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2.5毫克/千克与5毫克/千克全身应用贝伐单抗治疗新生血管性年龄相关性黄斑变性的比较:一项非对照前瞻性队列研究的24周结果

Comparison of 2.5 mg/kg and 5 mg/kg systemic bevacizumab in neovascular age-related macular degeneration: twenty-four week results of an uncontrolled, prospective cohort study.

作者信息

Geitzenauer Wolfgang, Michels Stephan, Prager Franz, Rosenfeld Philip J, Kornek Gabriela, Vormittag Laurenz, Schmidt-Erfurth Ursula

机构信息

Department of Ophthalmology, Medical University of Vienna, Austria.

出版信息

Retina. 2008 Nov-Dec;28(10):1375-86. doi: 10.1097/IAE.0b013e3181863f96.

Abstract

BACKGROUND

To compare safety, visual acuity (VA), and anatomic outcomes of 2.5 mg/kg and 5 mg/kg intravenous bevacizumab in patients with neovascular age-related macular degeneration.

METHODS

In an institutional cohort study, 16 patients (2 cohorts, 27 eyes) with neovascular age-related macular degeneration were treated with 5 mg/kg intravenous bevacizumab and 2.5 mg/kg, respectively. All patients received 3 initial intravenous infusions at 2-week intervals. The main outcome measures were VA, optical coherence tomography, and fluorescein angiography.

RESULTS

No serious systemic or ocular adverse events were identified. By Day 7, mean VA increased from 56 letters (20/80(+1)) at baseline to 60 letters (20/63) in the 5 mg/kg group and mean central retinal thickness decreased by 83 microm. In the 2.5 mg/kg group, mean VA increased from 55 letters (20/80) to 66 letters (20/50(+1)) and mean central retinal thickness decreased by 93 microm. By Month 3, VA improved by 10 letters compared to baseline in the 5 mg/kg group and by 9 letters in the 2.5 mg/kg group. Central retinal thickness was reduced by 128 microm in the 5 mg/kg group and by 127 microm in the 2.5 mg/kg group. These benefits were sustained through 6 months. No statistically significant difference was found between both treatment groups regarding safety, VA, and anatomic outcomes.

CONCLUSION

Similar VA, optical coherence tomography, and angiographic improvements were observed in both treatment groups up to 6 months. Further follow-up is required to evaluate the long-term durability and safety of both treatment regimens.

摘要

背景

比较2.5mg/kg和5mg/kg静脉注射贝伐单抗治疗新生血管性年龄相关性黄斑变性患者的安全性、视力(VA)和解剖学结果。

方法

在一项机构队列研究中,16例(2个队列,27只眼)新生血管性年龄相关性黄斑变性患者分别接受5mg/kg和2.5mg/kg静脉注射贝伐单抗治疗。所有患者均接受3次初始静脉输注,间隔2周。主要观察指标为视力、光学相干断层扫描和荧光素血管造影。

结果

未发现严重的全身或眼部不良事件。至第7天,5mg/kg组平均视力从基线时的56字母(20/80(+1))提高到60字母(20/63),平均视网膜中央厚度减少83微米。在2.5mg/kg组,平均视力从55字母(20/80)提高到66字母(20/50(+1)),平均视网膜中央厚度减少93微米。至第3个月,5mg/kg组视力较基线提高10字母,2.5mg/kg组提高9字母。5mg/kg组视网膜中央厚度减少128微米,2.5mg/kg组减少127微米。这些益处持续了6个月。在安全性、视力和解剖学结果方面,两个治疗组之间未发现统计学显著差异。

结论

在长达6个月的时间里,两个治疗组在视力、光学相干断层扫描和血管造影改善方面均相似。需要进一步随访以评估两种治疗方案的长期疗效和安全性。

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