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雷珠单抗和阿柏西普对年龄相关性黄斑变性的视网膜色素上皮脱离、脉络膜视网膜下和视网膜内液的影响。

EFFECT OF RANIBIZUMAB AND AFLIBERCEPT ON RETINAL PIGMENT EPITHELIAL DETACHEMENT, SUBRETINAL AND INTRARETINAL FLUID IN AGE-RELATED MACULAR DEGENERATION.

出版信息

Cesk Slov Oftalmol. 2022 Summer;78(4):176-185. doi: 10.31348/2022/20.

Abstract

PURPOSE

The aim of the study was to compare the effect of three initial doses of the anti-VEGF ranibizumab and aflibercept medication on serous pigment epithelial detachment (PED), subretinal fluid (SRF) and intraretinal fluid (IRF) in the macula of treatment naive neovascular AMD (nvAMD) patients.

MATERIAL AND METHODS

The cohort consists of 148 patients, of which 74 patients were treated with ranibizumab (51 females and 23 males) and 74 with aflibercept (46 females and 28 males). The data was recorded prospectively from the moment of diagnosis and start of treatment for a period of 3 months. At the moment of diagnosis and 3 months later, an OCT examination (Spectralis OCT, Heidelberg Engineering, Heidelberg, Germany) was performed. The OCT examination included a macular scan with 25 scans. Using the OCT instrument software, we measured the maximum anterior-posterior elevation of serous PED, the highest thickness of SRF and the largest diameter of the intraretinal cystic space. The statistical significance of differences between groups was evaluated using the t-test for continuous data and the Fisher exact test for categorical data. Changes in values of continuous variables over time were evaluated using the Wilcoxon paired test. Paired comparisons of binary parameters were determined by the McNemar test.

RESULTS

Full regression of PED, SRF and IRF occurred in 3 (4.1%), 25 (39%) and 20 (51%) patients treated with ranibizumab, and in 5 (7.9%, p = 0.470), 28 (47%, p = 0.470) and 25 (57%, p = 0.827) patients treated with aflibercept, respectively. The average regression of PED, SRF and IRF was -60.4 μm (median -37.5 μm), -84.3 μm (median -85 μm) and -109.3 μm (median -81 μm) in patients treated with ranibizumab, and -46.3 μm (median -30 μm, p = 0.389), -127.7 μm (median -104 μm, p = 0.096) and -204.4 μm (median -163 μm, p = 0.005) in patients treated with aflibercept, respectively. We did not show a statistically significant difference in the regression rates of PED, SRF and IRF between the ranibizumab and aflibercept groups. (in patients with IRF after adjustment of the higher baseline IRF volumes in patients treated with aflibercept, p = 0.891).

CONCLUSION

We are convinced that ranibizumab and aflibercept have the same effect on serous PED, SRF and IRF in the macula in patients with treatment naive nvAMD during the initial loading phase.

摘要

目的

本研究旨在比较三种初始剂量的抗血管内皮生长因子雷珠单抗和阿柏西普药物对治疗初发性新生血管性年龄相关性黄斑变性(nvAMD)患者黄斑区浆液性色素上皮脱离(PED)、视网膜下液(SRF)和视网膜内液(IRF)的影响。

材料和方法

该队列包括 148 名患者,其中 74 名患者接受雷珠单抗治疗(51 名女性和 23 名男性),74 名患者接受阿柏西普治疗(46 名女性和 28 名男性)。从诊断和治疗开始的那一刻起,前瞻性地记录数据,持续 3 个月。在诊断时和 3 个月后,进行 OCT 检查(Spectralis OCT,Heidelberg Engineering,Heidelberg,Germany)。OCT 检查包括 25 个扫描的黄斑扫描。使用 OCT 仪器软件,我们测量了浆液性 PED 的最大前后抬高、SRF 的最大厚度和视网膜内囊状空间的最大直径。使用 t 检验评估组间连续数据的统计学意义,使用 Fisher 确切检验评估分类数据的统计学意义。使用 Wilcoxon 配对检验评估连续变量随时间的变化。通过 McNemar 检验确定二元参数的配对比较。

结果

雷珠单抗治疗的 3 名(4.1%)、25 名(39%)和 20 名(51%)患者的 PED、SRF 和 IRF 完全消退,阿柏西普治疗的 5 名(7.9%,p=0.470)、28 名(47%,p=0.470)和 25 名(57%,p=0.827)患者的 PED、SRF 和 IRF 分别完全消退。雷珠单抗治疗的 PED、SRF 和 IRF 的平均消退分别为 -60.4μm(中位数-37.5μm)、-84.3μm(中位数-85μm)和-109.3μm(中位数-81μm),阿柏西普治疗的 PED、SRF 和 IRF 的平均消退分别为 -46.3μm(中位数-30μm,p=0.389)、-127.7μm(中位数-104μm,p=0.096)和-204.4μm(中位数-163μm,p=0.005)。我们没有显示雷珠单抗和阿柏西普组 PED、SRF 和 IRF 的消退率存在统计学差异。(在调整阿柏西普治疗患者较高的基线 IRF 体积后,IRF 患者的统计学差异为 p=0.891)。

结论

我们相信,在治疗初发性新生血管性年龄相关性黄斑变性患者的初始负荷阶段,雷珠单抗和阿柏西普对黄斑区浆液性 PED、SRF 和 IRF 具有相同的作用。

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