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雷珠单抗与阿柏西普治疗年龄相关性黄斑变性的再治疗时间和视觉功能比较

Comparison of Time to Retreatment and Visual Function Between Ranibizumab and Aflibercept in Age-Related Macular Degeneration.

作者信息

Inoue Maiko, Yamane Shin, Sato Shimpei, Sakamaki Kentaro, Arakawa Akira, Kadonosono Kazuaki

机构信息

Department of Ophthalmology, Yokohama City University Medical Center, Yokohama, Japan.

Department of Ophthalmology, Yokohama City University Medical Center, Yokohama, Japan.

出版信息

Am J Ophthalmol. 2016 Sep;169:95-103. doi: 10.1016/j.ajo.2016.06.021. Epub 2016 Jun 16.

Abstract

PURPOSE

To compare time to retreatment and visual function between patients with treatment-naïve neovascular age-related macular degeneration (AMD) treated with either intravitreal ranibizumab (IVR) or intravitreal aflibercept (IVA) in routine clinical practice.

DESIGN

Retrospective, interventional comparative case series.

PARTICIPANTS

A total of 200 eyes of 197 patients with neovascular AMD.

METHODS

A total of 99 patients in the IVR group and 101 patients in the IVA group who met the inclusion criteria with 12 months of follow-up were included in the present study. All patients received 3 consecutive monthly injections of 0.5 mg/0.05 mL ranibizumab or 2.0 mg/0.05 mL aflibercept as loading doses. Retreatment was allowed if evidence of clinical deterioration or the presence of intraretinal edema or subretinal fluid on spectral-domain optical coherence tomography examination performed at the 1-month follow-up was noted. The time to retreatment after the third injection during the loading phase to the first recurrence during the maintenance phase was compared between treatments using the Kaplan-Meier analysis. Functional and anatomic outcomes were also compared between the IVR and IVA groups.

RESULTS

The median time to retreatment after the last induction dose was 5 months in both groups. The proportion of IVR patients who required injection retreatment was not significantly higher than that of IVA patients (67.7% and 63.4%, respectively, at the 12-month follow up; log-rank test, P = .554). In both groups, significant improvements in postoperative best-corrected visual acuity (BCVA) compared with preoperative visual acuity was observed over the 12-month follow-up period (P < .05 for both). Central foveal thickness (CFT) decreased from the baseline values in both groups during the follow-up period (P < .001 for both). Although there was a trend toward greater BCVA improvements in the IVA group, no significant differences in BCVA or CFT were observed between the treatment groups.

CONCLUSIONS

Both IVR and IVA were well tolerated and demonstrated efficacy in improving the visual acuity in treatment-naïve patients with AMD. Despite a trend toward greater BCVA improvements in the IVA group, a similar injection burden was observed following the loading phases of both ranibizumab and aflibercept.

摘要

目的

在常规临床实践中,比较初治的新生血管性年龄相关性黄斑变性(AMD)患者接受玻璃体内注射雷珠单抗(IVR)或阿柏西普(IVA)治疗后的再次治疗时间和视觉功能。

设计

回顾性、介入性比较病例系列研究。

参与者

197例新生血管性AMD患者的200只眼。

方法

本研究纳入了IVR组的99例患者和IVA组的101例患者,这些患者符合纳入标准并接受了12个月的随访。所有患者均接受连续3个月每月一次的0.5mg/0.05mL雷珠单抗或2.0mg/0.05mL阿柏西普注射作为负荷剂量。如果在1个月随访时进行的光谱域光学相干断层扫描检查发现临床恶化证据或存在视网膜内水肿或视网膜下液,则允许再次治疗。使用Kaplan-Meier分析比较负荷期第三次注射后至维持期首次复发的再次治疗时间。还比较了IVR组和IVA组的功能和解剖学结果。

结果

两组最后一次诱导剂量后的再次治疗中位时间均为5个月。需要注射再次治疗的IVR患者比例并不显著高于IVA患者(12个月随访时分别为67.7%和63.4%;对数秩检验,P = 0.554)。在12个月的随访期内,两组术后最佳矫正视力(BCVA)均较术前视力有显著改善(两组P均<0.05)。随访期间两组中央凹厚度(CFT)均较基线值下降(两组P均<0.001)。尽管IVA组BCVA改善有更大的趋势,但治疗组之间BCVA或CFT无显著差异。

结论

IVR和IVA耐受性均良好,在初治的AMD患者中均显示出提高视力的疗效。尽管IVA组BCVA改善有更大的趋势,但雷珠单抗和阿柏西普负荷期后的注射负担相似。

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