Комбинированная терапия как современное направление лечения аллергического ринита - Журнал Терапевтический архив №8 Вопросы лечения 2021

Комбинированная терапия как современное направление лечения аллергического ринита

Емельянов А.В. Комбинированная терапия как современное направление лечения аллергического ринита. Терапевтический архив. 2021; 93 (8): 986–990. DOI: 10.26442/00403660.2021.08.200995

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Emelyanov AV. Combine therapy as a modern approach to treatment of allergic rhinitis. Terapevticheskii Arkhiv (Ter. Arkh.). 2021; 93 (8): 986–990. DOI: 10.26442/00403660.2021.08.200995

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Аннотация

Аллергический ринит (АР) является одним из наиболее распространенных заболеваний, поражающих от 10 до 40% населения в разных странах мира, в том числе и в России. Оно является значимым фактором риска развития бронхиальной астмы и болезней верхних дыхательных путей, существенно ухудшает качество жизни пациентов, оказывая отрицательное влияние на качество их сна, способность к обучению, производительность труда, может вызывать депрессию и тревогу, повышает риск производственного травматизма и из-за широкой распространенности имеет высокую стоимость лечения. Предпосылками создания для терапии АР фиксированных комбинаций, содержащих интраназальные глюкокортикостероиды и Н1-антигистаминные средства, явились потребность большинства пациентов в нескольких препаратах из-за тяжести его течения, недостаточный контроль заболевания при монотерапии, фармакологические свойства входящих в состав компонентов и результаты выполненных клинических исследований. В настоящем обзоре обсуждаются характеристики новой интраназальной комбинации, содержащей мометазона фуроат (МФ) и олопатадин (ОЛО). Результаты выполненных двойных слепых плацебо-контролируемых и открытых исследований свидетельствуют о том, что она уменьшает выраженность назальных и глазных симптомов сезонного и круглогодичного АР. Назальный спрей МФ/ОЛО улучшает качество жизни и характеризуется хорошей безопасностью. Эффективность комбинации МФ/ОЛО выше, чем у входящих в ее состав отдельных компонентов. Быстрота действия, выраженное и стойкое (в течение 12 мес) влияние на симптомы способны повысить приверженность пациентов проводимому лечению и улучшить контроль АР.

Ключевые слова: аллергический ринит, фиксированные комбинации, мометазона фуроат, олопатадин

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Allergic rhinitis (AR) is one the most common allergic diseases affecting from 10 to 40% of the population in different countries, including Russia. AR is a risk factor of bronchial asthma, other upper airway disease and may decrease patient quality of life, their productivity, increase probability of occupational traumatism, depression and anxiety. AR also presents a substantial economic burden. The rationale to use fixed dose combination of intranasal steroids and topical H1 antihistamines includes suboptimal control of symptoms by monotherapy, its complementary pharmacologic activity and the results of clinical trials. This review focused on fixed dose combination of intranasal mometasone furoate and olopataine. Double blind placebo-controlled and open clinical trials have confirmed that this combination decreased severity of nasal and ocular symptoms of seasonal and perennial AR, improved patient quality of life and had a good tolerability. Its efficacy was higher than those of monotherapy. Fast onset of action and sustainable effect on symptoms (during 1 yr) may improve adherence patients to the treatment and control of symptoms of AR.

Keywords: allergic rhinitis, fixed dose combinations, mometasone furoate, olopatadine

Список литературы

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опроса. РМЖ «Медицинское обозрение». 2021;51(1):25-31 [Nenasheva NM, Shilenkova VV. Control of allergic rhinitis symptoms in adults in the Russian Federation: online survey results. Russian Medical Inquiry. 2021;5(1):25-31 (in Russian)]. DOI:10.32364/2587-6821-2021-5-1-25-31
8. Caimmi D, Baiz N, Sanyal S, et al. Discriminating severe seasonal allergic rhinitis. Results from a large nation-wide database. PLoS One. 2018;13(11):e0207290. DOI:10.1371/journal.pone.0207290
9. Pitman R, Paracha N, Parker C, et al. Episode pattern and healthcare utilisation in patients with seasonal allergic rhinitis. Allergy. 2012;67(Suppl. 96):342.
10. Penagos M, Compalati E, Tarantini F, et al. Efficacy of mometasone furoate nasal spray in the treatment of allergic rhinitis. Meta-analysis of randomized, double-blind, placebo-controlled, clinical trials. Allergy. 2008;63:1280-91. DOI:10.1111/j.1398-9995.2008.01808.x
11. Pasali D, Spinosi MC, Crisanti A, Bellussi LM. Mometasone furoate nasal spray: a systematic review. Multidiscip Respir Med. 2016;11:18. DOI:10.1186/s40248-016-0054-3
12. Sharif NA, Xu SX, Yanni JM. Olopatadine (AL-4943A): ligand binding and functional studies on a novel, long acting H1-selective histamine antagonist and anti-allergic agent for use in allergic conjunctivitis. J Ocul Pharmacol Ther. 1996;12(4):401-7. DOI:10.1089/jop.1996.12.401
13. Brockman HL, Momsen MM, Knudtson JR, et al. Interactions of olopatadine and selected antihistamines with model and natural membranes. Ocul Immunol Inflamm. 2003;11(4):247-68. DOI:10.1076/ocii.11.4.247.18261
14. Yanni JM, Miller ST, Gamache DA, et al. Comparative effects of topical ocular anti-allergy drugs on human conjunctival mast cells. Ann Allergy Asthma Immunol. 1997;79:541-5. DOI:10.1016/S1081-1206(10)63063-3
15. Patel P, Roland RS, Marple BF, et al. An assessment of the onset and duration of action of olopatadine nasal spray. Otoryngol Head Neck Surg. 2007;137(6):918-24. DOI:10.1016/j.otohns.2007.08.005
16. Ratner PH, Hampel FC, Amar NJ, et al. Safety and efficacy of olopatadine hydrochloride nasal spray for the treatment of seasonal allergic rhinitis to mountain cedar. Ann Allergy Asthma Immunol. 2005;95(5):474-9. DOI:10.1016/S1081-1206(10)61174-X
17. Meltzer EO, Hampel FC, Ratner PH, et al. Safety and efficacy of olopatadine hydrochloride nasal spray for the treatment of seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 2005;95(6):600-6. DOI:10.1016/S1081-1206(10)61025-3
18. Kaliner MA, Storms W, Tilles S, et al. Comparison of olopatadine 0.6% nasal spray versus fluticasone propionate 50 mcg in the treatment of seasonal allergic rhinitis. Allergy Asthma Proc. 2009;30:259-62. DOI:10.2500/aap.2009.30.3232
19. Meltzer EO, Garadi R, Laforce C, et al. Comparative study of sensory attributes of two antihistamine nasal sprays: olopatadine 0.6% and azelastine 0.1%. Allergy Asthma Proc. 2008;29(6):659-68. DOI:10.2500/aap.2008.29.3181
20. Shah SR, Nayak A, Ratner P, et al. Effects of olopatadine hydrochloride nasal spray 0.6% in the treatment of seasonal allergic rhinitis: a phase III, multicenter, randomized, double-blind, active- and placebo-controlled study in adolescents and adults. Clin Ther. 2009;31(1):99-107. DOI:10.1016/j.clinthera.2009.01.016
21. Patel D, Garadi R, Brubaker M, et al. Onset and duration of action of nasal sprays in seasonal allergic rhinitis patients: olopatadine hydrochloride versus mometasone furoate monohydrate. Allergy Asthma Proc. 2007;28(5):592-9. DOI:10.2500/aap2007.28.3033
22. Dykewicz MS, Wallace DV, Baroody F, et al. Treatment of seasonal allergic rhinitis: an evidence-based focused 2017 guideline update. Ann Allergy Asthma Immunol. 2017;119:489-511.e41. DOI:10.1016/j.anai.2017.08.012
23. Bousquet J, Devillier P, Arnavielhe S, et al. Treatment of allergic rhinitis using mobile technology with real-world data: the MASK observational pilot study. Allergy. 2018;73:1763-74. DOI:10.1111/all.13406
24. Patel P, Salapatek AM, Talluri RS, Tantry SK. Pharmacokinetics of intranasal mometasone in the fixed dose combination GSP301 versus two monotherapy intranasal mometasone formulations. Allergy Asthma Proc. 2018;39:232-9. DOI:10.2500/aap.2018.39.4134
25. Patel P, Salapatek AM, Talluri RS, Tantry SK. Pharmacokinetics of intranasal olopatadine in the fixed-dose combination GSP301 versus two monotherapy intranasal olopatadine formulations. Allergy Asthma Proc. 2018;39:224-31. DOI:10.2500/aap.2018.39.4133
26. Andrews СP, Mohar D, Salhi Y, Tantry SK. Efficacy and safety of twice-daily and once-daily olopatadine-mometasone combination nasal spray for seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 2020;124:171-8. DOI:10.1016/j.anai.2019.11.007
27. Gross GN, Berman G, Amar NJ, et al. Efficacy and safety of olopatadine-mometasone combination nasal spray for the treatment of seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 2019;122:630-8. DOI:10.1016/j.anai.2019.03.017
28. Hampel FC, Pedinoff AJ, Jacobs RL, et al. Olopatadine-mometasone combination nasal spray: Evaluation of efficacy and safety in patients with seasonal allergic rhinitis. Allergy Asthma Proc. 2019;40:261-72. DOI:10.2500/aap.2019.40.4223
29. Patel P, Salapatek AM, Tantry SK. Effect of olopatadine-mometasone combination nasal spray on seasonal allergic rhinitis symptoms in an environmental exposure chamber study. Ann Allergy Asthma Immunol. 2019;122(2):160-6. DOI:10.1016/j.anai.2018.10.011
30. Segall N, Prenner B, Lumry W, et al. Long-term safety and efficacy of olopatadine-mometasone combination nasal spray in patients with perennial allergic rhinitis. Allergy Asthma Proc. 2019;40:301-10. DOI:10.2500/aap.2019.40.4233
31. Ненашева Н.М., Назарова Е.В., Терехова Е.П., и др. Эффективность и безопасность комбинированного препарата GSP 301 НС у пациентов с сезонным аллергическим ринитом: результаты российского многоцентрового рандомизированного открытого клинического исследования. Практическая аллергология. 2021;1:66-77 [Nenasheva NM, Nazarova EV, Terekhova EP, et al. Efficacy and safety of the combined preparation GSP 301 NS in patients with seasonal allergic rhinitis: results of a Russian multicenter randomized open clinical. Prakticheskaia allergologiia. 2021;1:66-77 (in Russian)]. DOI:10.46393/2712-9667_2021_1_66-77

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1. Bousquet J, Anto JM, Bachert C, et al. Allergic rhinitis. Nat Rev Dis Primers. 2020;6:95. DOI:10.1038/s41572-020-00227-0
2. Cardell LO, Olsson P, Andersson M, et al. TOTALL: high cost of allergic rhinitis – a national Swedish population-based questionnaire study. NPJ Prim Care Respir Med. 2016;26:15082. DOI:10.1038/npjpcrm.2015.82
3. Zuberbier T, Lötvall J, Simoens S, et al. Economic burden of inadequate management of allergic diseases in the European Union: a GA(2) LEN review. Allergy. 2014;69(10):1275-9. DOI:10.1111/all.12470
4. Dierick BJH, van der Molen T, Flokstra-de Blok BMJ, et al. Burden and socioeconomics of asthma, allergic rhinitis, atopic dermatitis and food allergy. Expert Rev Pharmacoecon Outcomes Res. 2020;20(5):437-53. DOI:10.1080/14737167.2020.1819793
5. Bousquet J, van Cavuwenberge P, Khaltaev N, et al. Allergic rhinitis and its impact on asthma (ARIA). J Allergy Clin Immunol. 2001;108(Suppl. 5):S.147-334. DOI:10.1067/mai.2001.118891
6. Fedoseev GB, Emelyanov AV, Sergeeva GR, et al. Prevalence of bronchial asthma and allergic rhinitis among adult population of Saint-Petersburg. Terapevticheskii Arkhiv (Ter. Arkh.). 2003;75(1):23-6 (in Russian)
7. Nenasheva NM, Shilenkova VV. Control of allergic rhinitis symptoms in adults in the Russian Federation: online survey results. Russian Medical Inquiry. 2021;5(1):25-31 (in Russian) DOI:10.32364/2587-6821-2021-5-1-25-31
8. Caimmi D, Baiz N, Sanyal S, et al. Discriminating severe seasonal allergic rhinitis. Results from a large nation-wide database. PLoS One. 2018;13(11):e0207290. DOI:10.1371/journal.pone.0207290
9. Pitman R, Paracha N, Parker C, et al. Episode pattern and healthcare utilisation in patients with seasonal allergic rhinitis. Allergy. 2012;67(Suppl. 96):342.
10. Penagos M, Compalati E, Tarantini F, et al. Efficacy of mometasone furoate nasal spray in the treatment of allergic rhinitis. Meta-analysis of randomized, double-blind, placebo-controlled, clinical trials. Allergy. 2008;63:1280-91. DOI:10.1111/j.1398-9995.2008.01808.x
11. Pasali D, Spinosi MC, Crisanti A, Bellussi LM. Mometasone furoate nasal spray: a systematic review. Multidiscip Respir Med. 2016;11:18. DOI:10.1186/s40248-016-0054-3
12. Sharif NA, Xu SX, Yanni JM. Olopatadine (AL-4943A): ligand binding and functional studies on a novel, long acting H1-selective histamine antagonist and anti-allergic agent for use in allergic conjunctivitis. J Ocul Pharmacol Ther. 1996;12(4):401-7. DOI:10.1089/jop.1996.12.401
13. Brockman HL, Momsen MM, Knudtson JR, et al. Interactions of olopatadine and selected antihistamines with model and natural membranes. Ocul Immunol Inflamm. 2003;11(4):247-68. DOI:10.1076/ocii.11.4.247.18261
14. Yanni JM, Miller ST, Gamache DA, et al. Comparative effects of topical ocular anti-allergy drugs on human conjunctival mast cells. Ann Allergy Asthma Immunol. 1997;79:541-5. DOI:10.1016/S1081-1206(10)63063-3
15. Patel P, Roland RS, Marple BF, et al. An assessment of the onset and duration of action of olopatadine nasal spray. Otoryngol Head Neck Surg. 2007;137(6):918-24. DOI:10.1016/j.otohns.2007.08.005
16. Ratner PH, Hampel FC, Amar NJ, et al. Safety and efficacy of olopatadine hydrochloride nasal spray for the treatment of seasonal allergic rhinitis to mountain cedar. Ann Allergy Asthma Immunol. 2005;95(5):474-9. DOI:10.1016/S1081-1206(10)61174-X
17. Meltzer EO, Hampel FC, Ratner PH, et al. Safety and efficacy of olopatadine hydrochloride nasal spray for the treatment of seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 2005;95(6):600-6. DOI:10.1016/S1081-1206(10)61025-3
18. Kaliner MA, Storms W, Tilles S, et al. Comparison of olopatadine 0.6% nasal spray versus fluticasone propionate 50 mcg in the treatment of seasonal allergic rhinitis. Allergy Asthma Proc. 2009;30:259-62. DOI:10.2500/aap.2009.30.3232
19. Meltzer EO, Garadi R, Laforce C, et al. Comparative study of sensory attributes of two antihistamine nasal sprays: olopatadine 0.6% and azelastine 0.1%. Allergy Asthma Proc. 2008;29(6):659-68. DOI:10.2500/aap.2008.29.3181
20. Shah SR, Nayak A, Ratner P, et al. Effects of olopatadine hydrochloride nasal spray 0.6% in the treatment of seasonal allergic rhinitis: a phase III, multicenter, randomized, double-blind, active- and placebo-controlled study in adolescents and adults. Clin Ther. 2009;31(1):99-107. DOI:10.1016/j.clinthera.2009.01.016
21. Patel D, Garadi R, Brubaker M, et al. Onset and duration of action of nasal sprays in seasonal allergic rhinitis patients: olopatadine hydrochloride versus mometasone furoate monohydrate. Allergy Asthma Proc. 2007;28(5):592-9. DOI:10.2500/aap2007.28.3033
22. Dykewicz MS, Wallace DV, Baroody F, et al. Treatment of seasonal allergic rhinitis: an evidence-based focused 2017 guideline update. Ann Allergy Asthma Immunol. 2017;119:489-511.e41. DOI:10.1016/j.anai.2017.08.012
23. Bousquet J, Devillier P, Arnavielhe S, et al. Treatment of allergic rhinitis using mobile technology with real-world data: the MASK observational pilot study. Allergy. 2018;73:1763-74. DOI:10.1111/all.13406
24. Patel P, Salapatek AM, Talluri RS, Tantry SK. Pharmacokinetics of intranasal mometasone in the fixed dose combination GSP301 versus two monotherapy intranasal mometasone formulations. Allergy Asthma Proc. 2018;39:232-9. DOI:10.2500/aap.2018.39.4134
25. Patel P, Salapatek AM, Talluri RS, Tantry SK. Pharmacokinetics of intranasal olopatadine in the fixed-dose combination GSP301 versus two monotherapy intranasal olopatadine formulations. Allergy Asthma Proc. 2018;39:224-31. DOI:10.2500/aap.2018.39.4133
26. Andrews СP, Mohar D, Salhi Y, Tantry SK. Efficacy and safety of twice-daily and once-daily olopatadine-mometasone combination nasal spray for seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 2020;124:171-8. DOI:10.1016/j.anai.2019.11.007
27. Gross GN, Berman G, Amar NJ, et al. Efficacy and safety of olopatadine-mometasone combination nasal spray for the treatment of seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 2019;122:630-8. DOI:10.1016/j.anai.2019.03.017
28. Hampel FC, Pedinoff AJ, Jacobs RL, et al. Olopatadine-mometasone combination nasal spray: Evaluation of efficacy and safety in patients with seasonal allergic rhinitis. Allergy Asthma Proc. 2019;40:261-72. DOI:10.2500/aap.2019.40.4223
29. Patel P, Salapatek AM, Tantry SK. Effect of olopatadine-mometasone combination nasal spray on seasonal allergic rhinitis symptoms in an environmental exposure chamber study. Ann Allergy Asthma Immunol. 2019;122(2):160-6. DOI:10.1016/j.anai.2018.10.011
30. Segall N, Prenner B, Lumry W, et al. Long-term safety and efficacy of olopatadine-mometasone combination nasal spray in patients with perennial allergic rhinitis. Allergy Asthma Proc. 2019;40:301-10. DOI:10.2500/aap.2019.40.4233
31. Nenasheva NM, Nazarova EV, Terekhova EP, et al. Efficacy and safety of the combined preparation GSP 301 NS in patients with seasonal allergic rhinitis: results of a Russian multicenter randomized open clinical. Prakticheskaia allergologiia. 2021;1:66-77 (in Russian) DOI:10.46393/2712-9667_2021_1_66-77

Авторы

А.В. Емельянов*

ФГБОУ ВО «Северо-Западный государственный медицинский университет им. И.И. Мечникова» Минздрава России, Санкт-Петербург, Россия
*emelav@inbox.ru

________________________________________________

Alexander V. Emelyanov*

Mechnikov North-Western State Medical University, Saint Petersburg, Russia
*emelav@inbox.ru

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