Систематический обзор как основа клинических рекомендаций: рекомендации CHEST-2019 по терапии легочной артериальной гипертензии у взрослых
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Shmalts A.A., Gorbachevsky S.V. A systematic review as а method of gathering scientific evidence into clinical guidelines: CHEST-2019 guideline for the therapy pulmonary arterial hypertension in adults. Therapeutic Archive. 2019; 91 (12): 105–114. DOI: 10.26442/00403660.2019.12.000468
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Ключевые слова: легочная гипертензия, легочная артериальная гипертензия, специфическая терапия, рекомендации.
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The updated fourth version of the CHEST guideline presents the evidence base and treatment algorithm for pulmonary arterial hypertension in adults. The CHEST approach to creating clinical guidelines differs from the European one (ESC/ERS) and, in fact, consists in a systematic review of clinical trials and a summary of their postulates.
Keywords: pulmonary hypertension, pulmonary arterial hypertension, specific therapy, guideline.
2. Galie N, Humbert M, Vachiery JL, et al. 2015 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension: The Joint Task Force for the Diagnosis and Treatment of Pulmonary Hypertension of the European Society of Cardiology (ESC) and the European Respiratory Society (ERS): Endorsed by: Association for European Paediatric and Congenital Cardiology (AEPC),International Society for Heart and Lung Transplantation (ISHLT). Eur Respir J. 2015;46(4):903-75. doi: 10.1183/13993003.01032-2015
3. Galiè N, Channick RN, Frantz RP, et al. Risk stratification and medical therapy of pulmonary arterial hypertension. Eur Respir J. 2019;53(1). pii: 1801889. doi: 10.1183/13993003.01889-2018
4. Легочная гипертензия. Российские клинические рекомендации, 2016. Доступно по ссылке: http://cr.rosminzdrav.ru /schema.html?id=136#/text [Pulmonary hypertension. Russian clinical guidelines, 2016. Available at: http://cr.rosminzdrav.ru/ schema.html?id=136#/text (In Russ.)].
5. Klinger JR, Elliott CG, Levine DJ, et al. Therapy for Pulmonary Arterial Hypertension in Adults: Update of the CHEST Guideline and Expert Panel Report. Chest. 2019;155(3):565-86. doi: 10.1016/j.chest.2018.11.030
6. McCrory DC, Coeytaux RR, Schmit KM, et al. AHRQ Comparative Effectiveness Reviews. Pulmonary Arterial Hypertension: Screening, Management, and Treatment. Rockville (MD): Agency for Healthcare Research and Quality (US), 2013.
7. Taichman DB, Ornelas J, Chung L, et al. Pharmacologic therapy for pulmonary arterial hypertension in adults: CHEST guideline and expert panel report. Chest. 2014;146(2):449-75. doi: 10.1378/chest.14-0793
8. Мартынюк Т.В., Чазова И.Е. Стратегия медикаментозного лечения легочной артериальной гипертензии в свете современных зарубежных рекомендаций. Системные гипертензии. 2016;13(2):46-64 [Martyniuk TV, Chazova IE. Strategy of medical treatment of pulmonary arterial hypertension in the current international recommendations. Systemic Hypertension. 2016;13(2):46-64 (In Russ.)]. doi: 10.26442/2075-082x_13.2.46-64
9. Andrews J, Guyatt G, Oxman AD, et al. GRADE guidelines: 14. Going from evidence to recommendations: the significance and presentation of recommendations. J Clin Epidemiol. 2013;66(7):719-25. doi: 10.1016/j.jclinepi.2012.03.013
10. Balshem H, Helfand M, Schünemann HJ, et al. GRADE guidelines: 3. Rating the quality of evidence. J Clin Epidemiol. 2011;64(4):401-6. doi: 10.1016/j.jclinepi.2010.07.015
11. Simonneau G, Torbicki A, Hoeper MM, et al. Selexipag: an oral, selective prostacyclin receptor agonist for the treatment of pulmonary arterial hypertension. Eur Respir J. 2012;40(4):874-80. doi: 10.1183/ 09031936.00137511
12. Sitbon O, Channick R, Chin KM, et al. Selexipag for the treatment of pulmonary arterial hypertension. N Engl J Med. 2015;373(26):2522-33. doi: 10.1056/nejmoa1503184
13. Jing ZC, Parikh K, Pulido T, et al. Efficacy and safety of oral treprostinil monotherapy for the treatment of pulmonary arterial hypertension: a randomized, controlled trial. Circulation. 2013;127(5):624-33. doi: 10.1161/circulationaha.112.124388
14. McLaughlin V, Channick RN, Ghofrani HA, et al. Bosentan added to sildenafil therapy in patients with pulmonary arterial hypertension. Eur Respir J. 2015;46(2):405-13. doi: 10.1183/13993003.02044-2014
15. Galie N, Barbera JA, Frost AE, et al. Initial use of ambrisentan plus tadalafil in pulmonary arterial hypertension. N Engl J Med. 2015;373(9):834-44. doi: 10.1056/nejmoa1413687
16. Zhuang Y, Jiang B, Gao H, Zhao W. Randomized study of adding tadalafil to existing ambrisentan in pulmonary arterial hypertension. Hypertens Res. 2014;37(6):507-12. doi: 10.1038/hr.2014.28
17. Tapson VF, Jing ZC, Xu KF, et al. Oral treprostinil for the treatment of pulmonary arterial hypertension in patients receiving background endothelin receptor antagonist and phosphodiesterase type 5 inhibitor therapy (the FREEDOM-C2 study): a randomized controlled trial. Chest. 2013;144(3):952-8. doi: 10.1378/chest.12-2875
18. Hoeper MM, Simonneau G, Corris PA, et al. RESPITE: switching to riociguat in pulmonary arterial hypertension patients with inadequate response to phosphodiesterase-5 inhibitors. Eur Respir J. 2017;50(3):1602425. doi: 10.1183/13993003.02425-2016
19. Chia KS, Wong PK, Faux SG, et al. The benefit of exercise training in pulmonary hypertension: a clinical review. Intern Med J. 2017;47(4):361-9. doi: 10.1111/imj.13159
20. Inagaki T, Terada J, Tanabe N, et al. Home-based pulmonary rehabilitation in patients with inoperable or residual chronic thromboembolic pulmonary hypertension: a preliminary study. Respir Investig. 2014;52(6):357-64. doi: 10.1016/j.resinv.2014.07.002
21. Zafrir B. Exercise training and rehabilitation in pulmonary arterial hypertension: rationale and current data evaluation. J Cardiopulm Rehabil Prev. 2013;33(5):263-73. doi: 10.1097/hcr.0b013e3182a0299a
22. Ganderton L, Jenkins S, Gain K, et al. Short term effects of exercise training on exercise capacity and quality of life in patients with pulmonary arterial hypertension: protocol for a randomized controlled trial. BMC Pulm Med. 2011;11:25. doi: 10.1186/1471-2466-11-25
23. Weinstein AA, Chin LM, Keyser RE, et al. Effect of aerobic exercise training on fatigue and physical activity in patients with pulmonary arterial hypertension. Respir Med. 2013;107(5):778-84. doi: 10.1016/j.rmed.2013.02.006
24. Ehlken N, Lichtblau M, Klose H, et al. Exercise training improves peak oxygen consumption and haemodynamics in patients with severe pulmonary arterial hypertension and inoperable chronic thrombo-embolic pulmonary hypertension: a prospective, randomized, controlled trial. Eur Heart J. 2016;37(1):35-44. doi: 10.1093/eurheartj/ehv337
25. Morris NR, Kermeen FD, Holland AE. Exercise-based rehabilitation programmes for pulmonary hypertension. Cochrane Database Syst Rev. 2017;1:CD011285. doi: 10.1002/14651858.cd011285.pub2
26. Saglam M, Arikan H, Vardar-Yagli N, et al. Inspiratory muscle training in pulmonary arterial hypertension. J Cardiopulm Rehabil Prev. 2015;35(3):198-206. doi: 10.1097/hcr.0000000000000117
27. Ezedunukwe IR, Enuh H, Nfonoyim J, Enuh Collins U. Anticoagulation therapy versus placebo for pulmonary hypertension. Cochrane Database Syst Rev. 2014;(6):CD010695. doi: 10.1002/ 14651858.cd010695.pub2
28. Olsson KM, Delcroix M, Ghofrani HA, et al. Anticoagulation and survival in pulmonary arterial hypertension: results from the Comparative, Prospective Registry of Newly Initiated Therapies for Pulmonary Hypertension (COMPERA). Circulation. 2014;129(1):57-65. doi: 10.1161/CIRCULATIONAHA.113.004526
29. Preston IR, Roberts KE, Miller DP, et al. Effect of warfarin treatment on survival of patients with pulmonary arterial hypertension (PAH) in the Registry to Evaluate Early and Long-Term PAH Disease Management (REVEAL). Circulation. 2015;132(25):2403-11. doi: 10.1161/circulationaha.115.018435
30. Kang BJ, Oh Y-M, Lee S-D, Lee JS. Survival benefits of warfarin in Korean patients with idiopathic pulmonary arterial hypertension. Korean J Intern Med. 2015;30(6):837-45. doi: 10.3904/kjim.2015. 30.6.837
31. Kawut SM, Bagiella E, Lederer DJ, et al. Randomized clinical trial of aspirin and simvastatin for pulmonary arterial hypertension: ASASTAT. Circulation. 2011;123(25):2985-93. doi: 10.1161/circulationaha.110.015693
32. Kawut SM, Horn EM, Berekashvili KK, et al. Selective serotonin reuptake inhibitor use and outcomes in pulmonary arterial hypertension. Pulm Pharmacol Ther. 2006;19(5):370-4. doi: 10.1016/ j.pupt.2006.01.001
33. Sitbon O, Gomberg-Maitland M, Granton J, et al. Clinical trial design and new therapies for pulmonary arterial hypertension. Eur Respir J. 2019;53(1). pii: 1801908. doi: 10.1183/13993003.01908-2018
34. McLaughlin VV, Badesch DB, Delcroix M, et al. End points and clinical trial design in pulmonary arterial hypertension. J Am Coll Cardiol. 2009;54(1 Suppl):S97-S107. doi: 10.1016/j.jacc.2009.04.007
35. Шмальц А.А., Горбачевский С.В. Биохимический путь оксида азота в терапиилегочной артериальной гипертензии и результаты исследования RESPITE. Системные гипертензии. 2018;15(2):72-6 [Shmalts АА, Gorbachevsky SV. Nitrogen oxide biochemical pathway in pulmonary arterial hypertension therapy and REPLACE trial results. Systemic Hypertension. 2018;15(2):72-6 (In Russ.)]. doi: 10.26442/ 2075-082x_2018.2.72-76
36. Шмальц А.А., Горбачевский С.В. Риоцигуат и силденафил в лечении легочной гипертензии: сходства и различия. Пульмонология. 2016;26(1):85-91 [Shmalts АА, Gorbachevsky SV. Riociguat and sildenafil in the treatment of pulmonary hypertension: similarities and differences. Pulmonology. 2016;26(1):85-91 (In Russ.)].
37. REPLACE. Riociguat replacing PDE-5i therapy evaluated against continued PDE-5i therapy. Сlinical Trials.gov Identifier: NCT02891850.
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1. Galie N, Humbert M, Vachiery JL, et al. 2015 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension: The Joint Task Force for the Diagnosis and Treatment of Pulmonary Hypertension of the European Society of Cardiology (ESC) and the European Respiratory Society (ERS): Endorsed by: Association for European Paediatric and Congenital Cardiology (AEPC), International Society for Heart and Lung Transplantation (ISHLT). Eur Heart J. 2016;37(1):67-119. doi: 10.1093/eurheartj/ehv317
2. Galie N, Humbert M, Vachiery JL, et al. 2015 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension: The Joint Task Force for the Diagnosis and Treatment of Pulmonary Hypertension of the European Society of Cardiology (ESC) and the European Respiratory Society (ERS): Endorsed by: Association for European Paediatric and Congenital Cardiology (AEPC),International Society for Heart and Lung Transplantation (ISHLT). Eur Respir J. 2015;46(4):903-75. doi: 10.1183/13993003.01032-2015
3. Galiè N, Channick RN, Frantz RP, et al. Risk stratification and medical therapy of pulmonary arterial hypertension. Eur Respir J. 2019;53(1). pii: 1801889. doi: 10.1183/13993003.01889-2018
4. Легочная гипертензия. Российские клинические рекомендации, 2016. Доступно по ссылке: http://cr.rosminzdrav.ru /schema.html?id=136#/text [Pulmonary hypertension. Russian clinical guidelines, 2016. Available at: http://cr.rosminzdrav.ru/ schema.html?id=136#/text (In Russ.)].
5. Klinger JR, Elliott CG, Levine DJ, et al. Therapy for Pulmonary Arterial Hypertension in Adults: Update of the CHEST Guideline and Expert Panel Report. Chest. 2019;155(3):565-86. doi: 10.1016/j.chest.2018.11.030
6. McCrory DC, Coeytaux RR, Schmit KM, et al. AHRQ Comparative Effectiveness Reviews. Pulmonary Arterial Hypertension: Screening, Management, and Treatment. Rockville (MD): Agency for Healthcare Research and Quality (US), 2013.
7. Taichman DB, Ornelas J, Chung L, et al. Pharmacologic therapy for pulmonary arterial hypertension in adults: CHEST guideline and expert panel report. Chest. 2014;146(2):449-75. doi: 10.1378/chest.14-0793
8. [Martyniuk TV, Chazova IE. Strategy of medical treatment of pulmonary arterial hypertension in the current international recommendations. Systemic Hypertension. 2016;13(2):46-64 (In Russ.)]. doi: 10.26442/2075-082x_13.2.46-64
9. Andrews J, Guyatt G, Oxman AD, et al. GRADE guidelines: 14. Going from evidence to recommendations: the significance and presentation of recommendations. J Clin Epidemiol. 2013;66(7):719-25. doi: 10.1016/j.jclinepi.2012.03.013
10. Balshem H, Helfand M, Schünemann HJ, et al. GRADE guidelines: 3. Rating the quality of evidence. J Clin Epidemiol. 2011;64(4):401-6. doi: 10.1016/j.jclinepi.2010.07.015
11. Simonneau G, Torbicki A, Hoeper MM, et al. Selexipag: an oral, selective prostacyclin receptor agonist for the treatment of pulmonary arterial hypertension. Eur Respir J. 2012;40(4):874-80. doi: 10.1183/ 09031936.00137511
12. Sitbon O, Channick R, Chin KM, et al. Selexipag for the treatment of pulmonary arterial hypertension. N Engl J Med. 2015;373(26):2522-33. doi: 10.1056/nejmoa1503184
13. Jing ZC, Parikh K, Pulido T, et al. Efficacy and safety of oral treprostinil monotherapy for the treatment of pulmonary arterial hypertension: a randomized, controlled trial. Circulation. 2013;127(5):624-33. doi: 10.1161/circulationaha.112.124388
14. McLaughlin V, Channick RN, Ghofrani HA, et al. Bosentan added to sildenafil therapy in patients with pulmonary arterial hypertension. Eur Respir J. 2015;46(2):405-13. doi: 10.1183/13993003.02044-2014
15. Galie N, Barbera JA, Frost AE, et al. Initial use of ambrisentan plus tadalafil in pulmonary arterial hypertension. N Engl J Med. 2015;373(9):834-44. doi: 10.1056/nejmoa1413687
16. Zhuang Y, Jiang B, Gao H, Zhao W. Randomized study of adding tadalafil to existing ambrisentan in pulmonary arterial hypertension. Hypertens Res. 2014;37(6):507-12. doi: 10.1038/hr.2014.28
17. Tapson VF, Jing ZC, Xu KF, et al. Oral treprostinil for the treatment of pulmonary arterial hypertension in patients receiving background endothelin receptor antagonist and phosphodiesterase type 5 inhibitor therapy (the FREEDOM-C2 study): a randomized controlled trial. Chest. 2013;144(3):952-8. doi: 10.1378/chest.12-2875
18. Hoeper MM, Simonneau G, Corris PA, et al. RESPITE: switching to riociguat in pulmonary arterial hypertension patients with inadequate response to phosphodiesterase-5 inhibitors. Eur Respir J. 2017;50(3):1602425. doi: 10.1183/13993003.02425-2016
19. Chia KS, Wong PK, Faux SG, et al. The benefit of exercise training in pulmonary hypertension: a clinical review. Intern Med J. 2017;47(4):361-9. doi: 10.1111/imj.13159
20. Inagaki T, Terada J, Tanabe N, et al. Home-based pulmonary rehabilitation in patients with inoperable or residual chronic thromboembolic pulmonary hypertension: a preliminary study. Respir Investig. 2014;52(6):357-64. doi: 10.1016/j.resinv.2014.07.002
21. Zafrir B. Exercise training and rehabilitation in pulmonary arterial hypertension: rationale and current data evaluation. J Cardiopulm Rehabil Prev. 2013;33(5):263-73. doi: 10.1097/hcr.0b013e3182a0299a
22. Ganderton L, Jenkins S, Gain K, et al. Short term effects of exercise training on exercise capacity and quality of life in patients with pulmonary arterial hypertension: protocol for a randomized controlled trial. BMC Pulm Med. 2011;11:25. doi: 10.1186/1471-2466-11-25
23. Weinstein AA, Chin LM, Keyser RE, et al. Effect of aerobic exercise training on fatigue and physical activity in patients with pulmonary arterial hypertension. Respir Med. 2013;107(5):778-84. doi: 10.1016/j.rmed.2013.02.006
24. Ehlken N, Lichtblau M, Klose H, et al. Exercise training improves peak oxygen consumption and haemodynamics in patients with severe pulmonary arterial hypertension and inoperable chronic thrombo-embolic pulmonary hypertension: a prospective, randomized, controlled trial. Eur Heart J. 2016;37(1):35-44. doi: 10.1093/eurheartj/ehv337
25. Morris NR, Kermeen FD, Holland AE. Exercise-based rehabilitation programmes for pulmonary hypertension. Cochrane Database Syst Rev. 2017;1:CD011285. doi: 10.1002/14651858.cd011285.pub2
26. Saglam M, Arikan H, Vardar-Yagli N, et al. Inspiratory muscle training in pulmonary arterial hypertension. J Cardiopulm Rehabil Prev. 2015;35(3):198-206. doi: 10.1097/hcr.0000000000000117
27. Ezedunukwe IR, Enuh H, Nfonoyim J, Enuh Collins U. Anticoagulation therapy versus placebo for pulmonary hypertension. Cochrane Database Syst Rev. 2014;(6):CD010695. doi: 10.1002/ 14651858.cd010695.pub2
28. Olsson KM, Delcroix M, Ghofrani HA, et al. Anticoagulation and survival in pulmonary arterial hypertension: results from the Comparative, Prospective Registry of Newly Initiated Therapies for Pulmonary Hypertension (COMPERA). Circulation. 2014;129(1):57-65. doi: 10.1161/CIRCULATIONAHA.113.004526
29. Preston IR, Roberts KE, Miller DP, et al. Effect of warfarin treatment on survival of patients with pulmonary arterial hypertension (PAH) in the Registry to Evaluate Early and Long-Term PAH Disease Management (REVEAL). Circulation. 2015;132(25):2403-11. doi: 10.1161/circulationaha.115.018435
30. Kang BJ, Oh Y-M, Lee S-D, Lee JS. Survival benefits of warfarin in Korean patients with idiopathic pulmonary arterial hypertension. Korean J Intern Med. 2015;30(6):837-45. doi: 10.3904/kjim.2015. 30.6.837
31. Kawut SM, Bagiella E, Lederer DJ, et al. Randomized clinical trial of aspirin and simvastatin for pulmonary arterial hypertension: ASASTAT. Circulation. 2011;123(25):2985-93. doi: 10.1161/circulationaha.110.015693
32. Kawut SM, Horn EM, Berekashvili KK, et al. Selective serotonin reuptake inhibitor use and outcomes in pulmonary arterial hypertension. Pulm Pharmacol Ther. 2006;19(5):370-4. doi: 10.1016/ j.pupt.2006.01.001
33. Sitbon O, Gomberg-Maitland M, Granton J, et al. Clinical trial design and new therapies for pulmonary arterial hypertension. Eur Respir J. 2019;53(1). pii: 1801908. doi: 10.1183/13993003.01908-2018
34. McLaughlin VV, Badesch DB, Delcroix M, et al. End points and clinical trial design in pulmonary arterial hypertension. J Am Coll Cardiol. 2009;54(1 Suppl):S97-S107. doi: 10.1016/j.jacc.2009.04.007
35. [Shmalts АА, Gorbachevsky SV. Nitrogen oxide biochemical pathway in pulmonary arterial hypertension therapy and REPLACE trial results. Systemic Hypertension. 2018;15(2):72-6 (In Russ.)]. doi: 10.26442/ 2075-082x_2018.2.72-76
36. [Shmalts АА, Gorbachevsky SV. Riociguat and sildenafil in the treatment of pulmonary hypertension: similarities and differences. Pulmonology. 2016;26(1):85-91 (In Russ.)].
37. REPLACE. Riociguat replacing PDE-5i therapy evaluated against continued PDE-5i therapy. Сlinical Trials.gov Identifier: NCT02891850.
1 ФГБУ «Национальный медицинский исследовательский центр сердечно-сосудистой хирургии им. А.Н. Бакулева» Минздрава России, Москва, Россия;
2 ФГБОУ ДПО «Российская медицинская академия непрерывного профессионального образования» Минздрава России, Москва, Россия
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A.A. Shmalts 1,2, S.V. Gorbachevsky 1,2
1 Bakoulev Scientific Center for Cardiovascular Surgery, Moscow, Russia;
2 Russian State Medical Postgraduate Academy, Moscow, Russia