Department of Ophthalmology and Visual Sciences, Yamagata University Faculty of Medicine, 2-2-2, Iidanishi, Yamagata, Yamagata, 9909585, Japan.
Graefes Arch Clin Exp Ophthalmol. 2010 Jun;248(6):805-10. doi: 10.1007/s00417-010-1316-y. Epub 2010 Feb 24.
To evaluate the efficacy of treatment of refractory diabetic macular edema (DME) after vitrectomy with difluprednate ophthalmic emulsion 0.05% (Durezol(TM)), and to compare this treatment with sub-Tenon's injection of triamcinolone (STTA).
This study enrolled patients with refractory diabetic macular edema that persisted despite pars plana vitrectomy in our clinic. In all subjects, more than 3 months had passed since prior treatment. Eleven eyes in ten subjects were treated with STTA (STTA group), and 11 eyes in seven subjects were treated with difluprednate ophthalmic emulsion 0.05% (Durezol(TM), Sirion Therapeutics Inc., USA) 4 times daily for the first month and then twice daily for 2 months (eye drop group).
In the eye drop group, mean VA (+/- SD) was 0.67 +/- 0.35 logMAR and mean retinal thickness was 500.6 +/- 207.7 mum at baseline. After 3 months of treatment, mean VA was 0.67 +/- 0.29 and mean retinal thickness had decreased to 341.2 +/- 194.8 mum. The mean minimum value of RT during the treatment period was 300.6 +/- 123.2 mum, and significantly lower than that at baseline (Mann-Whitney U test: P = 0.003). In the STTA group, mean VA (+/- SD) was 0.67 +/- 0.35 logMAR, and mean retinal thickness was 543.3 +/- 132.6 mum at baseline. After 3 months of treatment, mean VA was 0.49 +/- 0.67, and mean retinal thickness had decreased to 378.6 +/- 135 mum. The mean minimum value of RT during the treatment period was 349.9 +/- 113.8 mum, and significantly lower than at baseline (Mann-Whitney U test: P = 0.003). The rate of effective improvement in RT did not differ between the eye drop group (73%) and STTA group (84%) (Fisher's exact test: P = 1).
Comparable improvements of retinal thickness were observed in the STTA and eye drop groups. Instillation of difluprednate ophthalmic emulsion 0.05% is a safe and effective treatment that does not require surgical intervention and does not produce severe side-effects.
评估玻璃体切割术后难治性糖尿病黄斑水肿（DME）应用二氟泼尼龙眼用混悬液（地塞米松）治疗的疗效，并与经睫状体平坦部玻璃体内注射曲安奈德（STTA）进行比较。
本研究纳入了在我院接受玻璃体切割术治疗后仍持续存在难治性糖尿病黄斑水肿的患者。所有患者在接受治疗前均已超过 3 个月。10 例患者的 11 只眼接受了 STTA（STTA 组）治疗，7 例患者的 11 只眼接受了二氟泼尼龙眼用混悬液（地塞米松）0.05%（Sirion Therapeutics Inc.，美国）4 次/日治疗 1 个月，随后改为 2 次/日治疗 2 个月（滴眼组）。
在滴眼组，治疗前平均视力（VA）（±标准差）为 0.67 ± 0.35 logMAR，平均视网膜厚度（RT）为 500.6 ± 207.7μm。治疗 3 个月后，平均 VA 为 0.67 ± 0.29，平均 RT 降至 341.2 ± 194.8μm。治疗期间 RT 的平均最低值为 300.6 ± 123.2μm，显著低于基线值（Mann-Whitney U 检验：P=0.003）。在 STTA 组，治疗前平均 VA（±标准差）为 0.67 ± 0.35 logMAR，平均 RT 为 543.3 ± 132.6μm。治疗 3 个月后，平均 VA 为 0.49 ± 0.67，平均 RT 降至 378.6 ± 135μm。治疗期间 RT 的平均最低值为 349.9 ± 113.8μm，显著低于基线值（Mann-Whitney U 检验：P=0.003）。滴眼组（73%）和 STTA 组（84%）的 RT 有效改善率无差异（Fisher 确切概率检验：P=1）。
STTA 组和滴眼组的 RT 改善情况相当。二氟泼尼龙眼用混悬液 0.05%的滴眼治疗安全有效，无需手术干预，且不会产生严重的副作用。
