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玻璃体内注射英夫利昔单抗治疗白塞病难治性葡萄膜炎:一项安全性和有效性临床研究。

INTRAVITREAL INFLIXIMAB IN REFRACTORY UVEITIS IN BEHCET'S DISEASE: A Safety and Efficacy Clinical Study.

作者信息

Hamza Mostafa M E, Macky Tamer A, Sidky Mohamed Karim, Ragab Gaafar, Soliman Mahmoud M

机构信息

Departments of *Ophthalmology, and†Internal Medicine, Kasr El Aini Hospital, Cairo University, El-Manial, Cairo, Egypt.

出版信息

Retina. 2016 Dec;36(12):2399-2408. doi: 10.1097/IAE.0000000000001109.

DOI:10.1097/IAE.0000000000001109
PMID:27870802
Abstract

PURPOSE

To assess the safety and efficacy of intravitreal infliximab (1 mg/0.05 mL) in patients with refractory posterior uveitis in Behcet's disease.

METHODS

Twenty patients were included in this study. Best corrected visual acuity (BCVA), vitreous haze (graded 0-4), vasculitis, retinitis, and papillopathy (presence or absence) were assessed at baseline, Day 1 and Week 2, 4, 6, 8, 12, and 18. Optical coherence tomography (OCT) central foveal thickness, fluorescein angiography, and flash electroretinogram were done at baseline and 4, 12, and 18 weeks.

RESULTS

Mean baseline logMAR BCVA was 0.94 (20/160), had improved significantly by Week 2 to 0.6 (20/80) (P < 0.0001), and reached 0.36 (20/40) by Weeks 18 with three injections (P < 0.0001). Mean central foveal thickness OCT decreased significantly from baseline 361 μm to 180 μm at the end of follow-up (P < 0.0001). Profound decrease in mean vitreous haze gradings from two to 0.2 by the end follow-up (P < 0.05). There was a significant reduction in the number of patients with vasculitis (15 at baseline to 1 weeks at 18 weeks), retinitis (nine at baseline to none at 4 weeks), and papillitis (two at baseline to none at 4 weeks) (P < 0.05). No significant electrophysiological changes or ocular adverse inflammatory reactions were observed during the study period.

CONCLUSION

Intravitreal infliximab appeared to be safe and effective in treating uveitis in Behcet's disease and should be considered as an alternative to systemic therapies.

摘要

目的

评估玻璃体内注射英夫利昔单抗(1毫克/0.05毫升)治疗白塞病难治性后葡萄膜炎患者的安全性和有效性。

方法

本研究纳入20例患者。在基线、第1天以及第2、4、6、8、12和18周时评估最佳矫正视力(BCVA)、玻璃体混浊(分级为0 - 4级)、血管炎、视网膜炎和视乳头病变(存在与否)。在基线以及第4、12和18周时进行光学相干断层扫描(OCT)中央凹厚度、荧光素血管造影和闪光视网膜电图检查。

结果

平均基线对数最小分辨角视力(logMAR BCVA)为0.94(20/160),到第2周时显著改善至0.6(20/80)(P < 0.0001),经三次注射后到第18周时达到0.36(20/40)(P < 0.0001)。OCT测量的平均中央凹厚度从基线时的361微米在随访结束时显著降至180微米(P < 0.0001)。平均玻璃体混浊分级在随访结束时从2级大幅降至0.2级(P < 0.05)。血管炎患者数量显著减少(基线时15例至18周时1周时)、视网膜炎患者数量显著减少(基线时9例至4周时无)以及视乳头炎患者数量显著减少(基线时2例至4周时无)(P < 0.05)。在研究期间未观察到明显的电生理变化或眼部不良炎症反应。

结论

玻璃体内注射英夫利昔单抗治疗白塞病葡萄膜炎似乎安全有效,应被视为全身治疗的替代方法。

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