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固定间隔与 OCT 引导的可变剂量玻璃体内注射贝伐单抗治疗新生血管性年龄相关性黄斑变性:一项 12 个月的随机前瞻性研究。

Fixed-interval versus OCT-guided variable dosing of intravitreal bevacizumab in the management of neovascular age-related macular degeneration: a 12-month randomized prospective study.

机构信息

Department of Ophthalmology, American University of Beirut, Lebanon.

出版信息

Am J Ophthalmol. 2012 Mar;153(3):481-489.e1. doi: 10.1016/j.ajo.2011.08.018. Epub 2011 Oct 19.

DOI:10.1016/j.ajo.2011.08.018
PMID:22014603
Abstract

PURPOSE

To compare the efficacy of as-needed or variable dosing of intravitreal bevacizumab to continuous fixed-interval dosing in the management of neovascular age-related macular degeneration (AMD).

DESIGN

Prospective, open-label, randomized clinical study.

METHODS

One hundred twenty eyes of 120 patients with treatment-naïve subfoveal neovascular AMD participated in this study at the American University of Beirut and Hotel Dieu de France Retina Clinics. Eyes were randomized (1:1) to fixed-interval dosing (every 4 to 6 weeks) or variable dosing with intravitreal bevacizumab (1.25 mg/0.05 mL). Best-corrected visual acuity (BCVA) and central retinal thickness (CRT) using optical coherence tomography (OCT) were measured at baseline and at each follow-up visit. Presence or recurrence of fluid on OCT was the main indicator for retreatment in variable dosing. Main outcome measure was improvement in BCVA and CRT at 12 months.

RESULTS

Compared to baseline, variable dosing had a mean improvement in BCVA of 11.0 letters after 12 months vs 9.2 letters for fixed-interval dosing (P = .81). Similarly, CRT decreased after 12 months by 80.7 μm for variable dosing vs 100.5 μm for fixed-interval dosing (P = .37). The average number of injections over 12 months was higher for fixed-interval dosing than variable dosing (9.5 vs 3.8 injections, P < .001).

CONCLUSIONS

Fixed-interval and variable dosing regimens of intravitreal bevacizumab improved visual acuity and anatomic outcomes after 12 months in eyes with neovascular AMD. However, variable dosing had a reduced treatment burden. Larger trials are needed to confirm these results.

摘要

目的

比较按需或变时剂量玻璃体内注射贝伐单抗与连续固定间隔剂量治疗新生血管性年龄相关性黄斑变性(AMD)的疗效。

设计

前瞻性、开放标签、随机临床研究。

方法

在贝鲁特美国大学和法国医院视网膜炎诊所,120 名患有未经治疗的黄斑下新生血管性 AMD 的患者的 120 只眼参与了这项研究。将这些眼随机(1:1)分为固定间隔剂量(每 4 至 6 周)或变时剂量玻璃体内注射贝伐单抗(1.25mg/0.05ml)组。使用光学相干断层扫描(OCT)在基线和每次随访时测量最佳矫正视力(BCVA)和中央视网膜厚度(CRT)。在变时剂量组中,OCT 上出现或复发的液体是再次治疗的主要指标。主要观察指标是 12 个月时 BCVA 和 CRT 的改善情况。

结果

与基线相比,变时剂量组治疗 12 个月后 BCVA 平均提高 11.0 个字母,而固定间隔剂量组为 9.2 个字母(P =.81)。同样,CRT 在 12 个月后,变时剂量组下降 80.7μm,而固定间隔剂量组下降 100.5μm(P =.37)。在 12 个月内,固定间隔剂量组的平均注射次数多于变时剂量组(9.5 次与 3.8 次,P<0.001)。

结论

在患有新生血管性 AMD 的眼中,固定间隔和变时剂量玻璃体内贝伐单抗治疗方案在 12 个月后均可改善视力和解剖学结果。然而,变时剂量治疗负担较低。需要更大规模的试验来证实这些结果。

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