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[抗血管内皮生长因子治疗糖尿病性黄斑水肿。从理论到临床实践]

[Anti-VEGF therapy for diabetic macular edema. From theory to clinical practice].

作者信息

Fursova A Zh, Chubar N V, Tarasov M S, Niculich I F, Vasilyeva M A, Gusarevich O G

机构信息

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.

出版信息

Vestn Oftalmol. 2018;134(2):12-22. doi: 10.17116/oftalma2018134212-22.

Abstract

PURPOSE

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.

MATERIAL AND METHODS

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).

RESULTS

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.

CONCLUSION

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.

摘要

目的

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。

材料与方法

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。

结果

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。

结论

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。

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