ОПЫТ ПРИМЕНЕНИЯ ПАЛИВИЗУМАБА ДЛЯ ПРОФИЛАКТИКИ РЕСПИРАТОРНО-СИНЦИТИАЛЬНОЙ ВИРУСНОЙ ИНФЕКЦИИ У НЕДОНОШЕННЫХ ДЕТЕЙ С БРОНХОЛЕГОЧНОЙ ДИСПЛАЗИЕЙ

The data on prophylaxis efficacy of the Palivizumab (synagis) against respiratory syncytial viral infection in premature children with bronchopulmonary dysplasia are shown in the article. No side-effects, good tolerance and decrease of the frequency of bronchopulmonary dysplasia relapses and other viral diseases in whole in such children were registered.Представлены данные об эффективности профилактики респираторно-синцитиальной вирусной инфекции у недоношенных детей с бронхолегочной дисплазией препаратом паливизумаб (синагис); отмечено отсутствие  осложнений  от введения препарата, его хорошая переносимость, снижение частоты обострений бронхолегочной дисплазии и в целом заболеваний  этих детей вирусной инфекцией.

ЭФФЕКТИВНОСТЬ ПАЛИВИЗУМАБА В СНИЖЕНИИ ЧАСТОТЫ ГОСПИТАЛИЗАЦИИ ДЕТЕЙ С РСВ ИНФЕКЦИЕЙ В ГРУППАХ ВЫСОКОГО РИСКА: ПРОСПЕКТИВНОЕ НАБЛЮДАТЕЛЬНОЕ МНОГОЦЕНТРОВОЕ ИССЛЕДОВАНИЕ

Background: Palivizumab is indicated for the prevention of serious respiratory syncytial virus (RSV) disease in high-risk infants.Aims: The purpose of the study was to assess the real-world effectiveness and safety of palivizumab in children at high risk for serious RSV disease during the 2014−2015 RSV season in the Russian Federation.Methods: A prospective, observational, multicentre, cohort study was conducted in a population of infants at high-risk for serious RSV illness: infants born ≤35 weeks of gestation and infants ≤24 months with bronchopulmonary dysplasia (BDP) or congenital heart disease (CHD), who were administered palivizumab immunoprophylaxis in routine clinical settings. The study was conducted at 16 investigational sites of European Russia and Western Siberia.Results: A total of 359 infants were enrolled (180 boys and 179 girls). Of them, 148 (41.2%) infants had BDP, 45 (12.5%) infants had hemodynamically significant CHD, and 166 (46.2%) children of prematurity were at the risk of RSV. The majority of infants (86.9%) received three or more injections during the course of study. Of the 359 participants enrolled, 11 (3.1%; 95% CI 1.5−5.4) patients were hospitalized for lower respiratory tract infection. A RSV diagnostic test was performed in 9 infants, and RSV was detected in one patient giving an overall incidence of RSV hospitalization as 0.3% (95% CI 0.0−1.5).Conclusions: This study showed that immunoprophylaxis with palivizumab was associated with a low rate of RSV hospitalization. Overall, therapy with palivizumab was well-tolerated and showed a favourable benefit-risk profile.Обоснование. Паливизумаб предназначен для профилактики тяжелых форм респираторной синцитиальной вирусной (РСВ) инфекции у детей групп высокого риска.Цель исследования ― оценка эффективности и безопасности паливизумаба в повседневной клинической практике при применении у детей с высоким риском развития тяжелой РСВ инфекции в эпидемический сезон 2014−2015 гг. в Российской Федерации.Методы. Проведено проспективное наблюдательное многоцентровое когортное исследование с участием детей грудного и раннего детского возраста групп высокого риска по развитию тяжелой РСВ инфекции: дети с гестационным возрастом при рождении ≤35 нед; дети в возрасте ≤24 мес с бронхолегочной дисплазией (БЛД) или врожденным пороком сердца (ВПС), которым в рамках рутинной клинической практики была назначена иммунопрофилактика паливизумабом. Работа выполнена на базе 16 исследовательских центров, расположенных в европейской части России и Западной Сибири.Результаты. Всего в исследование были включены 359 (180 мальчиков и 179 девочек) детей раннего детского возраста, из них 148 (41,2%) имели БЛД, 45 (12,5%) ― гемодинамически значимый ВПС, 166 (46,2%) относились к группе высокого риска тяжелого течения РСВ инфекции по причине недоношенности. Большинство детей (86,9%) получили три и более инъекции препарата. Из 359 детей, включенных в исследование, были госпитализированы по причине развития инфекции нижних дыхательных путей 11 (3,1%; 95% ДИ 1,5–5,4). Диагностический тест на РСВ был выполнен у 9 детей, РСВ инфекция подтверждена у 1 ребенка. Таким образом, частота РСВ-ассоциированной госпитализации составила 0,3% (95% ДИ 0,0–1,5).Заключение. Исследование продемонстрировало низкую частоту РСВ-ассоциированной госпитализации при проведении иммунопрофилактики паливизумабом. Терапия препаратом хорошо переносилась и показала благоприятный профиль риск/польза

ANTIFEBRILE THERAPY IN INFANTS

The article demonstrates the necessity to prescribe the anti febrile medications to children on medical authority only. Besides, the authors stress that the doctor's tactics should be differential in the various types of fever. It is specifically essential for the pediatricians to take account both of the efficiency and safety of a prescribed medication, while choosing one.Key words: fever, fever types, antifebrile medications, children

ANTIFEBRILE THERAPY IN INFANTS

The article demonstrates the necessity to prescribe the anti febrile medications to children on medical authority only. Besides, the authors stress that the doctor's tactics should be differential in the various types of fever. It is specifically essential for the pediatricians to take account both of the efficiency and safety of a prescribed medication, while choosing one.Key words: fever, fever types, antifebrile medications, children

ЖАРОПОНИЖАЮЩАЯ ТЕРАПИЯ У ДЕТЕЙ ДО 1 ГОДА

The article demonstrates the necessity to prescribe the anti febrile medications to children on medical authority only. Besides, the authors stress that the doctor's tactics should be differential in the various types of fever. It is specifically essential for the pediatricians to take account both of the efficiency and safety of a prescribed medication, while choosing one.Key words: fever, fever types, antifebrile medications, children.В статье демонстрируется необходимость назначения жаропонижающих средств у детей только по строгим показаниям. Кроме того, авторы подчеркивают, что тактика врача должна быть дифференциальной тактики ведения пациентов с различными типами лихорадки. Педиатрам особенно важно при выборе лекарственного средства руководствоваться не только данными об эффективности, но и безопасности назначаемого препарата. Ключевые слова: лихорадка, типы лихорадки, жаропонижающие средства, дети. (Педиатрическая фармакология. – 2008;5(6):75-78

STRATEGIES OF DOMESTIC NEONATOLOGY: CHALLENGES OF THE PRESENT AND LOOK INTO THE FUTURE

The article presents the main directions of development of modern neonatology and pediatrics of early age. Along with the unconditional achievements in the field of nursing newborns, important issues are raised for further improving the organization and ensuring adequate and effective follow-up of children after discharge from the hospital, which is primarily aimed at improving outcomes. Early respiratory therapy, open resuscitation and priority of breastfeeding, treatment and prevention of bronchopulmonary dysplasia, prevention of respiratory syncytial viral infection, as well as the organization of postneonatal habilitation of premature babies, audits to improve the quality of medical care for newborns and children are the main ones, but far from all directions that are indicated by the team of authors in this publication. At the same time, attention is focused on the most pressing issues of drug and technical support, personnel shortage, safety and effectiveness of the use of modern technologies in neonatal practice, which we all have to solve in the future. The purpose of the publication is to draw attention to the pressing problems of everyone on whom the development strategies of domestic neonatology and pediatrics depend. The authors invite everyone to express their opinions and suggestions by sending their letters collectively or individually to the editorial office. © 2022

A prospective, open-label, non-comparative study of palivizumab prophylaxis in children at high risk of serious respiratory syncytial virus disease in the Russian Federation

Background: Respiratory syncytial virus (RSV) is a leading cause of lower respiratory tract infections (LRTIs) in children globally. Predisposing conditions for the development of serious RSV disease include preterm infants and those with cardiopulmonary illness, including congenital heart disease (CHD) and bronchopulmonary dysplasia (BPD). No vaccine is currently approved for the prevention of RSV infection. It is recommended that children at high risk be prophylactically administered palivizumab, a monoclonal antibody that has been shown in a number of clinical studies to reduce hospitalization rates due to serious RSV infection. The objective of the current study was to determine the safety and effectiveness of palivizumab in preventing serious RSV disease in high-risk children in the Russian Federation. Children at high risk of serious RSV disease (ie, born at ≤35 wk gestational age and ≤6 mo of age, and/or aged ≤24 mo with BPD or hemodynamically significant CHD) were enrolled. Subjects were to receive 3 to 5 monthly injections of palivizumab 15 mg/kg (depending on the month of the initial injection) over the RSV season. The primary endpoint was RSV-related hospitalizations. Adverse events (AEs) were reported through 100 days following the final injection. Results: One hundred subjects received ≥1 injection of palivizumab; 94 completed their dosing schedule. There were no RSV hospitalizations or deaths. Six of 7 subjects hospitalized for respiratory/cardiac conditions had an RSV test, which was negative in all cases. Three non-serious AEs (acute intermittent rhinitis and rhinitis, 1 subject; atopic dermatitis, 1 subject) were considered possibly related to palivizumab. All other AEs were mild or moderate and considered not related/probably not related to palivizumab. Conclusion: Palivizumab was generally well tolerated and effectively prevented serious RSV infection in a mixed population of high-risk children in the Russian Federation. Trial registration. ClinicalTrials.gov: NCT01006629. © 2012 Turti et al.; licensee BioMed Central Ltd

Clinical outcomes of hospitalization of premature infants (Gestational age 33–35 weeks) with lower respiratory tract infections, associated and not associated with the respiratory syncytial virus, in the poni international study

Study rationale: premature infants have a higher risk of developing severe lower respiratory tract infections (LRTI), compared with full-term children. Respiratory syncytial virus (RSV) is the most common cause of LRTI in preschool children, including children aged up to 1 year. Objective of the research – to determine the incidence, severity, course and outcome of hospitalizations caused by LRTI associated and not associated with RSV in preterm infants who had no immunoprophylaxis. Study materials and methods: a surveillance epidemiological study was conducted in 23 countries (Western Europe, Eastern Europe and Russia, Middle East, Mexico, Korea) from September 2013 to July 2014. The study included premature infants born from 33 weeks +0 days to 35 weeks +6 days of gestation, within 6 months before the start of RSV season. Data were obtained from medical records during a conversation/telephone contact with the parents. Results: of 2390 children included, 64 were hospitalized due to LRTI and had at least one positive RSV test result (RSV+ group), 100 – at least one negative RSV test result (RSV–). Results for RSV+ and RSV– groups were, respectively: the incidence of coughing was in 31,3 and 8%of children; hospitalization duration (median) 7 and 5,5 days; use of additional oxygen: 73,4 and 40% of children; hospitalization in the intensive care unit: 29,7 and 24%; artificial lung ventilation: 10,9 and 8% of children; its duration (median) 4 and 3 days. Conclusion: premature infants with RSV, in contrast to preterm infants without RSV, have more severe symptoms and signs of LRTI, more frequent use of supplemental oxygen and a tendency to more severe hospitalization course. © 2017, Pediatria Ltd. All rights reserved

Clinical outcomes of hospitalization of premature infants (Gestational age 33–35 weeks) with lower respiratory tract infections, associated and not associated with the respiratory syncytial virus, in the poni international study

Study rationale: premature infants have a higher risk of developing severe lower respiratory tract infections (LRTI), compared with full-term children. Respiratory syncytial virus (RSV) is the most common cause of LRTI in preschool children, including children aged up to 1 year. Objective of the research – to determine the incidence, severity, course and outcome of hospitalizations caused by LRTI associated and not associated with RSV in preterm infants who had no immunoprophylaxis. Study materials and methods: a surveillance epidemiological study was conducted in 23 countries (Western Europe, Eastern Europe and Russia, Middle East, Mexico, Korea) from September 2013 to July 2014. The study included premature infants born from 33 weeks +0 days to 35 weeks +6 days of gestation, within 6 months before the start of RSV season. Data were obtained from medical records during a conversation/telephone contact with the parents. Results: of 2390 children included, 64 were hospitalized due to LRTI and had at least one positive RSV test result (RSV+ group), 100 – at least one negative RSV test result (RSV–). Results for RSV+ and RSV– groups were, respectively: the incidence of coughing was in 31,3 and 8%of children; hospitalization duration (median) 7 and 5,5 days; use of additional oxygen: 73,4 and 40% of children; hospitalization in the intensive care unit: 29,7 and 24%; artificial lung ventilation: 10,9 and 8% of children; its duration (median) 4 and 3 days. Conclusion: premature infants with RSV, in contrast to preterm infants without RSV, have more severe symptoms and signs of LRTI, more frequent use of supplemental oxygen and a tendency to more severe hospitalization course. © 2017, Pediatria Ltd. All rights reserved