Udaondo Patricia, Díaz-Llopis Manuel, García-Delpech Salvador, Salom David, Romero Francisco J
Retina and Uveitis Unit, Department of Ophthalmology, Hospital La Fe de Valencia, Valencia, Spain.
Arch Ophthalmol. 2011 Mar;129(3):283-7. doi: 10.1001/archophthalmol.2011.8.
To evaluate the effects and safety of intravitreal injections of autologous plasmin enzyme (APE), without vitrectomy, as a treatment for macular edema secondary to branch retinal vein occlusion.
Prospective, comparative, interventional case series.
Patients were recruited and enrolled consecutively from February 1 through October 31, 2008, at the Retina Unit of the Hospital General Universitario, Valencia, Spain. An eye from 8 patients diagnosed as having macular edema due to branch retinal vein occlusion received an injection, after having received topical anesthesia, of 0.2 mL of APE, which had been obtained using a simplified method. Best-corrected visual acuity and central macular thickness measured by optical coherence tomography constitute the main outcome measures of the study.
The mean (SD) central macular thickness decreased from 494.875 (68.82) to 226.375 (28.67) μm 1 month after APE injection and to 228.570 (21.53) μm after 6 months (P < .001). The best-corrected visual acuity (logarithm of the minimal angle of resolution) improved from a preoperative value of 0.552 (0.17) to 0.217 (0.087) (mean, 20/80-20/32, Snellen equivalent) at the end of follow-up (P < .01). No secondary effects were observed during 6 months of follow-up.
This pilot study suggests that intravitreal injection of APE as a treatment for macular edema secondary to branch retinal vein occlusion improves central macular thickness and best-corrected visual acuity and may be a safe and effective alternative therapy for this condition if confirmed in controlled trials compared with standard care with longer follow-up.
评估不进行玻璃体切割术的情况下,玻璃体内注射自体纤溶酶(APE)治疗视网膜分支静脉阻塞继发黄斑水肿的疗效和安全性。
前瞻性、对比性、干预性病例系列研究。
2008年2月1日至10月31日期间,在西班牙巴伦西亚综合大学医院视网膜科连续招募患者。8例被诊断为视网膜分支静脉阻塞继发黄斑水肿的患者,在局部麻醉后,接受了使用简化方法获取的0.2 mL APE注射。研究的主要观察指标为最佳矫正视力和光学相干断层扫描测量的中心黄斑厚度。
APE注射1个月后,中心黄斑厚度平均(标准差)从494.875(68.82)μm降至226.375(28.67)μm,6个月后降至228.570(21.53)μm(P <.001)。随访结束时,最佳矫正视力(最小分辨角对数)从术前的0.552(0.17)提高到0.217(0.087)(平均,20/80 - 20/32,Snellen等效值)(P <.01)。随访6个月期间未观察到继发效应。
这项初步研究表明,玻璃体内注射APE治疗视网膜分支静脉阻塞继发黄斑水肿可改善中心黄斑厚度和最佳矫正视力,与标准治疗相比,如果在更长随访期的对照试验中得到证实,可能是一种安全有效的替代疗法。