Karatas Gamze, Erden Burak, Cakir Akin, Bolukbasi Selim, Erdenoz Serkan, Argon Bora Deniz, Elcioglu Mustafa Nuri
Department of Ophthalmology, Osmaniye State Hospital, Osmaniye, Turkey.
Department of Ophthalmology, University of Health Sciences, Okmeydani Training and Research Hospital, Istanbul, Turkey.
Beyoglu Eye J. 2021 Sep 27;6(3):229-235. doi: 10.14744/bej.2021.53315. eCollection 2021.
This is a retrospective, comparative evaluation of the short-term efficacy and safety of intravitreal ranibizumab (IVR) and IVR combined with posterior subtenon triamcinolone acetonide (STA) in the treatment of diabetic macular oedema (DME).
A total of 79 pseudophakic eyes of 57 patients with DME who underwent IVR injection treatment were examined retrospectively. All of the patients were treatment-naive. In the study group (STA+IVR), consisting of 30 eyes of 39 patients, the STA and IVR were administered in the first treatment session simultaneously, followed by 2 consecutive monthly IVR injections. In the control group (IVR only) comprised 40 eyes of 27 patients, 3 consecutive monthly IVR injections were administered. Patients with serous retinal detachment (SRD) according to optical coherence tomography images were identified in both groups for subgroup analyses. The primary outcome measures were changes in central macular thickness (CMT), best corrected visual acuity (BCVA), and the intraocular pressure (IOP) at 1, 2, and 3 months post-injection.
There was no statistically significant difference between the demographic characteristics of the patients' baseline BCVA and CMT measurements (p>0.05). For the IVR group, the mean pre-treatment CMT and BCVA was 421.20±89.10 μm and 0.42±0.24 logMAR, respectively. After the third injection, the mean was 308.12±59.07 μm and 0.20±0.12 logMAR, respectively. The combined treatment group baseline measurements were 454.50±122.52 μm and 0.54±0.29 logMAR, respectively. After the third injection, the mean was 294.22±50.33 μm and 0.27±0.21 logMAR, respectively. The decrease was statistically significant for both groups (p=0.001). Comparison of the CMT within groups revealed a statistically significant difference in favor of the combined group after the second injection (p=0.017). There was no statistically significant difference in the BCVA gains between groups (p>0.05). Patients with SRD were evaluated as a subgroup, and at the first month, the mean gain in CMT was -71.63±57.98 μm in the control group and -123.61±93.46 μm in the study group (p=0.048). The required anti-glaucomatous treatment was statistically significant in the combined group (p=0.008).
Both treatments provided improvement in BCVA and CMT and can be considered functional and anatomically effective treatment options for DME.
本研究旨在对玻璃体内注射雷珠单抗（IVR）以及IVR联合球后注射曲安奈德（STA）治疗糖尿病性黄斑水肿（DME）的短期疗效和安全性进行回顾性比较评估。
回顾性检查了57例接受IVR注射治疗的DME患者的79只假晶状体眼。所有患者均为初治患者。研究组（STA+IVR）由39例患者的30只眼组成，在首次治疗时同时给予STA和IVR，随后连续每月注射2次IVR。对照组（仅IVR）由27例患者的40只眼组成，连续每月注射3次IVR。根据光学相干断层扫描图像确定两组中患有浆液性视网膜脱离（SRD）的患者进行亚组分析。主要观察指标为注射后1、2和3个月时的中心黄斑厚度（CMT）、最佳矫正视力（BCVA）和眼压（IOP）的变化。
患者基线BCVA和CMT测量的人口统计学特征之间无统计学显著差异（p>0.05）。对于IVR组，治疗前CMT和BCVA的平均值分别为421.20±89.10μm和0.42±0.24 logMAR。第三次注射后，平均值分别为308.12±59.07μm和0.20±0.12 logMAR。联合治疗组的基线测量值分别为454.50±122.52μm和0.54±0.29 logMAR。第三次注射后，平均值分别为294.22±50.33μm和0.27±0.21 logMAR。两组的降低均具有统计学显著性（p=0.001）。组内CMT比较显示，第二次注射后联合组有统计学显著差异（p=0.017）。两组之间BCVA增益无统计学显著差异（p>0.05）。将患有SRD的患者作为亚组进行评估，在第一个月，对照组CMT的平均增益为-71.63±57.98μm，研究组为-123.61±93.46μm（p=0.048）。联合组所需的抗青光眼治疗具有统计学显著性（p=0.008）。
两种治疗方法均能改善BCVA和CMT，可被认为是治疗DME的功能和解剖学有效治疗选择。
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