Оценка безопасности, переносимости и эффективности первого отечественного генерика ацеклофенака у пациентов с недифференцированным артритом
Оценка безопасности, переносимости и эффективности первого отечественного генерика ацеклофенака у пациентов с недифференцированным артритом
Заводовский Б.В., Сивордова Л.Е., Полякова Ю.В. и др. Оценка безопасности, переносимости и эффективности первого отечественного генерика ацеклофенака у пациентов с недифференцированным артритом. Терапевтический архив. 2020; 92 (5): 61–68. DOI: 10.26442/00403660.2020.05.000589
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Zavodovsky B.V., Sivordova L.E., Polyakova Yu.V., et al. Assessment of the safety, tolerability and effectiveness of first Russian generic aceclofenac in patients with undifferentiated peripheral inflammatory arthritis. Therapeutic Archive. 2020; 92 (5): 61–68.
DOI: 10.26442/00403660.2020.05.000589
Оценка безопасности, переносимости и эффективности первого отечественного генерика ацеклофенака у пациентов с недифференцированным артритом
Заводовский Б.В., Сивордова Л.Е., Полякова Ю.В. и др. Оценка безопасности, переносимости и эффективности первого отечественного генерика ацеклофенака у пациентов с недифференцированным артритом. Терапевтический архив. 2020; 92 (5): 61–68. DOI: 10.26442/00403660.2020.05.000589
________________________________________________
Zavodovsky B.V., Sivordova L.E., Polyakova Yu.V., et al. Assessment of the safety, tolerability and effectiveness of first Russian generic aceclofenac in patients with undifferentiated peripheral inflammatory arthritis. Therapeutic Archive. 2020; 92 (5): 61–68.
DOI: 10.26442/00403660.2020.05.000589
Цель. Оценить эффективность и переносимость препарата Аленталь (АО «Вертекс», Россия) у больных с недифференцированным артритом (НдА). Материалы и методы. Обследовали 60 пациентов (39 женщин и 21 мужчина) с НдА по критериям G. Hazlewood (2011 г.). Пациенты разделены на 3 группы: с моноартритом, олигоартритом и полиартритом. Всем рекомендовался препарат Аленталь, согласно инструкции, 100 мг 2 раза в сутки, курс терапии 3 нед, 4 визита. Результаты. Наблюдалось достоверное снижение уровня боли по визуальной аналоговой шкале: у больных моноартритом – на 69,3 мм (p<0,001); олигоартритом – на 47,5 мм (p<0,001), полиартритом – на 30 мм (p<0,001) и повышение качества жизни по индексу EQ-5D-5L: от 0,616 до 0,829 (p<0,001). Наибольшая удовлетворенность терапией наблюдалась в группе больных моноартритом – 80% больных, и в 93% случаев врачи отметили ее высокую эффективность; олигоартритом – 53 и 39%; полиартритом – 74 и 64% соответственно. Возможно, различия связаны с преобладанием в группе моно- и олигоартритов пациентов с начальными формами серонегативных спондилоартропатий, при которых эффективность нестероидных противовоспалительных препаратов (НПВП) традиционно более высокая; а в группе с полиартритом НдА, вероятно, являлся дебютом ревматоидного. Нежелательные явления наблюдались со стороны желудочно-кишечного тракта (диспепсия, повышение аланинаминотрансферазы) – у 10 пациентов и сердечно-сосудистой системы (повышение артериального давления) – у 1 пациента, однако выражены клинически незначимо и не требовали отмены терапии. Заключение. Проведено пострегистрационное наблюдательное исследование первого отечественного генерика ацеклофенака. Наибольшая эффективность НПВП отмечалась в группе больных с моно- и олигоартритами. Большинство пациентов отмечали повышение мобильности, способности к самообслуживанию и круглосуточный контроль за болевым синдромом. Таким образом, препарат Аленталь обладает хорошей эффективностью, переносимостью и безопасностью и может быть рекомендован для лечения НдА.
Aim. To evaluate the effectiveness and tolerability of the drug in patients with undifferentiated peripheral inflammatory arthritis (UPIA). Materials and methods. We observed 60 patients (39 women and 21 men) met G. Hazlewood et al., UPIA criteria, 2011. Patients were divided into 3 groups: with monoarthritis, oligoarthritis and polyarthritis. They took aceclofenac 100 mg twice day for 3 weeks. Results. We noted significant decreasing in pain level according to visual analogue scale: in patients with monoarthritis – by 69.3 mm (p<0.001); in oligoarthritis group – by 47.5 mm (p<0.001), in patients with polyarthritis – by 30 mm (p<0.001). The life quality by the EQ-5D-5L index was improved too in all groups from 0.616 to 0.829 (p<0.001). The satisfaction with the therapy was: in monoarthritis patients (80% of patients and 93% of doctors noted good results), in oligoarthritis group (53% and 39% accordingly) and polyarthritis (74% and 64% respectively). We suppose the difference was due to the fact that mono- and oligoarthritis patients suffered from initial forms of seronegative spondylarthropathy, in which the effectiveness of NSAIDs is traditionally higher; polyarthritis patients probably had debut of rheumatoid arthritis. Adverse events of therapy were mild. We noted gastrointestinal tract symptoms (dyspepsia) and increased ALT in 10 patients and increased blood pressure – in 1 patient. The symptoms did not require discontinuation of therapy. Сonclusion. Post-registration observational study of first Russian generic aceclofenac (“Alental”, Vertex, Russia) was conducted. In UPIA patients aceclofenac therapy was most effective in mono- and oligoarthritis patients. The first Russian generic aceclofenac (“Alental”, Vertex, Russia) has good efficacy, tolerability and safety and can be recommended for arthritis treatment.
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1. Hazlewood G, Aletaha D, Carmona L, et al. Algorithm for Identification of Undifferentiated Peripheral Inflammatory Arthritis: A Multinational Collaboration Through the 3e Initiative. J Rheumatol. 2011;38(Suppl. 87). doi: 10.3899/jrheum.101076
2. Nekhaychik TA, Rudoi AS, Bova AA. Modern aspects of diagnosis, management tactics for patients with undifferentiated arthritis. Evrazijskij zhurnal vnutrennej mediciny. Rekomendacii i mnenija jekspertov. = Eurasian Journal of Internal Medicine. Recommendations and expert opinions. 2014;1:24-8 (In Russ.) https://euat.ru/magazine/number-1-year-2014-book-0/sovremennye-aspekty-diagnostiki-taktika-vedenija-....
3. Luchikhina EL, Karateev DE, Novikov AA, et al. Prediction of the development of rheumatoid arthritis in patients with early undifferentiated arthritis. Rheumatology Science and Practice. 2009;2:31-7 (In Russ.) https://cyberleninka.ru/article/n/prognozirovanie-razvitiya-revmatoidnogo-artrita-u-bolnyh-s-rannim-....
4.Karateev DE, Luchikhina EL, Togizbaev G. Modern principles of management of patients with early arthritis. Russkij medicinskij zhurnal = Russian medical journal. 2008;24:1610 (In Russ.) https://www.rmj.ru/articles/revmatologiya/Sovremennye_principy_vedeniya_bolynyh__rannim_artritom/#ix...
5. Jansen LM, van Schaardenburg D, van der Horst-Bruinsma IE, Dijkmans BA. One year outcome of undifferentiated polyarthritis. Ann Rheum Dis. 2002;61(8):700-3. doi: 10.1136/ard.61.8.700
6. Quinn MA, Green MJ, Marzo-Ortega H. Prognostic factors in a large cohort of patients with early undifferentiated inflammatory arthritis after application of a structured management protocol. Arthritis Rheum. 2003;48(11):3039-45. https://www.ncbi.nlm.nih.gov/pubmed/14613264. doi: 10.1002/art.11269
7. Bizzaro N, Bartoloni E, Morozzi G, et al. Anti-cyclic citrullinated peptide antibody titer predicts time to rheumatoid arthritis onset in patients with undifferentiated arthritis: results from a 2-year prospective study. Arthritis Res Ther. 2013;15:16. doi: 10.1186/ar4148
8.Alexandrova GA, Polikarpov AV, Golubev NA, et al. The incidence of adult population in Russia in 2018 with a diagnosis established for the first time in life. Statistical materials. Part III. Moscow: Department monitoring, analysis and strategic development of the Health Ministry of the Russian Federation, the FSBU "CNIIOIS" of the Russian Ministry of Health, 2017 (InRuss.) https://mednet.ru/images/materials/statistika/zabolevaemost_2019.ZIP
9. Насонов Е.Л. Рекомендации EULAR по диагностике и лечению раннего артрита: 2016. Научно-практическая ревматология. 2017;55(2):138-50 [Nasonov EL. The 2016 EULAR guidelines for the diagnosis and treatment of early arthritis. Nauchno-Prakticheskaya Revmatologiya = Rheumatology Science and Practice. 2017;55(2):138-50 (In Russ.)]. doi: 10.14412/1995-4484-2017-138-150
10. Smolen JS, Landewe R, Bijlsma J, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2016 update. Ann Rheum Dis. 2017. pii: annrheumdis-2016-210715. doi: 10.1136/annrheumdis-2016-210715
11. Verschueren P, de Cock D, Corluy L, et al. Methotrexate in combination with other DMARDs is not superior to methotrexate alone for remission induction with moderate-to-high-dose glucocorticoid ridging in early rheumatoid arthritis after 16 weeks of treatment: the CareRA trial. Ann Rheum Dis. 2015;74:27-34. doi: 10.1136/annrheumdis-2014-205489
12. Den Uyl D, ter Wee M, Boers M, et al. A non-inferiority trial of an attenuated combination strategy (“COBRA-light”) compared to the original COBRA strategy: clinical results after 26 weeks. Ann Rheum Dis. 2014;73:1071-8. doi: 10.1136/annrheumdis-2012-202818
13. De Jong PH, Hazes JM, Han HK, et al. Randomised comparison of initial triple DMARD therapy with methotrexate monotherapy in combination with low-dose glucocorticoid bridging therapy; 1-year data of the tREACH trial. Ann Rheum Dis. 2014;73:1331-9. doi: 10.1136/annrheumdis-2013-204788
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