pulmoПульмонологияPULMONOLOGIYA0869-01892541-9617Scientific and Practical Journal “PULMONOLOGIYA” LLC10.18093/0869-0189-2006-1-81-87pulmo-1418Research ArticleСтатьиРоль Альмитрина в терапии хронической дыхательной недостаточности у больных ХОБЛ. Открытое Проспективное Мультицентровое ИсследованиеЧучалинА.Г.noemail@neicon.ruАвдеевС.Н.noemail@neicon.ruГайдарЕ.Н.noemail@neicon.ruГончароваТ.А.noemail@neicon.ruСуточниковаО.А.noemail@neicon.ruЦветковаО.А.noemail@neicon.ruЧерейскаяН.К.noemail@neicon.ru200628022006018187Copyright © Чучалин А., Авдеев С., Гайдар Е., Гончарова Т., Суточникова О., Цветкова О., Черейская Н., 20062006Чучалин А., Авдеев С., Гайдар Е., Гончарова Т., Суточникова О., Цветкова О., Черейская Н.Чучалин А., Авдеев С., Гайдар Е., Гончарова Т., Суточникова О., Цветкова О., Черейская Н.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://journal.pulmonology.ru/pulm/article/view/1418

Проведено открытое проспективное мультицентровое исследование по изучению безопасности и эффективности альмитрина при умеренной хронической дыхательной недостаточности (ХДН) у больных ХОБЛ. В исследование было включено 598 больных ХОБЛ (M : Ж - 484 : 114, средний возраст 60,7 ± 9,3 лет; ОФВ1 46,1 ± 16,4 %, PaO2 55,7 ± 16,4 mm Hg, SpO2 88,4 ± 4,7 %). Терапия альмитрином осуществлялась по следующей схеме: 1 мг / кг / сут. в течение 3 мес., затем перерыв 1 мес. и вновь 2-месячный прием по той же схеме (всего 6 мес.). Терапия альмитрином привела к уменьшению одышки (шкала MRC): исходно - 3,5 ± 0,8, через 1 мес. - 3,0 ± 0,8, через 3 мес. - до 2,5 ± 0,8, через 6 мес. - до 2,5 ± 0,7 баллов (р < 0,001). Отмечено повышение РаО2: через 1 мес. - до 59,9 ± 16,1 mm Hg, через 3 мес. - до 60,8 ± 15,9 mm Hg, через 6 мес. - до 61,5 ± 14,0 mm Hg (р < 0,001). Терапия альмитрином привела к приросту дистанции во время 6!минутного теста: исходно - 290 ± 118 м, через 3 мес. - 328 ± 128 м, через 6 мес. - 333 ± 145 м (р < 0,001). По различным причинам из исследования выбыли 83 (13,9 %) больных ХОБЛ. Среди побочных явлений наиболее часто встречались расстройства ЖКТ (4,7 %), периферическая нейропатия (3,8 %) и др. Выводы: у больных ХОБЛ с умеренной гипоксемией альмитрин уменьшает одышку во время повседневной активности, повышает физическую работоспособность, улучшает оксигенацию артериальной крови, является относительно безопасным препаратом.

ReferencesGlobal Initiative for Chronic Obstructive Lung Disease (GOLD). Global strategy for diagnosis, management, and prevention of chronic obstructive pulmonary disease. NHLBI/WHO workshop report. Publication Number 2701. The updated 2005 report is available on www.goldcopd.com.Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global strategy for diagnosis, management, and prevention of chronic obstructive pulmonary disease. NHLBI/WHO workshop report. Publication Number 2701. The updated 2005 report is available on www.goldcopd.com.Celli B.R., MacNee W., committee members of ATS / ERS Task Force. Standards for the diagnosis and treatment of patients with COPD: a summary of the ATS / ERS position paper. Eur. Respir. J. 2004; 23: 932-946.Celli B.R., MacNee W., committee members of ATS / ERS Task Force. Standards for the diagnosis and treatment of patients with COPD: a summary of the ATS / ERS position paper. Eur. Respir. J. 2004; 23: 932-946.Mannino D.M., Homa D.M., Akinbami L.J. et al. Chronic obstructive pulmonary disease surveillance - United States, 1971-2000. Mordid. Mortal. Wkly Rep. Surveill. Summ. 2002; 51: 1-16.Mannino D.M., Homa D.M., Akinbami L.J. et al. Chronic obstructive pulmonary disease surveillance - United States, 1971-2000. Mordid. Mortal. Wkly Rep. Surveill. Summ. 2002; 51: 1-16.Zielinski J. Causes of death in chronic respiratory failure. Monaldi Arch. Chest Dis. 2003; 59: 240-243.Zielinski J. Causes of death in chronic respiratory failure. Monaldi Arch. Chest Dis. 2003; 59: 240-243.Nocturnal Oxygen Therapy Trial Group: Continuous or noc! turnal oxygen therapy in hypoxemic chronic obstructive lung disease: a clinical trial. Ann. Intern. Med. 1980; 93: 391-398.Nocturnal Oxygen Therapy Trial Group: Continuous or noc! turnal oxygen therapy in hypoxemic chronic obstructive lung disease: a clinical trial. Ann. Intern. Med. 1980; 93: 391-398.Medical Research Council Working Party. Long!term domiciliary oxygen therapy in chronic hypoxic cor pul! monale complicating chronic bronchitis and emphysema. Lancet 1981; 1: 681-686.Medical Research Council Working Party. Long!term domiciliary oxygen therapy in chronic hypoxic cor pul! monale complicating chronic bronchitis and emphysema. Lancet 1981; 1: 681-686.Gorecka D., Gorzelak K., Sliwinski P. et al. Effect of long! term oxygen therapy on survival in patients with chronic obstructive pulmonary disease with moderate hypoxaemia. Thorax 1997; 52: 674-679.Gorecka D., Gorzelak K., Sliwinski P. et al. Effect of long! term oxygen therapy on survival in patients with chronic obstructive pulmonary disease with moderate hypoxaemia. Thorax 1997; 52: 674-679.Voisin C., Howard P., Ansquer J.C. Almitrine bismesylate: a long!term placebo!controlled double!blind study in COAD - Vectarion International Multicentre Study Group. Bull. Eur. Physiopathol. Respir. 1987; 23 (suppl.11): 169s-182s.Voisin C., Howard P., Ansquer J.C. Almitrine bismesylate: a long!term placebo!controlled double!blind study in COAD - Vectarion International Multicentre Study Group. Bull. Eur. Physiopathol. Respir. 1987; 23 (suppl.11): 169s-182s.Weitzenblum E., Arnaud F., Bignon J. et al. Administration sequentielle d'une posologie reduite d'almitrine a des malades BPCO. Etude multicentrique controlee. Rev. Mal. Respir. 1992; 9: 455-463.Weitzenblum E., Arnaud F., Bignon J. et al. Administration sequentielle d'une posologie reduite d'almitrine a des malades BPCO. Etude multicentrique controlee. Rev. Mal. Respir. 1992; 9: 455-463.Bardsley P.A., Howard P., Tang O. et al. Sequential treat! ment with low dose almitrine bismesylate in hypoxaemic chronic obstructive airways disease. Eur. Respir. J. 1992; 5: 1054-1061.Bardsley P.A., Howard P., Tang O. et al. Sequential treat! ment with low dose almitrine bismesylate in hypoxaemic chronic obstructive airways disease. Eur. Respir. J. 1992; 5: 1054-1061.Gorecka D., Sliwinski P., Palasiewicz G. et al. Effects of almitrine bismesylate on arterial blood gases in patients with chronic obstructive pulmonary disease and moderate hypoxaemia: a multicentre, randomized double!blind, placebo!controlled study. Respiration 2003; 70: 275-283.Gorecka D., Sliwinski P., Palasiewicz G. et al. Effects of almitrine bismesylate on arterial blood gases in patients with chronic obstructive pulmonary disease and moderate hypoxaemia: a multicentre, randomized double!blind, placebo!controlled study. Respiration 2003; 70: 275-283.Saas-Torres J., Domingo C., Moron A. et al. Long!term effects of almitrine bismesylate in COPD patients with chronic hypoxaemia. Respir. Med. 2003; 97: 599-605.Saas-Torres J., Domingo C., Moron A. et al. Long!term effects of almitrine bismesylate in COPD patients with chronic hypoxaemia. Respir. Med. 2003; 97: 599-605.Чучалин А.Г., Авдеев С.Н., Безлепко А.В. и др. Применение альмитрина при хронической дыхательной недостаточности у больных ХОБЛ. Пульмонология 2005; 2: 92-100.Чучалин А.Г., Авдеев С.Н., Безлепко А.В. и др. Применение альмитрина при хронической дыхательной недостаточности у больных ХОБЛ. Пульмонология 2005; 2: 92-100.Paggiaro P.L., Dahle R., Bakran I. et al. Multicentre randomised placebo-controlled trial of inhaled fluticasone propionate in patients with chronic obstructive pulmonary disease. International COPD Study Group. Lancet 1998; 351: 773-780.Paggiaro P.L., Dahle R., Bakran I. et al. Multicentre randomised placebo-controlled trial of inhaled fluticasone propionate in patients with chronic obstructive pulmonary disease. International COPD Study Group. Lancet 1998; 351: 773-780.Mahler D., Weinberg D., Wells C., Feinstein A. The measurement of dyspnea: contents, interobserver agreement and physiologic correlates of two new clinical indexes. Chest 1984; 85: 751-758.Mahler D., Weinberg D., Wells C., Feinstein A. The measurement of dyspnea: contents, interobserver agreement and physiologic correlates of two new clinical indexes. Chest 1984; 85: 751-758.Enright P.L., Sherrill D.L. Reference equations for the six-minute walk in healthy adults. Am. J. Respir. Crit. Care Med. 1998; 158: 1384-1387.Enright P.L., Sherrill D.L. Reference equations for the six-minute walk in healthy adults. Am. J. Respir. Crit. Care Med. 1998; 158: 1384-1387.Duranti R., Scano G., Ambrosino N. Is there a place for respiratory analeptics or related drugs in stable COPD patients? In: Similowski T., Whitelaw W.A., Derenne J.!P., eds. Clinical management of stable COPD. New York: Marcel Dekker, Inc; 2000. 383-404.Duranti R., Scano G., Ambrosino N. Is there a place for respiratory analeptics or related drugs in stable COPD patients? In: Similowski T., Whitelaw W.A., Derenne J.!P., eds. Clinical management of stable COPD. New York: Marcel Dekker, Inc; 2000. 383-404.Almaraz L., Rigual R., Obeso A. et al. Effects of almitrine on the release of catecholamines from the rabbit carotid body in vitro. Br. J. Pharmacol. 1992; 106: 697-702.Almaraz L., Rigual R., Obeso A. et al. Effects of almitrine on the release of catecholamines from the rabbit carotid body in vitro. Br. J. Pharmacol. 1992; 106: 697-702.Romaldini H., Rodriguez-Roisin R., Wagner P., West J.B. Enhancement of hypoxic pulmonary vasoconstriction by almitrine in the dog. Am. Rev. Respir. Dis. 1983; 128: 288-293.Romaldini H., Rodriguez-Roisin R., Wagner P., West J.B. Enhancement of hypoxic pulmonary vasoconstriction by almitrine in the dog. Am. Rev. Respir. Dis. 1983; 128: 288-293.Saadjian A.Y., Philip-Joel F.F., Barret A. et al. Effect of almitrine bismesylate on pulmonary vasoreactivity to hypoxia in chronic obstructive pulmonary disease. Eur. Respir. J. 1994; 7: 862-868.Saadjian A.Y., Philip-Joel F.F., Barret A. et al. Effect of almitrine bismesylate on pulmonary vasoreactivity to hypoxia in chronic obstructive pulmonary disease. Eur. Respir. J. 1994; 7: 862-868.Chen L., Miller F.L., Malmkvist G. et al. High-dose almitrine bismesylate inhibits hypoxic pulmonary vasoconstriction in closed!chest dogs. Anesthesiology 1987; 67: 534-542.Chen L., Miller F.L., Malmkvist G. et al. High-dose almitrine bismesylate inhibits hypoxic pulmonary vasoconstriction in closed!chest dogs. Anesthesiology 1987; 67: 534-542.Chen L., Miller F.L., Clarke W.R. et al. Low-dose almitrine bismesylate enhances hypoxic pulmonary vasoconstriction in closed chest dogs. Anesth. Analg. 1990; 71: 475-483.Chen L., Miller F.L., Clarke W.R. et al. Low-dose almitrine bismesylate enhances hypoxic pulmonary vasoconstriction in closed chest dogs. Anesth. Analg. 1990; 71: 475-483.Melot C., Naeije R., Rothschild T. et al. Improvement in ventilation!perfusion matching by almitrine in COPD. Chest 1983; 83: 528-533.Melot C., Naeije R., Rothschild T. et al. Improvement in ventilation!perfusion matching by almitrine in COPD. Chest 1983; 83: 528-533.Castaing Y., Manier G., Varene N., Guenard H. Almitrine orale et distribution des rapports VA / Q dans les bronchopneumopathies chroniques obstructives. Bull. Eur. Physiol. Respir. 1981; 17: 917-932.Castaing Y., Manier G., Varene N., Guenard H. Almitrine orale et distribution des rapports VA / Q dans les bronchopneumopathies chroniques obstructives. Bull. Eur. Physiol. Respir. 1981; 17: 917-932.Bakran I., Vrhovac B., Stangl B. et al. Double-blind placebo controlled clinical trial of almitrine bismesylate in patients with chronic respiratory insufficiency. Eur. J. Clin. Pharmacol. 1990; 38: 249-253.Bakran I., Vrhovac B., Stangl B. et al. Double-blind placebo controlled clinical trial of almitrine bismesylate in patients with chronic respiratory insufficiency. Eur. J. Clin. Pharmacol. 1990; 38: 249-253.Evans T.W., Tweney J., Waterhouse J.C. et al. Almitrine bismesylate and oxygen therapy in hypoxic cor pulmonale. Thorax 1990; 45: 16-21.Evans T.W., Tweney J., Waterhouse J.C. et al. Almitrine bismesylate and oxygen therapy in hypoxic cor pulmonale. Thorax 1990; 45: 16-21.Bardsley P.A. Chronic respiratory failure in COPD: Is there a place for a respiratory stimulant? Thorax 1993; 48: 781-784.Bardsley P.A. Chronic respiratory failure in COPD: Is there a place for a respiratory stimulant? Thorax 1993; 48: 781-784.Voisin C. The hypoxaemia in chronic obstructive pulmonary disease (COPD) and its management. Wiad. Lek. 1998; 51: 11-14.Voisin C. The hypoxaemia in chronic obstructive pulmonary disease (COPD) and its management. Wiad. Lek. 1998; 51: 11-14.Zielinsky J., Tobiasz M., Hawrylkiewicz I. et al. Effects of long!term oxygen therapy on pulmonary hemodynamics in COPD patients. A 6!year prospective study. Chest 1998; 113: 65-70.Zielinsky J., Tobiasz M., Hawrylkiewicz I. et al. Effects of long!term oxygen therapy on pulmonary hemodynamics in COPD patients. A 6!year prospective study. Chest 1998; 113: 65-70.Chuchalin A.G., Avdeev S.N. Epidemiology and management of COPD in Russia. In: Similowski T., Whitelaw W.A., Derenne J.P., ed. Clinical management of stable COPD. New York: Marcel Dekker, Inc.; 2002. 987-1006.Chuchalin A.G., Avdeev S.N. Epidemiology and management of COPD in Russia. In: Similowski T., Whitelaw W.A., Derenne J.P., ed. Clinical management of stable COPD. New York: Marcel Dekker, Inc.; 2002. 987-1006.

The authors declare that there are no conflicts of interest present.