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雷珠单抗与血液稀释治疗视网膜中央静脉阻塞的早期管理比较

[Comparison of early management of central retinal vein occlusion with ranibizumab versus hemodilution].

作者信息

Graber M, Glacet-Bernard A, Fardeau C, Massamba N, Atassi M, Rostaqui O, Coscas F, Le Hoang P, Souied E H

机构信息

Service d'ophtalmologie, centre hospitalier intercommunal de Créteil, hôpital Henri-Mondor, université Paris-Est Créteil, 40, avenue de Verdun, 94000 Créteil, France.

Service d'ophtalmologie, centre hospitalier intercommunal de Créteil, hôpital Henri-Mondor, université Paris-Est Créteil, 40, avenue de Verdun, 94000 Créteil, France.

出版信息

J Fr Ophtalmol. 2015 Nov;38(9):815-21. doi: 10.1016/j.jfo.2015.03.016. Epub 2015 Oct 9.

Abstract

PURPOSE

This study was designed to evaluate and compare the efficacy of early treatment of CRVO with either hemodilution by erythrocytopheresis or intravitreal (IVT) ranibizumab, or both.

MATERIAL AND METHODS

A multicentric prospective randomized study including patients with CRVO for less than 1 month was designed. Patients were randomized into 3 treatment groups: hemodilution (HD group), 3 monthly intravitreal injections of ranibizumab followed by PRN treatment (IVT group), or combined treatment (IVT+HD group). A monthly evaluation during a 6-month follow-up included best-corrected visual acuity (BCVA) and macular thickness measurements with OCT. Fluorescein angiography was performed at baseline, month 2 and month 6. Local and systemic tolerability of the different treatments were also compared.

RESULTS

Forty-four CRVO patients were included between February 2010 and June 2013: 20 in the IVT group, 13 in the HD group and 11 in the HD+IVT group. The mean duration of CRVO at baseline was 10 days and 16 days at the time of treatment without any significant difference between groups. Retinal ischemia was present at baseline in 40% of eyes in each group. After a 6-month follow-up, no difference between the 3 groups was observed in BCVA (10.5 ETDRS letters, 14.6 and 14.1 in the IVT group, HD group and IVT+HD group respectively, P=0.726) or in macular thickness (398 μ, 440 μ and 379 μ respectively, P=0.465). The time until treatment from CRVO onset, ranging from 1 to 35 days, was not correlated to final outcomes. No significant difference in the mean number of IVT (3.2 in the IVT+HD group vs 3.7 in the IVT group) was observed at 6 months.

CONCLUSION

No difference in BCVA nor in macular thickness was seen at M6 between the study groups. The duration of CRVO at the time of the initiation of the treatment was not correlated to better visual outcomes. Therefore, etiologic treatment with HD can still be proposed as a first-line treatment in young patients, which allows delaying or avoiding the IVT treatment and its potential side effects. Anti-VEGF IVT still remains an effective option in every case and can be started one month after the beginning of the CRVO.

摘要

目的

本研究旨在评估和比较红细胞单采血液稀释术或玻璃体内注射雷珠单抗或两者联合应用对视网膜中央静脉阻塞(CRVO)进行早期治疗的疗效。

材料与方法

设计了一项多中心前瞻性随机研究,纳入CRVO病程小于1个月的患者。患者被随机分为3个治疗组:血液稀释组(HD组)、每月玻璃体内注射雷珠单抗3次,随后按需治疗组(IVT组)或联合治疗组(IVT + HD组)。在6个月的随访期间,每月评估包括最佳矫正视力(BCVA)和用光学相干断层扫描(OCT)测量黄斑厚度。在基线、第2个月和第6个月进行荧光素血管造影。还比较了不同治疗的局部和全身耐受性。

结果

2010年2月至2013年6月期间纳入了44例CRVO患者:IVT组20例,HD组13例,HD + IVT组11例。基线时CRVO的平均病程为10天,治疗时为16天,组间无显著差异。每组40%的患眼在基线时存在视网膜缺血。经过6个月的随访,3组之间在BCVA(IVT组、HD组和IVT + HD组分别为10.5个早期糖尿病性视网膜病变研究(ETDRS)字母、14.6和14.1,P = 0.726)或黄斑厚度(分别为398μm、440μm和379μm,P = 0.465)方面未观察到差异。从CRVO发作到开始治疗的时间为1至35天,与最终结果无关。6个月时,IVT的平均次数在IVT + HD组(3.2次)和IVT组(3.7次)之间无显著差异。

结论

研究组之间在第6个月时BCVA和黄斑厚度均无差异。治疗开始时CRVO的病程与更好的视力结果无关。因此,对于年轻患者,血液稀释的病因治疗仍可作为一线治疗提出,这可以延迟或避免玻璃体内注射治疗及其潜在的副作用。抗血管内皮生长因子(VEGF)玻璃体内注射在每种情况下仍然是一种有效的选择,可在CRVO开始1个月后开始。

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