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贝伐单抗联合地塞米松眼内植入剂治疗视网膜静脉阻塞的效果。

Effect of combination therapy with bevacizumab and dexamethasone intravitreal implant in patients with retinal vein occlusion.

机构信息

Medical Center Ophthalmology Associates, San Antonio, Texas, USA.

出版信息

Retina. 2012 Jul;32(7):1289-94. doi: 10.1097/IAE.0b013e318242b838.

Abstract

OBJECTIVE

The objective of this study was to determine if dexamethasone intravitreal implant 0.7 mg (Ozurdex; Allergan, Inc) with bevacizumab (Avastin; Genentech, Inc) therapy can be synergistic, providing further improvements in visual acuity, sustainability, and macular thickness when compared with dexamethasone intravitreal implant 0.7 mg alone.

METHODS

This is a prospective, interventional case series intended to monitor changes in visual acuity and macular thickness in patients diagnosed with retinal vein occlusion (RVO), after injection of bevacizumab followed by a scheduled dexamethasone intravitreal implant. This study was designed to emulate patient care as received in the typical ophthalmology practice. Patients diagnosed with RVO, who were seen between September 2009 and July 2010, were included in this study if they had received previous anti-vascular endothelial growth factor therapy. Patients were included in analysis if the previous anti-vascular endothelial growth factor therapy was at least 6 weeks before and optical coherence tomography (OCT) was >300 μm on spectral-domain OCT. Exclusion criteria included history of vitrectomy, and/or rubeotic or advanced glaucoma. All patients were evaluated with Snellen visual acuity and measured for macular thickness (calculated by spectral-domain OCT) and intraocular pressure. At baseline, all patients were injected with bevacizumab, followed by dexamethasone intravitreal implant injection 2 weeks later. These patients were reexamined on a monthly basis and retreated when edema occurred.

RESULTS

The primary outcome measure was the time to reinjection based on OCT and vision criteria. The secondary outcomes were increases in visual acuity and the reduction of OCT thickness during that period. Thirty-four eyes of 33 patients, with a mean age of 72.8 years, were identified. Thirty-five percent were diagnosed with central RVO, while the other 65% were with branch RVO. Of these patients, 97% gained vision during the study. Mean visual acuity improved from initially 11 letters to a maximum of 25 letters during the study period. In addition, vision improved by at least 15 letters in 29% of patients initially up to 64% during the study period. Macular thickness decreased with the combination treatment by OCT, and the effect continued an average of 126 days from the initial bevacizumab treatment. Retreatment was unnecessary in 18% of the population during the 6-month study period.

CONCLUSION

This study demonstrates efficacy and the duration of effect using a combination of bevacizumab and dexamethasone versus dexamethasone alone. The combination is synergistic, increasing visual acuity and prolonging the time between injections, compared with either of these medications alone. Therefore, the combination of a vascular endothelial growth factor inhibitor and a dexamethasone implant may be a valuable option for RVO treatment.

摘要

目的

本研究旨在确定与单独使用地塞米松玻璃体内植入物 0.7mg(Ozurdex;Allergan,Inc)相比,地塞米松玻璃体内植入物 0.7mg 联合贝伐单抗(Avastin;Genentech,Inc)治疗是否具有协同作用,能否进一步提高视力、维持视力和减轻黄斑水肿。

方法

这是一项前瞻性、干预性病例系列研究,旨在监测接受贝伐单抗注射后,再行地塞米松玻璃体内植入物治疗的视网膜静脉阻塞(RVO)患者的视力和黄斑厚度变化。该研究旨在模拟眼科临床实践中的常规治疗。本研究纳入了 2009 年 9 月至 2010 年 7 月间诊断为 RVO 且接受过抗血管内皮生长因子治疗的患者。如果患者此前接受过抗血管内皮生长因子治疗,且治疗时间至少在 6 周之前,且频域光相干断层扫描(OCT)显示黄斑水肿厚度>300μm,则纳入本研究进行分析。排除标准包括玻璃体切除术史和/或新生血管性或晚期青光眼。所有患者均接受视力表视力检查和黄斑厚度(通过频域 OCT 测量)和眼压检查。基线时,所有患者均接受贝伐单抗注射,2 周后再接受地塞米松玻璃体内植入物注射。当出现水肿时,患者每月接受一次检查,并进行治疗。

结果

主要终点是根据 OCT 和视力标准确定的再注射时间。次要终点是在此期间视力和 OCT 厚度的增加。研究共纳入 33 例患者的 34 只眼,平均年龄为 72.8 岁。35%的患者诊断为中央 RVO,65%的患者诊断为分支 RVO。这些患者中有 97%在研究期间视力得到改善。平均视力从最初的 11 个字母提高到研究期间的最高 25 个字母。此外,在研究期间,29%的患者视力至少提高了 15 个字母,提高到 64%。OCT 显示,联合治疗后黄斑水肿厚度下降,且贝伐单抗治疗后平均 126 天内持续起效。在 6 个月的研究期间,18%的患者无需再次治疗。

结论

本研究表明,与单独使用地塞米松相比,贝伐单抗联合地塞米松治疗具有疗效和更长的作用时间。与这两种药物单独使用相比,联合治疗具有协同作用,可提高视力并延长注射间隔时间。因此,血管内皮生长因子抑制剂联合地塞米松植入物可能是治疗 RVO 的一种有价值的选择。

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