Мукоактивная терапия амброксолом пациентов с продуктивным кашлем: время действовать на ключевые механизмы

Бабак С.Л., Горбунова М.В., Мишина А.В., Шашенков И.В. Мукоактивная терапия амброксолом пациентов с продуктивным кашлем: время действовать на ключевые механизмы. Consilium Medicum. 2026;28(3):154–158. DOI: 10.26442/20751753.2026.3.203650

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Babak SL, Gorbunova MV, Mishina AV, Shashenkov IV. Mucoactive therapy with ambroxol in patients with productive cough: time to target the key mechanisms. A review. Consilium Medicum. 2026;28(3):154–158. DOI: 10.26442/20751753.2026.3.203650

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Аннотация

Амброксол – один из наиболее изученных мукоактивных препаратов, применяемых при заболеваниях дыхательных путей, сопровождающихся продуктивным кашлем, гиперсекрецией и нарушением мукоцилиарного клиренса. В статье обобщены современные данные об его фармакологических свойствах, механизмах действия, клинической эффективности и безопасности у детей и взрослых. Амброксол обладает многофакторным действием: уменьшает вязкость трахеобронхиального секрета, усиливает его эвакуацию, стимулирует мукоцилиарный транспорт, модулирует синтез и секрецию легочного сурфактанта, а также проявляет антиоксидантные и противовоспалительные свойства. Экспериментальные исследования показывают, что препарат влияет на секрецию муцинов, активность реснитчатого эпителия, защиту альвеолярных структур и выраженность воспалительного ответа. Клинические данные подтверждают, что амброксол способствует уменьшению интенсивности кашля, облегчает отхождение мокроты, улучшает субъективное самочувствие и качество жизни пациентов. Отдельное значение имеют результаты исследований ингаляционных форм, в том числе у детей с инфекциями нижних дыхательных путей и взрослых пациентов в реальной клинической практике, где показаны быстрый клинический эффект и хорошая переносимость терапии. Высокий профиль безопасности амброксола подтвержден результатами многочисленных исследований и многолетним опытом применения. С практической точки зрения амброксол может рассматриваться как рациональный компонент мукоактивной терапии при острых и хронических заболеваниях дыхательных путей с продуктивным кашлем, особенно в ситуациях, когда требуется опора на доказательную базу, предсказуемый клинический эффект и хорошая переносимость. В педиатрической практике это особенно важно, поскольку для многих растительных и гомеопатических средств убедительная доказательная база остается ограниченной. Препарат представлен в различных лекарственных формах, включая пероральные, парентеральные и ингаляционные варианты, что позволяет индивидуализировать выбор терапии с учетом возраста пациента, клинической ситуации и характера бронхиальной секреции. Совокупность экспериментальных, рандомизированных клинических и наблюдательных данных обосновывает его широкое использование в повседневной пульмонологической и педиатрической практике при инфекционно-воспалительных и хронических бронхолегочных заболеваниях у разных категорий пациентов.

Ключевые слова: амброксол, мукоцилиарный клиренс, продуктивный кашель, мукоактивная терапия, трахеобронхиальный секрет, безопасность

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Ambroxol is one of the best studied mucoactive agents used in respiratory diseases associated with productive cough, mucus hypersecretion, and impaired mucociliary clearance. This article summarizes current data on its pharmacological properties, mechanisms of action, clinical efficacy, and safety in children and adults. Ambroxol has a multimodal activity profile: it reduces the viscosity of tracheobronchial secretions, facilitates their clearance, stimulates mucociliary transport, modulates the synthesis and secretion of pulmonary surfactant, and also demonstrates antioxidant and anti-inflammatory effects. Experimental studies show that the drug influences mucin secretion, ciliary epithelial activity, protection of alveolar structures, and the intensity of the inflammatory response. Clinical evidence confirms that ambroxol helps reduce cough severity, facilitates sputum expectoration, and improves patients’ subjective well-being and quality of life. Of particular importance are the results of studies of inhaled formulations, including in children with lower respiratory tract infections and in adult patients in real-world clinical practice, where a rapid clinical effect and good tolerability have been demonstrated. The favorable safety profile of ambroxol has been confirmed by numerous studies and many years of clinical use. From a practical perspective, ambroxol may be regarded as a rational component of mucoactive therapy in acute and chronic respiratory diseases with wet cough, especially when a robust evidence base, predictable clinical effect, and good tolerability are required. This is particularly important in pediatric practice, because the evidence supporting the efficacy and safety of many herbal and homeopathic remedies remains limited. The availability of different dosage forms allows therapy to be individualized according to age, clinical setting, and the characteristics of bronchial secretions. The totality of experimental, randomized clinical, and observational data supports its widespread use in everyday pulmonology and pediatric practice for infectious-inflammatory and chronic bronchopulmonary diseases in various patient categories.

Keywords: ambroxol, mucociliary clearance, productive cough, mucoactive therapy, tracheobronchial secretions, safety

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Список литературы

1. Houtmeyers E, Gosselink R, Gayan-Ramirez G, Decramer M. Effects of drugs on mucus clearance. Eur Respir J. 1999;14(2):452-67. DOI:10.1034/j.1399-3003.1999.14b35.x
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7. Cazan D, Klimek L, Sperl A, et al. Safety of ambroxol in the treatment of airway diseases in adult patients. Expert Opin Drug Saf. 2018;17(12):1211-24. DOI:10.1080/14740338.2018.1533954
8. Kantar A, Klimek L, Cazan D, et al. An overview of efficacy and safety of ambroxol for the treatment of acute and chronic respiratory diseases with a special regard to children. Multidiscip Respir Med. 2020;15(1):511. DOI:10.4081/mrm.2020.511
9. Malerba M, Ragnoli B. Ambroxol in the 21st century: pharmacological and clinical update. Expert Opin Drug Metab Toxicol. 2008;4(8):1119-29. DOI:10.1517/17425255.4.8.1119
10. Guo Z, Chen Y, Ding X, et al. Simultaneous determination of ambroxol and salbutamol in human plasma by ultra-performance liquid chromatography-tandem mass spectrometry and its application to a pharmacokinetic study. Biomed Chromatogr. 2016;30(11):1789-95. DOI:10.1002/bmc.3754
11. Jauch R, Bozler G, Hammer R, et al. Ambroxol, studies of biotransformation in man and determination in biological samples (author's transl). Arzneimittelforschung. 1978;28(5a):904-11 (in German).
12. Ishiguro N, Senda C, Kishimoto W, et al. Identification of CYP3A4 as the predominant isoform responsible for the metabolism of ambroxol in human liver microsomes. Xenobiotica. 2000;30(1):71-80. DOI:10.1080/004982500237839
13. Pueschmann S, Engelhorn R. Pharmacological study on the bromhexine metabolite ambroxol (author's transl). Arzneimittelforschung. 1978;28(5a):889-98 (in German).
14. Kyle H, Robinson NP, Widdicombe JG. Mucus secretion by tracheas of ferret and dog. Eur J Respir Dis. 1987;70(1):14-22.
15. Iravani J, Melville GN. Mucociliary function of the respiratory tract as influenced by drugs. Respiration. 1974;31(4):350-7. DOI:10.1159/000193595
16. Bossi R, Braga PC, Allegra L. Ambroxol and mucociliary transport. Arch Monaldi. 1984;39(3):227-33 (in Italian).
17. Wirtz HR. Effect of ambroxol on surfactant secretion and synthesis in isolated type II alveolar cells. Pneumologie. 2000;54(7):278-83 (in German). DOI:10.1055/s-2000-4452
18. Fois G, Hobi N, Felder E, et al. A new role for an old drug: Ambroxol triggers lysosomal exocytosis via pH-dependent Ca2+ release from acidic Ca2+ stores. Cell Calcium. 2015;58(6):628-37. DOI:10.1016/j.ceca.2015.10.002
19. Miyata T, Kai H, Saito M, et al. Effects of ambroxol on pulmonary surfactant-analysis of the fatty acid composition of phosphatidylcholine in the sputum and normal respiratory tract fluid in rabbits. Nihon Yakurigaku Zasshi. 1986;88(1):57-64 (in Japanese). DOI:10.1254/fpj.88.57
20. Tahvanainen J, Hallman M. Surfactant abnormality after endotoxin-induced lung injury in guinea-pigs. Eur J Respir Dis. 1987;71(4):250-8.
21. Dauberschmidt R, Kuckelt W, Bender V, et al. Effects of bromhexine metabolite VIII (NA 872) in an animal model of the respiratory distress syndrome. Bull Eur Physiopathol Respir. 1980;16(2):135-43.
22. Jang YY, Song JH, Shin YK, et al. Depressant effects of ambroxol and erdosteine on cytokine synthesis, granule enzyme release, and free radical production in rat alveolar macrophages activated by lipopolysaccharide. Pharmacol Toxicol. 2003;92(4):173-9. DOI:10.1034/j.1600-0773.2003.920407.x
23. Ottonello L, Arduino N, Bertolotto M, et al. In vitro inhibition of human neutrophil histotoxicity by ambroxol: evidence for a multistep mechanism. Br J Pharmacol. 2003;140(4):736-42. DOI:10.1038/sj.bjp.0705497
24. Koyama I, Matsunaga T, Harada T, et al. Ambroxol reduces LPS toxicity mediated by induction of alkaline phosphatases in rat lung. Clin Biochem. 2004;37(8):688-93. DOI:10.1016/j.clinbiochem.2004.02.004
25. Yang B, Yao DF, Ohuchi M, et al. Ambroxol suppresses influenza-virus proliferation in the mouse airway by increasing antiviral factor levels. Eur Respir J. 2002;19(5):952-8. DOI:10.1183/09031936.02.00253302
26. Cavalu S, Sharaf H, Saber S, et al. Ambroxol, a mucolytic agent, boosts HO-1, suppresses NF-κB, and decreases the susceptibility of the inflamed rat colon to apoptosis: A new treatment option for treating ulcerative colitis. FASEB J. 2022;36(9):e22496. DOI:10.1096/fj.202200749R
27. Yoshida S, Yokohira M, Yamakawa K, et al. Effects of the expectorant drug ambroxol hydrochloride on chemically induced lung inflammatory and neoplastic lesions in rodents. J Toxicol Pathol. 2018;31(4):255-65. DOI:10.1293/tox.2018-0012
28. Leffler A, Reckzeh J, Nau C. Block of sensory neuronal Na+ channels by the secretolytic ambroxol is associated with an interaction with local anesthetic binding sites. Eur J Pharmacol. 2010;630(1-3):19-28. DOI:10.1016/j.ejphar.2009.12.027
29. Guerra-Farfan E, Garcia-Sanchez Y, Jornet-Gibert M, et al. Clinical practice guidelines: The good, the bad, and the ugly. Injury. 2023;54(Suppl. 3):S26-9. DOI:10.1016/j.injury.2022.01.047
30. Prevention of chronic bronchitis exacerbations with ambroxol (mucosolvan retard). An open, long-term, multicenter study in 5,635 patients. Respiration. 1989;55(Suppl. 1):84-96. DOI:10.1159/000195757
31. Malerba M, Ponticiello A, Radaeli A, et al. Effect of twelve-months therapy with oral ambroxol in preventing exacerbations in patients with COPD. Double-blind, randomized, multicenter, placebo-controlled study (the AMETHIST Trial). Pulm Pharmacol Ther. 2004;17(1):27-34. DOI:10.1016/j.pupt.2003.08.004
32. Ratjen F, Wönne R, Posselt HG, et al. A double-blind placebo-controlled trial with oral ambroxol and N-acetylcysteine for mucolytic treatment in cystic fibrosis. Eur J Pediatr. 1985;144(4):374-8. DOI:10.1007/BF00441781
33. Fegiz G. Prevention by ambroxol of bronchopulmonary complications after upper abdominal surgery: double-blind Italian multicenter clinical study versus placebo. Lung. 1991;169(2):69-76. DOI:10.1007/BF02714144
34. Hashizume T. Pulmonary alveolar proteinosis successfully treated with ambroxol. Intern Med. 2002;41(12):1175-8. DOI:10.2169/internalmedicine.41.1175
35. Алекса В.И., Прозорова В.К., Мальцева Н.А., Шатихина Л.Н. Эффективность применения лазолвана у больных хроническим обструктивным бронхитом и неатопической бронхиальной астмой. Терапевтический архив. 2001;73(3):48-51 [Aleksa VI, Prozorova VK, Maltseva NA, Shatikhina LN. Effectiveness of lasolvan in patients with chronic obstructive bronchitis and non-atopic bronchial asthma. Terapevticheskii Arkhiv (Ter. Arkh.). 2001;73(3):48-51 (in Russian)].
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1. Houtmeyers E, Gosselink R, Gayan-Ramirez G, Decramer M. Effects of drugs on mucus clearance. Eur Respir J. 1999;14(2):452-67. DOI:10.1034/j.1399-3003.1999.14b35.x
2. Zaitsev AA, Leshchenko IV, Esaulova NA, Viktorova IA. Evaluation of the efficacy and safety of a combination drug containing ambroxol, guaifenesin, and levosalbutamol versus a fixed-dose combination of bromhexine/guaifenesin/salbutamol in the treatment of productive cough in adult patients with acute bronchitis. Terapevticheskii Arkhiv (Ter. Arkh.). 2023;95(3):236-42 (in Russian). DOI:10.26442/00403660.2023.03.202099
3. Baranwal AK, Murthy AS, Singhi SC. High-dose Oral Ambroxol for Early Treatment of Pulmonary Acute Respiratory Distress Syndrome: an Exploratory, Randomized, Controlled Pilot Trial. J Trop Pediatr. 2015;61(5):339-50. DOI:10.1093/tropej/fmv033
4. Xu B, Han P, Shang Y, et al. Efficacy and safety of inhaled ambroxol solution in improving sputum of lower respiratory tract infection in children: a multicenter, randomized, double-blind, placebo-controlled trial. BMC Pulm Med. 2025;25(1):382. DOI:10.1186/s12890-025-03845-0
5. Kardos P, Beeh KM, Sent U, et al. Characterization of differential patient profiles and therapeutic responses of pharmacy customers for four ambroxol formulations. BMC Pharmacol Toxicol. 2018;19(1):40. DOI:10.1186/s40360-018-0229-y
6. Ma J, Zheng J, Chen L, et al. Safety and efficacy of inhalable ambroxol hydrochloride aerosol for adult patients with respiratory diseases: an open-label, single-arm, multicentre study. BMJ Open Respir Res. 2025;12(1):e002096. DOI:10.1136/bmjresp-2023-002096
7. Cazan D, Klimek L, Sperl A, et al. Safety of ambroxol in the treatment of airway diseases in adult patients. Expert Opin Drug Saf. 2018;17(12):1211-24. DOI:10.1080/14740338.2018.1533954
8. Kantar A, Klimek L, Cazan D, et al. An overview of efficacy and safety of ambroxol for the treatment of acute and chronic respiratory diseases with a special regard to children. Multidiscip Respir Med. 2020;15(1):511. DOI:10.4081/mrm.2020.511
9. Malerba M, Ragnoli B. Ambroxol in the 21st century: pharmacological and clinical update. Expert Opin Drug Metab Toxicol. 2008;4(8):1119-29. DOI:10.1517/17425255.4.8.1119
10. Guo Z, Chen Y, Ding X, et al. Simultaneous determination of ambroxol and salbutamol in human plasma by ultra-performance liquid chromatography-tandem mass spectrometry and its application to a pharmacokinetic study. Biomed Chromatogr. 2016;30(11):1789-95. DOI:10.1002/bmc.3754
11. Jauch R, Bozler G, Hammer R, et al. Ambroxol, studies of biotransformation in man and determination in biological samples (author's transl). Arzneimittelforschung. 1978;28(5a):904-11 (in German).
12. Ishiguro N, Senda C, Kishimoto W, et al. Identification of CYP3A4 as the predominant isoform responsible for the metabolism of ambroxol in human liver microsomes. Xenobiotica. 2000;30(1):71-80. DOI:10.1080/004982500237839
13. Pueschmann S, Engelhorn R. Pharmacological study on the bromhexine metabolite ambroxol (author's transl). Arzneimittelforschung. 1978;28(5a):889-98 (in German).
14. Kyle H, Robinson NP, Widdicombe JG. Mucus secretion by tracheas of ferret and dog. Eur J Respir Dis. 1987;70(1):14-22.
15. Iravani J, Melville GN. Mucociliary function of the respiratory tract as influenced by drugs. Respiration. 1974;31(4):350-7. DOI:10.1159/000193595
16. Bossi R, Braga PC, Allegra L. Ambroxol and mucociliary transport. Arch Monaldi. 1984;39(3):227-33 (in Italian).
17. Wirtz HR. Effect of ambroxol on surfactant secretion and synthesis in isolated type II alveolar cells. Pneumologie. 2000;54(7):278-83 (in German). DOI:10.1055/s-2000-4452
18. Fois G, Hobi N, Felder E, et al. A new role for an old drug: Ambroxol triggers lysosomal exocytosis via pH-dependent Ca2+ release from acidic Ca2+ stores. Cell Calcium. 2015;58(6):628-37. DOI:10.1016/j.ceca.2015.10.002
19. Miyata T, Kai H, Saito M, et al. Effects of ambroxol on pulmonary surfactant-analysis of the fatty acid composition of phosphatidylcholine in the sputum and normal respiratory tract fluid in rabbits. Nihon Yakurigaku Zasshi. 1986;88(1):57-64 (in Japanese). DOI:10.1254/fpj.88.57
20. Tahvanainen J, Hallman M. Surfactant abnormality after endotoxin-induced lung injury in guinea-pigs. Eur J Respir Dis. 1987;71(4):250-8.
21. Dauberschmidt R, Kuckelt W, Bender V, et al. Effects of bromhexine metabolite VIII (NA 872) in an animal model of the respiratory distress syndrome. Bull Eur Physiopathol Respir. 1980;16(2):135-43.
22. Jang YY, Song JH, Shin YK, et al. Depressant effects of ambroxol and erdosteine on cytokine synthesis, granule enzyme release, and free radical production in rat alveolar macrophages activated by lipopolysaccharide. Pharmacol Toxicol. 2003;92(4):173-9. DOI:10.1034/j.1600-0773.2003.920407.x
23. Ottonello L, Arduino N, Bertolotto M, et al. In vitro inhibition of human neutrophil histotoxicity by ambroxol: evidence for a multistep mechanism. Br J Pharmacol. 2003;140(4):736-42. DOI:10.1038/sj.bjp.0705497
24. Koyama I, Matsunaga T, Harada T, et al. Ambroxol reduces LPS toxicity mediated by induction of alkaline phosphatases in rat lung. Clin Biochem. 2004;37(8):688-93. DOI:10.1016/j.clinbiochem.2004.02.004
25. Yang B, Yao DF, Ohuchi M, et al. Ambroxol suppresses influenza-virus proliferation in the mouse airway by increasing antiviral factor levels. Eur Respir J. 2002;19(5):952-8. DOI:10.1183/09031936.02.00253302
26. Cavalu S, Sharaf H, Saber S, et al. Ambroxol, a mucolytic agent, boosts HO-1, suppresses NF-κB, and decreases the susceptibility of the inflamed rat colon to apoptosis: A new treatment option for treating ulcerative colitis. FASEB J. 2022;36(9):e22496. DOI:10.1096/fj.202200749R
27. Yoshida S, Yokohira M, Yamakawa K, et al. Effects of the expectorant drug ambroxol hydrochloride on chemically induced lung inflammatory and neoplastic lesions in rodents. J Toxicol Pathol. 2018;31(4):255-65. DOI:10.1293/tox.2018-0012
28. Leffler A, Reckzeh J, Nau C. Block of sensory neuronal Na+ channels by the secretolytic ambroxol is associated with an interaction with local anesthetic binding sites. Eur J Pharmacol. 2010;630(1-3):19-28. DOI:10.1016/j.ejphar.2009.12.027
29. Guerra-Farfan E, Garcia-Sanchez Y, Jornet-Gibert M, et al. Clinical practice guidelines: The good, the bad, and the ugly. Injury. 2023;54(Suppl. 3):S26-9. DOI:10.1016/j.injury.2022.01.047
30. Prevention of chronic bronchitis exacerbations with ambroxol (mucosolvan retard). An open, long-term, multicenter study in 5,635 patients. Respiration. 1989;55(Suppl. 1):84-96. DOI:10.1159/000195757
31. Malerba M, Ponticiello A, Radaeli A, et al. Effect of twelve-months therapy with oral ambroxol in preventing exacerbations in patients with COPD. Double-blind, randomized, multicenter, placebo-controlled study (the AMETHIST Trial). Pulm Pharmacol Ther. 2004;17(1):27-34. DOI:10.1016/j.pupt.2003.08.004
32. Ratjen F, Wönne R, Posselt HG, et al. A double-blind placebo-controlled trial with oral ambroxol and N-acetylcysteine for mucolytic treatment in cystic fibrosis. Eur J Pediatr. 1985;144(4):374-8. DOI:10.1007/BF00441781
33. Fegiz G. Prevention by ambroxol of bronchopulmonary complications after upper abdominal surgery: double-blind Italian multicenter clinical study versus placebo. Lung. 1991;169(2):69-76. DOI:10.1007/BF02714144
34. Hashizume T. Pulmonary alveolar proteinosis successfully treated with ambroxol. Intern Med. 2002;41(12):1175-8. DOI:10.2169/internalmedicine.41.1175
35. Aleksa VI, Prozorova VK, Maltseva NA, Shatikhina LN. Effectiveness of lasolvan in patients with chronic obstructive bronchitis and non-atopic bronchial asthma. Terapevticheskii Arkhiv (Ter. Arkh.). 2001;73(3):48-51 (in Russian).
36. Shmeleva NM. Mukoreguliruiushchaia terapiia pri zabolevaniiakh organov dykhaniia: vozmozhnosti ambroksola. Consilium Medicum. 2012;14(11):7-11 (in Russian). EDN:RAIFOP

Авторы

С.Л. Бабак*, М.В. Горбунова, А.В. Мишина, И.В. Шашенков

ФГБОУ ВО «Российский университет медицины», Москва, Российская Федерация
*sergbabak@mail.ru

________________________________________________

Sergei L. Babak*, Marina V. Gorbunova, Anastasiia V. Mishina, Ivan V. Shashenkov

Russian University of Medicine, Moscow, Russian Federation
*sergbabak@mail.ru

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