pulmoПульмонологияPULMONOLOGIYA0869-01892541-9617Scientific and Practical Journal “PULMONOLOGIYA” LLCpulmo-2624Research ArticleОРИГИНАЛЬНЫЕ ИССЛЕДОВАНИЯORIGINAL STUDIESПрименение небулизированного будесонида при тяжелом обострении хронической обструктивной болезни легких. Рандомизированное контролируемое исследованииNebulized budesonide suspension in acute severe exacerbation of COPD. Randomized controlled trialАвдеевС. Н.AvdeevS. N.

Москва

СуточниковаО. А.SoutochnikovaO. A.

Москва

БелевскийА. С.BelevskyA. S.

Москва

ЧучалинА. Г.ChuchalinA. G.

Москва

НИИ пульмонологии Минздрава РФRussian Federation200303092021058188Copyright © Авдеев С.Н., Суточникова О.А., Белевский А.С., Чучалин А.Г., 20212021Авдеев С.Н., Суточникова О.А., Белевский А.С., Чучалин А.Г.Avdeev S.N., Soutochnikova O.A., Belevsky A.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/2624

Нами проведено рандомизированное плацебо-контролируемое одноцентровое исследование по оценке эффективности и безопасности небулизированного будесонида суспензии (BUD; Pulm icort Respules®) у больных с тяжелым обострением ХОБЛ. Критерии включения больных: обострение ХОБЛ, возраст старше 50 лет, анамнез курения более 20 пачек/лет, ОФВ1<50%, неиспользование системных стероидов в течение 30 дней до начала исследования, отсутствие потребности в респираторной поддержке. В исследование были включены 42 больных ХОБЛ (М:Ж 35:7, средний возраст 67±7 лет; ОФВ1 0,82±0,22 л, ра02 66±9 мм рт.ст.), которые методом рандомизации были разделены на 2 группы: терапия BUD 2 мг 2 раза в сутки (/7=21) и терапия плацебо (/7=21) в течение 10 дней. Все больные также получали бронхолитики, антибиотики и кислород при необходимости. Терапия ингаляционным BUD по сравнению с плацебо привела к более выраженному улучшению параметров ФВД (прирост ОФВ1 через 2, 7, 10 дней: 115, 171 и 257 мл в группе BUD против 53, 112 и 139 мл в группе плацебо) и оксигенации (прирост ра02 через 2, 7, 10 дней: 1,8, 2,3 и 5,1 мм рт.ст. в группе BUD против 1,2, 2,4 и 2,6 мм рт.ст. в группе плацебо). Уменьшение диспное было достигнуто более быстро у больных, принимавших BUD (2-й день; р<0,05). Частота развития побочных эффектов оказалась сходной в обеих группах. Число рецидивов обострения ХОБЛ в течение 8 нед после терапии было достоверно ниже у больных, получавших BUD (22% против 50%, р < 0,05).

The randomized placebo-controlled single-hospital centre study assessed the efficacy and safety of nebulized budesonide suspension (BUD; Pulmicort Respules®) in patients with acute exacerbation of COPD. Inclusion criteria were acute exacerbation of COPD (Anthonisen et al., 1987), age elder than 50 yrs, smoking history more than 20 pack yrs, FEV1<50%, no use of systemic steroids in previous 30 days, no need for respiratory support. Forty-two patients with severe COPD (M:F 35:7, mean age 67±7 yrs; FEV1 0.82±0.22 L, pa02 66±9 mm Hg) were randomized to BUD 2 mg bid (n=21) or nebulized placebo (n=21) for 10 days. All patients also received bronchodilators, antibiotics and oxygen if necessary. Treatment with BUD rather than placebo resulted in more rapid improvement in spirometry (AFEV1 after 2, 7, 10 days: 115, 171 and 257 ml in BUD group vs 53, 112 and 139 ml in placebo group respectively) and oxygenation (Δpa02 after 2, 7, 10 days: 1.8, 2.3 and 5.1 mm Hg in BUD group vs 1.2, 2.4 and 2.6 mm Hg in placebo group respectively). Dyspnea score also improved more rapidly in patients received BUD (the 2nd day: p<0.05). The incidence of adverse events was similar between the groups. Hospital readmission rate during 8 weeks after the study therapy was significantly lower in the BUD group (22% vs 50%, p<0.05). Nebulized budesonide suspension is an effective and safe adjunct to the usual treatment of acute exacerbation of COPD.

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