Vingolo Enzo Maria, Calabro Mattia, Mascolo Simona, Miccichè Filippo, Casillo Lorenzo, Lupo Stefano, Menna Feliciana
U.O.C. Ophthalmology, Polo Pontino-Ospedale A. Fiorini, Sense Organs Department, University Sapienza of Rome, 04019 Terracina, Italy.
Pharmaceutics. 2025 May 2;17(5):605. doi: 10.3390/pharmaceutics17050605.
This study aimed to assess the impact of an oral formulation combining bromelain (250 mg) derived from (L.) Merr. Jambs and diosmin mcgSMIN Plus (250 mg) on visual acuity and central retinal thickness (CRT) in patients undergoing anti-VEGF intravitreal maintenance therapy (IVT) for cystoid, center-involving diabetic macular edema (DME). A total of forty patients with type 2 diabetes and center-involving DME, all receiving anti-VEGF maintenance therapy, were prospectively enrolled in a case-control study. Group A (20 eyes) was administered one tablet containing 250 mg of bromelain and 250 mg of diosmin mcgSMIN Plus twice daily for a period of two months. Group B (20 eyes) was monitored without drug administration until the next IVT. After two months and IVT administration, the groups were switched. At the end of the study, the collected data were divided into two groups. The treatment group included data from patients who received the dietary supplement, and the control group consisted of data from patients who were only observed during anti-VEGF therapy. Best-corrected visual acuity (BCVA) and CRT measurements were assessed at baseline, after two months, and after four months. A statistically significant improvement in CRT was observed in the treatment group compared to the control group during follow-up ( < 0.05). However, the improvement in BCVA was not statistically significant. Orally administered combination of bromelain 250 mg and 250 mg diosmin mcgSMIN Plus has positive impact on central retinal thickness in patients treated for cystoid center-involving diabetic macular edema (DME) with anti-VEGF intravitreal maintenance therapy.
本研究旨在评估一种口服制剂（其包含源自凤梨科植物凤梨（L.） Merr. 的菠萝蛋白酶（250毫克）和微化纯化微粒化地奥司明（250毫克））对接受抗血管内皮生长因子（anti-VEGF）玻璃体内维持治疗（IVT）的黄斑囊样水肿、累及中心的糖尿病性黄斑水肿（DME）患者的视力和中心视网膜厚度（CRT）的影响。总共40例患有2型糖尿病且累及中心的DME患者，均接受抗VEGF维持治疗，被前瞻性纳入一项病例对照研究。A组（20只眼）每天两次服用一片含250毫克菠萝蛋白酶和250毫克微化纯化微粒化地奥司明的制剂，持续两个月。B组（20只眼）在不给予药物的情况下进行监测，直至下一次IVT。两个月后及进行IVT给药后，两组进行了切换。在研究结束时，收集的数据被分为两组。治疗组包括接受膳食补充剂患者的数据，对照组由仅在抗VEGF治疗期间接受观察的患者的数据组成。在基线、两个月后和四个月后评估最佳矫正视力（BCVA）和CRT测量值。在随访期间，治疗组与对照组相比，CRT有统计学显著改善（P<0.05）。然而，BCVA的改善无统计学显著性。口服250毫克菠萝蛋白酶和250毫克微化纯化微粒化地奥司明的组合对接受抗VEGF玻璃体内维持治疗的黄斑囊样累及中心的糖尿病性黄斑水肿（DME）患者的中心视网膜厚度有积极影响。
