Офтальмохирургия. 2021; : 39-45
Сравнительная характеристика результатов применения разнонаправленной интравитреальной фармакотерапии в лечении диабетического макулярного отека
https://doi.org/10.25276/0235-4160-2021-1-39-45Аннотация
Цель. Провести сравнительный анализ эффективности интравитреального введения (ИВВ) препарата группы глюкокортикостероидов – имплантата с дексаметазоном и ингибитора ангиогенеза – афлиберцепта при макулярном отеке у пациентов с сахарным диабетом.
Материал и методы. В исследовании участвовали 80 пациентов (80 глаз) с диабетическим макулярным отеком. В 1-ю группу исследования вошли 38 пациентов (38 глаз), которым было выполнено однократное ИВВ дексаметазон-содержащего биодеградируемого имплантата «Озурдекс» в дозе 0,7 мг по стандартной методике. Во 2-й группе 42 пациентам (42 глаза) было выполнено 5 загрузочных доз афлиберцепта с интервалом 1 мес. Всем пациентам ежемесячно проводили спектральную оптическую когерентную томографию (ОКТ) макулярной области, а также визометрию и тонометрию на протяжении срока наблюдения (6 мес.).
Результаты. Через 1 мес. после ИВВ исследуемых препаратов в обеих группах воспалительных реакций ни в одном случае выявлено не было. По данным ОКТ, сохранялся кистозный отек макулярной области с тенденцией к уменьшению толщины в фовеа. После лечения афлиберцептом средняя толщина сетчатки в макуле составила 186,4±15,1 мкм, острота зрения в среднем составляла 0,48±0,05 у 85,7% пациентов. На фоне терапии ИВВ препарата «Озурдекс» повышение остроты зрения отмечали у 89,4% пациент ов.
Заключение. В ходе данного исследования установлено, что интравитреальная фармакотерапия блокатором ангиогенеза и имплантатом с дексаметазоном пациентам с диабетическим макулярным отеком сопоставима по своей эффективности – 85,7 и 89,4% соответственно. При отсутствии по ряду причин возможности проведения систематической антиангиогенной терапии целесообразно применение имплантанта с дексаметазоном пролонгированного действия.
Список литературы
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Fyodorov Journal of Ophthalmic Surgery. 2021; : 39-45
Comparative characteristics of the outcomes of the use of multidirectional intravitreal pharmacotherapy in the treatment of diabetic macular edema
https://doi.org/10.25276/0235-4160-2021-1-39-45Abstract
Purpose. To conduct a comparative analysis of the effectiveness of intravitreal injection of dexamethasone-containing implant and aflibercept in macular edema in patients with diabetes mellitus.
Material and methods. The study involved 80 patients (80 eyes) with macular edema. The group 1 included 38 patients (38 eyes) who underwent a single intravitreal injection of dexamethasone-containing biodegradable implant «Ozurdex» in a dose of 0.7 mg according to the standard technique. In the group 2, 42 patients (42 eyes) received 5 loading doses of aflibercept with an interval of one month. All patients underwent monthly spectral optical coherence tomography (OCT) of the macular area, as well as visometry and tonometry during the observation period.
Results. One month after intravitreal injection of the studied drugs in both groups, no inflammatory reactions were detected in any case. According to OCT data, cystic edema of the macular area with a tendency to decrease the thickness in the fovea was preserved. After treatment with aflibercept, the average retinal thickness in the macula was 186.4±15.1 μm, and visual acuity averaged 0.48±0.05 in 85.7% of patients. During therapy with intravitreal injection of Ozurdex, an increase in visual acuity was noted in 89.4% of patients.
Conclusion. This study found that intravitreal pharmacotherapy with an angiogenesis blocker and a dexamethasone implant in patients with diabetic macular edema are comparable in its effectiveness – 85.7 and 89.4% respectively. If systematic anti-angiogenesis therapy is not possible for a number of reasons, it is advisable to use a prolonged dexamethasone implant.
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20. Tamura H, Miyamoto K, Kiryu J, et al. Intravitreal injection of corticosteroid attenuates leukostasis and vascular leakage in experimental diabetic retina. Invest Ophthalmol Vis Sci. 2005;46: 1440–1444. doi: 10.1167/iovs.04-0905
21. Chang-Lin JE, Attar M, Acheampong AA, et al. Pharmacokinetics and pharmacodynamics of a sustained-release dexamethasone intravitreal implant. Invest Ophthalmol Vis Sci. 2011;52: 80–86. doi: 10.1167/iovs.10-5285
22. Haller JA, Kuppermann BD, Blumenkranz MS, et al. Dexamethasone DDS Phase II Study Group. Randomized controlled trial of an intravitreous dexamethasone drug delivery system in patients with diabetic macular edema. Arch Ophthalmol. 2010;128:289–296. doi: 10.1001/archophthalmol.2010.21
23. Kodjikian L. International pharmacological management of diabetic macular edema in real-life observational studies. Biomed Res Int. 2018;8: 8289253. doi: 10.1155/2018/8289253
24. Pacella E, Vestri AR, Muscella R, et al. Preliminary results of an intravitreal dexamethasone implant (Ozurdex) in patients with persistent diabetic macular edema. Clin Ophthalmol. 2013;7: 1423–1428. doi: 10.2147/OPTH.S48364
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28. Korobelnik JF, Do DV, Schmidt-Erfurth U, et al. Intravitreal aflibercept for diabetic macular edema. Ophthalmology. 2014;121: 2247–2254. doi: 10.1016/j.ophtha.2014.05.006
29. Ziemssen F, Schlottman PG, Lim JI, et al. Initiation of intravitreal afliber-cept injection treatment in patients with diabetic macular edema: a review of VIVID DME and VISTA DME data. Int J Retina Vitreous. 2016;2: 16. doi: 10.1186/s40942-016-0041-z
30. Marco A. Zarbin anti-VEGF agents and the risk of arteriothrombotic events. Asia Pac J Ophthalmol. 2018;1: 63–67. doi: 10.22608/APO.2017495
31. Martínez AH, Delgado EP, Silva G, et al. Early versus late switch: How long should we extend the anti-vascular endothelial growth factor therapy in unresponsive diabetic macular edema patients? Eur J Ophthalmol. 2019;5: 1–8. doi: 10.1177/1120672119848257
32. Busch S, Zur D, Fraser‑Bell S, Laíns I, et al. Shall we stay, or shall we switch? Continued anti-VEGF therapy versus early switch to dexamethasone implant in refractory diabetic macular edema. Acta Diabetologica. 2018;55: 789–796. doi: 10.1007/s00592-018-1151-x
