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玻璃体内注射阿柏西普治疗糖尿病性黄斑水肿:48周结果

Intravitreal Ziv-Aflibercept for Diabetic Macular Edema: 48-Week Outcomes.

作者信息

de Andrade Gabriel Costa, de Oliveira Dias João Rafael, Maia André, Farah Michel Eid, Meyer Carsten H, Rodrigues Eduardo Buchele

出版信息

Ophthalmic Surg Lasers Imaging Retina. 2018 Apr 1;49(4):245-250. doi: 10.3928/23258160-20180329-06.

Abstract

BACKGROUND AND OBJECTIVE

To study the safety and efficacy of intravitreal injections of ziv-aflibercept (IVI-ZA) (Zaltrap; Sanofi-Aventis and Regeneron Pharmaceuticals, Tarrytown, NY) during a period of 48 weeks in patients with diabetic macular edema (DME).

PATIENTS AND METHODS

Seven consecutive patients with DME were enrolled and submitted to 12 consecutive IVI-ZA with a 4-week interval. The safety parameters included changes in full-field electroretinogram (ERG) and systemic or ocular complications, and the efficacy parameters were the mean change from baseline in best-corrected visual acuity (BCVA) and central retinal thickness (CRT).

RESULTS

No significant differences were found in any ERG component after IVI-ZA, and no systemic or ocular complication was observed. The improvement of BCVA was most significant after the first IVI-ZA and remained until week 48 (P < .05). The CRT significantly decreased during the course of 48 weeks.

CONCLUSION

The 48-week results are consistent with our previous 24-week findings, supporting IVI-ZA as a safe, efficient, and well-tolerated therapy for patients with DME. [Ophthalmic Surg Lasers Imaging Retina. 2018;49:245-250.].

摘要

背景与目的

研究玻璃体内注射阿柏西普(IVI-ZA)(Zaltrap;赛诺菲-安万特公司和再生元制药公司,纽约塔里敦)48周期间对糖尿病性黄斑水肿(DME)患者的安全性和有效性。

患者与方法

连续纳入7例DME患者,每隔4周连续进行12次IVI-ZA注射。安全性参数包括全视野视网膜电图(ERG)的变化以及全身或眼部并发症,有效性参数为最佳矫正视力(BCVA)和中心视网膜厚度(CRT)相对于基线的平均变化。

结果

IVI-ZA注射后,任何ERG成分均未发现显著差异,也未观察到全身或眼部并发症。首次IVI-ZA注射后BCVA改善最为显著,且持续至48周(P <.05)。48周内CRT显著降低。

结论

48周的结果与我们之前24周的研究结果一致,支持IVI-ZA作为一种对DME患者安全、有效且耐受性良好的治疗方法。[《眼科手术、激光与视网膜成像》。2018年;49:245 - 250。]

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