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全视网膜光凝术与全视网膜光凝术联合玻璃体内注射贝伐单抗治疗高危增殖性糖尿病视网膜病变(IBeHi研究)

Panretinal photocoagulation versus PRP plus intravitreal bevacizumab for high-risk proliferative diabetic retinopathy (IBeHi study).

作者信息

Tonello Matheus, Costa Rogério A, Almeida Felipe P P, Barbosa José C, Scott Ingrid U, Jorge Rodrigo

机构信息

Department of Ophthalmology, School of Medicine of Ribeirão Preto, Ribeirão Preto, São Paulo, Brazil.

出版信息

Acta Ophthalmol. 2008 Jun;86(4):385-9. doi: 10.1111/j.1600-0420.2007.01056.x. Epub 2007 Nov 7.

Abstract

PURPOSE

To evaluate the effects of panretinal photocoagulation (PRP) compared with PRP plus intravitreal bevacizumab on best corrected visual acuity (BCVA) and total area of fluorescein leakage from active new vessels (NVs) in patients with high-risk proliferative diabetic retinopathy (PDR).

METHODS

We carried out a prospective study of patients with high-risk PDR and no prior laser treatment who were randomly assigned to receive PRP (PRP group) or PRP plus intravitreal injection of 1.5 mg of bevacizumab (PRP-plus group). In all patients, the PRP was administered at two time-points (weeks 1 and 3), with the intravitreal bevacizumab delivered at the end of the second laser episode in the PRP-plus group. Standardized ophthalmic evaluation including Early Treatment Diabetic Retinopathy Study BCVA as well as stereoscopic fundus photography and fluorescein angiography were performed at baseline and at weeks 4, 9 (+/- 1) and 16 (+/- 2). Main outcome measures included changes in BCVA and in total area of fluorescein leakage from active NVs.

RESULTS

Twenty-two (n = 30 eyes) consecutive patients completed the 16-week follow-up. There was no significant difference between the PRP and PRP-plus groups with respect to age, gender, type or duration of diabetes, area of fluorescein leakage from active NVs or BCVA. No significant difference in BCVA was observed between the groups throughout the study period. However, the total area of actively leaking NVs was significantly reduced in the PRP-plus group compared with the PRP group at weeks 4, 9 and 16 (p < 0.001). No major adverse events were identified.

CONCLUSIONS

In the short-term, the adjunctive use of intravitreal bevacizumab with PRP was associated with a greater reduction in the area of active leaking NVs than PRP alone in patients with high-risk PDR.

摘要

目的

评估全视网膜光凝(PRP)与PRP联合玻璃体内注射贝伐单抗相比,对高危增殖性糖尿病视网膜病变(PDR)患者最佳矫正视力(BCVA)以及新生血管(NVs)活动性荧光素渗漏总面积的影响。

方法

我们对高危PDR且未接受过激光治疗的患者进行了一项前瞻性研究,这些患者被随机分配接受PRP(PRP组)或PRP联合玻璃体内注射1.5 mg贝伐单抗(PRP联合组)。所有患者中,PRP在两个时间点(第1周和第3周)进行,PRP联合组在第二次激光治疗结束时给予玻璃体内贝伐单抗。在基线以及第4、9(±1)和16(±2)周进行标准化眼科评估,包括糖尿病视网膜病变早期治疗研究BCVA以及立体眼底照相和荧光素血管造影。主要观察指标包括BCVA的变化以及活动性NVs荧光素渗漏总面积的变化。

结果

22例(n = 30只眼)连续患者完成了16周的随访。PRP组和PRP联合组在年龄、性别、糖尿病类型或病程、活动性NVs荧光素渗漏面积或BCVA方面无显著差异。在整个研究期间,两组之间的BCVA无显著差异。然而,在第4、9和16周时,PRP联合组与PRP组相比,活动性渗漏NVs的总面积显著减少(p < 0.001)。未发现重大不良事件。

结论

在短期内,对于高危PDR患者,玻璃体内贝伐单抗与PRP联合使用比单独使用PRP能使活动性渗漏NVs面积有更大程度的减少。

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