Scaramuzzi Matteo, Querques Giuseppe, Spina Carlo La, Lattanzio Rosangela, Bandello Francesco
*Department of Ophthalmology, University Vita-Salute, Scientific Institute San Raffaele, Milan, Italy; and †Department of Ophthalmology, University Paris Est Creteil, Centre Hospitalier Intercommunal de Creteil, Creteil, France.
Retina. 2015 Jun;35(6):1216-22. doi: 10.1097/IAE.0000000000000443.
To evaluate the effects of repeated intravitreal dexamethasone implant.
We reviewed the charts of 12 patients with diabetic macular edema, who received at least 2 intravitreal Ozurdex (0.7 mg) on an "as needed" basis. Main outcome measures included changes in best-corrected visual acuity, central macular thickness, retreatment interval, and incidence of side effects.
A total of 15 eyes of 12 patients (6 men, 6 women; mean age 62 ± 12 years) were included. Retreatment was judged necessary after mean of 7.8 ± 4.1 months from the first Ozurdex (median, 6 months) (15 of 15 eyes), mean of 4.8 ± 0.9 months from the second Ozurdex (median, 5 months) (7 of 15 eyes), mean of 5.3 ± 1.5 months from the third Ozurdex (median, 5 months) (3 of 15 eyes), and mean of 5.6 ± 2 months from the fourth Ozurdex (median, 5 months) (3 of 15 eyes). Mean baseline best-corrected visual acuity was 0.67 ± 0.33 logMAR in the overall diabetic macular edema population; it significantly improved to 0.53 ± 0.31 logMAR after mean of 40.9 ± 18.2 days from the first Ozurdex (peaking efficacy) (P < 0.001), to 0.53 ± 0.29 logMAR after mean of 34.4 ± 9.0 days from the second Ozurdex (peaking efficacy) (P < 0.003), and stabilized to 0.62 ± 0.26 logMAR after mean of 29.8 ± 12.1 days from the third Ozurdex (peaking efficacy) (P = 0.05), to 0.5 ± 0.26 logMAR after mean of 36.3 ± 3.2 days from the fourth Ozurdex (peaking efficacy) (P = 0.2), and to 0.50 ± 0.26 logMAR after mean of 37.0 ± 2.6 days from the fifth Ozurdex (peaking efficacy) (P = 0.2). Mean baseline central macular thickness significantly decreased from 546 ± 139 μm to 292 ± 43 μm at 39.4 ± 17.9 days from the first Ozurdex (peaking efficacy) (P < 0.001), to 297 ± 47 μm at 33 ± 9.4 days from the second Ozurdex (peaking efficacy) (P < 0.001), to 293 ± 22 μm at 29.8 ± 12.1 days from the third Ozurdex (peaking efficacy) (P = 0.01), and stabilized to 309 ± 35 μm at 36.3 ± 3.2 days from the fourth Ozurdex (peaking efficacy) (P = 0.1), and to 295 ± 7 μm at 37.0 ± 2.6 days from the fifth Ozurdex (peaking efficacy) (P = 0.1). No serious adverse events were observed; three eyes developed a transient intraocular pressure increase, and cataract was extracted in one eye.
Repeated intravitreal Ozurdex on an "as needed" basis with a variable retreatment interval may produce long-term clinically meaningful benefits in the treatment of diabetic macular edema, without other significant side effects than expected after intraocular corticosteroid treatment.
评估重复玻璃体内注射地塞米松植入剂的效果。
我们回顾了12例糖尿病性黄斑水肿患者的病历，这些患者根据需要接受了至少2次玻璃体内注射Ozurdex（0.7毫克）。主要观察指标包括最佳矫正视力、黄斑中心厚度、再次治疗间隔和副作用发生率的变化。
共纳入12例患者的15只眼（6例男性，6例女性；平均年龄62±12岁）。从首次注射Ozurdex起平均7.8±4.1个月（中位数，6个月）后（15只眼中的15只）判定需要再次治疗，从第二次注射Ozurdex起平均4.8±0.9个月（中位数，5个月）后（15只眼中的7只），从第三次注射Ozurdex起平均5.3±1.5个月（中位数，5个月）后（15只眼中的3只），从第四次注射Ozurdex起平均5.6±2个月（中位数，5个月）后（15只眼中的3只）。在整个糖尿病性黄斑水肿患者群体中，平均基线最佳矫正视力为0.67±0.33 logMAR；在首次注射Ozurdex后平均40.9±18.2天（达到峰值疗效）显著提高至0.53±0.31 logMAR（P<0.001），在第二次注射Ozurdex后平均34.4±9.0天（达到峰值疗效）提高至0.53±0.29 logMAR（P<0.003）, 在第三次注射Ozurdex后平均29.8±12.1天（达到峰值疗效）稳定至0.62±0.26 logMAR（P = 0.05），在第四次注射Ozurdex后平均36.3±3.2天（达到峰值疗效）稳定至0.5±0.26 logMAR（P = 0.2），在第五次注射Ozurdex后平均37.0±2.6天（达到峰值疗效）稳定至0.50±0.26 logMAR（P = 0.2）。平均基线黄斑中心厚度在首次注射Ozurdex后39.4±17.9天（达到峰值疗效）时从546±139μm显著降至292±43μm（P<0.001），在第二次注射Ozurdex后33±9.4天（达到峰值疗效）时降至297±47μm（P<0.001），在第三次注射Ozurdex后29.8±12.1天（达到峰值疗效）时降至293±22μm（P = 0.01），在第四次注射Ozurdex后36.3±3.2天（达到峰值疗效）时稳定至309±35μm（P = 0.1），在第五次注射Ozurdex后37.0±2.6天（达到峰值疗效）时稳定至295±7μm（P = 0.1）。未观察到严重不良事件；3只眼出现短暂眼压升高，1只眼进行了白内障摘除术。
根据需要重复玻璃体内注射Ozurdex且再次治疗间隔可变，在治疗糖尿病性黄斑水肿方面可能产生长期具有临床意义的益处，除眼内皮质类固醇治疗后预期的副作用外无其他显著副作用。
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