Razzaghpour Nayyereh, Najafi Amin, Sabouri Mohammad Rasoul, Ashoori Negin, Shahraki Kourosh
Department of Ophthalmology, Ardabil University of Medical Sciences, Ardabil, Iran.
Department of Ophthalmology, Guilan University of Medical Sciences, Rasht, Iran.
Med Hypothesis Discov Innov Ophthalmol. 2023 Dec 31;12(3):150-156. doi: 10.51329/mehdiophthal1480. eCollection 2023 Fall.
Diabetic macular edema (DME) affects approximately 10% of patients with diabetes mellitus. This condition can cause blurred or distorted vision, which significantly affects the quality of life of these patients. We evaluated the therapeutic effects of intravitreal methotrexate (MTX) injections on persistent DME.
This prospective interventional case series included patients with confirmed persistent DME that was unresponsive to previous standard treatments. The patients underwent comprehensive eye examinations and macular imaging with optical coherence tomography (OCT). A single intravitreal MTX injection (400 µg MTX in 0.16 mL solution) was administered, followed by patient assessments at 1, 3, and 6 months after injection. Best-corrected distance visual acuity (BCDVA), intraocular pressure (IOP), macular thickness (MT), and central subfield thickness (CST) were measured at baseline and post-injection to evaluate treatment efficacy.
We included 33 eyes of 30 patients with a mean (standard deviation [SD], range) age of 62.7 (8.3, 44 to 77) years, of whom 17 (56.7%) were men and 13 (43.3%) were women. All participants had type 2 diabetes mellitus, with a mean (SD, range) duration of 17.0 (6.8, 10 to 31) years. Most participants (n = 27 eyes, 81.8%) had non-proliferative diabetic retinopathy, and six eyes (18.2%) had regressed proliferative diabetic retinopathy. Four eyes (12.1%) had undergone prior macular laser photocoagulation. The mean (SD) number of prior intravitreal bevacizumab injections was 3.4 (0.8), and 29 eyes (87.8%) had received one intravitreal triamcinolone injection. During the study period, a statistically significant difference was observed in CST (0.05); however, no statistically significant differences were observed in BCDVA, MT, or IOP (> 0.05). Pairwise comparison revealed a significant decrease in CST at 6 months post-injection compared to the baseline value (0.05). During the investigation period, no side effects of MTX, such as macular edema, retinal tears, vitreous hemorrhage, endophthalmitis, or vision loss, were observed.
A single intravitreal MTX injection significantly reduced CST in patients with persistent DME, without relevant safety concerns. However, no significant improvement in functional outcomes was observed. Therefore, there is no strong evidence to recommend its use as a treatment for pDME. Further studies, preferably randomized clinical trials with long-term follow-ups, are warranted to assess the long-term efficacy, safety, and potential benefits of intravitreal MTX for the treatment of persistent DME.
糖尿病性黄斑水肿（DME）影响约10%的糖尿病患者。这种情况可导致视力模糊或扭曲，严重影响这些患者的生活质量。我们评估了玻璃体内注射甲氨蝶呤（MTX）对持续性DME的治疗效果。
本前瞻性干预性病例系列研究纳入了确诊为持续性DME且对先前标准治疗无反应的患者。患者接受了全面的眼科检查和光学相干断层扫描（OCT）黄斑成像。给予单次玻璃体内注射MTX（400μg MTX溶于0.16mL溶液中），随后在注射后1、3和6个月对患者进行评估。在基线和注射后测量最佳矫正远视力（BCDVA）、眼压（IOP）、黄斑厚度（MT）和中心子野厚度（CST），以评估治疗效果。
我们纳入了30例患者的33只眼，平均（标准差[SD]，范围）年龄为62.7（8.3，44至77）岁，其中17例（56.7%）为男性，13例（43.3%）为女性。所有参与者均患有2型糖尿病，平均（SD，范围）病程为17.0（6.8，10至31）年。大多数参与者（n = 27只眼，81.8%）患有非增殖性糖尿病视网膜病变，6只眼（18.2%）患有消退性增殖性糖尿病视网膜病变。4只眼（12.1%）曾接受过黄斑激光光凝治疗。先前玻璃体内注射贝伐单抗的平均（SD）次数为3.4（0.8），29只眼（87.8%）接受过一次玻璃体内注射曲安奈德。在研究期间，CST观察到有统计学意义的差异（0.05）；然而，BCDVA、MT或IOP未观察到统计学意义的差异（>0.05）。两两比较显示，与基线值相比，注射后6个月CST显著降低（0.05）。在研究期间，未观察到MTX的副作用，如黄斑水肿、视网膜裂孔、玻璃体积血、眼内炎或视力丧失。
单次玻璃体内注射MTX可显著降低持续性DME患者的CST，且无相关安全问题。然而，未观察到功能结局有显著改善。因此，没有充分证据推荐将其用于治疗持续性DME。有必要进行进一步研究，最好是长期随访的随机临床试验，以评估玻璃体内注射MTX治疗持续性DME的长期疗效、安全性和潜在益处。
