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两种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的疗效和生长因子变化:一项随机对照临床试验。

Visual outcomes and growth factor changes of two dosages of intravitreal bevacizumab for neovascular age-related macular degeneration: a randomized, controlled trial.

机构信息

Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong.

出版信息

Retina. 2009 Oct;29(9):1218-26. doi: 10.1097/IAE.0b013e3181b32c45.

Abstract

PURPOSE

To evaluate the visual and growth factor changes of two different intravitreal bevacizumab dosages for neovascular age-related macular degeneration.

METHODS

Fifty eyes of 50 patients with neovascular age-related macular degeneration were randomized to receive 3 monthly intravitreal injections of 1.25 mg (24 eyes) or 2.5 mg (26 eyes) bevacizumab. Patients were observed for 6 months, and the logarithm of minimal angle of resolution best-corrected visual acuity, central foveal thickness, aqueous vascular endothelial growth factor, and pigment epithelial derived factor levels were assessed.

RESULTS

Both groups had significant central foveal thickness reductions at 6 months (P < 0.001). Six (23.1%) eyes in the 2.5-mg group lost 3 or more lines compared with none in the 1.25-mg group (P = 0.023). No significant difference in logarithm of minimal angle of resolution best-corrected visual acuity, central foveal thickness, or growth factors levels was found between the two groups at all visits. Eyes with persistent angiographic leakage at 3 months had significantly higher baseline aqueous vascular endothelial growth factor levels compared with eyes without leakage (P = 0.013). Logistic regression analysis showed that high baseline aqueous vascular endothelial growth factor level was the only significant factor associated with persistent leakage at 3 months (P = 0.040).

CONCLUSION

Three monthly intravitreal 1.25-mg bevacizumab injections seemed to result in better visual outcome than 2.5 mg bevacizumab. Baseline aqueous vascular endothelial growth factor level might have a role in predicting angiographic response after bevacizumab injections.

摘要

目的

评估两种不同剂量玻璃体内贝伐单抗治疗新生血管性年龄相关性黄斑变性的视力和生长因子变化。

方法

50 例(50 眼)新生血管性年龄相关性黄斑变性患者随机分为两组,分别接受每月玻璃体内注射 1.25mg(24 眼)或 2.5mg(26 眼)贝伐单抗,共 3 次。观察 6 个月,评估最佳矫正视力的最小分辨角对数、中心凹视网膜厚度、房水血管内皮生长因子和色素上皮衍生因子水平。

结果

两组在 6 个月时均有明显的中心凹视网膜厚度减少(P < 0.001)。2.5mg 组有 6 只(23.1%)眼视力丧失 3 行或更多,而 1.25mg 组无(P = 0.023)。两组在所有随访时间点的最佳矫正视力的最小分辨角对数、中心凹视网膜厚度或生长因子水平均无显著差异。3 个月时存在持续性血管造影渗漏的眼与无渗漏的眼相比,房水血管内皮生长因子水平明显更高(P = 0.013)。Logistic 回归分析显示,高基线房水血管内皮生长因子水平是与 3 个月时持续性渗漏相关的唯一显著因素(P = 0.040)。

结论

每月玻璃体内注射 1.25mg 贝伐单抗似乎比 2.5mg 贝伐单抗更能获得良好的视力结果。基线房水血管内皮生长因子水平可能在预测贝伐单抗注射后的血管造影反应方面具有一定作用。

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