rspНаучно-практическая ревматологияRheumatology Science and Practice1995-44841995-4492IMA-PRESS, LLC10.14412/1995-4484-2017-41-47rsp-2337Research ArticleОРИГИНАЛЬНЫЕ ИССЛЕДОВАНИЯORIGINAL RESEARCHВопросы оптимизации терапии метотрексатом у больных ревматоидным артритомISSUES OF OPTIMIZATION OF METHOTREXATE THERAPY IN PATIENTS WITH RHEUMATOID ARTHRITISГридневаГ. И.GridnevaG. I.

Москва, Россия 115522 Москва, Каширское шоссе, 34А

Moscow, Russia 34A, Kashirskoe Shosse, Moscow 115522

gigridneva@mail.ruМуравьевЮ. В.MuravyevYu. V.

Москва, Россия 115522 Москва, Каширское шоссе, 34А

Moscow, Russia 34A, Kashirskoe Shosse, Moscow 115522

ЛучихинаЕ. Л.LuchikhinaE. L.

Москва, Россия 115522 Москва, Каширское шоссе, 34А

Moscow, Russia 34A, Kashirskoe Shosse, Moscow 115522

ДемидоваН. В.DemidovaN. V.

Москва, Россия 115522 Москва, Каширское шоссе, 34А

Moscow, Russia 34A, Kashirskoe Shosse, Moscow 115522

КаратеевД. Е.KarateevD. E.

Москва, Россия 115522 Москва, Каширское шоссе, 34А

Moscow, Russia 34A, Kashirskoe Shosse, Moscow 115522

ФГБНУ «Научно-исследовательский институт ревматологии им. В.А. Насоновой»РоссияV.A. Nasonova Research Institute of RheumatologyRussian Federation2017080320175514147Copyright © Гриднева Г.И., Муравьев Ю.В., Лучихина Е.Л., Демидова Н.В., Каратеев Д.Е., 20172017Гриднева Г.И., Муравьев Ю.В., Лучихина Е.Л., Демидова Н.В., Каратеев Д.Е.Gridneva G.I., Muravyev Y.V., Luchikhina E.L., Demidova N.V., Karateev D.E.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://rsp.mediar-press.net/rsp/article/view/2337

Цель исследования – оценка безопасности и эффективности монотерапии больных ревматоидным артритом (РА) метотрексатом (МТ) в форме раствора для подкожного введения (ПК МТ) с использованием расчетного дозирования

Материал и методы

Материал и методы. В 12-месячное проспективное контролируемое исследование включены 106 больных ранним РА, которым назначался ПК МТ. Исследование проводилось на базе ФГБНУ НИИР им. В.А. Насоновой в рамках общеинститутской программы РЕМАРКА (Российское исслЕдование МетотрексАта и биологических препаратов при Раннем аКтивном Артрите).

Результаты и обсуждение

Результаты и обсуждение. При монотерапии ПК МТ в течение 12 мес цель лечения (ремиссия или низкая активность) достигнута у 68% больных активным РА, которые не нуждались в назначении генно-инженерных биологических препаратов (ГИБП). У 36% больных лечение сопровождалось возникновением нежелательных реакций (НР), явившихся основанием для полной его отмены у 8%. Лечебный эффект ПК МТ зависел от индекса массы тела (ИМТ) и более выражен у больных с нормальными его значениями (≤25 кг/м2), нежели при избыточной массе тела или ожирении. Частота развития НР не зависела от длительности заболевания и массы тела больного, получающего ПК МТ. Добавление ГИБП к монотерапии ПК МТ не привело к увеличению частоты НР. При раннем РА эффект был лучше при назначении ПК МТ в комбинации с низкими дозами пероральных глюкокортикоидов. Полученные результаты показали целесообразность интенсивного применения МТ в дозах, рассчитанных на 1 м2 поверхности тела, зависимость лечебного действия и независимость частоты и тяжести НР от ИМТ больного.

Objective

Objective: to evaluate the safety and efficiency of monotherapy with methotrexate (MTX) solution for subcutaneous injection (SC MTX), by using the estimated dosing, in patients with rheumatoid arthritis (RA).

Subjects and methods

Subjects and methods. A 12-month prospective controlled study enrolled 106 patients with early RA who were given SC MTX was conducted at the V.A. Nasonova Research Institute of Rheumatology in the framework of the REMARCA (Russian invEstigation of MethotrexAte and biologicals for eaRly aCtive Arthritis) program.

Results and discussion

Results and discussion. 12-month SC MTX monotherapy could achieve the treatment goal (remission or low disease activity) in 68% of the patients with active RA who did not need biological agents (BAs). In 36% of the patients, the treatment caused adverse reactions (ARs) that were the basis for its complete discontinuation in 8%. The therapeutic effect of SC MTX depended on body mass index (BMI) and was more pronounced in patients with its normal values (≤25 kg/m2) than in those with overweight or obesity. The incidence of ARs did not depend on the duration of the disease and the weight of a patient receiving SC MTX. Addition of BAs to SC MTX monotherapy did not lead to an increase in the frequency of ARs. In early RA, the effect was better when SC MTX was used in combination with lowdose oral glucocorticoids. The findings showed the expediency of intensively using SC MTX at the doses calculated per 1 m2 of the body surface, the dependence of therapeutic action and the independence of the frequency and severity of ARs from the patient’s BMI.

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