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基线中央视网膜厚度对阿柏西普治疗糖尿病性黄斑水肿疗效的影响:捷克共和国的真实世界证据。

EFFECT OF BASELINE CENTRAL RETINAL THICKNESS ON THE RESULTS OF TREATMENT OF DIABETIC MACULAR EDEMA WITH AFLIBERCEPT: REAL-LIFE EVIDENCE IN THE CZECH REPUBLIC.

出版信息

Cesk Slov Oftalmol. 2022 Spring;78(2):64-70. doi: 10.31348/2022/9.

Abstract

AIM

Presentation of the 1-year results of aflibercept treatment in patients suffering from diabetic macular edema (DME) and comparison of the response to treatment of patients with different baseline central retinal thickness (CRT).

METHODS

This was a multicentre, retrospective observational study of a series of cases. Patients with DME were treated in a fixed regimen (5 injections at 1-monthly intervals and then injections at 2-monthly intervals). The period of follow-up was 12 months. The development of best corrected visual acuity (BCVA) and CRT was evaluated. Measurements were performed prior to the commencement of treatment and then after 4, 6, 8, 10, and 12 months.

RESULTS

The therapeutically naive group consisted of 82 eyes of 79 patients. The total cohort of patients was divided into 3 groups according to the baseline values of CRT. The first group was composed of 28 eyes with baseline CRT < 450 μm (34.1%), the second included 25 eyes with CRT in the range of 450-550 μm (30.5%), and the third group consisted of 29 eyes with baseline CRT > 550 μm (35.4%). The average baseline BCVA and SD in the first group was 66 ±7.1 letters ETDRS optotypes, and then 70 ±7 letters, 69.6 ±7.3 letters, and 71.3 ±7 letters at the follow-ups after 4, 8, and 12 months. The average baseline value of CRT and SD in the first group was 379 ±48.6 μm, and then 337.1 ±76.5 μm, 320.2 ±74.1 μm, and 315.1 ±62.2 μm after 4, 8, and 12 months. The average baseline BCVA and SD in the second group was 64.1 ±9.7 ETDRS letters, and then 66.9 ±10 letters, 70 ±9.9 letters, and 70.5 ±11.5 letters after 4, 8, and 12 months. The average baseline value of CRT and SD in the second group was 497.4 ±76.4 μm, and then 376.5 ±106.1 μm, 360.8 ±70 μm, and 351.3 ±91.3 μm after 4, 8, and 12 months. In the third group, the average baseline value of BCVA and SD was 59.7 ±10.4 ETDRS letters, and then 65 ±10.6 letters, 64.8 ±9.6 letters, and 67 ±10 letters after 4, 8, and 12 months. The average baseline value of CRT and SD in the third group was 639.4 ±79.6 μm, and then 396.7 ±147.1 μm, 416.9 ±139.8 μm, and 368.5 ±109.9 μm after 4, 8, and 12 months. All these changes were statistically significant (p < 0.05).

CONCLUSION

Aflibercept treatment in a fixed regimen in patients suffering from DME results in a statistically significant improvement in BCVA and a decrease in CRT in the first year of treatment. Patients with a higher baseline CRT showed the best anatomical and functional results of the 1-year treatment with aflibercept.

摘要

目的

介绍接受阿柏西普治疗的糖尿病黄斑水肿(DME)患者的 1 年治疗结果,并比较不同基线中央视网膜厚度(CRT)患者对治疗的反应。

方法

这是一项多中心、回顾性观察性研究,对一系列病例进行了研究。DME 患者采用固定方案(每月 1 次,共 5 次,然后每 2 个月 1 次)进行治疗。随访期为 12 个月。评估最佳矫正视力(BCVA)和 CRT 的变化。在开始治疗前和治疗后 4、6、8、10 和 12 个月进行测量。

结果

治疗初治组包括 79 例患者的 82 只眼。根据基线 CRT 值,将总患者队列分为 3 组。第一组 28 只眼,基线 CRT < 450 µm(34.1%);第二组 25 只眼,基线 CRT 在 450-550 µm 范围内(30.5%);第三组 29 只眼,基线 CRT > 550 µm(35.4%)。第一组平均基线 BCVA 和 SD 分别为 66 ±7.1 ETDRS 视标,然后在 4、8 和 12 个月的随访时分别为 70 ±7 个字母、69.6 ±7.3 个字母和 71.3 ±7 个字母。第一组平均基线 CRT 和 SD 分别为 379 ±48.6 µm 和 337.1 ±76.5 µm,然后在 4、8 和 12 个月的随访时分别为 337.1 ±76.5 µm、320.2 ±74.1 µm 和 315.1 ±62.2 µm。第二组平均基线 BCVA 和 SD 分别为 64.1 ±9.7 ETDRS 字母,然后在 4、8 和 12 个月的随访时分别为 66.9 ±10 个字母、70 ±9.9 个字母和 70.5 ±11.5 个字母。第二组平均基线 CRT 和 SD 分别为 497.4 ±76.4 µm 和 376.5 ±106.1 µm,然后在 4、8 和 12 个月的随访时分别为 376.5 ±106.1 µm、360.8 ±70 µm 和 351.3 ±91.3 µm。第三组平均基线 BCVA 和 SD 分别为 59.7 ±10.4 ETDRS 字母,然后在 4、8 和 12 个月的随访时分别为 65 ±10.6 个字母、64.8 ±9.6 个字母和 67 ±10 个字母。第三组平均基线 CRT 和 SD 分别为 639.4 ±79.6 µm 和 396.7 ±147.1 µm,然后在 4、8 和 12 个月的随访时分别为 396.7 ±147.1 µm、416.9 ±139.8 µm 和 368.5 ±109.9 µm。所有这些变化均具有统计学意义(p < 0.05)。

结论

DME 患者接受阿柏西普固定方案治疗,在第 1 年治疗中可显著改善 BCVA,并降低 CRT。基线 CRT 较高的患者在接受阿柏西普治疗 1 年后的解剖学和功能结果最佳。

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