ppharmПедиатрическая фармакологияPediatric pharmacology1727-57762500-3089Издательство «ПедиатрЪ»10.15690/pf.v13i6.1668ppharm-1479Research ArticleОРИГИНАЛЬНЫЕ СТАТЬИORIGINAL ARTICLESПЕРВЫЕ РЕЗУЛЬТАТЫ ДЛИТЕЛЬНОГО ДИНАМИЧЕСКОГО МОНИТОРИНГА ДЕТЕЙ С БРОНХИАЛЬНОЙ АСТМОЙ ТЯЖЕЛОГО ПЕРСИСТИРУЮЩЕГО НЕКОНТРОЛИРУЕМОГО ТЕЧЕНИЯPRIMARY RESULTS OF LONG-TERM DYNAMIC MONITORING OF CHILDREN WITH BRONCHIAL ASTHMA OF UNCONTROLLED SEVERE PERSISTENT COURSEhttps://orcid.org/0000-0002-2209-7531Намазова-БарановаЛ. С.Namazova-BaranovaL. S.https://orcid.org/0000-0001-7398-0562ВишнёваЕ. А.VishnyovaE. A.

Москва

https://orcid.org/0000-0002-3696-3293ДобрынинаЕ. А.DobryninaE. A.

Добрынина Елена Андреевна - врач аллерголог-иммунолог  отделения восстановительного  лечения детей с аллергическими болезнями и заболеваниями органов дыхания НИИ педиатрии НЦЗД.

119991, Москва Ломоносовский пр-т, д. 2 стр. 3, тел.: +7 (499) 134-03-92, e-mail: elenadobrinina@gmail.com

elenadobrinina@gmail.comhttps://orcid.org/0000-0001-5665-7835АлексееваА. А.AlekseevaA. A.

Moscow

СмирновВ. И.SmirnovV. I.

Москва

ЛевинаЮ. Г.LevinaJ. G.АнтоноваЕ. В.AntonovaE. V.

Москва

Научный центр здоровья детей; Первый Московский государственный медицинский университет имени И.М. Сеченова; Российский национальный исследовательский медицинский университет имени Н.И. ПироговаРоссияScientific Center of Children’s Health; Russian Federation N.I. Pirogov Russian National Research Medical University; I.M. Sechenov First Moscow State Medical UniversityRussian FederationНаучный центр здоровья детейРоссияScientific Center of Children’s HealthRussian FederationНаучный центр здоровья детей; Первый Московский государственный медицинский университет имени И.М. СеченоваРоссияScientific Center of Children’s Health; Russian Federation N.I. Pirogov Russian National Research Medical UniversityRussian Federation201615022017136554559Copyright © Намазова-Баранова Л.С., Вишнёва Е.А., Добрынина Е.А., Алексеева А.А., Смирнов В.И., Левина Ю.Г., Антонова Е.В., 20172017Намазова-Баранова Л.С., Вишнёва Е.А., Добрынина Е.А., Алексеева А.А., Смирнов В.И., Левина Ю.Г., Антонова Е.В.Namazova-Baranova L.S., Vishnyova E.A., Dobrynina E.A., Alekseeva A.A., Smirnov V.I., Levina J.G., Antonova E.V.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.pedpharma.ru/jour/article/view/1479

Регистры пациентов помогают получать  актуальную  информацию о клиническом течении заболеваний,  о безопасности и эффективности  используемых  медицинских технологий.  Цель  исследования: проанализировать эффективность и безопасность омализумаба у детей с тяжелой  персистирующей неконтролируемой  бронхиальной астмой (БА) по данным разработанного  регистра. Методы. Разработан регистр больных с тяжелой  БА неконтролируемого  течения, получающих омализумаб дополнительно к базисной терапии. Результаты. Проанализированы  результаты лечения 101 ребенка в возрасте от 6 до 17 лет. Продолжительность терапии омализумабом составила  от 1 до 85 мес, медиана 16 (10; 44) мес. Препарат использовали  в дозах от 75 до 600 мг, медиана 300 (225; 375) мг. На фоне терапии омализумабом удалось добиться лучшего контроля над заболеванием (АСТ-тест до начала терапии — 14 (11; 17) баллов,  через 1 год — 20 (13; 25); p < 0,001), уменьшения объема ежедневной базисной терапии (до начала терапии средняя доза ингаляционных глюкокортикостероидов в пересчете на флутиказон  была 629 ± 304 мкг (n = 15), через 4 года — 524 ± 342 мкг; р = 0,065), сокращения количества обострений и потребности в применении короткодействующих    2-агонистов.  Нежелательных системных явлений  на введение  генно-инженерных  биологических препаратов не зафиксировано. Заключение. Регистр больных с тяжелой  персистирующей БА может использоваться в качестве инструмента длительного мониторинга и комплексной оценки эффективности  и безопасности терапии. 

Background

Background. Patients registers help obtain the latest information about the clinical course of a disease, safety and effectiveness of the medical technology. Objective: Our aim was to analyze the efficiency and safety of omalizumab with children suffering from uncontrolled severe persistent bronchial asthma (BA) according to the data of the developed register.

Methods

Methods.  A register of patients with severe asthma of uncontrolled course receiving omalizumab in addition to basic therapy has been developed.

Results

Results. Results of treatment of 101 children aged 6–17 have been analyzed. The duration of therapy with omalizumab lasted from 1 to 85 months, with a median of 16 (10; 44) months. The drug was used in doses of 75 to 600 mg, with a median of 300 (225; 375) mg. The therapy with omalizumab allowed achieving a better control of the disease (AST test prior to start of therapy — 14 (11; 17) points, in 1 year — 20 (13; 25); p < 0,001); reduction of the volume of daily base therapy (prior to start of therapy, average dose of inhaled corticosteroids in terms of fluticasone was 629 ± 304 mg (n = 15), in 4 years — 524 ± 342 mg; p = 0.065); reduction of the number of aggravations and the need to use short-effectiv   2-agonists.  No adverse systemic effects of the introduction of genetically engineered biological drugs have been found.

Conclusion

Conclusion. Register of patients with severe persistent asthma can be used as a tool for long-term  monitoring and integrated assessment of the efficiency and safety of therapy.

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