Long-term inhaled corticosteroids in preschool children at high risk for asthma. N Engl J Med 2006; 354: 1985–97.
14. Nielsen KG, Bisgaard H. The effect of inhaled budesonide on symptoms, lung function, and cold air and methacholine responsiveness in 2- to 5-year-old asthmatic children. Am J Respir Crit Care Med 2000; 162: 1500–6.
15. Szefler SJ, Baker JW, Uryniak T et al. Comparative study of budesonide inhalation suspension and montelukast in young children with mild persistent asthma. J Allergy Clin Immunol 2007; 120: 1043–50.
16. Instruktsiia po meditsinskomu primeneniiu lekarstvennogo preparata Singuliar®. Gosudarstvennyi reestr lekarstvennykh sredstv. 06.02.2018 URL: http://grls.rosminzdrav.ru/Grls_View_v2.aspx?routingGuid=a148e32c-aedc-4936-b984-aa7ea5c111b0&am.... [in Russian]
17. Hvizdos KM, Jarvis B. Budesonide inhalation suspension: a review of its use in infants, children and adults with inflammatory respiratory disorders. Drugs 2000; 60 (5): 1141–78.
18. Knorr B, Franchi LM, Bisgaard H et al. Montelukast, a leukotriene receptor antagonist, for the treatment of persistent asthma in children aged 2 to 5 years. Pediatrics 2001; 108: E48.
19. Shah MB, Gohil J, Khapekar S, Dave J. Montelukast versus budesonide as a first line preventive therapy in mild persistent asthma in 2 to 18 y. Indian J Pediatr 2014; 81 (7): 655–9.
20. Szefler SJ, Carlsson LG, Uryniak T, Baker JW. Budesonide inhalation suspension versus montelukast in children aged 2 to 4 years with mild persistent asthma. J Allergy Clin Immunol Pract 2013; 1 (1): 58–64.
21. Edsbäcker S, Wollmer P, Selroos O et al. Do airway clearance mechanisms influence the local and systemic effects of inhaled corticosteroids? Pulm Pharmacol Ther 2008; 21: 247–2582.
22. Bhupendrasinh F Chauhan, Francine M Ducharme. Anti-leukotriene agents compared to inhaled corticosteroids in the management of recurrent and/or chronic asthma in adults and children. Cochraine library 06.02.2018 URL: http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD002314.pub3/full
23. Loke YK, Blanco P, Thavarajah M, Wilson AM. Impact of inhaled corticosteroids on growth in children with asthma: Systematic review and meta-analysis. PLoS One 2015; 10.
24. Kelly HW, Sternberg AL, Lescher R et al. Effect of inhaled glucocorticoids in childhood on adult height. N Engl J Med 2012; 367: 904–12.
25. Pedersen S. Do inhaled corticosteroids inhibit growth in children? Am J Respir Crit Care Med 2001; 164: 521–35.
26. Wallerstedt SM, Brunlöf G, Sundström A, Eriksson AL. Montelukast and psychiatric disorders in children. Pharmacoepidemiol Drug Saf 2009; 18 (9): 858–64.
27. Calapai G, Casciaro M, Miroddi M et al. Montelukast-induced adverse drug reactions: a review of case reports in the literature. Pharmacology 2014; 94 (1–2): 60–70.
28. Instruktsiya po meditsinskomu primeneniiu lekarstvennogo preparata Pulmikort® (suspenziya dlya ingalyatsii dozirovannaya 0,25 i 0,5 mg/ml) s uchetom izmenenii №1, 2, 3. Registratsionnoe udostoverenie P N013826/01 ot 14.09.2007, data pereoformleniya 24.11.2016. [in Russian]
29. Philip G et al. Analysis of behavior-related adverse experiences in clinical trials of montelukast. J Allergy Clin Immunol 2009; 124: 699–706.
30. Philip G et al. Reports of suicidality in clinical trials of montelukast. J Allergy Clin Immunol 2009; 124: 691–6.
31. Kelsay K. Assessing risk: data from montelukast clinical trials. J Allergy Clin Immunol 2009; 124: 697–8.
32. Marchand MS et al. Troubles psychiatriques associés au montélukast: données de la base nationale de pharmacovigilance. [Psychiatric disorders associated with montelukast: data from the National Pharmacovigilance Database]. Arch Pediatr 2013; 20: 269–73.
33. Aldea Perona A et al. Psychiatric disorders and montelukast in children: a disproportionality analysis of the VigiBase®. Drug Saf 2016; 39: 69–78.
34. Bygdell M et al. Psychiatric adverse drug reactions reported during a 10-year period in the Swedish pediatric population. Pharmacoepidemiol Drug Saf 2012; 21: 79–86.
35. Benard B et al. Neuropsychiatric adverse drug reactions in children initiated on montelukast in real-life practice. Eur Respir J 2017; 50 (2): 1700148.