rpcardioRational Pharmacotherapy in CardiologyРациональная Фармакотерапия в Кардиологии1819-64462225-3653«SILICEA-POLIGRAF» LLC10.20996/1819-6446-2016-12-3-306-313rpcardio-1274Research ArticlePAGES OF RUSSIAN NATIONAL SOCIETY OF EVIDENCE-BASED PHARMACOTHERAPYСТРАНИЦЫ НАЦИОНАЛЬНОГО ОБЩЕСТВА ДОКАЗАТЕЛЬНОЙ ФАРМАКОТЕРАПИИADVERSE EVENT OF DRUG THERAPY (THE FIRST RESULTS OF THE STUDY ACCORDING TO THE PROFILE OUTPATIENT REGISTER)НЕЖЕЛАТЕЛЬНЫЕ ЯВЛЕНИЯ ЛЕКАРСТВЕННОЙ ТЕРАПИИ (ПЕРВЫЕ РЕЗУЛЬТАТЫ ИССЛЕДОВАНИЯ ПО ДАННЫМ АМБУЛАТОРНОГО РЕГИСТРА ПРОФИЛЬ)ЛукинаЮ. В.LukinaYu. V.

к.м.н., с.н.с. лаборатории фармакоэпидемиологических исследований отдела профилактической фармакотерапии ГНИЦПМ

yuvlu@mail.ruДмитриеваН. А.DmitrievaN. A.

к.м.н., с.н.с. отдела профилактической фармакотерапии ГНИЦПМ

yuvlu@mail.ruЗахароваА. В.ZakharovaA. V.

к.м.н., с.н.с. отдела профилактической фармакотерапии ГНИЦПМ

yuvlu@mail.ruЗагребельныйА. В.ZagrebelnyyA. V.

к.м.н., с.н.с. отдела профилактической фармакотерапии ГНИЦПМ

yuvlu@mail.ruКутишенкоН. П.KutishenkoN. P.

д.м.н., руководитель лаборатории фармакоэпидемиологических исследований отдела профилактической фармакотерапии ГНИЦПМ

yuvlu@mail.ruМарцевичС. Ю.MartsevichS. Yu.

д.м.н., профессор, руководитель отдела профилактической фармакотерапии ГНИЦПМ

yuvlu@mail.ruГосударственный научно-исследовательский центр профилактической медицины 101990, Москва, Петроверигский пер., 10.РоссияState Research Centre for Preventive Medicine. Petroverigsky per. 10, Moscow, 101990 RussiaRussian Federation201630062016123306313Copyright © Lukina Y.V., Dmitrieva N.A., Zakharova A.V., Zagrebelnyy A.V., Kutishenko N.P., Martsevich S.Y., 20162016Лукина Ю.В., Дмитриева Н.А., Захарова А.В., Загребельный А.В., Кутишенко Н.П., Марцевич С.Ю.Lukina Y.V., Dmitrieva N.A., Zakharova A.V., Zagrebelnyy A.V., Kutishenko N.P., Martsevich S.Y.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.rpcardio.online/jour/article/view/1274

Adverse events (As) of medicines are becoming a more serious problem of health care and society due to the growth of the pharmaceutical market. Incomplete information about AEs of drug therapy is an important aspect of this problem. The use of the register method is very promising in the study of adverse drug reactions in clinical practice. Aim. To study the AEs of drug therapy in the PROFILE outpatient register. Material and methods. Primary patients (n=1531) were included into the PROFILE outpatient register from January 2011 to August 2015. The median age of patients was 63 (54; 71) years. The registration card of patients and patient questionnaires were used within the register for the database creation. Analysis of retrospective data of the register was fulfilled Results. Various AEs were reported in 223 (14.6%) patients. Total anamnestic information on 301 cases of AEs was collected: 223 cases were recorded once, 63 – twice, 15 – three times. Patients with AEs were older than patients without AEs ((p<0.0001). AEs were registered most frequently in the use of ACE inhibitors and acetylsalicylic acid: an average of 15% of all cases, each. Various allergic reactions and symptoms of gastrointestinal disorders (pain, nausea, vomiting, diarrhea, etc.) were leaders in the structure of AEs. Naturally there were more patients without AEs among those, who did not take medications. Among patients treated with 6 to 10 medications per day, there were 1.5 times more people who had at least one AE (p<0.0001). Conclusion. The use of the register method allows to add information about the safety of various drugs. However, analysis of the prospective data of the PROFILE register looks the most promising for the solution of this problem.

В связи с ростом фармацевтического рынка нежелательные эффекты лекарственных средств становятся все более серьезной проблемой здравоохранения и общества в целом. Одним из важных аспектов этой проблемы являются далеко не полные сведения о нежелательных явлениях (НЯ) лекарственной терапии. Использование метода регистра представляется весьма перспективным при изучении проблемы нежелательных лекарственных реакций в условиях реальной клинической практики. Цель. Изучить НЯ лекарственной терапии в рамках амбулаторного регистра ПРОФИЛЬ. Материал и методы. За период с января 2011 г. по август (включительно) 2015 г. в амбулаторный регистр ПРОФИЛЬ был включен 1531 первичный пациент. Средний возраст пациентов составил 63 (54;71) года. В рамках регистра были использованы регистрационные карты больных, проведено анкетирование пациентов, на основании этих сведений создана база данных. Выполнен анализ ретроспективных данных регистра. Результаты. У 223 (14,6 %) больных были зарегистрированы различные НЯ. Всего была собрана анамнестическая информация о 301 случае НЯ: 223 случая зафиксированы однократно, 63 – двукратно, 15 – троекратно. Пациенты с НЯ были старше, чем больные без НЯ (р<0,0001). Наиболее часто регистрировались НЯ при приеме ингибиторов АПФ и ацетилсалициловой кислоты: в среднем по 15% от всех случаев НЯ. По структуре НЯ лидирующие позиции занимали различные аллергические реакции и симптомы со стороны ЖКТ (боли, тошнота, рвота, диарея и др.). Среди больных, не принимавших лекарственных препаратов, закономерно преобладала группа без НЯ, а среди пациентов, принимавших от 6 до 10 препаратов в день, было в 1,5 раза больше человек, у которых было зарегистрировано хотя бы одно НЯ (p<0,0001). Заключение. Использование метода регистра позволяет дополнить сведения о безопасности различных лекарственных препаратов, однако наиболее перспективным решением данной проблемы представляется анализ данных проспективной части регистра ПРОФИЛЬ. 

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