Efficacy and safety of levosalbutamol in patients with mild to moderate asthma compared with racemic salbutamol: results of a crossover placebo-controlled study

Aim. Effectiveness and safety of levosalbutamol metered dose inhaler (MDI) in comparison with placebo and salbutamol. Materials and methods. In this multicenter, randomized, placebo-controlled, 3-period crossover study, all asthma patients (n=91) received levosalbutamol (90 mcg), salbutamol (180 mcg), and placebo using standard MDI. Pulmonary function testing – forced expiratory volume in the first second (FEV1) and forced vital capacity (FVC) – was performed 45 and 15 minutes before and 5, 10, 15, 30, 60, 90, 120, 180, 240, 300 and 360 minutes after dosing. The primary efficacy endpoint was the baseline-corrected area under FEV1 curve from 0 to 6 hours (AUC(0–6h)). Secondary endpoints were the baseline adjusted FEV1 and FVC peak values, as well as the onset of drug action. Results. The FEV1 AUC0–6 hours analysis confirmed similar bronchodilatory levosalbutamol and salbutamol effect (p=0.595), significantly improved compared with placebo (p0.001). The peak values of FEV1 and FVC after levosalbutamol or salbutamol dosing were similar (p=0.643) and significantly higher compared with placebo group (p0.001). The active therapy effect was observed 5 minutes after dosing and throughout the entire observation period up to 6 hours, however, there was some tendency towards a longer duration of action of levosalbutamol compared to salbutamol. Levosalbutamol was well tolerated by patients; after levosalbutamol dosing twiсе fewer adverse reactions were observed compared to salbutamol. Conclusion. Levosalbutamol at a 90-mcg dose showed efficacy similar to that of salbutamol at a dose of 180 mcg, assosiated with a good safety profile

Pilot Project «All-Russian Registry of Patients with Severe Bronchial Asthma.» The First Results in a Children’s Group of Patients (Moscow’s Observation Program)

The article presents the first results of the pilot observation program «The All-Russian Severe Asthma Patient Registry» which was started in Moscow. Objectives. The objective of this initiative is the accumulation of clinical data on patients with severe bronchial asthma in the Russian Federation. Methods. The chosen method was a registry, the rights holders of which were 3 professional associations — Interregional Public Organization «Russian Respiratory Society», Public Organization «Union of Pediatricians of Russia», All-Russian Public Organization «Association of Allergologists and Clinical Immunologists». Results. The results of the pilot project are presented by the data analysis of electronic case report forms of 36 children (totally, the project included 100 patients, 64 adults and 36 children) enrolled in the program from June to December 2016. Using the registry, a detailed analysis of the clinical characteristics of a group of children with severe atopic bronchial asthma was carried out, the results of a pharmacoepidemiological evaluation of therapy were given. Obtained by the researchers, a high frequency of the assignment of a genetically engineered biologic drug of omalizumab meets the international recommendations but does not reflect the all-Russian reality and can be explained by inclusion in the registry of pediatric patients observed only in the Federal State Autonomous Institution «National Scientific and Practical Center of Children’s Health» of the Ministry of Health of the Russian Federation. Conclusion. To determine true indicators that characterize bronchial asthma in children in the Russian Federation it is necessary, undoubtedly, to expand the geography of project participants

Пилотный проект «Общероссийский регистр пациентов с тяжелой бронхиальной астмой». Первые результаты в детской группе пациентов (наблюдательная программа г. Москвы)

The article presents the first results of the pilot observation program «The All-Russian Severe Asthma Patient Registry» which was started in Moscow. Objectives. The objective of this initiative is the accumulation of clinical data on patients with severe bronchial asthma in the Russian Federation. Methods. The chosen method was a registry, the rights holders of which were 3 professional associations — Interregional Public Organization «Russian Respiratory Society», Public Organization «Union of Pediatricians of Russia», All-Russian Public Organization «Association of Allergologists and Clinical Immunologists». Results. The results of the pilot project are presented by the data analysis of electronic case report forms of 36 children (totally, the project included 100 patients, 64 adults and 36 children) enrolled in the program from June to December 2016. Using the registry, a detailed analysis of the clinical characteristics of a group of children with severe atopic bronchial asthma was carried out, the results of a pharmacoepidemiological evaluation of therapy were given. Obtained by the researchers, a high frequency of the assignment of a genetically engineered biologic drug of omalizumab meets the international recommendations but does not reflect the all-Russian reality and can be explained by inclusion in the registry of pediatric patients observed only in the Federal State Autonomous Institution «National Scientific and Practical Center of Children’s Health» of the Ministry of Health of the Russian Federation. Conclusion. To determine true indicators that characterize bronchial asthma in children in the Russian Federation it is necessary, undoubtedly, to expand the geography of project participants.В статье представлены первые результаты пилотной наблюдательной программы «Общероссийский регистр пациентов с тяжелой бронхиальной астмой», стартовавшей в Москве. Цель данной инициативы — аккумуляция клинических сведений о больных тяжелой бронхиальной астмой в Российской Федерации. Методы. Методом был выбран регистр, правообладателями которого стали 3 профессиональные ассоциации — Межрегиональная общественная организация «Российское респираторное общество», Общественная организация «Союз педиатров России», Всероссийская общественная организация «Ассоциация аллергологов и клинических иммунологов». Результаты пилотного проекта, представлены анализом данных электронных индивидуальных регистрационных карт 36 пациентов детского возраста (всего в проект было включено 100 больных, из них 64 взрослых и 36 детей), прошедших регистрацию в программе с июня по декабрь 2016 г. С использованием регистра проведен подробный анализ клинической характеристики группы детей с тяжелой атопической бронхиальной астмой, даны результаты фармакоэпидемиологической оценки терапии. Полученная исследователями высокая частота назначения генно- инженерного биологического препарата омализумаба соответствует международным рекомендациям, однако не отражает общероссийской действительности и может быть объяснена включением в регистр пациентов детского возраста, наблюдающихся только в ФГАУ «ННПЦЗД» Минздрава России. Заключение. Для определения истинных показателей, характеризующих бронхиальную астму у детей в Российской Федерации, несомненно, необходимо расширение географии участников проекта.

Amino acid formulas in patients with food allergy

The article presents modern approaches to the use of balanced formulas for nutrition and diet correction in children with various forms of food allergies. The guidelines are based on all available up to date evidence on the efficacy, safety and utility of using such innovative medical technology as specialized amino acid formulas. This formula is the targeted medical intervention for food allergies and confirmed cow's milk protein allergy, and particularly for patients with reduced physical growth and development (growth rates included). The material is based on methodological guidelines on the amino acid formulas usage previously developed by specialist experts of the Union of pediatricians of Russia in 2020

Amino Acid Formulas in Patients with Gastrointestinal Diseases

Modern approaches for the management of children with gastrointestinal pathologies include optimal nutritional support that makes it possible to replete energy failure and restore essential nutrients balance. The article presents key information on gastrointestinal diseases in which modern amino acid formulas can be used to regulate nutritional status. The authors have conducted the extensive analysis of all available for now evidence on the efficacy, safety and utility of using such innovative medical technology as special elemental formula in gastrointestinal tract pathological conditions. This material is the basis for guidlines on the use of amino acid formulas developed by expert specialists of the Union of Pediatricians of Russia in 2020

Применение аминокислотных смесей при пищевой аллергии

The article presents modern approaches to the use of balanced formulas for nutrition and diet correction in children with various forms of food allergies. The guidelines are based on all available up to date evidence on the efficacy, safety and utility of using such innovative medical technology as specialized amino acid formulas. This formula is the targeted medical intervention for food allergies and confirmed cow's milk protein allergy, and particularly for patients with reduced physical growth and development (growth rates included). The material is based on methodological guidelines on the amino acid formulas usage previously developed by specialist experts of the Union of pediatricians of Russia in 2020.В статье приводятся современные подходы к использованию сбалансированных детских смесей, которые предназначены для вскармливания и коррекции рациона детей, страдающих различными формами пищевой аллергии. Рекомендации разработаны на основании всех доступных на сегодняшний день доказательств эффективности, безопасности и полезности использования такой инновационной медицинской технологии, как специализированные аминокислотные смеси. Данная формула является таргетным медицинским вмешательством при пищевой аллергии и подтвержденной аллергии к белкам коровьего молока, особенно для пациентов со сниженными показателями физического развития, в том числе темпов роста. Материал основан на методическом руководстве по применению аминокислотных смесей, ранее разработанном экспертами-специалистами Союза педиатров России в 2020 г

Применение аминокислотных смесей при заболеваниях желудочно-кишечного тракта

Modern approaches for the management of children with gastrointestinal pathologies include optimal nutritional support that makes it possible to replete energy failure and restore essential nutrients balance. The article presents key information on gastrointestinal diseases in which modern amino acid formulas can be used to regulate nutritional status. The authors have conducted the extensive analysis of all available for now evidence on the efficacy, safety and utility of using such innovative medical technology as special elemental formula in gastrointestinal tract pathological conditions. This material is the basis for guidlines on the use of amino acid formulas developed by expert specialists of the Union of Pediatricians of Russia in 2020.Современные подходы к ведению детей с патологией желудочно-кишечного тракта включают оптимальную нутритивную поддержку, которая позволяет восполнить энергетический дефицит и восстановить баланс основных нутриентов. В статье представлены ключевые сведения о заболеваниях пищеварительного тракта, при которых в целях коррекции нутритивного статуса могут быть использованы современные аминокислотные смеси. Авторами проведен тщательный анализ всех доступных на сегодняшний день доказательств эффективности, безопасности и полезности применения такой инновационной медицинской технологии, как специальная элементная формула при патологических состояниях желудочно-кишечного тракта. Материал является основой методического руководства по применению аминокислотных смесей, разработанного экспертами-специалистами Союза педиатров России в 2020 г