rentradВестник рентгенологии и радиологииJournal of radiology and nuclear medicine0042-46762619-0478Limited Liability Company "LUCHEVAYA DIAGNOSTIKA", Russian Association of Radiologists10.20862/0042-4676-2017-98-2-97-102rentrad-210Research ArticleОБЗОРЫ ЛИТЕРАТУРЫREVIEWS OF LITERATUREДИАГНОСТИЧЕСКАЯ ЭФФЕКТИВНОСТЬ, БЕЗОПАСНОСТЬ И БИОЭКВИВАЛЕНТНОСТЬ ПРИМЕНЕНИЯ ГАДОБУТРОЛА У ДЕТЕЙ ДО 2 ЛЕТ ПО СРАВНЕНИЮ С БОЛЕЕ СТАРШИМИ ДЕТЬМИ И ВЗРОСЛЫМИTHE DIAGNOSTIC EFFICACY, SAFETY AND BIOEQUIVALENCE OF GADOBUTROL USED IN INFANTS AGED LESS THAN 2 YEARS COMPARED WITH OLDER CHILDREN AND ADULTShttps://orcid.org/0000-0001-8097-7919АлихановА. А.AlikhanovA. A.

д. м. н., профессор, заведующий отделением лучевой диагностики,

Ленинский пр-т, 117, Москва, 119571

MD, PhD, DSc, Professor, Head of Department of Radiology,

Leninskiy prospekt, 117, Moscow, 119571

https://orcid.org/0000-0001-8887-4420ШимановскийН. Л.ShimanovskiyN. L.

д. м. н., профессор, чл.-корр. РАН, заведующий кафедрой молекулярной фармакологии и радиобиологии им. академика П.В. Сергеева,

ул. Островитянова, 1, Москва, 117997

MD, PhD, DSc, Professor, Corresponding Member of Russian Academy of Sciences, Head of Chair of Molecular Pharmacology and Radiobiology named after Academician P.V. Sergeev,

ul. Ostrovityanova, 1, Moscow, 117997

shimannn@yandex.ruФГБУ «Российская детская клиническая больница» Минздрава РоссииРоссияRussian State Children Hospital, Ministry of Health of the RFRussian FederationФГБОУ ВО «Российский национальный исследовательский медицинский университет имени Н.И. Пирогова» Минздрава РоссииРоссияPirogov Russian National Research Medical University, Ministry of Health of the RFRussian Federation20172804201798297102Copyright © Алиханов А.А., Шимановский Н.Л., 20172017Алиханов А.А., Шимановский Н.Л.Alikhanov A.A., Shimanovskiy N.L.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.russianradiology.ru/jour/article/view/210

Приведены сведения о безопасности, диагностической эффективности и биоэквивалентности применения гадобутрола у новорожденных и младенцев по сравнению с детьми более старшего возраста и взрослыми пациентами. Профиль фармакокинетики гадобутрола у детей в возрасте младше 2 лет, включая доношенных новорожденных, аналогичен тому, что имеет место у детей более старшего возраста и взрослых. При стандартной дозе 0,1 ммоль/кг массы тела гадобутрол имеет благоприятный профиль безопасности и хорошо переносится детьми любого возраста и взрослыми. Получены доказательства возможности экстраполяции применения гадобутрола у детей младше 2 лет, включая доношенных новорожденных, для эффективной диагностики нарушений гематоэнцефалического барьера и патологических изменений сердечно-сосудистой системы и очаговых заболеваний других внутренних органов.

The paper provides information on the safety, diagnostic efficiency, and bioequivalence of using gadobutrol in neonates and babies compared to older children and adult patients. In infants aged less than 2 years, including full-term newborns, the pharmacokinetic profile of gadobutrol is similar to that in older children and adults. Gadobutrol given at a standard dose of 0.1 mmol/kg body weight has a favorable safety profile and is well tolerated by children of any age and by adults. There is evidence that the use of gadobutrol may be extrapolated to infants younger than 2 years of age, including full-term neonates, for the effective diagnosis of blood-brain barrier disorders, pathological changes in the cardiovascular system, and focal diseases of the internal organs of the whole body.

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