clinvestКачественная клиническая практикаKachestvennaya Klinicheskaya Praktika = Good Clinical Practice2588-05192618-8473ООО «Издательство ОКИ10.24411/2588-0519-2018-10052clinvest-418Research ArticleФАРМАКОНАДЗОРPHARMACOVILIGANCEГепатотоксичность новых оральных антикоагулянтов: обзор литературыHepatotoxicity of new oral anticoagulants: literature reviewhttps://orcid.org/0000-0001-8912-2060ПоповаН. С.PopovaN. S.

Попова Наталия Сергеевна

Санкт-Петербург

SPIN-код: 3592-9814

Popova Natalya

Saint-Petersburg

SPIN-code: 3592-9814

https://orcid.org/0000-0003-3499-4608ФилипповаА. В.PhilippovaA. V.

Филиппова Анастасия Владимировна, аспирант кафедры клинической фармакологии и доказательной медицины

Санкт-Петербург

SPIN-код: 3989-9803

Filippova Anastasia, Post-graduate student, Department of Clinical Pharmacology and Evidence-Based Medicine, First St. Petersburg State Medical University named afer I.P. Pavlova

Saint-Petersburg

SPIN-code: 3989-9803

a.v.flippova2012@gmail.comhttps://orcid.org/0000-0002-8784-856XГаланкинТ. Л.GakankinT. L.

Галанкин Тимофей Леонидович, кандидат медицинских наук, заведующий лабораторией фармакоэпидемиологии и фармакокинетики

Санкт-Петербург

SPIN-код: 7808-0586

Gakankin Timofey, Candidate of Medical Sciences, Head of the laboratory of pharmacoepidemiology and pharmacokinetics in the First St. Petersburg State Medical University named afer acad. I.P. Pavlov of the Ministry of Health of the Russian Federation

Saint-Petersburg

SPIN-code: 7808-0586 

https://orcid.org/0000-0002-1919-2909КолбинА. С.KolbinA. S.

Колбин Алексей Сергеевич, доктор медицинских наук, профессор, заведующий кафедрой клинической фармакологии и доказательной медицины, ФГБОУ ВО ПСПбГМУ им. И.П. Павлова Минздрава России; профессор кафедры фармакологии медицинского факультета Санкт-Петербургского государственного университета

Санкт-Петербург

SPIN-код: 7966-0845

Kolbin Alexey,  MD, Professor, Head of the Department of Clinical Pharmacology and Evidence-Based Medicine, FSBEI HE I.P. Pavlov SPbSMU MOH Russia; professor of the Department of Pharmacology, Medical Faculty, St. Petersburg State University

Saint-Petersburg

SPIN-code: 7966-0845

https://orcid.org/0000-0001-6284-7133КасимоваА. Р.KasimovaA. R.

Касимова Алина Рашидовна

Санкт-Петербург

SPIN-код: 3131-4385 

Kasimova Alina

Saint-Petersburg

SPIN-code: 3131-4385

ФГБОУ ВО «Первый Санкт-Петербургский государственный медицинский университет им. академика И.П. Павлова»РоссияFSBEI HE I.P. Pavlov SPbSMU MOH RussiaRussian FederationФГБОУ ВО «Первый Санкт-Петербургский государственный медицинский университет им. академика И.П. Павлова»; Федеральное государственное бюджетное образовательное учреждение высшего образования «Санкт-Петербургский государственный университет»РоссияFSBEI HE I.P. Pavlov SPbSMU MOH Russia; Federal State Budgetary Educational Institution of Higher Education «Saint-Petersburg State University»Russian FederationФГБОУ ВО «Первый Санкт-Петербургский государственный медицинский университет им. академика И.П. Павлова»; Российский научно-исследовательский институт травматологии и ортопедии им Р.Р. ВреденаРоссияFSBEI HE I.P. Pavlov SPbSMU MOH Russia; Russian research Institute of traumatology and orthopedics named afer R. R. VredenRussian Federation201817012019036672Copyright © Попова Н.С., Филиппова А.В., Галанкин Т.Л., Колбин А.С., Касимова А.Р., 20192019Попова Н.С., Филиппова А.В., Галанкин Т.Л., Колбин А.С., Касимова А.Р.Popova N.S., Philippova A.V., Gakankin T.L., Kolbin A.S., Kasimova A.R.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.clinvest.ru/jour/article/view/418

Статья представляет собой обзор литературы, посвящённый анализу данных о гепатотоксичности новых оральных антикоагулянтов, полученных с помощью различных методов фармаконадзора. В обзор включено 35 источников: 24 статьи, 4 методических и регуляторных рекомендации, 3 публикации экспертных сообществ, 3 обзора регистрационных материалов по лекарственным средствам и 1 источник, представляющий собой выборку из реестра исследований.

Tis article presents a literature review of hepatotoxicity of new oral anticoagulants which was obtained by different methods options of pharmacovigilance. Te overview includes 35 information sources 24 articles, 4 methodic or regulatory guidelines, 3 expert group publications, 3 new drug application overviews and 1 source being clinical trial register search results. Upon the results of the literature review, it was concluded that pharmacovigilance methods analyzing data obtained within real world medical practice give more opportunities for safety signal management comparing to those analyzing only data obtained within randomized clinical trials.

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