glaucomaНациональный журнал ГлаукомаNational Journal glaucoma2078-41042311-6862Federal State Budgetary Institution of Science “Krasnov Research Institute of Eye Diseases”glaucoma-159Research ArticleОРИГИНАЛЬНЫЕ СТАТЬИORIGINAL ARTICLESЭффективность и переносимость фиксированной комбинации травопроста 0,004% и тимолола 0,5% в лечении первичной открытоугольной глаукомы или офтальмогипертензии при недостаточной эффективности монотерапии бета-блокаторамиEfficacy and tolerability of travoprost 0.004%/timolol 0.5% fixed-dose combination for the treatment of primary open-angle glaucoma or ocular hypertension inadequately controlled with beta-blockerЛернерС. Ф.LernerS. F.postmaster@glaucomajournal.ruПаркК. Х.ParkK. H.postmaster@glaucomajournal.ruХубатчД. А.HubatschD. A.postmaster@glaucomajournal.ruЕричевВ. П.ErichevV. P.postmaster@glaucomajournal.ruПачкаХ. А.PaczkaJ. A.postmaster@glaucomajournal.ruРобертсТ. В.RobertsT. V.postmaster@glaucomajournal.ruМедицинская исследовательская организация, Аргентина, Буэнос-Айрес; Фонд изучения глаукомы, Аргентина, Буэнос-Айрес;АргентинаOrganizaci n Medica de Investigaci n, Buenos Aires, Argentina; Fundaci n para el Estudio del Glaucoma, Buenos Aires, ArgentinaArgentinaГоспиталь Сеульского Университета, Корейская республика, СеулЮжная КореяSeoul National University Hospital, Seoul, Republic of KoreaKorea, Republic ofОбщество с ограниченной ответственностью «Алкон Рисерч», Форт-Уэрт, ТехасСоединённые Штаты АмерикиAlcon Research, Ltd., FortWorth, TX, USAUnited StatesФГБНУ «Научно-исследовательский институт глазных болезней»РоссияResearch Institute of Eye DiseasesRussian FederationИнститут зрения и офтальмологии, Университет Гвадалахары, Мексика, Гвадалахара; Институт глаукомы, отдел ранней диагностики, Мексика, ГвадалахараМексикаInstituto de Oftalmologia y Ciencias Visuales, Guadalajara, Mexico; Unidad de Diagnostico Temprano del Glaucoma, Global Glaucoma Institute Occidente, Guadalajara, MexicoMexicoМедицинская школа Сиднея, Университет Сиднея, Австралия, Сидней; Институт глаза, Австралия, СиднейАвстралияSydney Medical School, University of Sydney, Sydney, Australia; Vision Eye Institute, Sydney, AustraliaAustralia2017131020171631827Copyright © Лернер С.Ф., Парк К.Х., Хубатч Д.А., Еричев В.П., Пачка Х.А., Робертс Т.В., 20172017Лернер С.Ф., Парк К.Х., Хубатч Д.А., Еричев В.П., Пачка Х.А., Робертс Т.В.Lerner S.F., Park K.H., Hubatsch D.A., Erichev V.P., Paczka J.A., Roberts T.V.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.glaucomajournal.ru/jour/article/view/159ЦЕЛЬ

ЦЕЛЬ. Оценка эффективности и переносимости фиксированной комбинации травопроста 0,004% и тимолола 0,5% у пациентов с первичной открытоугольной глаукомой (ПОУГ) и офтальмогипертензией в случае недостаточной гипотензивной эффективности монотерапии бета-блокаторами. МЕТОДЫ. В открытом исследовании IV фазы приняли участие 156 пациентов, получавших монотерапию бета- блокаторами, средний уровень внутриглазного давления (ВГД) у которых составил от 18 до 32 мм рт.ст. Эти пациенты были подвергнуты рандомизации (без периода вымывания) для назначения фиксированной комбинации травопрост/тимолол в течение 8 недель или продолжения монотерапии бета-блокаторами в течение 4 недель с последующим переходом на фиксированную комбинацию в течение еще 4 недель. РЕЗУЛЬТАТЫ. Исходно средний уровень ВГД составил 22,5±2,5 мм рт.ст. в группе фиксированной комбинации и 22,2±2,3 мм рт.ст. в группе бета-блокаторов. Через 4 недели средний уровень ВГД равнялся 16,7±3,1 и 21,1±3,1 мм рт.ст. соответственно, а через 8 недель — 16,1±3,1 и 16,1±2,8 мм рт.ст. соответственно. При измерении ВГД в 8 часов утра через 4 недели имели место статистически достоверные отличия среднего Ро между группой фиксированной комбинации и группой бета-блокаторов (на 4,6 мм рт.ст., р<0,0001). Оба варианта лечения хорошо переносились. ЗАКЛЮЧЕНИЕ. Фиксированная комбинация траво- прост/тимолол позволяет лучше контролировать ВГД у пациентов с ПОУГ или офтальмогипертензией при недостаточной эффективности бета-блокаторов. Ранее неизвестных побочных явлений не выявлено. КЛЮЧЕВЫЕ СЛОВА: первичная открытоугольная глау- кома, травопрост, тимолол.>< 0,0001). Оба варианта лечения хорошо переносились. ЗАКЛЮЧЕНИЕ. Фиксированная комбинация травопрост/тимолол позволяет лучше контролировать ВГД у пациентов с ПОУГ или офтальмогипертензией при недостаточной эффективности бета-блокаторов. Ранее неизвестных побочных явлений не выявлено.

 

 

PURPOSE

PURPOSE: To evaluate the efficacy and tolerability of travoprost 0.004%/timolol 0.5% fixed-dose combination (TTFC) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT) inadequately controlled on betablocker monotherapy. METHODS: In this phase IV, open-label study, 156 patients on beta-blocker monotherapy with mean intraocular pressure (IOP) between 18 and 32 mmHg were randomized (no washout period) to receive TTFC for 8 weeks (TTFC group) or to continue beta-blocker monotherapy for 4 weeks followed by TTFC for the remaining 4 weeks (beta-blocker group). RESULTS: The mean IOP at baseline in the TTFC and betablocker groups was 22.5±2.5 mmHg and 22.2±2.3 mmHg, respectively, and at weeks 4 and 8, was 16.7±3.1 mmHg and 16.1±3.1 mmHg, respectively, in TTFC group and 21.1±3.1 mmHg and 16.1±2.8 mmHg, respectively, in the beta-blocker group. There was a significant least squares mean difference between TTFC and beta-blocker in 8 a.m. IOP at week 4 (−4.6 mmHg; ????0.0001). Both treatments were well tolerated. CONCLUSION: Superior IOP control was achieved with TTFC in patients with OAG or OHT previously uncontrolled with beta-blockers. No new safety findings were identified.

 

 

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