Terapevticheskii arkhivTerapevticheskii arkhivТерапевтический архив0040-36602309-5342LLC Obyedinennaya Redaktsiya31726Editorial articleПередовая статьяResearch ArticleEfficiency and safety of different etoricoxib regimens in patients with axial spondyloarthritis, including ankylosing spondylitisЭффективность и безопасность различных режимов назначения эторикоксиба у пациентов с аксиальным спондилоартритом, включая анкилозирующий спондилитGaydukovaI ZГайдуковаИ ЗRebrovA PРебровА П«Саратовский ГМУ им. В.И. Разумовского» Минздрава России15032015873VOL 87, NO3 ()ТОМ 87, №3 (2015)778210042020Copyright ©; 2015, Consilium MedicumCopyright ©; 2015, ООО "Консилиум Медикум"2015Consilium MedicumООО "Консилиум Медикум"https://creativecommons.org/licenses/by-nc-sa/4.0https://ter-arkhiv.ru/0040-3660/article/view/31726

Aim. To study the clinical and laboratory efficiency and safety of different etoricoxib (ET) regimens in patients with axial spondyloarthritis (axSpA), including ankylosing spondylitis. Subjects and methods. Forty patients with high axSpA activity (Bath Ankylosing Disease Activity Index (BASDAI ≥4) were examined and randomized to 2 groups: 1) 30 patients who received ET 90 mg continuously every day; 2) 10 patients who took the drug in the same dose intermittently 1—3 times weekly. The activity of axSpA (BASDAI, Ankylosing Spondylitis Disease Activity Score (ASDAS), erythrocyte sedimentation rate (ESR), and high-sensitivity C-reactive protein (hs-CRP)) was evaluated at baseline, 2 and 12 weeks; adverse events were recorded at baseline, 2, 6, and 12 weeks. The number of patients who had achieved an ASAS40 response at 2 and 12 weeks were taken into consideration. Results. At 12 weeks, the continuous administration group displayed decreases in BASDAI from 8 to 4, in ASDAS from 3.8 to 2.6, and in hs-CRP levels from 9.5 to 3.9 mg/l; the intermittent administration group exhibited decreases in BASDAI from 7.6 to 6.0, in ASDAS from 3.5 to 3.1, and hs-CRP from 8.8 to 4.5 mg/l (p<0.05). At this time, an AS40 response was achieved by 22 (73.3%) and 2 (20%) patients in Groups 1 and 2, respectively (p<0.05 for all). No serious adverse events were recorded. Conclusion. The efficacy of ET given in a daily dose of 90 mg was much higher than that of the drug used thrice or less weekly in the patients with axSpA.

Цель исследования. Изучить клинико-лабораторную эффективность и безопасность различных режимов применения 90 мг эторикоксиба (ЭТ) у пациентов с аксиальным спондилоартритом (аксСпА), включая анкилозирующий спондилит (АС). Материалы и методы. Обследовали 40 пациентов с высокой активностью аксСпА (BASDAI ≥4), которых рандомизировали на 2 группы: 30 пациентов принимали 90 мг ЭТ ежедневно (постоянный прием), 10 пациентов — 90 мг ЭТ 1—3 раза в неделю (прерывистый прием). Исходно, на 2-й и 12-й неделях оценивали активность аксСпА (BASDAI, ASDAS, скорость оседания эритроцитов — CОЭ, высокочувствительный С-реактивный белок — вч-СРБ), исходно, на 2, 6 и 12-й неделях регистрировали нежелательные явления. Учитывали число пациентов, достигших ответа ASAS40 на 2-й и 12-й неделях. Результаты. У больных группы постоянного приема к 12-й неделе индекс BASDAI снизился с 8 до 4, ASDAS — с 3,8 до 2,6, уровень вч-СРБ — с 9,5 до 3,9 мг/л. У больных группы прерывистого приема к 12-й неделе индекс BASDAI снизился с 7,6 до 6,0, ASDAS — с 3,5 до 3,1, уровень вч-СРБ — с 8,8 до 4,5 мг/л (p<0,05). На 12-й неделе ответа ASAS40 достигли 22 (73,3%) и 2 (20%) пациента групп постоянного и прерывистого приема соответственно (p<0,01 для всех). Тяжелых нежелательных явлений не зафиксировано. Заключение. У пациентов с аксСпА применение 90 мг ЭТ ежедневно существенно превосходит по эффективности применение препарата 3 раза в неделю и менее.

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