Fursova A Zh, Chubar N V, Tarasov M S, Niculich I F, Vasilyeva M A, Gusarevich O G
Novosibirsk State Regional Clinical Hospital, 130 Nemirovicha-Danchenko St., Novosibirsk, Russian Federation, 630008; Novosibirsk State Region University, 52 Krasny Prospect, Novosibirsk, Russian Federation, 630091.
Novosibirsk State Regional Clinical Hospital, 130 Nemirovicha-Danchenko St., Novosibirsk, Russian Federation, 630008.
Vestn Oftalmol. 2018;134(2):12-22. doi: 10.17116/oftalma2018134212-22.
To evaluate clinical effectiveness of aflibercept therapy for patients with diabetic macular edema (DME) - both naïve to the drug and unresponsive to previous anti-VEGF treatment.
The study included 127 patients (127 eyes) divided into two groups. The first group consisted of 100 primary DME patients (100 eyes) with mean age of 68.48±2.56 years and average disease duration of 12.50±7.85 years. The second group comprised 27 patients (27 eyes) with resistant macular edema who had received three or more 0.5 mg ranibizumab loading injections. Their average age was 66±4.12 and the mean number of previous anti-VEGF injections before changing therapy was 4.56±1.21. The evaluation parameters included Best Corrected Visual Acuity (BCVA) and Central Retinal Thickness (CRT) that were assessed initially and after each 2 mg aflibercept injection (at 1-month intervals during the 6 months of DME therapy).
The average number of aflibercept injections in the first group was 4.34±1.22. BCVA improved in 100% of patients of that group after the 3 injection with resulting mean value of 0.32±0.15. Maximum BCVA improvement was seen after the 6 injection amounting to 0.46±0.2. CRT decreased in 100% of patients of that group after the 1 injection. One month after the therapy start, CRT decreased in average by 17.96% - to 370.89±50.55 µm; at 3 months, CRT was 344.65±48.56 µm; after 6 month - 283.40±49.76 µm. All patients of the second group had retinal morphology restored, visual function improved in 55% of patients. Mean CRT decrease was 180±44 µm, BCVA improvement - 0.13±0.08, mean number of aflibercept injections - 4.86±0.9.
Aflibercept can be used as first-choice drug for treatment of DME patients (both therapy-naïve and unresponsive to previous ranibizumab therapy) to improve anatomical parameters and visual function.
评估阿柏西普治疗糖尿病性黄斑水肿（DME）患者的临床疗效，这些患者既未接受过该药物治疗，也对先前的抗血管内皮生长因子（VEGF）治疗无反应。
该研究纳入了127例患者（127只眼），分为两组。第一组由100例初发DME患者（100只眼）组成，平均年龄为68.48±2.56岁，平均病程为12.50±7.85年。第二组包括27例（27只眼）难治性黄斑水肿患者，他们接受了三次或更多次0.5mg雷珠单抗负荷注射。他们的平均年龄为66±4.12岁，在改变治疗前先前抗VEGF注射的平均次数为4.56±1.21次。评估参数包括最佳矫正视力（BCVA）和中心视网膜厚度（CRT），在初始时以及每次注射2mg阿柏西普后（在DME治疗的6个月期间，每隔1个月）进行评估。
第一组阿柏西普注射的平均次数为4.34±1.22次。该组100%的患者在注射3次后BCVA得到改善，最终平均值为0.32±0.15。在注射6次后BCVA改善最大，达到0.46±0.2。该组100%的患者在注射1次后CRT下降。治疗开始1个月后，CRT平均下降17.96%，降至370.89±50.55µm；在3个月时，CRT为344.65±48.56µm；6个月后为283.40±49.76µm。第二组所有患者的视网膜形态均恢复，55%的患者视觉功能得到改善。CRT平均下降180±44µm，BCVA改善0.13±0.08，阿柏西普注射的平均次数为4.86±0.9次。
阿柏西普可作为治疗DME患者（包括初治患者和先前对雷珠单抗治疗无反应的患者）的首选药物，以改善解剖学参数和视觉功能。
