Mello Filho Paulo, Andrade Gabriel, Maia Andre, Maia Mauricio, Biccas Neto Laurentino, Muralha Neto Acacio, Moura Brasil Oswaldo, Minelli Eduardo, Dalloul Claudio, Iglicki Matias
Department of Ophthalmology, Federal University of São Paulo, São Paulo, Brazil.
Department of Ophthalmology, Federal University of São Paulo, São Paulo, Brazil,
Ophthalmologica. 2019;241(1):9-16. doi: 10.1159/000492132. Epub 2018 Nov 8.
There are few real-life studies on the intravitreal 0.7-mg dexamethasone implant for the treatment of diabetic macular edema (DME) conducted in Latin America. We aimed to assess the effectiveness and safety of this implant in clinical practice.
Twenty-seven centers from Brazil and one from Argentina provided information on patients with DME treated with Ozurdex. The efficacy outcome variables were best-corrected visual acuity (BCVA) in Snellen and central retinal thickness (CRT). Safety was assessed by the elevation in intraocular pressure (IOP), occurrence of cataracts, and adverse events.
A total of 329 eyes (both treated cases and naïve eyes) from 282 patients underwent treatment. The time since diagnosis of DME ranged from 1 to 156 months. The median BCVA was 0.7 logMAR/50 letters at baseline and 0.3 logMAR/70 letters after treatment (both p < 0.001). Median CRT values decreased from 425 µm at baseline to 270 µm after treatment (p < 0.001). Increases in IOP of at least 10 mm Hg were observed in 7.4% of eyes, and 4% of eyes had cataract evolution. No cases of endophthalmitis were reported.
These real-life results suggest that the intravitreal dexamethasone implant is effective and safe for eyes with DME.
在拉丁美洲,关于玻璃体内注射0.7毫克地塞米松植入物治疗糖尿病性黄斑水肿(DME)的实际研究较少。我们旨在评估该植入物在临床实践中的有效性和安全性。
来自巴西的27个中心和来自阿根廷的1个中心提供了接受Ozurdex治疗的DME患者的信息。疗效结果变量为Snellen视力表的最佳矫正视力(BCVA)和中心视网膜厚度(CRT)。通过眼压(IOP)升高、白内障发生情况及不良事件评估安全性。
282例患者的329只眼(包括治疗眼和初治眼)接受了治疗。DME诊断后的时间为1至156个月。基线时BCVA中位数为0.7 logMAR/50字母,治疗后为0.3 logMAR/70字母(均p < 0.001)。CRT中位数从基线时的425 µm降至治疗后的270 µm(p < 0.001)。7.4%的眼眼压升高至少10 mmHg,4%的眼有白内障进展。未报告眼内炎病例。
这些实际结果表明,玻璃体内地塞米松植入物对DME患眼有效且安全。