biopreparatБИОпрепараты. Профилактика, диагностика, лечениеBiological Products. Prevention, Diagnosis, Treatment2221-996X2619-1156Scientific Centre for Expert Evaluation of Medicinal Productsbiopreparat-37Research ArticleОБЗОРЫREVIEWSБезопасность биологических препаратов. Сообщение 1. Вопросы терминологии и классификацииSafety of biological preparations. Report 1. Terminology and classification issuesСолдатовА. А.SoldatovA. A.

Главный эксперт Управления экспертизы аллергенов, цитокинов и других иммуномодуляторов Центра экспертизы и контроля МИБП, д-р мед. наук

Chief expert of Office of expertise allergens, cytokines and other immunomodulators of Center for examination and control of medical immunobiological preparations. Doctor of Medical Sciences

Soldatov@expmed.ruАвдееваЖ. И.AvdeevaZh. I.

Главный эксперт Управления экспертизы аллергенов, цитокинов и других иммуномодуляторов Центра экспертизы и контроля МИБП, д-р мед. наук, профессор

Chief expert of Office of expertise allergens, cytokines and other immunomodulators of Center for examination and control of medical immunobiological preparations. Doctor of Medical Sciences, professor

noemail@neicon.ruОлефирЮ. В.OlefirYu. V.

Генеральный директор, д-р мед. наук

Director General. Doctor of Medical Sciences

noemail@neicon.ruМеркуловВ. А.MerkulovV. A.

Заместитель генерального директора по экспертизе лекарственных средств, д-р мед. наук, профессор

Deputy Director General for the expertise of drugs. Doctor of Medical Sciences, professor

noemail@neicon.ruБондаревВ. П.BondarevV. P.

Директор Центра экспертизы и контроля МИБП, д-р мед. наук, профессор

Director of Center for examination and control of medical immunobiological preparations. Doctor of Medical Sciences, professor

noemail@neicon.ruНаучный центр экспертизы средств медицинского примененияРоссияScientific Centre for Expert Evaluation of Medicinal ProductsRussian Federation2016200220181611426Copyright © Солдатов А.А., Авдеева Ж.И., Олефир Ю.В., Меркулов В.А., Бондарев В.П., 20182018Солдатов А.А., Авдеева Ж.И., Олефир Ю.В., Меркулов В.А., Бондарев В.П.Soldatov A.A., Avdeeva Z.I., Olefir Y.V., Merkulov V.A., Bondarev V.P.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.biopreparations.ru/jour/article/view/37

Применение лекарственных средств сопровождается развитием побочных реакций (ПР). Для объективного анализа причин и механизмов их развития, с целью разработки методов купирования и предупреждения ПР, необходимо использовать стандартные критерии для характеристики ПР. Обычно, описание ПР включает указание поврежденного органа или ткани и частоту развития ПР. Для характеристики ПР на низкомолекулярные химические препараты предложена А/В классификация и ее модификации, основанная на возможных механизмах развития ПР. Биологические препараты отличаются от химических препаратов по ряду параметров, в том числе и по механизму действия. Учитывая особенности биологических (биотехнологических) препаратов, было предложено несколько классификаций ПР, вызываемых данной группой препаратов. Наиболее популярной является предложенная W. J. Pichler классификация ПР биологических препаратов, основанная на участии иммунологических механизмов в развитии ПР. Данная классификация делит ПР биологических препаратов на 5 типов: тип α (реакции, обусловленные высоким уровнем цитокинов), тип β (реакции гиперчувствительности), тип γ (реакции, вызванные нарушением баланса факторов иммунитета), тип δ (развитие реакций перекрестной реактивности) и тип ε (реакции, обусловленные неиммунологическими механизмами). В качестве недостатков данной классификации следует указать то, что она распространяется не на все биологические препараты, а только на лекарственные препараты, включающие цитокины, гормоны и препараты моноклональных антител, и не учитывает ПР, развивающиеся без участия иммунных механизмов (например, повышение артериального давления при применении препаратов рекомбинантных эритропоэтинов).

Adverse drug reactions (ADR) are injuries caused by taking a medication. For the purpose of an objective analysis of the reasons and mechanisms of ADR, with a view to developing the methods for their relief and prevention, one should use standard criteria for the characterization of ADR. Typically, the description of ADR includes information about the damaged organ or tissue and the frequency of ADR occurrence. To characterize ADRs caused by low molecular weight chemicals proposed, an A/B classification and its modifications have been proposed, based on the possible mechanisms of ADR. Biological preparations differ from chemicals by a number of characteristics, including the mechanism of action. Considering the nature of biological/biotechnological preparations, several types of ADR classifications, related to the mentioned drug group, have been suggested. The most popular classification for ADR related to biological preparations have been suggested by W. J. Pichler. It is based on the involvement of immunological mechanisms in ADR occurrence. This classification divides ADR related to biologicals into 5 types: type α (reactions caused by high level of cytokines), type β (hypersensitivity reaction), type γ (reactions caused by the imbalance of immune factors), type δ (cross-reactivity reactions) and type ε (reactions caused by non-immunological mechanisms). The mentioned classification method has certain disadvantages: it does not cover all biological preparations, but only drugs, containing cytokines, hormones and monoclonal antibodies preparations; and it does not consider ADR occurring without immune mechanisms (such as increased blood pressure when administering preparations of recombinant erythropoietins).

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