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Биластин – новый антигистаминный препарат II поколения
Биластин – новый антигистаминный препарат II поколения
Дворянкова Е.В. Биластин – новый антигистаминный препарат II поколения. Дерматология (Прил. к журн. Consilium Medicum). 2019; 2: 10–12. DOI: 10.26442/24143537.2019.2.190371
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Аннотация
Биластин – новый антигистаминный препарат II поколения, который является результатом эволюции в исследованиях антигистаминных лекарственных средств, касающихся эффективности и безопасности. В ходе проведения ряда клинических исследований была продемонстрирована эффективность биластина в терапии аллергического ринита и идиопатической крапивницы, а также улучшения качества жизни больных на фоне приема данного препарата. Профиль безопасности биластина схож с аналогичным показателем в группах пациентов, получавших плацебо. Баланс эффективности и безопасности биластина сохраняется при повышении стандартной дозировки в 4 раза.
Ключевые слова: антигистаминные препараты, биластин, аллергический ринит, хроническая крапивница, эффективность, безопасность.
Key words: antihistamines, bilastine, allergic rhinitis, chronic urticaria, efficacy, safety.
Ключевые слова: антигистаминные препараты, биластин, аллергический ринит, хроническая крапивница, эффективность, безопасность.
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Key words: antihistamines, bilastine, allergic rhinitis, chronic urticaria, efficacy, safety.
Полный текст
Список литературы
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2. Leurs R, Church MK, Taglialatela M. H1-antihistamines: inverse agonism, anti-inflammatory actions and cardiac effects. Clin Exp Allergy 2002; p. 32489–98.
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12. Horak F, Zieglmayer P, Zieglmayer R, Lemell P. The effects of bilastine compared with cetirizine, fexofenadine, and placebo on allergen-induced nasal and ocular symptoms in patients exposed to aeroallergen in the Vienna Challenge Chamber. Inflamm Res. 2010; 59 (5): 391–8.
13. Bachert C, Kuna P, Sanquer F et al. Comparison of the efficacy and safety of bilastine 20 mg vs desloratadine 5 mg in seasonal allergic rhinitis patients. Allergy 2009; 64: 158–65.
14. Kuna P, Bachert C, Nowacki Z et al. Efficacy and safety of bilastine 20 mg compared with cetirizine 10 mg and placebo for the symptomatic treatment of seasonal allergic rhinitis: A randomized, double-blind, parallelgroup study. Clin Exp Allergy 2009; 39: 1338–47.
15. Zuberbier T, Oanta A, Bogacka E et al. Comparison of the efficacy and safety of bilastine 20 mg vs levocetirizine 5 mg for the treatment of chronic idiopathic urticaria: a multi-centre, double-blind, randomized, placebo-controlled study. Allergy 2010; 65 (4): 516–28.
16. Farré M, Pérez-Mañá C, Papaseit E et al. Bilastine vs. hydroxyzine: occupation of brain histamine H1-receptors evaluated by positron emission tomography in healthy volunteers. Br J Clin Pharmacol 2014; 78 (5): 970–80.
17. Tyl B, Kabbaj M, Azzam S et al. Lack of significant effect of bilastine administered at therapeutic and supratherapeutic doses and concomitantly with ketoconazole on ventricular repolarization: results of a thorough QT study (TQTS) with QT-concentration analysis. J Clin Pharmacol 2012; 52 (6): 893–903.
18. García-Gea C, Martínez J, Ballester MR et al. Psychomotor and subjective effects of bilastine, hydroxyzine, and cetirizine, in combination with alcohol: a randomized, double-blind, crossover, and positive-controlled and placebo-controlled Phase I clinical trials. Hum Psychopharmacol 2014; 29 (2): 120–32.
19. Graff C, Struijk JJ, Kanters JK et al. Effects of bilastine on T-wave morphology and the QTc interval: a randomized, double-blind, placebo-controlled, thorough QTc study. Clin Drug Investig 2012; 32 (5): 339–51.
2. Leurs R, Church MK, Taglialatela M. H1-antihistamines: inverse agonism, anti-inflammatory actions and cardiac effects. Clin Exp Allergy 2002; p. 32489–98.
3. Hill SJ, Ganelin CR, Timmerman H et al. International Union of Pharmacology. XIII. Classification of histamine receptors. Pharmacol Rev 1997; 49: 253–78.
4. Bovet D, Staub AM. Action protective de ethers phenoliques au cours de l’ntoxication histaminique. Compt Rend Soc Biol 1937; 124: 547–9.
5. Milligan G, Bond RA, Lee M. Inverse agonism: pharmacological curiosity or potential therapeutic strategy? Trends Pharmacol Sci 1995; 16: 10–3.
6. Bakker RA, Schoonus SB, Smit MJ et al. Histamine H(1)-receptor activation of nuclear factor-kappa B: roles for G beta gamma- and G alpha(q/11)-subunits in constitutive and agonistmediated signaling. Mol Pharmacol 2001; 60: 1133–42.
7. Corcóstegui R, Labeaga L, Innerárity A et al. Preclinical pharmacology of bilastine, a new selective histamine H1 receptor antagonist: receptor selectivity and in vitro antihistaminic activity. Drugs R D 2005; 6 (6): 371–84.
8. Corcóstegui R, Labeaga L, Innerárity A et al. In vivo pharmacological characterisation of bilastine, a potent and selective histamine H1 receptor antagonist. Drugs R D 2006; 7 (4): 219–31.
9. Alvarez-Mon M, San Antonio E, Lucero M et al. Bilastine, a novel antihistamine that preferentially inhibits histamine and interleukin-4 release from human mast cells and granulocytes. Allergy 2009; 64 (Suppl. 90): 555.
10. Jauregizar N, de la Fuente L, Lucero ML et al. Pharmacokinetic-pharmacodynamic modelling of the antihistaminic (H1) effect of bilastine. Clin Pharmacokinet 2009; 48 (8): 543–54.
11. Lucero ML, Gonzalo A, Ganza A et al. Interactions of bilastine, a new oral H (1) antihistamine, with human transporter systems. Drug Chem Toxicol 2012; 35 (Suppl. 1): 8–17.
12. Horak F, Zieglmayer P, Zieglmayer R, Lemell P. The effects of bilastine compared with cetirizine, fexofenadine, and placebo on allergen-induced nasal and ocular symptoms in patients exposed to aeroallergen in the Vienna Challenge Chamber. Inflamm Res. 2010; 59 (5): 391–8.
13. Bachert C, Kuna P, Sanquer F et al. Comparison of the efficacy and safety of bilastine 20 mg vs desloratadine 5 mg in seasonal allergic rhinitis patients. Allergy 2009; 64: 158–65.
14. Kuna P, Bachert C, Nowacki Z et al. Efficacy and safety of bilastine 20 mg compared with cetirizine 10 mg and placebo for the symptomatic treatment of seasonal allergic rhinitis: A randomized, double-blind, parallelgroup study. Clin Exp Allergy 2009; 39: 1338–47.
15. Zuberbier T, Oanta A, Bogacka E et al. Comparison of the efficacy and safety of bilastine 20 mg vs levocetirizine 5 mg for the treatment of chronic idiopathic urticaria: a multi-centre, double-blind, randomized, placebo-controlled study. Allergy 2010; 65 (4): 516–28.
16. Farré M, Pérez-Mañá C, Papaseit E et al. Bilastine vs. hydroxyzine: occupation of brain histamine H1-receptors evaluated by positron emission tomography in healthy volunteers. Br J Clin Pharmacol 2014; 78 (5): 970–80.
17. Tyl B, Kabbaj M, Azzam S et al. Lack of significant effect of bilastine administered at therapeutic and supratherapeutic doses and concomitantly with ketoconazole on ventricular repolarization: results of a thorough QT study (TQTS) with QT-concentration analysis. J Clin Pharmacol 2012; 52 (6): 893–903.
18. García-Gea C, Martínez J, Ballester MR et al. Psychomotor and subjective effects of bilastine, hydroxyzine, and cetirizine, in combination with alcohol: a randomized, double-blind, crossover, and positive-controlled and placebo-controlled Phase I clinical trials. Hum Psychopharmacol 2014; 29 (2): 120–32.
19. Graff C, Struijk JJ, Kanters JK et al. Effects of bilastine on T-wave morphology and the QTc interval: a randomized, double-blind, placebo-controlled, thorough QTc study. Clin Drug Investig 2012; 32 (5): 339–51.
2. Leurs R, Church MK, Taglialatela M. H1-antihistamines: inverse agonism, anti-inflammatory actions and cardiac effects. Clin Exp Allergy 2002; p. 32489–98.
3. Hill SJ, Ganelin CR, Timmerman H et al. International Union of Pharmacology. XIII. Classification of histamine receptors. Pharmacol Rev 1997; 49: 253–78.
4. Bovet D, Staub AM. Action protective de ethers phenoliques au cours de l’ntoxication histaminique. Compt Rend Soc Biol 1937; 124: 547–9.
5. Milligan G, Bond RA, Lee M. Inverse agonism: pharmacological curiosity or potential therapeutic strategy? Trends Pharmacol Sci 1995; 16: 10–3.
6. Bakker RA, Schoonus SB, Smit MJ et al. Histamine H(1)-receptor activation of nuclear factor-kappa B: roles for G beta gamma- and G alpha(q/11)-subunits in constitutive and agonistmediated signaling. Mol Pharmacol 2001; 60: 1133–42.
7. Corcóstegui R, Labeaga L, Innerárity A et al. Preclinical pharmacology of bilastine, a new selective histamine H1 receptor antagonist: receptor selectivity and in vitro antihistaminic activity. Drugs R D 2005; 6 (6): 371–84.
8. Corcóstegui R, Labeaga L, Innerárity A et al. In vivo pharmacological characterisation of bilastine, a potent and selective histamine H1 receptor antagonist. Drugs R D 2006; 7 (4): 219–31.
9. Alvarez-Mon M, San Antonio E, Lucero M et al. Bilastine, a novel antihistamine that preferentially inhibits histamine and interleukin-4 release from human mast cells and granulocytes. Allergy 2009; 64 (Suppl. 90): 555.
10. Jauregizar N, de la Fuente L, Lucero ML et al. Pharmacokinetic-pharmacodynamic modelling of the antihistaminic (H1) effect of bilastine. Clin Pharmacokinet 2009; 48 (8): 543–54.
11. Lucero ML, Gonzalo A, Ganza A et al. Interactions of bilastine, a new oral H (1) antihistamine, with human transporter systems. Drug Chem Toxicol 2012; 35 (Suppl. 1): 8–17.
12. Horak F, Zieglmayer P, Zieglmayer R, Lemell P. The effects of bilastine compared with cetirizine, fexofenadine, and placebo on allergen-induced nasal and ocular symptoms in patients exposed to aeroallergen in the Vienna Challenge Chamber. Inflamm Res. 2010; 59 (5): 391–8.
13. Bachert C, Kuna P, Sanquer F et al. Comparison of the efficacy and safety of bilastine 20 mg vs desloratadine 5 mg in seasonal allergic rhinitis patients. Allergy 2009; 64: 158–65.
14. Kuna P, Bachert C, Nowacki Z et al. Efficacy and safety of bilastine 20 mg compared with cetirizine 10 mg and placebo for the symptomatic treatment of seasonal allergic rhinitis: A randomized, double-blind, parallelgroup study. Clin Exp Allergy 2009; 39: 1338–47.
15. Zuberbier T, Oanta A, Bogacka E et al. Comparison of the efficacy and safety of bilastine 20 mg vs levocetirizine 5 mg for the treatment of chronic idiopathic urticaria: a multi-centre, double-blind, randomized, placebo-controlled study. Allergy 2010; 65 (4): 516–28.
16. Farré M, Pérez-Mañá C, Papaseit E et al. Bilastine vs. hydroxyzine: occupation of brain histamine H1-receptors evaluated by positron emission tomography in healthy volunteers. Br J Clin Pharmacol 2014; 78 (5): 970–80.
17. Tyl B, Kabbaj M, Azzam S et al. Lack of significant effect of bilastine administered at therapeutic and supratherapeutic doses and concomitantly with ketoconazole on ventricular repolarization: results of a thorough QT study (TQTS) with QT-concentration analysis. J Clin Pharmacol 2012; 52 (6): 893–903.
18. García-Gea C, Martínez J, Ballester MR et al. Psychomotor and subjective effects of bilastine, hydroxyzine, and cetirizine, in combination with alcohol: a randomized, double-blind, crossover, and positive-controlled and placebo-controlled Phase I clinical trials. Hum Psychopharmacol 2014; 29 (2): 120–32.
19. Graff C, Struijk JJ, Kanters JK et al. Effects of bilastine on T-wave morphology and the QTc interval: a randomized, double-blind, placebo-controlled, thorough QTc study. Clin Drug Investig 2012; 32 (5): 339–51.
________________________________________________
2. Leurs R, Church MK, Taglialatela M. H1-antihistamines: inverse agonism, anti-inflammatory actions and cardiac effects. Clin Exp Allergy 2002; p. 32489–98.
3. Hill SJ, Ganelin CR, Timmerman H et al. International Union of Pharmacology. XIII. Classification of histamine receptors. Pharmacol Rev 1997; 49: 253–78.
4. Bovet D, Staub AM. Action protective de ethers phenoliques au cours de l’ntoxication histaminique. Compt Rend Soc Biol 1937; 124: 547–9.
5. Milligan G, Bond RA, Lee M. Inverse agonism: pharmacological curiosity or potential therapeutic strategy? Trends Pharmacol Sci 1995; 16: 10–3.
6. Bakker RA, Schoonus SB, Smit MJ et al. Histamine H(1)-receptor activation of nuclear factor-kappa B: roles for G beta gamma- and G alpha(q/11)-subunits in constitutive and agonistmediated signaling. Mol Pharmacol 2001; 60: 1133–42.
7. Corcóstegui R, Labeaga L, Innerárity A et al. Preclinical pharmacology of bilastine, a new selective histamine H1 receptor antagonist: receptor selectivity and in vitro antihistaminic activity. Drugs R D 2005; 6 (6): 371–84.
8. Corcóstegui R, Labeaga L, Innerárity A et al. In vivo pharmacological characterisation of bilastine, a potent and selective histamine H1 receptor antagonist. Drugs R D 2006; 7 (4): 219–31.
9. Alvarez-Mon M, San Antonio E, Lucero M et al. Bilastine, a novel antihistamine that preferentially inhibits histamine and interleukin-4 release from human mast cells and granulocytes. Allergy 2009; 64 (Suppl. 90): 555.
10. Jauregizar N, de la Fuente L, Lucero ML et al. Pharmacokinetic-pharmacodynamic modelling of the antihistaminic (H1) effect of bilastine. Clin Pharmacokinet 2009; 48 (8): 543–54.
11. Lucero ML, Gonzalo A, Ganza A et al. Interactions of bilastine, a new oral H (1) antihistamine, with human transporter systems. Drug Chem Toxicol 2012; 35 (Suppl. 1): 8–17.
12. Horak F, Zieglmayer P, Zieglmayer R, Lemell P. The effects of bilastine compared with cetirizine, fexofenadine, and placebo on allergen-induced nasal and ocular symptoms in patients exposed to aeroallergen in the Vienna Challenge Chamber. Inflamm Res. 2010; 59 (5): 391–8.
13. Bachert C, Kuna P, Sanquer F et al. Comparison of the efficacy and safety of bilastine 20 mg vs desloratadine 5 mg in seasonal allergic rhinitis patients. Allergy 2009; 64: 158–65.
14. Kuna P, Bachert C, Nowacki Z et al. Efficacy and safety of bilastine 20 mg compared with cetirizine 10 mg and placebo for the symptomatic treatment of seasonal allergic rhinitis: A randomized, double-blind, parallelgroup study. Clin Exp Allergy 2009; 39: 1338–47.
15. Zuberbier T, Oanta A, Bogacka E et al. Comparison of the efficacy and safety of bilastine 20 mg vs levocetirizine 5 mg for the treatment of chronic idiopathic urticaria: a multi-centre, double-blind, randomized, placebo-controlled study. Allergy 2010; 65 (4): 516–28.
16. Farré M, Pérez-Mañá C, Papaseit E et al. Bilastine vs. hydroxyzine: occupation of brain histamine H1-receptors evaluated by positron emission tomography in healthy volunteers. Br J Clin Pharmacol 2014; 78 (5): 970–80.
17. Tyl B, Kabbaj M, Azzam S et al. Lack of significant effect of bilastine administered at therapeutic and supratherapeutic doses and concomitantly with ketoconazole on ventricular repolarization: results of a thorough QT study (TQTS) with QT-concentration analysis. J Clin Pharmacol 2012; 52 (6): 893–903.
18. García-Gea C, Martínez J, Ballester MR et al. Psychomotor and subjective effects of bilastine, hydroxyzine, and cetirizine, in combination with alcohol: a randomized, double-blind, crossover, and positive-controlled and placebo-controlled Phase I clinical trials. Hum Psychopharmacol 2014; 29 (2): 120–32.
19. Graff C, Struijk JJ, Kanters JK et al. Effects of bilastine on T-wave morphology and the QTc interval: a randomized, double-blind, placebo-controlled, thorough QTc study. Clin Drug Investig 2012; 32 (5): 339–51.
Авторы
Е.В. Дворянкова*
ФГБУН «Центр теоретических проблем физико-химической фармакологии» РАН, Москва, Россия
*dvoriankova@mail.ru
Center for Theoretical Problems of Physicochemical Pharmacology of the Russian Academy of Sciences, Moscow, Russia
*dvoriankova@mail.ru
ФГБУН «Центр теоретических проблем физико-химической фармакологии» РАН, Москва, Россия
*dvoriankova@mail.ru
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Center for Theoretical Problems of Physicochemical Pharmacology of the Russian Academy of Sciences, Moscow, Russia
*dvoriankova@mail.ru
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