rspНаучно-практическая ревматологияRheumatology Science and Practice1995-44841995-4492IMA-PRESS, LLC10.14412/1995-4484-2015-371-374rsp-2106Research ArticleОРИГИНАЛЬНЫЕ ИССЛЕДОВАНИЯORIGINAL RESEARCHБезопасность применения метотрексата в форме раствора для подкожных инъекций у больных ревматоидным артритомSAFETY OF USING METHOTREXATE SOLUTION FOR SUBCUTANEOUS INJECTIONS IN PATIENTS WITH RHEUMATOID ARTHRITISМуравьевЮ. В.MuravyevYu. V.murawyu@mail.ruГридневаГ. И.GridnevaG. I.КаратеевД. Е.KarateevD. E.ЛучихинаЕ. Л.LuchichinaE. L.ФГБНУ Научно-исследовательский институт ревматологии им. В.А. Насоновой, Москва, Россия 115522 Москва, Каширское шоссе, 34АРоссияV.A. Nasonova Research Institute of Rheumatology, Moscow, Russia 34A, Kashirskoe Shosse, Moscow 115522Russian Federation201510092015534371374Copyright © Муравьев Ю.В., Гриднева Г.И., Каратеев Д.Е., Лучихина Е.Л., 20152015Муравьев Ю.В., Гриднева Г.И., Каратеев Д.Е., Лучихина Е.Л.Muravyev Y.V., Gridneva G.I., Karateev D.E., Luchichina E.L.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/2106

Цель – оценить безопасность лечения метотрексатом (МТ) в форме раствора для подкожных инъекций больных ревматоидным артритом (РА).

Материал и методы

Материал и методы. Включенным в исследование 237 больным РА в рамках протокола РЕМАРКА назначался МТ в форме раствора для подкожных инъекций (Методжект) с оценкой стандартных показателей безопасности лечения.

Результаты

Результаты. В целом неблагоприятные реакции отмечались у 49 (21%) больных: у 30 (30%) в группе I (с РА длительностью <6 мес) и у 19 (14%) – в группе II (с РА длительностью >6 мес), в большинстве случаев – на фоне достигнутой средней разовой дозы МТ 20,9±3,45 мг/нед. Часто (>1%, но <10%) наблюдались: повышение уровней аланинаминотрансферазы и аспартатаминотрансферазы, тошнота, постинъекционные реакции, алопеция, сыпь, кожные реакции в месте введения, инфекции, лейкопения; нечасто (термин ВОЗ, соответствующий 0,1–1%) отмечались: диарея, металлический привкус во рту, абсцесс/инфильтрат мягких тканей, развившийся в отдалении от места инъекции, что привело к отмене МТ у 4,2% больных.

Заключение

Заключение. Полученные результаты позволяют обсуждать целесообразность подкожного применения МТ до назначения генно-инженерных биологических препаратов, что может не только уменьшить финансовые затраты, но и улучшить безопасность больных.

Objective

Objective: to evaluate the safety of treatment with methotrexate (MT) solution for subcutaneous injections in patients with rheumatoid arthritis (RA).

Subjects and methods

Subjects and methods. 237 RA patients enrolled in the study within the REMARCA protocol were given MT solution for subcutaneous injections (Metoject) to assess the standard parameters of therapy safety.

Results

Results. Overall, adverse events (AE) were noted in 49 (21%) patients. In 30 (30%) of them RA duration was less than 6 months (Group 1) and in 19 (14%) – more than 6 months (Group 2), in most cases average MT dose was 20.9±3.45 mg/week. Elevation of alanine aminotransferase and aspartate aminotransferase levels, nausea, postinjection reactions, alopecia, rash, infections, and leukopenia, were common (> 1%, but <10%); diarrhea, metallic taste in the mouth, soft tissue abscess/infiltration developing far from the injection site, were uncommon (the WHO term corresponding to 0.1–1%). AE required MT discontinuation in 4.2% of the patients.

Conclusion

Conclusion. The results of the study allow discussing subcutaneous MT administration before treatment with biologicals, which makes it possible not only to reduce financial expenditures, but also to improve patient safety

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