surgoncoКреативная хирургия и онкологияCreative surgery and oncology2076-30932307-0501Башкирский государственный медицинский университет10.24060/2076-3093-2024-14-1-69-77surgonco-918Research ArticleОБЗОР ЛИТЕРАТУРЫREVIEWSБезопасность применения противоопухолевых лекарственных препаратов «вне инструкции» в онкологииSafety of Off-Label Use of Anticancer Drugs in Oncologyhttps://orcid.org/0000-0001-6062-5318КарабинаЕ. В.KarabinaE. V.

Карабина Елена Владимировна — отделение противоопухолевой лекарственной терапии, кафедра онкологии и клинической морфологии

Тула

Уфа

Elena V. Karabina — Anticancer Drug Therapy Unit, Department of Oncology and Clinical Morphology

Tula

Ufa, Republic of Bashkortostan

   

kev-251@yandex.ruhttps://orcid.org/0000-0003-4341-6017СакаеваД. Д.SakaevaD. D.

Сакаева Дина Дамировна — д.м.н., профессор, кафедра фармакологии

Уфа

   

Dina D. Sakaeva — Dr. Sci. (Med.), Prof., Department of Pharmacology

Ufa, Republic of Bashkortostan

   

https://orcid.org/0000-0002-8867-504XЛипатовО. Н.LipatovO. N.

Липатов Олег Николаевич — д.м.н., профессор, кафедра онкологии и клинической морфологии

Уфа

Oleg N. Lipatov — Dr. Sci. (Med.), Prof., Department of Oncology and Clinical Morphology

Ufa, Republic of Bashkortostan

Тульский областной клинический онкологический диспансер; Башкирский государственный медицинский университетРоссияTula Regional Clinical Oncology Dispensary; Bashkir State Medical UniversityRussian FederationБашкирский государственный медицинский университет; Клинический госпиталь «Мать и дитя»РоссияBashkir State Medical University; Mother and Child Clinical HospitalRussian FederationБашкирский государственный медицинский университетРоссияBashkir State Medical UniversityRussian Federation2024180420241416977Copyright © Карабина Е.В., Сакаева Д.Д., Липатов О.Н., 20242024Карабина Е.В., Сакаева Д.Д., Липатов О.Н.Karabina E.V., Sakaeva D.D., Lipatov O.N.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.surgonco.ru/jour/article/view/918

Ключевой проблемой использования противоопухолевых лекарственных препаратов «вне инструкции» является безопасность. Как правило, преимущества подобных назначений в онкологии ассоциированы с превышением потенциальной клинической пользы над рисками возникновения осложнений. Однако в определенных клинических ситуациях, когда соотношение польза/риск полностью не установлено, применение указанных агентов не в соответствии с инструкцией может создать угрозу жизни и здоровью пациента. Данная статья посвящена изучению безопасности противоопухолевой лекарственной терапии «вне инструкции» в реальной клинической практике. Систематический учет и тщательный мониторинг нежелательных явлений, связанных с использованием лекарственных препаратов «вне инструкции», представляет собой приоритетное направление организации здравоохранения и работы в условиях рутинной клинической практики. Создание системы унифицированного учета применения лекарственной терапии «вне инструкции» в онкологии и создание крупных баз данных (на площадках учреждений с возможностью объединения полученных сведений на уровне округов, областей, регионов и страны) позволит аккумулировать значительный объем информации о безопасности и эффективности подобного подхода. Реализация этой концепции будет способствовать формированию прогнозируемого характера лечения и управляемому профилю его токсических эффектов. Изучение причин применения лекарственных препаратов «вне инструкции» в онкологии, а также исследование спектра и тяжести нежелательных явлений, возникших вследствие реализации данных назначений, позволит получить детальную информацию о безопасности использования противоопухолевых агентов не в соответствии с инструкцией у пациентов со злокачественными новообразованиями на разных этапах лечения опухолевого процесса.

Safety is recognized as a crucial issue of off-label use of anticancer drugs. The potential benefits of such prescriptions in oncology are associated with prevailing the expected clinical benefits over the risks of complications. However, in certain clinical situations with uncertain benefit/risk ratio, an off-label use of drugs may threaten the life and health of the patient. The present paper explores the safety of off-label anticancer drug therapy in real clinical practice. Health care and routine clinical practice are given particular emphasis on systematic recording and careful monitoring of adverse events associated with the off-label use of medicinal products. The creation of a unified registration system for off-label use of drug therapy in oncology along with the creation of large databases (on the sites of institutions with an option to combine the data obtained at the level of districts, regions and the country) enables a significant amount of information on the safety and effectiveness of this approach to be gathered. As a result, a predictable nature of treatment and manageable toxic effects are potentially provided. The study into reasons behind off-label use of drugs in oncology, as well as the study into spectrum and severity of adverse events resulting from the implementation of these prescriptions, will provide detailed information on the safety of off-label use of anticancer agents in patients with malignant neoplasms at different stages of oncological treatment.

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