Karst Sonja G, Lammer Jan, Mitsch Christoph, Schober Manuela, Mehta Janhvi, Scholda Christoph, Kundi Michael, Kriechbaum Katharina, Schmidt-Erfurth Ursula
Department of Ophthalmology and Optometry, Medical University Vienna, Vienna, Austria.
Jaslok Hospital and Research Centre, Mumbai, India.
Graefes Arch Clin Exp Ophthalmol. 2018 Jan;256(1):49-58. doi: 10.1007/s00417-017-3828-1. Epub 2017 Oct 28.
Our purpose was to compare the impact in diabetic macula edema (DME) of two intravitreal drugs (0.5 mg ranibizumab vs. 8 mg triamcinolone) on changes in retinal morphology in spectral-domain optical coherence tomography (SD OCT) images, color fundus photography (CF) and fluorescein angiography (FA) images during a 1-year follow-up.
Post hoc analysis was conducted of morphologic characteristics in OCT, FA and CF images of eyes with a center involving DME that were included in a prospective double-masked randomized trial. Eligible patients were divided at random into two groups receiving either pro re nata treatment with 0.5 mg ranibizumab or 8 mg triamcinolone after a fixed loading dose. OCT and CF images were acquired at monthly visits and FA images every three months.
Twenty-five eyes of 25 patients (ranibizumab: n = 10; triamcinolone: n = 15) were included in this study. Patients treated with ranibizumab showed better visual acuity results after 12 months than patients receiving triamcinolone (p = 0.015) although edema reduction was similar (p = 0.426) in both groups. The initial effect on macular edema shedding after a single ranibizumab injection could be amplified with the following two injections of the loading dose. After a single injection of triamcinolone the beneficial initial effect on the macula edema faded within 3 months. Subretinal fluid and INL cystoid spaces diminished early in the course of treatment while fluid accumulation in the ONL seemed to be more persistent in both treatment arms. In FA, the area of leakage diminished significantly in both treatment arms. After repeated injections the morphologic OCT and FA characteristics of the treatment arms converged.
Despite the higher dosage of triamcinolone, both therapies were safe and effective for treating diabetic macular edema. Fluid accumulation in the INL and subretinal space was more responsive to therapy than fluid accumulation in the ONL. Clinicaltrials.gov : NCT00682539.
我们的目的是比较两种玻璃体内注射药物（0.5毫克雷珠单抗与8毫克曲安奈德）对糖尿病性黄斑水肿（DME）患者在1年随访期间，其光谱域光学相干断层扫描（SD OCT）图像、彩色眼底照相（CF）和荧光素血管造影（FA）图像中视网膜形态变化的影响。
对一项前瞻性双盲随机试验中纳入的中心性DME患者的OCT、FA和CF图像的形态学特征进行事后分析。符合条件的患者在接受固定负荷剂量后，随机分为两组，分别接受按需注射0.5毫克雷珠单抗或8毫克曲安奈德治疗。每月进行一次OCT和CF图像采集，每三个月进行一次FA图像采集。
本研究纳入了25例患者的25只眼（雷珠单抗组：n = 10；曲安奈德组：n = 15）。雷珠单抗治疗的患者在12个月后的视力结果优于接受曲安奈德治疗的患者（p = 0.015），尽管两组的水肿减轻情况相似（p = 0.426）。单次注射雷珠单抗后对黄斑水肿消退的初始效果可通过后续两次负荷剂量注射得到增强。单次注射曲安奈德后，对黄斑水肿的有益初始效果在3个月内消退。视网膜下液和内核层囊样间隙在治疗早期减少，而外核层的液体积聚在两个治疗组中似乎更持久。在FA中，两个治疗组的渗漏面积均显著减少。重复注射后，两个治疗组的OCT和FA形态学特征趋于一致。
尽管曲安奈德剂量较高，但两种疗法治疗糖尿病性黄斑水肿均安全有效。内核层和视网膜下间隙的液体积聚对治疗的反应比外核层的液体积聚更敏感。Clinicaltrials.gov：NCT00682539。
