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雷珠单抗对年龄相关性黄斑变性所致黄斑中心凹下脉络膜新生血管患者的疗效

Effects of ranibizumab in patients with subfoveal choroidal neovascularization attributable to age-related macular degeneration.

作者信息

Rothenbuehler Simon P, Waeber David, Brinkmann Christian K, Wolf Sebastian, Wolf-Schnurrbusch Ute E K

机构信息

Bern Photographic Reading Center, Universitätsklinik für Augenheilkunde, Inselspital, University Bern, Bern, Switzerland.

出版信息

Am J Ophthalmol. 2009 May;147(5):831-7. doi: 10.1016/j.ajo.2008.12.005. Epub 2009 Feb 13.

Abstract

PURPOSE

To demonstrate not only prevention of vision loss but also improvement in best-corrected visual acuity (BCVA) after treatment with ranibizumab on a variable-dosing regimen over 24 months in patients with age-related macular degeneration (AMD).

DESIGN

Interventional case series.

SETTING

Institutional.

STUDY POPULATION

One hundred and thirty-eight eyes of 138 patients treated intravitreally with 0.5 mg ranibizumab (Lucentis; Novartis, Basel, Switzerland). Age above 50 years, BCVA 0.2 to 1.2 logarithm of the minimal angle of resolution (logMAR), primary or recurrent subfoveal choroidal neovascularization (CNV) secondary to AMD.

OBSERVATION PROCEDURES

After single initial treatment, monthly follow-up examination. Retreatment in case of one of the following: sign of subretinal fluid or intraretinal edema, increase in central retinal thickness (CRT) on optical coherence tomography (OCT), active CNV on fluorescein angiography, increase of metamorphopsia, and loss of BCVA > 5 letters on Early Treatment Diabetic Retinopathy Study (ETDRS) chart.

MAIN OUTCOME MEASURES

Compared with baseline: proportion of eyes gaining > or = 15 letters, proportion of eyes losing or gaining < 15 letters, change in CRT.

RESULTS

After 24 months, 30% of eyes gained > or = 15 letters. After 24 months, 55% of eyes lost or gained < 15 letters. Mean CRT of 386 +/- 145 microm at baseline was significantly reduced to 211 +/- 39 microm after 24 months (P = .036). Mean injection number per patient was 5.6 +/- 2.9 and 4.3 +/- 3.8 from baseline to month 12 and month 12 to 24, respectively.

CONCLUSION

Intravitreal ranibizumab on a variable-dosing regimen was effective in significantly increasing mean BVCA and reducing CRT. This beneficial outcome was achieved with a low-rate of mild ocular adverse effects among our patients.

摘要

目的

证明在年龄相关性黄斑变性(AMD)患者中,使用雷珠单抗进行24个月可变剂量方案治疗后,不仅可预防视力丧失,还能改善最佳矫正视力(BCVA)。

设计

干预性病例系列。

地点

医疗机构。

研究人群

138例患者的138只眼,接受玻璃体内注射0.5毫克雷珠单抗(Lucentis;诺华公司,瑞士巴塞尔)治疗。年龄超过50岁,BCVA为0.2至1.2最小分辨角对数(logMAR),继发于AMD的原发性或复发性黄斑下脉络膜新生血管(CNV)。

观察程序

单次初始治疗后,每月进行随访检查。出现以下情况之一时进行再次治疗:视网膜下液或视网膜内水肿迹象、光学相干断层扫描(OCT)显示视网膜中央厚度(CRT)增加、荧光素血管造影显示活动性CNV、变形视增加以及早期糖尿病视网膜病变研究(ETDRS)图表上BCVA下降超过5个字母。

主要观察指标

与基线相比:视力提高≥15个字母的眼的比例、视力下降或提高<15个字母的眼的比例、CRT的变化。

结果

24个月后,30%的眼视力提高≥15个字母。24个月后,55%的眼视力下降或提高<15个字母。基线时平均CRT为386±145微米,24个月后显著降至211±39微米(P = 0.036)。每位患者从基线到第12个月以及从第12个月到第24个月的平均注射次数分别为5.6±2.9次和4.3±3.8次。

结论

可变剂量方案的玻璃体内注射雷珠单抗可有效显著提高平均BCVA并降低CRT。在我们的患者中,以较低的轻度眼部不良反应发生率取得了这一有益结果。

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