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在年龄相关性黄斑变性所致脉络膜新生血管患者中同日给予维替泊芬和0.5毫克雷珠单抗。

Same-day administration of verteporfin and ranibizumab 0.5 mg in patients with choroidal neovascularisation due to age-related macular degeneration.

作者信息

Schmidt-Erfurth U, Wolf S

机构信息

Department of Ophthalmology, Universitätsklinik fur Augenheilkunde und Optometrie, University of Vienna, AKH Vienna, Währinger Gürtel 18-20, A-1090 Vienna, Austria.

出版信息

Br J Ophthalmol. 2008 Dec;92(12):1628-35. doi: 10.1136/bjo.2007.135277. Epub 2008 Sep 4.

Abstract

OBJECTIVE

To evaluate safety of same-day administration of verteporfin and ranibizumab.

METHODS

Prospective, open-label, multicentre study; patients with predominantly classic (n = 13) or occult (n = 19) choroidal neovascularisation secondary to age-related macular degeneration received standard-fluence verteporfin at baseline and months 3, 6 and 9, based on fluorescein angiography (FA). Ranibizumab 0.5 mg was administered at baseline and months 1, 2 and 3.

MAIN OUTCOME MEASURE

The incidence of severe vision loss (best-corrected visual acuity (BCVA) loss > or = 30 letters; primary safety assessment).

RESULTS

No severe vision loss due to ocular inflammation or uveitis occurred. One patient had moderate vision loss (BCVA loss > or = 15 letters). Three patients had mild/moderate uveitis. Two serious ocular adverse events occurred (retinal pigment epithelial tear and moderate BCVA decrease). No systemic adverse events occurred. At 9 months, all lesions were inactive with no recurrent leakage on FA and optical coherence tomography; macular oedema and subretinal fluid resolved. The mean BCVA measured at 2 m improved by 6.9 letters at 4 months and 2.4 letters at 9 months. CONCLUSIONS/APPLICATION TO CLINICAL PRACTICE: Same-day verteporfin and ranibizumab was safe and not associated with severe vision loss or severe ocular inflammation. Lesions stabilized, with minimal treatment required after month 3.

摘要

目的

评估维替泊芬与雷珠单抗同日给药的安全性。

方法

前瞻性、开放标签、多中心研究;年龄相关性黄斑变性继发的主要为典型性(n = 13)或隐匿性(n = 19)脉络膜新生血管患者,根据荧光素血管造影(FA)在基线、第3、6和9个月接受标准剂量的维替泊芬治疗。在基线、第1、2和3个月给予0.5 mg雷珠单抗。

主要观察指标

严重视力丧失的发生率(最佳矫正视力(BCVA)下降≥30个字母;主要安全性评估)。

结果

未发生因眼部炎症或葡萄膜炎导致的严重视力丧失。1例患者出现中度视力丧失(BCVA下降≥15个字母)。3例患者出现轻度/中度葡萄膜炎。发生2例严重眼部不良事件(视网膜色素上皮撕裂和BCVA中度下降)。未发生全身不良事件。在9个月时,所有病变均无活性,FA和光学相干断层扫描未见复发性渗漏;黄斑水肿和视网膜下液消退。在2 m处测量的平均BCVA在4个月时提高了6.9个字母,在9个月时提高了2.4个字母。结论/临床实践应用:维替泊芬与雷珠单抗同日给药安全,与严重视力丧失或严重眼部炎症无关。病变稳定,3个月后所需治疗最少。

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