pulmoПульмонологияPULMONOLOGIYA0869-01892541-9617Scientific and Practical Journal “PULMONOLOGIYA” LLC10.18093/0869-0189-2005-0-2-92-100pulmo-2057Research ArticleОРИГИНАЛЬНЫЕ ИССЛЕДОВАНИЯORIGINAL STUDIESПрименение альмитрина при хронической дыхательной недостаточности у больных хронической обструктивной болезнью легких. Открытое проспективное мультицентровое исследованиеAlmitrine bismesylate treatment in patient with chronic obstructive pulmonary disease and moderate chronic respiratory failure. Open prospective multicentre trialЧучалинА. Г.ChuchalinA. G.

Москва

АвдеевС. Н.AvdeevS. N.

Москва

БезлепкоА. В.BezlepkoA. V.

Москва

ДобрыхВ. А.DobrichV. A.

Хабаровск

ИгнатьевВ. А.IgnatievV. A.

Санкт-Петербург

ЛещенкоИ. В.LeshenkoI. V.

Екатеринбург

МартыненкоТ. И.MartinenkoT. I.

Барнаул

МещеряковаН. Н.MesheriakovaN. N.

Москва

СуточниковаО. А.SoutochnikovaO. A.

Москва

ШмелевЕ. И.ShmelevE. I.

Москва

ЦойА. Н.TsoiA. N.

Москва

ЧернякБ. А.CherniakB. A.

Иркутск

ЧернякА. В.CherniakА. V.

Москва

НИИ пульмонологии МЗ РФRussian FederationГлавный военный клинический госпиталь им. Н.Н.БурденкоRussian FederationДальневосточный государственный медицинский университетRussian FederationНИИ пульмонологии СПБ ГМУ им. акад. И.П.ПавловаRussian FederationУральская государственная медицинская академия, Медицинское объединение "Новая больница"Russian FederationАлтайский краевой пульмонологический центрRussian FederationЦентральный НИИ туберкулеза РАМНRussian FederationММА им. И.М.Сеченова, ГКБ № 23 им. МедсантрудRussian FederationИркутский институт усовершенствования врачейRussian Federation2005280420050292100Copyright © Чучалин А.Г., Авдеев С.Н., Безлепко А.В., Добрых В.А., Игнатьев В.А., Лещенко И.В., Мартыненко Т.И., Мещерякова Н.Н., Суточникова О.А., Шмелев Е.И., Цой А.Н., Черняк Б.А., Черняк А.В., 20052005Чучалин А.Г., Авдеев С.Н., Безлепко А.В., Добрых В.А., Игнатьев В.А., Лещенко И.В., Мартыненко Т.И., Мещерякова Н.Н., Суточникова О.А., Шмелев Е.И., Цой А.Н., Черняк Б.А., Черняк А.В.Chuchalin A.G., Avdeev S.N., Bezlepko A.V., Dobrich V.A., Ignatiev V.A., Leshenko I.V., Martinenko T.I., Mesheriakova N.N., Soutochnikova O.A., Shmelev E.I., Tsoi A.N., Cherniak B.A., Cherniak А.V.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/2057

Нами проведено открытое проспективное мультицентровое исследование по изучению эффективности альмитрина при хронической дыхательной недостаточности у больных хронической обструктивной болезнью легких (ХОБЛ). В исследование были включены 77 больных ХОБЛ (M / Ж — 57 / 20, средний возраст — 63,2 ± 9,7 лет; ОФВ1 — 0,95 ± 0,38 л, PaO2 — 63,3 ± 5.4 mmHg, PaСO2 — 44,1 ± 7,3 mmHg). 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 повышению РаО2: через 1 мес. до 71,5 ± 10,6 mmHg, через 3 мес. — до 70,3 ± 8,3 mmHg, через 6 мес. — до 72,5 ± 14,2 mmHg (р < 0.001). Отмечено уменьшение одышки во время повседневной активности больных (шкала MRC): исходно — 3,5 ± 0,9, через 1 мес. — 3,0 ± 0,9, через 3 мес. — до 2,8 ± 0,9, через 6 мес. — до 2,6 ± 0,7 баллов (р < 0,001). Терапия альмитрином привела к приросту дистанции во время 6 минутного теста: исходно — 334 ± 108 м, через 1 мес. — 371 ± 101 м, через 3 мес. — 377 ± 88 м, через 6 мес. — 398 ± 104 м (р < 0,001). Было также отмечено снижение выраженности десатурации по данным пульсоксиметрии в конце нагрузочного теста (р < 0.001) и уменьшение выраженности одышки по шкале Борга после выполнения нагрузки (р < 0,001). Было выявлено достоверное улучшение практически всех критериев качества жизни больных ХОБЛ по шкале SF 36. По различным причинам из исследования выбыли 19 больных ХОБЛ. Среди побочных явлений наиболее часто встречались парестезии (6,4 %), усиление одышки (5 %), давление в легочной артерии практически не изменилось. Выводы: у больных ХОБЛ с умеренной гипоксемией альмитрин улучшает оксигенацию артериальной крови, уменьшает одышку во время повседневной активности и при физических нагрузках, повышает физическую работоспособность больных, улучшает качество жизни больных.

The efficacy and safety of almitrine bismesylate treatment was assessed in COPD patients in 6 month open prospective multicentre trial. 77 COPD patients with moderate hypoxemia were included (males / females — 57 / 20, mean age 63.2 ± 9.7 years; mean FEV1 0.95 ± 0.38 L, mean PaO2 63.3 ± 5.4 mmHg, mean PaСO2 44.1 ± 7.3 mmHg). We used an intermittent regime of almitrine administration: 1 mg / kg / day, for 3 months, then a "window" of 1 month, and again active therapy for 2 months. Almitrine therapy resulted in improvement of РаО2: rise after 1 month to 71.5 ± 10.6 mmHg, after 3 month — to 70.3 ± 8.3 mmHg, and after 6 month — to 72.5 ± 14.2 mmHg (р < 0.001). There was a significant fall in dyspnea during daily life activities (MRC score): from 3.5 ± 0.9 to 3.0 ± 0.9 (1 month), 2.8 ± 0.9 (3 month), 2.6 ± 0.7 (6 month) (р < 0.001). The distance during 6 minute walk test (6 MWT) increased from 334 ± 108 m to 371 ± 101 m (1 month), 377 ± 88 m (3 month), 398 ± 104 m (6 month) (р < 0.001). The levels of desaturation and Borg dyspnea score during 6 MWT significantly decreased (both р < 0.001). During almitrine treatment an improvement in almost all domains of SF 36 quality of life questionnaire was noted. 58 COPD patients completed the study. The most common adverse effects were parasthesia (6.4 %) and worsening of dyspnea (5 %), pulmonary artery pressure did not change during study. Conclusions: almitrine treatment in COPD patients with moderate hypoxemia resulted in improvement of arterial oxygenation, reduction of dyspnea during daily life activities and exercise, increase of physical capacity and improvement of health related quality of life.

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