vedomostiregmedРегуляторные исследования и экспертиза лекарственных средствRegulatory Research and Medicine Evaluation3034-30623034-3453Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)vedomostiregmed-113Research ArticleДОКЛИНИЧЕСКОЕ И КЛИНИЧЕСКОЕ ИЗУЧЕНИЕ ЛЕКАРСТВЕННЫХ СРЕДСТВPRECLINICAL AND CLINICAL STUDY OF MEDICINESМетодики фенотипирования изофермента CYP3A4, применяемые для персонализации фармакотерапииCYP3A4 isoenzyme phenotyping for personalisation of pharmacotherapyЕгоренковЕ. А.EgorenkovE. A.noemail@neicon.ruСмирновВ. В.SmirnovV. V.noemail@neicon.ruКузинаВ. Н.KuzinaV. N.noemail@neicon.ruДементьевС. П.DementievS. P.noemail@neicon.ruРаменскаяГ. В.RamenskayaG. V.noemail@neicon.ruПервый Московский государственный медицинский университет им. И. М. СеченоваРоссияI. M. Sechenov First Moscow State Medical UniversityRussian FederationПервый Московский государственный медицинский университет им. И. М. Сеченова; Научный центр экспертизы средств медицинского примененияРоссияI. M. Sechenov First Moscow State Medical University; Scientific Centre for Expert Evaluation of Medicinal ProductsRussian Federation201713022018712024Copyright © Егоренков Е.А., Смирнов В.В., Кузина В.Н., Дементьев С.П., Раменская Г.В., 20182018Егоренков Е.А., Смирнов В.В., Кузина В.Н., Дементьев С.П., Раменская Г.В.Egorenkov E.A., Smirnov V.V., Kuzina V.N., Dementiev S.P., Ramenskaya G.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.vedomostincesmp.ru/jour/article/view/113

Проведен обзор существующих методов фенотипического определения активности изофермента CYP3A4, а также оценены актуальность проблемы оценки активности данного изофермента и возможность использования данных методов в клинической практике для корректировки доз назначаемых препаратов с целью минимизации риска возникновения нежелательных реакций. Показана возможность разработки методики совместного определения нескольких субстратов CYP3A4, которая необходима для нивелирования ошибки, которая может возникнуть при включении прочих изоферментов цитохрома P450 в метаболизм какого-либо эндогенного субстрата. Предложено исключить использование крови в качестве биообъекта исследования с целью снижения инвазивности метода.

The article reviews existing methods of determining CYP3A4 isoenzyme activity. The authors assess the significance of CYP3A4 activity determination and the applicability of these methods in clinical practice to adjust drugs doses and minimize risks of adverse reactions. The article demonstrates the possibility of developing a method for simultaneous determination of several CYP3A4 substrates which is necessary to rule out potential errors arising upon introduction of other P450 cytochrome enzymes into metabolism of some endogenous substrate. It is suggested that blood should no longer be used as a biological object in the study in order to decrease the method’s invasiveness.

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