玻璃体内注射地塞米松植入剂Ozurdex®用于初治及难治性不同亚型糖尿病性黄斑水肿患者。
Intravitreal dexamethasone implant Ozurdex® in naïve and refractory patients with different subtypes of diabetic macular edema.
作者信息
Castro-Navarro Verónica, Cervera-Taulet Enrique, Navarro-Palop Catalina, Monferrer-Adsuara Clara, Hernández-Bel Laura, Montero-Hernández Javier
机构信息
University General Hospital of Valencia, Avenida Tres Cruces S/N, 46015, Valencia, Spain.
Ophthalmology Department, Avenida Tres Cruces S/N, CP/46015, Valencia, Spain.
出版信息
BMC Ophthalmol. 2019 Jan 11;19(1):15. doi: 10.1186/s12886-018-1022-9.
BACKGROUND
Diabetic macular edema (DME) can be treated with different alternatives, among them Dexamethasone intravitreal implant 0.7 mg (DEX 0.7) has demonstrated that may improve both central macular thickness (CMT) and best corrected visual acuity (BCVA). This study aimed to evaluate the effect of the intravitreal dexamethasone implant Ozurdex® in patients with different subtypes of diabetic macular edema over a 6-month follow-up period.
METHODS
Eighty-four (29 naïve and 55 previously treated) eyes were included in this retrospective study. For each patient, the BCVA [Early Treatment Diabetic Retinopathy Study (ETDRS) charts] and macular thickness on optical coherence tomography (OCT) at baseline visit and within the 2nd, 4th, and 6th months of follow-up were obtained. The main outcomes measurements were the mean change in BCVA and in CMT with respect to the baseline value. The percentage of patients gaining ≥5 letters and ≥ 10 letters in BCVA was also analyzed.
RESULTS
A total of 84 eyes, 29 (34.5%) naïve and 55 (65.5%) non-naïve, from 69 patients were included in the study. BCVA at baseline was 58.8 (16.4) and 61.8 (11.6) in naïve and refractory patients, respectively, p = 0.4513. At every visit, BCVA significantly improved from baseline in naïve and non-naïve eyes (p < 0.0001 and p = 0.0003, respectively; Friedman rank sum test). At baseline, the mean CMT was 466.2 (189.7) μm and 448.1 (110.7) μm in the naïve and non-naïve patients, respectively (p = 0.5830); and decreased to 339.3 (92.5) μm and 357.5 (79.1) μm, respectively (p = 0.0004 and p < 0.0001, respectively, Wilcoxon signed-rank test). The proportion of patients gaining ≥10 letters was significantly greater in the naïve group, p = 0.0199.
CONCLUSION
The intravitreal dexamethasone implant (Ozurdex) is effective for the treatment of diabetic macular edema, even in refractory cases that have failed to respond to previous therapies.
背景
糖尿病性黄斑水肿（DME）可有多种治疗选择，其中0.7毫克玻璃体内植入地塞米松（DEX 0.7）已证明可改善黄斑中心厚度（CMT）和最佳矫正视力（BCVA）。本研究旨在评估玻璃体内植入地塞米松Ozurdex®对不同亚型糖尿病性黄斑水肿患者在6个月随访期内的治疗效果。
方法
本回顾性研究纳入了84只眼（29只初治眼和55只曾接受治疗的眼）。为每位患者获取了基线访视时以及随访第2、4和6个月时的BCVA[早期糖尿病性视网膜病变研究（ETDRS）视力表]和光学相干断层扫描（OCT）测量的黄斑厚度。主要观察指标为BCVA和CMT相对于基线值的平均变化。还分析了BCVA提高≥5行和≥10行的患者百分比。
结果
本研究共纳入了69例患者的84只眼，其中29只（34.5%）初治眼和55只（65.5%）非初治眼。初治患者和难治性患者的基线BCVA分别为58.8（16.4）和61.8（11.6），p = 0.4513。每次访视时，初治眼和非初治眼的BCVA均较基线显著改善（分别为p < 0.0001和p = 0.0003；Friedman秩和检验）。基线时，初治患者和非初治患者的平均CMT分别为466.2（189.7）μm和448.1（110.7）μm（p = 0.5830）；随访后分别降至339.3（92.5）μm和357.5（79.1）μm（分别为p = 0.0004和p < 0.0001，Wilcoxon符号秩检验）。初治组中BCVA提高≥10行的患者比例显著更高，p = 0.0199。
结论
玻璃体内植入地塞米松（Ozurdex）对糖尿病性黄斑水肿有效，即使对先前治疗无反应的难治性病例也有效。
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