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两年阿柏西普三联疗法治疗三种湿性年龄相关性黄斑变性脉络膜新生血管膜的结果:捷克共和国的真实世界证据。

Two-year results of a combined regimen of aflibercept treatment in three types of choroidal neovascular membrane in the wet form of age-related macular degeneration: Real-life evidence in the Czech Republic.

机构信息

Department of Ophthalmology, Faculty Hospital in Hradec Kralove and Charles University Faculty of Medicine in Hradec Kralove, Hradec Kralove, Czech Republic.

Department of Ophthalmology, Faculty Hospital in Ostrava and Ostrava University Faculty of Medicine, Ostrava, Czech Republic.

出版信息

Eur J Ophthalmol. 2021 Sep;31(5):2488-2495. doi: 10.1177/1120672120971190. Epub 2020 Nov 16.

Abstract

AIM

To present the results of a 2-year therapy with aflibercept in real-life practice in a mixed regimen in patients with a neovascular form of age-related macular degeneration (nAMD) and to evaluate the treatment response of various types of choroidal neovascular membranes (CNV) - occult (Type 1), classic (Type 2) and minimally classic (Type 4).

METHODS

This was a multicentric, prospective, observational study of a series of cases. Patients diagnosed with the wet form of AMD were treated in a fixed regimen (3 injections at intervals of 1 month and then injections at 8-week intervals) in the first year, and in a regimen (PRN) in the second year. The period of investigation was 24 months. The development of the best corrected visual acuity (BCVA) was evaluated by means of ETDRS optotypes (Early Treatment Diabetic Retinopathy Study) and the central retinal thickness (CRT). Measurements were performed prior to the commencement of therapy and then after 4, 8, 12, 16, 20 and 24 months.

RESULTS

The therapeutically naïve group consisted of 135 eyes of 135 patients. Sixty-one eyes suffered from CNV of the 1st type, 50 eyes from CNV of the 2nd type and 24 eyes from CNV of the 4th type. The average baseline of BCVA ± SD in Type 1 CNV was 56.1 ± 10.8 letters of ETDRS, and then, respectively, 62.2 ± 12.9 letters, 62.8 ± 15.1 letters and 59.4 ± 13.2 letters after 4, 12 and 24 months. The average baseline value of CRT ± SD for Type 1 CNV was 442.4 ± 194.9 µm, and then 302.5 ± 144.4 µm, 277.7 ± 106.5 µm and 327.6 ± 138.6 µm at months 4, 12 and 24. The average baseline value of BCVA ± SD in Type 2 CNV was 55.6 ± 9.9 letters of ETDRS, and then 62.5 ± 11.1 letters, 62.5 ± 14.2 letters and 60.6 ± 15.1 letters after 4, 12 and 24 months. The average baseline value of CRT ± SD in Type 2 CNV was 446.8 ± 159.1 µm, and then 327.4 ± 127.0 µm, 316.7 ± 139.1 µm and 352.5 ± 132.4 µm at 4, 12 and 24 months. In Type 4 CNV, the average baseline value of BCVA ± SD was 56.7 ± 9.0 letters of ETDRS, and then 59.1 ± 10.6 letters, 59.2 ± 12.6 letters and 58 ± 8.8 letters after 4, 12 and 24 months. The average baseline value of CRT ± SD in Type 4 CNV was 492.1 ± 187.0 µm, and then 333.3 ± 137.5 µm, 326.7 ± 122.4 µm and 328.4 ± 132 µm at months 4, 12 and 24. All these changes were statistically significant ( < 0.05).

CONCLUSION

Therapy with aflibercept in a mixed regimen in patients with the wet form of AMD during the investigation resulted in a statistically significant improvement in BCVA and decrease in CRT in both the occult and classic type of CNV. Both the functional and anatomical response to therapy was worse in the minimally classic type (Type 4) of CNV.

SUMMARY DECLARATION

Patients suffering from the neovascular form of age-related macular degeneration were treated with aflibercept in a mixed regimen (fixed in the first year and PRN in the second year). After 24 months of examination, a significant improvement of both morphological and functional results was observed in three types of choroidal neovascular membrane.

摘要

目的

介绍在湿性年龄相关性黄斑变性(AMD)患者中应用阿柏西普混合方案(第一年固定方案,第二年 PRN 方案)进行为期 2 年的治疗结果,并评估各种类型脉络膜新生血管(CNV) - 隐匿型(1 型)、经典型(2 型)和最小经典型(4 型)的治疗反应。

方法

这是一项多中心、前瞻性、观察性病例系列研究。在第一年,所有诊断为湿性 AMD 的患者均接受固定方案(3 次间隔 1 个月的注射,然后 8 周间隔注射)治疗,第二年则采用 PRN 方案。研究期间为 24 个月。通过 ETDRS 视标(糖尿病性视网膜病变早期治疗研究)和中央视网膜厚度(CRT)评估最佳矫正视力(BCVA)的发展。在治疗开始前和治疗后 4、8、12、16、20 和 24 个月进行测量。

结果

在治疗初治组中,共有 135 名患者的 135 只眼。61 只眼患有 1 型 CNV,50 只眼患有 2 型 CNV,24 只眼患有 4 型 CNV。1 型 CNV 的平均基线 BCVA±SD 为 56.1±10.8 个 ETDRS 字母,然后分别为 4 个月、12 个月和 24 个月时的 62.2±12.9 个、62.8±15.1 个和 59.4±13.2 个。1 型 CNV 的平均基线 CRT±SD 值为 442.4±194.9μm,然后分别为治疗后 4、12 和 24 个月时的 302.5±144.4μm、277.7±106.5μm 和 327.6±138.6μm。2 型 CNV 的平均基线 BCVA±SD 值为 55.6±9.9 个 ETDRS 字母,然后分别为 4 个月、12 个月和 24 个月时的 62.5±11.1 个、62.5±14.2 个和 60.6±15.1 个。2 型 CNV 的平均基线 CRT±SD 值为 446.8±159.1μm,然后分别为治疗后 4、12 和 24 个月时的 327.4±127.0μm、316.7±139.1μm 和 352.5±132.4μm。在 4 型 CNV 中,平均基线 BCVA±SD 值为 56.7±9.0 个 ETDRS 字母,然后分别为 4 个月、12 个月和 24 个月时的 59.1±10.6 个、59.2±12.6 个和 58.0±8.8 个。4 型 CNV 的平均基线 CRT±SD 值为 492.1±187.0μm,然后分别为治疗后 4、12 和 24 个月时的 333.3±137.5μm、326.7±122.4μm 和 328.4±132.0μm。所有这些变化均具有统计学意义( < 0.05)。

结论

在湿性 AMD 患者中应用阿柏西普混合方案治疗 2 年,结果显示隐匿型和经典型 CNV 的 BCVA 均有统计学显著改善,CRT 降低。最小经典型(4 型)CNV 的治疗反应在功能和解剖学方面均较差。

总结声明

患有新生血管性年龄相关性黄斑变性的患者接受了阿柏西普的混合方案治疗(第一年固定方案,第二年 PRN 方案)。经过 24 个月的检查,三种脉络膜新生血管膜的形态和功能结果均有显著改善。

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