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玻璃体内注射贝伐单抗与假治疗急性视网膜分支静脉阻塞伴黄斑水肿:3 个月的结果(报告 1)。

Intravitreal bevacizumab vs. sham treatment in acute branch retinal vein occlusion with macular edema: results at 3 months (Report 1).

机构信息

Ophthalmic Research Center, Labbafinejad Medical Center, Pasdaran Ave. Boostan 9 St., Tehran, 16666, Iran.

出版信息

Graefes Arch Clin Exp Ophthalmol. 2011 Feb;249(2):193-200. doi: 10.1007/s00417-010-1440-8. Epub 2010 Aug 18.

Abstract

BACKGROUND

The goal of this work is to compare the visual and anatomical (central macular thickness; CMT) outcomes of intravitreal bevacizumab (IVB) injections relative to sham treatment in eyes with acute (less than 3 months in duration) branch retinal vein occlusion (BRVO).

METHODS

In a double-masked randomized clinical trial (RCT), patients with acute BRVO were randomly assigned to one of two treatment groups: IVB (two injections of 1.25 mg IVB 6 weeks apart) or sham treatment. Primary outcome measures included changes in best-corrected visual acuity (BCVA) and CMT in optical coherence tomography (OCT) during follow-up (FU) examinations. Any complications secondary to injections were considered secondary outcomes. FU results after 6 and 12 weeks are reported.

RESULTS

Eighty-one eyes (43 OD) of 81 patients (47 females) were enrolled in the study. Forty-two patients were enrolled in the IVB group, and 39 patients were enrolled in the sham group. Visual acuity and CMT improved in the IVB group after week 6 (two Snellen lines and 262 μm, respectively) and week 12 (three Snellen lines and 287 μm, respectively). After week 6, visual improvements in the IVB group were significantly increased relative to that of the sham group. However, visual improvements at week 12 were not significantly different between the two groups (1.5 Snellen lines visual improvement in the sham group at week 12).

CONCLUSIONS

In acute BRVO, two IVB injections resulted in significant improvement of vision and CMT at 6 weeks relative to the sham group. However, the visual improvements in the IVB group were not significantly different from those in the sham group at 12 weeks. IVB injections accelerate an initial improvement of visual acuity but do not have any significant effects on vision after 12 weeks.

摘要

背景

本研究旨在比较玻璃体内注射贝伐单抗(IVB)与假治疗对视神经和解剖学(中心黄斑厚度;CMT)结局的影响,观察对象为急性(病程小于 3 个月)分支视网膜静脉阻塞(BRVO)患者。

方法

在一项双盲随机临床试验(RCT)中,将急性 BRVO 患者随机分为两组:IVB 组(每 6 周注射两次 1.25mg IVB)或假治疗组。主要观察指标包括在随访(FU)检查中最佳矫正视力(BCVA)和光学相干断层扫描(OCT)CMT 的变化。将注射引起的任何并发症作为次要观察指标。报告第 6 周和第 12 周的 FU 结果。

结果

本研究共纳入 81 例患者(81 只眼,43 只右眼),其中 47 例为女性。42 例患者纳入 IVB 组,39 例患者纳入假治疗组。第 6 周和第 12 周时,IVB 组的视力和 CMT 均有所改善(分别提高了 2 个 Snellen 线和 262μm,3 个 Snellen 线和 287μm)。第 6 周时,IVB 组的视力改善明显优于假治疗组。然而,两组间第 12 周时的视力改善无明显差异(假治疗组第 12 周时视力提高了 1.5 个 Snellen 线)。

结论

在急性 BRVO 中,与假治疗组相比,两次 IVB 注射可在第 6 周时显著改善视力和 CMT。然而,第 12 周时,IVB 组的视力改善与假治疗组无明显差异。IVB 注射可加速视力的初始改善,但在 12 周后对视力无明显影响。

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