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Роль антагониста рецепторов эндотелина бозентана в современной стратегии лечения пациентов с легочной артериальной гипертензией
Роль антагониста рецепторов эндотелина бозентана в современной стратегии лечения пациентов с легочной артериальной гипертензией
Архипова О.А., Мартынюк Т.В. Роль антагониста рецепторов эндотелина бозентана в современной стратегии лечения пациентов с легочной артериальной гипертензией. Системные гипертензии. 2018; 15 (2): 66–71. DOI: 10.26442/2075-082X_2018.2.66-71
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Аннотация
Доказательная база по применению бозентана в настоящее время включает наибольшее число рандомизированных клинических исследований по сравнению с другими ЛАГ-специфическими препаратами. Бозентан может с успехом назначаться пациентам с идиопатической легочной гипертензией (ЛГ), легочной артериальной гипертензией (ЛАГ) с системными заболеваниями соединительной ткани (ЛАГ-СЗСТ), ВИЧ-инфекцией (ЛАГ-ВИЧ), врожденными пороками сердца (системно-легочные шунты) – ЛАГ-ВПС, для лечения ЛГ и замедления прогрессирования заболевания при сохранном функциональном классе, как в качестве монотерапии, так и в комбинациях с препаратами других групп. Он является единственным лекарственным препаратом ЛАГ-специфической терапии, зарегистрированным для лечения детей, и единственным препаратом, внесенным в список жизненно необходимых. В статье представлен обзор литературы по клиническим исследованиям с участием бозентана, рассмотрены показания, противопоказания, побочные действия препарата.
Ключевые слова: легочная артериальная гипертензия, лечение легочной гипертензии, антагонисты рецепторов эндотелина, бозентан.
Key words: pulmonary arterial hypertension, pulmonary hypertension treatment, endothelin receptor antagonist, bosentan.
Ключевые слова: легочная артериальная гипертензия, лечение легочной гипертензии, антагонисты рецепторов эндотелина, бозентан.
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Key words: pulmonary arterial hypertension, pulmonary hypertension treatment, endothelin receptor antagonist, bosentan.
Полный текст
Список литературы
1. Galiè N, Humbert M, Vachiery JL et al. 2015 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension. Eur Respir J 2015; 46: 903–75.
2. Клинические рекомендации. Легочная гипертензия 2016 г. http://cr.rosminzdrav.ru/schema.html?id=136#/text. / Klinicheskie rekomendatsii. Legochnaia gipertenziia 2016 g. http://cr.rosminzdrav.ru/schema.html?id=136#/text. [in Russian]
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6. Rubin LJ, Badesch DB, Barst RJ et al. Bosentan therapy for pulmonary arterial hypertension. N Engl J Med 2002; 34: 6896–903.
7. Galiè N, Hinderliter AL, Torbicki A et al. Effects of the Oral Endothelin-Receptor Antagonist Bosentan on Echocardiographic and Doppler Measures in Patients With Pulmonary Arterial Hypertension. J Am Coll Cardiol 2003; 41:1380–6.
8. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR__Scientific_Discussion/human/000401/WC500041457.pdf
9. Мартынюк Т.В., Наконечников С.Н., Чазова И.Е. Антагонисты рецепторов эндотелина при легочной артериальной гипертензии: вчера, сегодня, завтра. Рос. кардиол. журн. 2009; 4 (78): 73–81. / Martynyuk T.V., Nakonechnikov S.N., Chazova I.E. Antagonisty retseptorov endotelina pri legochnoi arterial'noi gipertenzii: vchera, segodnia, zavtra. Ros. kardiol. zhurn. 2009; 4 (78): 73–81. [in Russian]
10. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/000401/WC50...
11. Galiè N, Beghetti M, Gatzoulis MA et al. Bosentan therapy in patients with Eisenmenger syndrome: a multicenter, double-blind, randomized, placebo-controlled study. Circulation 2006; 114 (1): 48–54.
12. Sitbon O, Gressin V, Speich R et al. Bosentan for the treatment of human immunodeficiency virus-associated pulmonary arterial hypertension. Am J Respir Crit Care Med 2004; 170 (11): 1212–7.
13. Jaïs X, D'Armini AM, Jansa P et al. Bosentan for treatment of inoperable chronic thromboembolic pulmonary hypertension: BENEFiT (Bosentan Effects in iNopErable Forms of chronIc Thromboembolic pulmonary hypertension), a randomized, placebo-controlled trial. J Am Coll Cardiol 2008; 52 (25): 2127–34.
14. Hughes RJ, Jais X, Bonderman D et al. The efficacy of bosentan in inoperable chronic thromboembolic pulmonary hypertension: a 1-year follow-up study. Eur Respir J 2006; 28 (1): 138–43.
15. Galiè N, Rubin Lj, Hoeper M et al. Treatment of patients with mildly symptomatic pulmonary arterial hypertension with bosentan (EARLY study): a double-blind, randomised controlled trial. Lancet 2008; 371 (9630): 2093–100.
16. McLaughlin VV, Sitbon O, Badesch DB et al. Survival with first-line bosentan in patients with primary pulmonary hypertension. Eur Respir J 2005; 25: 244–9.
17. Provencher S, Sitbon O, Humbert M et al. Long-term outcome with first-line bosentan therapy in idiopathic pulmonary arterial hypertension. Eur Heart J 2006; 27 (5): 589–95.
18. Humbert M, Barst RJ, Robbins IM et al. Combination of bosentan with epoprostenol in pulmonary arterial hypertension: BREATHEE-2. Eur Respir J 2004; 24 (3): 353–9.
19. McLaughlin V, Channick RN, Ghofrani HA at al. Bosentan added to sildenafil therapy in patients with pulmonary arterial hypertension. Eur Respir J 2015; 46: 405–13.
20. McLaughlin VV, Oudiz RJ, Frost A et al. Randomized study of adding inhaled iloprost to existing bosentan in pulmonary arterial hypertension. Am J Respir Crit Care Med 2006; 174 (11): 1257–63.
21. McLaughlin VV, Archer SL, Badesch DB et al. ACCF/AHA 2009 Expert Consensus Document on Pulmonary Hypertension. Am Coll Cardiol 2009; 53: 1573–619.
22. Архипова О.А., Мартынюк Т.В., Лазуткина В.К. и др. Применение неселективного антагониста рецепторов эндотелина при идиопатической легочной гипертензии. Терапевт. архив. 2010; 82 (11): 70–3. / Arkhipova O.A., Martynyuk T.V., Lazutkina V.K. i dr. Primenenie neselektivnogo antagonista retseptorov endotelina pri idiopaticheskoi legochnoi gipertenzii. Terapevt. arkhiv. 2010; 82 (11): 70–3 [in Russian]
2. Klinicheskie rekomendatsii. Legochnaia gipertenziia 2016 g. http://cr.rosminzdrav.ru/schema.html?id=136#/text. [in Russian]
3. Legochnaia gipertenziia. Pod red. I.E.Chazovoi, T.V.Martyniuk. M.: Praktika, 2015. [in Russian]
4. Dremina N.N., Shurygin M.G., Shurygina I.A. Endoteliny v norme i patologii. Mezhdunar. zhurn. prikladnykh i fundamental'nykh issledovanii. 2016; 10: 210–4. [in Russian]
5. Channick RN, Simonneau G, Sitbon O et al. Effects of the dual endothelin-receptor antagonist bosentan in patients with pulmonary hypertension: a randomised placebo-controlled study. Lancet 2001; 6 (358): 1119–23.
6. Rubin LJ, Badesch DB, Barst RJ et al. Bosentan therapy for pulmonary arterial hypertension. N Engl J Med 2002; 34: 6896–903.
7. Galiè N, Hinderliter AL, Torbicki A et al. Effects of the Oral Endothelin-Receptor Antagonist Bosentan on Echocardiographic and Doppler Measures in Patients With Pulmonary Arterial Hypertension. J Am Coll Cardiol 2003; 41:1380–6.
8. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR__Scientific_Discussion/human/000401/WC500041457.pdf
9. Martynyuk T.V., Nakonechnikov S.N., Chazova I.E. Antagonisty retseptorov endotelina pri legochnoi arterial'noi gipertenzii: vchera, segodnia, zavtra. Ros. kardiol. zhurn. 2009; 4 (78): 73–81. [in Russian]
10. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/000401/WC50...
11. Galiè N, Beghetti M, Gatzoulis MA et al. Bosentan therapy in patients with Eisenmenger syndrome: a multicenter, double-blind, randomized, placebo-controlled study. Circulation 2006; 114 (1): 48–54.
12. Sitbon O, Gressin V, Speich R et al. Bosentan for the treatment of human immunodeficiency virus-associated pulmonary arterial hypertension. Am J Respir Crit Care Med 2004; 170 (11): 1212–7.
13. Jaïs X, D'Armini AM, Jansa P et al. Bosentan for treatment of inoperable chronic thromboembolic pulmonary hypertension: BENEFiT (Bosentan Effects in iNopErable Forms of chronIc Thromboembolic pulmonary hypertension), a randomized, placebo-controlled trial. J Am Coll Cardiol 2008; 52 (25): 2127–34.
14. Hughes RJ, Jais X, Bonderman D et al. The efficacy of bosentan in inoperable chronic thromboembolic pulmonary hypertension: a 1-year follow-up study. Eur Respir J 2006; 28 (1): 138–43.
15. Galiè N, Rubin Lj, Hoeper M et al. Treatment of patients with mildly symptomatic pulmonary arterial hypertension with bosentan (EARLY study): a double-blind, randomised controlled trial. Lancet 2008; 371 (9630): 2093–100.
16. McLaughlin VV, Sitbon O, Badesch DB et al. Survival with first-line bosentan in patients with primary pulmonary hypertension. Eur Respir J 2005; 25: 244–9.
17. Provencher S, Sitbon O, Humbert M et al. Long-term outcome with first-line bosentan therapy in idiopathic pulmonary arterial hypertension. Eur Heart J 2006; 27 (5): 589–95.
18. Humbert M, Barst RJ, Robbins IM et al. Combination of bosentan with epoprostenol in pulmonary arterial hypertension: BREATHEE-2. Eur Respir J 2004; 24 (3): 353–9.
19. McLaughlin V, Channick RN, Ghofrani HA at al. Bosentan added to sildenafil therapy in patients with pulmonary arterial hypertension. Eur Respir J 2015; 46: 405–13.
20. McLaughlin VV, Oudiz RJ, Frost A et al. Randomized study of adding inhaled iloprost to existing bosentan in pulmonary arterial hypertension. Am J Respir Crit Care Med 2006; 174 (11): 1257–63.
21. McLaughlin VV, Archer SL, Badesch DB et al. ACCF/AHA 2009 Expert Consensus Document on Pulmonary Hypertension. Am Coll Cardiol 2009; 53: 1573–619.
22. Arkhipova O.A., Martynyuk T.V., Lazutkina V.K. i dr. Primenenie neselektivnogo antagonista retseptorov endotelina pri idiopaticheskoi legochnoi gipertenzii. Terapevt. arkhiv. 2010; 82 (11): 70–3 [in Russian]
2. Клинические рекомендации. Легочная гипертензия 2016 г. http://cr.rosminzdrav.ru/schema.html?id=136#/text. / Klinicheskie rekomendatsii. Legochnaia gipertenziia 2016 g. http://cr.rosminzdrav.ru/schema.html?id=136#/text. [in Russian]
3. Легочная гипертензия. Под ред. И.Е.Чазовой, Т.В.Мартынюк. М.: Практика, 2015. / Legochnaia gipertenziia. Pod red. I.E.Chazovoi, T.V.Martyniuk. M.: Praktika, 2015. [in Russian]
4. Дремина Н.Н., Шурыгин М.Г., Шурыгина И.А. Эндотелины в норме и патологии. Междунар. журн. прикладных и фундаментальных исследований. 2016; 10: 210–4. / Dremina N.N., Shurygin M.G., Shurygina I.A. Endoteliny v norme i patologii. Mezhdunar. zhurn. prikladnykh i fundamental'nykh issledovanii. 2016; 10: 210–4. [in Russian]
5. Channick RN, Simonneau G, Sitbon O et al. Effects of the dual endothelin-receptor antagonist bosentan in patients with pulmonary hypertension: a randomised placebo-controlled study. Lancet 2001; 6 (358): 1119–23.
6. Rubin LJ, Badesch DB, Barst RJ et al. Bosentan therapy for pulmonary arterial hypertension. N Engl J Med 2002; 34: 6896–903.
7. Galiè N, Hinderliter AL, Torbicki A et al. Effects of the Oral Endothelin-Receptor Antagonist Bosentan on Echocardiographic and Doppler Measures in Patients With Pulmonary Arterial Hypertension. J Am Coll Cardiol 2003; 41:1380–6.
8. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR__Scientific_Discussion/human/000401/WC500041457.pdf
9. Мартынюк Т.В., Наконечников С.Н., Чазова И.Е. Антагонисты рецепторов эндотелина при легочной артериальной гипертензии: вчера, сегодня, завтра. Рос. кардиол. журн. 2009; 4 (78): 73–81. / Martynyuk T.V., Nakonechnikov S.N., Chazova I.E. Antagonisty retseptorov endotelina pri legochnoi arterial'noi gipertenzii: vchera, segodnia, zavtra. Ros. kardiol. zhurn. 2009; 4 (78): 73–81. [in Russian]
10. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/000401/WC50...
11. Galiè N, Beghetti M, Gatzoulis MA et al. Bosentan therapy in patients with Eisenmenger syndrome: a multicenter, double-blind, randomized, placebo-controlled study. Circulation 2006; 114 (1): 48–54.
12. Sitbon O, Gressin V, Speich R et al. Bosentan for the treatment of human immunodeficiency virus-associated pulmonary arterial hypertension. Am J Respir Crit Care Med 2004; 170 (11): 1212–7.
13. Jaïs X, D'Armini AM, Jansa P et al. Bosentan for treatment of inoperable chronic thromboembolic pulmonary hypertension: BENEFiT (Bosentan Effects in iNopErable Forms of chronIc Thromboembolic pulmonary hypertension), a randomized, placebo-controlled trial. J Am Coll Cardiol 2008; 52 (25): 2127–34.
14. Hughes RJ, Jais X, Bonderman D et al. The efficacy of bosentan in inoperable chronic thromboembolic pulmonary hypertension: a 1-year follow-up study. Eur Respir J 2006; 28 (1): 138–43.
15. Galiè N, Rubin Lj, Hoeper M et al. Treatment of patients with mildly symptomatic pulmonary arterial hypertension with bosentan (EARLY study): a double-blind, randomised controlled trial. Lancet 2008; 371 (9630): 2093–100.
16. McLaughlin VV, Sitbon O, Badesch DB et al. Survival with first-line bosentan in patients with primary pulmonary hypertension. Eur Respir J 2005; 25: 244–9.
17. Provencher S, Sitbon O, Humbert M et al. Long-term outcome with first-line bosentan therapy in idiopathic pulmonary arterial hypertension. Eur Heart J 2006; 27 (5): 589–95.
18. Humbert M, Barst RJ, Robbins IM et al. Combination of bosentan with epoprostenol in pulmonary arterial hypertension: BREATHEE-2. Eur Respir J 2004; 24 (3): 353–9.
19. McLaughlin V, Channick RN, Ghofrani HA at al. Bosentan added to sildenafil therapy in patients with pulmonary arterial hypertension. Eur Respir J 2015; 46: 405–13.
20. McLaughlin VV, Oudiz RJ, Frost A et al. Randomized study of adding inhaled iloprost to existing bosentan in pulmonary arterial hypertension. Am J Respir Crit Care Med 2006; 174 (11): 1257–63.
21. McLaughlin VV, Archer SL, Badesch DB et al. ACCF/AHA 2009 Expert Consensus Document on Pulmonary Hypertension. Am Coll Cardiol 2009; 53: 1573–619.
22. Архипова О.А., Мартынюк Т.В., Лазуткина В.К. и др. Применение неселективного антагониста рецепторов эндотелина при идиопатической легочной гипертензии. Терапевт. архив. 2010; 82 (11): 70–3. / Arkhipova O.A., Martynyuk T.V., Lazutkina V.K. i dr. Primenenie neselektivnogo antagonista retseptorov endotelina pri idiopaticheskoi legochnoi gipertenzii. Terapevt. arkhiv. 2010; 82 (11): 70–3 [in Russian]
________________________________________________
2. Klinicheskie rekomendatsii. Legochnaia gipertenziia 2016 g. http://cr.rosminzdrav.ru/schema.html?id=136#/text. [in Russian]
3. Legochnaia gipertenziia. Pod red. I.E.Chazovoi, T.V.Martyniuk. M.: Praktika, 2015. [in Russian]
4. Dremina N.N., Shurygin M.G., Shurygina I.A. Endoteliny v norme i patologii. Mezhdunar. zhurn. prikladnykh i fundamental'nykh issledovanii. 2016; 10: 210–4. [in Russian]
5. Channick RN, Simonneau G, Sitbon O et al. Effects of the dual endothelin-receptor antagonist bosentan in patients with pulmonary hypertension: a randomised placebo-controlled study. Lancet 2001; 6 (358): 1119–23.
6. Rubin LJ, Badesch DB, Barst RJ et al. Bosentan therapy for pulmonary arterial hypertension. N Engl J Med 2002; 34: 6896–903.
7. Galiè N, Hinderliter AL, Torbicki A et al. Effects of the Oral Endothelin-Receptor Antagonist Bosentan on Echocardiographic and Doppler Measures in Patients With Pulmonary Arterial Hypertension. J Am Coll Cardiol 2003; 41:1380–6.
8. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR__Scientific_Discussion/human/000401/WC500041457.pdf
9. Martynyuk T.V., Nakonechnikov S.N., Chazova I.E. Antagonisty retseptorov endotelina pri legochnoi arterial'noi gipertenzii: vchera, segodnia, zavtra. Ros. kardiol. zhurn. 2009; 4 (78): 73–81. [in Russian]
10. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/000401/WC50...
11. Galiè N, Beghetti M, Gatzoulis MA et al. Bosentan therapy in patients with Eisenmenger syndrome: a multicenter, double-blind, randomized, placebo-controlled study. Circulation 2006; 114 (1): 48–54.
12. Sitbon O, Gressin V, Speich R et al. Bosentan for the treatment of human immunodeficiency virus-associated pulmonary arterial hypertension. Am J Respir Crit Care Med 2004; 170 (11): 1212–7.
13. Jaïs X, D'Armini AM, Jansa P et al. Bosentan for treatment of inoperable chronic thromboembolic pulmonary hypertension: BENEFiT (Bosentan Effects in iNopErable Forms of chronIc Thromboembolic pulmonary hypertension), a randomized, placebo-controlled trial. J Am Coll Cardiol 2008; 52 (25): 2127–34.
14. Hughes RJ, Jais X, Bonderman D et al. The efficacy of bosentan in inoperable chronic thromboembolic pulmonary hypertension: a 1-year follow-up study. Eur Respir J 2006; 28 (1): 138–43.
15. Galiè N, Rubin Lj, Hoeper M et al. Treatment of patients with mildly symptomatic pulmonary arterial hypertension with bosentan (EARLY study): a double-blind, randomised controlled trial. Lancet 2008; 371 (9630): 2093–100.
16. McLaughlin VV, Sitbon O, Badesch DB et al. Survival with first-line bosentan in patients with primary pulmonary hypertension. Eur Respir J 2005; 25: 244–9.
17. Provencher S, Sitbon O, Humbert M et al. Long-term outcome with first-line bosentan therapy in idiopathic pulmonary arterial hypertension. Eur Heart J 2006; 27 (5): 589–95.
18. Humbert M, Barst RJ, Robbins IM et al. Combination of bosentan with epoprostenol in pulmonary arterial hypertension: BREATHEE-2. Eur Respir J 2004; 24 (3): 353–9.
19. McLaughlin V, Channick RN, Ghofrani HA at al. Bosentan added to sildenafil therapy in patients with pulmonary arterial hypertension. Eur Respir J 2015; 46: 405–13.
20. McLaughlin VV, Oudiz RJ, Frost A et al. Randomized study of adding inhaled iloprost to existing bosentan in pulmonary arterial hypertension. Am J Respir Crit Care Med 2006; 174 (11): 1257–63.
21. McLaughlin VV, Archer SL, Badesch DB et al. ACCF/AHA 2009 Expert Consensus Document on Pulmonary Hypertension. Am Coll Cardiol 2009; 53: 1573–619.
22. Arkhipova O.A., Martynyuk T.V., Lazutkina V.K. i dr. Primenenie neselektivnogo antagonista retseptorov endotelina pri idiopaticheskoi legochnoi gipertenzii. Terapevt. arkhiv. 2010; 82 (11): 70–3 [in Russian]
Авторы
О.А.Архипова*, Т.В.Мартынюк
Институт клинической кардиологии им. А.Л.Мясникова ФГБУ «Национальный медицинский исследовательский центр кардиологии» Минздрава России. 121552, Россия, Москва, ул. 3-я Черепковская, д. 15а
*olga_ark@list.ru
A.L.Myasnikov Institute of Clinical Cardiology of the National Medical Research Center of Cardiology of the Ministry of Health of the Russian Federation. 121552, Russian Federation, Moscow, ul. 3-ia Cherepkovskaia, d. 15a
*olga_ark@list.ru
Институт клинической кардиологии им. А.Л.Мясникова ФГБУ «Национальный медицинский исследовательский центр кардиологии» Минздрава России. 121552, Россия, Москва, ул. 3-я Черепковская, д. 15а
*olga_ark@list.ru
________________________________________________
A.L.Myasnikov Institute of Clinical Cardiology of the National Medical Research Center of Cardiology of the Ministry of Health of the Russian Federation. 121552, Russian Federation, Moscow, ul. 3-ia Cherepkovskaia, d. 15a
*olga_ark@list.ru
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