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玻璃体内注射阿柏西普或雷珠单抗前后年龄相关性黄斑变性患者血管内皮生长因子的全身水平:一项随机、前瞻性试验。

Systemic levels of vascular endothelial growth factor before and after intravitreal injection of aflibercept or ranibizumab in patients with age-related macular degeneration: a randomised, prospective trial.

作者信息

Zehetner Claus, Kralinger Martina T, Modi Yasha S, Waltl Inga, Ulmer Hanno, Kirchmair Rudolf, Bechrakis Nikolaos E, Kieselbach Gerhard F

机构信息

Department of Ophthalmology, Medical University Innsbruck, Innsbruck, Austria.

出版信息

Acta Ophthalmol. 2015 Mar;93(2):e154-9. doi: 10.1111/aos.12604. Epub 2014 Dec 8.

DOI:10.1111/aos.12604
PMID:25488124
Abstract

PURPOSE

To evaluate the changes of vascular endothelial growth factor (VEGF) plasma levels after intravitreal injections of aflibercept or ranibizumab in patients with exudative age-related macular degeneration (AMD).

METHODS

Thirty-eight patients with exudative AMD were included in this randomised, prospective study. Nineteen patients were randomised to treatment with intravitreal aflibercept (2.0 mg) and 19 to intravitreal ranibizumab (0.5 mg). The concentration of VEGF was measured by ELISA just before the injection, after 7 days and 1 month. Twenty-two age- and sex-matched healthy patients without chorioretinal diseases served as control.

RESULTS

The median baseline plasma VEGF concentration was 61.0 pg/ml in the control group, 43.0 pg/ml in the aflibercept group and 59.0 pg/ml in the ranibizumab group (p=0.127). Seven days after intravitreal injection of aflibercept plasma levels were significantly reduced to values below the minimum detectable dose (MDD) in 17 of 19 patients (89.5%) resulting in a median VEGF concentration of <9 pg/ml (p<0.001). The reduction persisted throughout 1 month with values below the MDD in 5 of 19 patients (26.3%) and a median measurement of 17.0 pg/ml (p<0.001). In patients treated with ranibizumab no significant effects could be observed with a baseline VEGF of 59.0 pg/ml, 54.0 pg/ml at 7 days (p=0.776) and 58.5 pg/ml at 4 weeks of follow-up (p=0.670).

CONCLUSION

After intravitreal aflibercept injection, the systemic VEGF levels were significantly reduced throughout the observational period of 4 weeks. No significant systemic effects of intravitreal ranibizumab on plasma VEGF were observed.

摘要

目的

评估玻璃体内注射阿柏西普或雷珠单抗后,渗出性年龄相关性黄斑变性(AMD)患者血浆血管内皮生长因子(VEGF)水平的变化。

方法

38例渗出性AMD患者纳入本随机、前瞻性研究。19例患者随机接受玻璃体内注射阿柏西普(2.0 mg)治疗,19例接受玻璃体内注射雷珠单抗(0.5 mg)治疗。在注射前、7天后和1个月时通过酶联免疫吸附测定(ELISA)法测量VEGF浓度。22例年龄和性别匹配、无脉络膜视网膜疾病的健康患者作为对照。

结果

对照组血浆VEGF浓度中位数为61.0 pg/ml,阿柏西普组为43.0 pg/ml,雷珠单抗组为59.0 pg/ml(p = 0.127)。玻璃体内注射阿柏西普7天后,19例患者中有17例(89.5%)血浆水平显著降低至最低可检测剂量(MDD)以下,VEGF浓度中位数<9 pg/ml(p<0.001)。这种降低在整个1个月内持续存在,19例患者中有5例(26.3%)的值低于MDD,中位数测量值为17.0 pg/ml(p<0.001)。在接受雷珠单抗治疗的患者中,基线VEGF为59.0 pg/ml,7天时为54.0 pg/ml(p = 0.776),随访4周时为58.5 pg/ml(p = 0.670),未观察到显著影响。

结论

玻璃体内注射阿柏西普后,在4周的观察期内全身VEGF水平显著降低。未观察到玻璃体内注射雷珠单抗对血浆VEGF有显著的全身影响。

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