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预处理和初发息肉状脉络膜血管病变患者固定剂量阿柏西普治疗的一年疗效。

One-year outcomes of fixed-dosing Aflibercept therapy for pre treated and naive polypoidal choroidal vasculopathy patient.

机构信息

Department of Ophthalmology, Wonju College of Medicine - Yonsei University, Wonju, Republic of Korea.

Department of Ophthalmology, First St. Marys Eye Clinic, Seoul, Republic of Korea.

出版信息

BMC Ophthalmol. 2021 Feb 18;21(1):94. doi: 10.1186/s12886-021-01829-2.

DOI:10.1186/s12886-021-01829-2
PMID:33602156
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7890830/
Abstract

BACKGROUND

Polypoidal choroidal vasculopathy (PCV) is a type of age-related macular degeneration that can cause permanent vision loss. The purpose of this paper was to report the one-year outcomes of fixed-dosing aflibercept therapy for the treatment of PCV.

METHODS

This was a prospective, single-arm, interventional case series study of 25 PCV patients; 12 pre-treated and 13 treatment-naïve patients. The patients were treated and monitored for 12 months. Each patient was administered with an aflibercept (2.0 mg) injection every month for the first 3 months (the loading phase), and thereafter, once every 2 months. At every follow-up visit, best-corrected visual acuity (BCVA) test, fundus examination, and optical coherence tomography for measuring the central subfield macular thickness (CSMT) were performed. Fluorescein and indocyanine green angiography were conducted at baseline and at 4 and 12 months.

RESULTS

After 12 months of aflibercept therapy, the mean BCVA of the patients significantly improved from 65.48 letters at baseline to 69.91 letters (p=0.001), and the CSMT significantly decreased from 406.92 um at baseline to 276.12 um (p< 0.001). Additionally, ten patients (40%) showed complete polyp regression. The treatment-naïve patients showed a statistically significant improvement in BCVA from 66.58 letters at baseline to 76.36 letters at 12 months, and a significant decrease in CSMT, from 462 to 243 um. In the pre-treated group, there was no change in BCVA (64.46 letters), and the decrease in CSMT from 356.08 to 303.69 um was not statistically significant.

CONCLUSIONS

The fixed-dosing aflibercept regimen is effective for treating patients with PCV and is more effective in treatment-naïve patients than in pre-treated patients.

TRIAL REGISTRATION

Clinical Research Information Service (CRiS), Republic of Korea. Identifer: KCT0005798, Registered: Jan 20, 2021. Retrospectively registered, URL: https://cris.nih.go.kr/cris/en/search/search_result_st01.jsp?seq=18546.

摘要

背景

息肉样脉络膜血管病变(PCV)是一种与年龄相关的黄斑退行性疾病,可导致永久性视力丧失。本文旨在报告固定剂量阿柏西普治疗 PCV 的一年治疗结果。

方法

这是一项前瞻性、单臂、干预性病例系列研究,共纳入 25 例 PCV 患者,其中 12 例为预处理患者,13 例为治疗初治患者。患者接受了为期 12 个月的治疗和监测。所有患者在前 3 个月(加载期)每月接受一次阿柏西普(2.0mg)注射,此后每 2 个月一次。每次随访时,均进行最佳矫正视力(BCVA)测试、眼底检查和光学相干断层扫描测量中心凹下黄斑厚度(CSMT)。在基线、4 个月和 12 个月时进行荧光素和吲哚青绿血管造影。

结果

阿柏西普治疗 12 个月后,患者的平均 BCVA 从基线时的 65.48 个字母显著提高到 69.91 个字母(p=0.001),CSMT 从基线时的 406.92μm显著降低到 276.12μm(p<0.001)。此外,10 名患者(40%)的息肉完全消退。治疗初治患者的 BCVA 从基线时的 66.58 个字母显著提高到 12 个月时的 76.36 个字母,CSMT 从 462μm显著降低到 243μm。预处理组患者的 BCVA 无变化(64.46 个字母),CSMT 从 356.08μm 降至 303.69μm,无统计学意义。

结论

固定剂量阿柏西普方案治疗 PCV 有效,对治疗初治患者比预处理患者更有效。

试验注册

临床研究信息服务(CRiS),韩国。标识符:KCT0005798,注册日期:2021 年 1 月 20 日。回顾性注册,网址:https://cris.nih.go.kr/cris/en/search/search_result_st01.jsp?seq=18546。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a89b/7890830/ceb6f17e4aba/12886_2021_1829_Fig5_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a89b/7890830/83e2e6fde7fa/12886_2021_1829_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a89b/7890830/ad1f53b03a77/12886_2021_1829_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a89b/7890830/e0edef90eb7d/12886_2021_1829_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a89b/7890830/3a8dd0156af3/12886_2021_1829_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a89b/7890830/ceb6f17e4aba/12886_2021_1829_Fig5_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a89b/7890830/83e2e6fde7fa/12886_2021_1829_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a89b/7890830/ad1f53b03a77/12886_2021_1829_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a89b/7890830/e0edef90eb7d/12886_2021_1829_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a89b/7890830/3a8dd0156af3/12886_2021_1829_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a89b/7890830/ceb6f17e4aba/12886_2021_1829_Fig5_HTML.jpg

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