pulmoПульмонологияPULMONOLOGIYA0869-01892541-9617Scientific and Practical Journal “PULMONOLOGIYA” LLC10.18093/0869-0189-2008-0-1-62-68pulmo-1767Research ArticleОРИГИНАЛЬНЫЕ ИССЛЕДОВАНИЯORIGINAL STUDIESЭффективность терапии препаратами ипратропия при обострении хронической обструктивной болезни легких у больных, регулярно принимающих тиотропийEfficacy and safety of short-acting anticholinergics in patients with acute exacerbation of chronic obstructive pulmonary disease receiving maintenance therapy with tiotropiumАвдеевС. Н.AvdeevS. N.

Москва

НуралиеваГ. С.NuralievaG. S.

Москва

ЧучалинА. Г.ChuchalinA. G.

Москва

ФГУ НИИ пульмонологии РосздраваRussian Federation200828022008016268Copyright © Авдеев С.Н., Нуралиева Г.С., Чучалин А.Г., 20082008Авдеев С.Н., Нуралиева Г.С., Чучалин А.Г.Avdeev S.N., Nuralieva G.S., Chuchalin A.G.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/1767

Целью исследования явилось изучение эффективности и безопасности ипратропия и ипратропия / фенотерола у больных с обострением ХОБЛ, принимавших до обострения тиотропий. Исследование носило проспективный, сравнительный рандомизированный, контролируемый перекрестный характер. В нем участвовали 36 больных с обострением ХОБЛ (средний возраст – 66 лет; средний объем форсированного выдоха за 1ю с (ОФВ1) – 26 %). Исследование проводилось на протяжении 2 последовательных дней: в 1й день изучался эффект одного из 2 препаратов – ипратропия или ипратропия / фенотерола (выбор препарата определялся случайным методом – рандомизация), во 2й день происходил "перекрест" терапии – больные принимали другой препарат. Исследование включало 2 протокола. По 1му протоколу больные получали ингаляцию ипратропия 500 мкг или ипратропия / фенотерола 500 / 1 000 мкг при помощи небулайзера. По 2му протоколу пациенты получали ингаляцию ипратропия 80 мкг или ипратропия / фенотерола 80 / 200 мкг при помощи дозированного аэрозольного ингалятора (ДАИ) и спейсера. Клинические показатели, параметры функции внешнего дыхания и гемодинамики оценивались до и через 1 и 4 ч от начала терапии. Небулайзерная терапия препаратами ипратропия и ипратропия / фенотерола приводила к клинически значимому приросту показателей ОФВ1 , форсированной жизненной емкости легких (ФЖЕЛ) и емкости вдоха через 1 и 4 ч после ингаляции (р < 0,01). Эффективность ипратропия / фенотерола была несколько выше по сравнению с монотерапией ипратропием. На фоне ингаляционной терапии не было отмечено серьезных побочных эффектов, в том числе и со стороны параметров гемодинамики (показатели артериального давления, ЭКГ и QTc); только после ингаляции ипратропия / фенотерола отмечено повышение частоты сердечных сокращений (ЧСС) на 3,8 мин –1 (p < 0,001). Ингаляционная терапия ипратропием и ипратропием / фенотеролом, назначаемая при помощи ДАИ и спейсера, приводила примерно к тем же результатам, что и терапия данными препаратами при помощи небулайзера. После приема ипратропия / фенотерола в этом случае отмечено повышение ЧСС на 3,7 мин –1 (p < 0,001). У больных с обострением ХОБЛ, принимающих тиотропий, назначение ипратропия и ипратропия / фенотерола приводит к достоверному бронхорасширяющему эффекту, не вызывая при этом развития дополнительных побочных эффектов.

The aim of the study was to assess efficacy and safety of ipratropium and ipratropium/fenoterol in patients with acute exacerbation of COPD receiving maintenance therapy with tiotropium. Design: prospective, randomized, controlled cross-over study. Patients and methods. Thirty six patients with COPD exacerbation (mean age 66 yrs; mean FEV1 26 %) were included in the study. Patients were randomized to receive either ipratropium or ipratropium/fenoterol on two different test days. The study consisted of two different protocols. In the 1st protocol, the patients received either nebulized solution of ipratropium 500 μg or ipratropium/fenoterol 500/1000 μg. In the 2nd protocol, patients received either ipratropium 80 μg via metered dose inhaler (MDI) and spacer or ipratropium/fenoterol 80/200 μg. Spirometry, clinical and hemodynamic measurements were performed immediately before and at 1 and 4 hours after inhalation of ipratropium or ipratropium/fenoterol. Nebulized therapy with ipratropium or ipratropium/fenoterol resulted in statistically and clinically significant improvement in FEV1 , FVC and IC at 1 and 4 hours after inhalation (р < 0.01). In terms of the bronchodilator effect, add-on therapy with ipratropium/fenoterol was nonsignificantly superior to add-on ipratropium. There were no serious adverse events after inhaled therapy including hemodynamic parameters (BP, ECG, QTc). Only ipratropium/fenoterol resulted in increase of heart rate, approximately by 3.8 beats per minute (bpm) at 1 hour after inhalation (p < 0.001). Inhaled therapy with ipratropium or ipratropium/fenoterol via MDI and spacer led to similar results as nebulized therapy. Heart rate was increased at 1 hour after inhalation of ipratropium/fenoterol via MDI and spacer by 3.7 bpm (p < 0.001). In patients with acute exacerbation of COPD receiving maintenance therapy with tiotropium, the addition of ipratropium or ipratropium / fenoterol provides significant bronchodilator effect without any serious adverse events.

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