Department of Ophthalmology, Monaldi Hospital, Azienda Ospedaliera dei Colli Via Leonardo Bianchi, 8013 Napoli, Italy.
Department of Ophthalmology, University of Campania "Luigi Vanvitelli", 80100 Napoli, Italy.
Nutrients. 2022 Apr 6;14(7):1520. doi: 10.3390/nu14071520.
Background: To investigate the effects of a fixed combination of Curcumin (200 mg), Artemisia (80 mg), Bromelain (80 mg), and Black pepper (2 mg) on vascular parameters in mild to moderate diabetic macular edema (DME). Design: Prospective, case-control study. Methods: Fifty-six patients affected by diabetes mellitus type II were enrolled in the study. Twenty-eight patients with DME received 2 tablets/day, before meals of a dietary complementary supplement containing in fixed combination Curcumin (200 mg), Artemisia (80 mg), Bromelain (80 mg), and Black pepper (2 mg) (Intravit®, OFFHEALTH Spa, Firenze, Italy) for 6 months. Twenty-eight age-matched subjects affected by diabetes mellitus type II were given placebo and served as control group. Patients underwent best correct visual acuity (BCVA), swept optical coherence tomography (OCT), and OCT-Angiography (OCTA). OCTA images of the superficial capillary plexus (SCP) and deep capillary plexus (DCP) were obtained for each eye. By the end of the follow-up patients were defined responder to the therapy when a decrease of more than 30 μm was registered in central retinal thickness (CRT) measurement, while a poor responder was determined by the absence of reduction or an increase in central retinal thickness at 6 months. We assessed the foveal avascular zone (FAZ) area, vessel density and quantified the number of microaneurysms in each layer. Results: A significant improvement of BCVA and CRT reduction was recorded at 6 months follow-up in the dietary complementary supplementation group compared to control (respectively p = 0.028 and p = 0.0003). VD of the total capillary plexus, microaneurysms count, glycaemia and HbA1c did not vary over the follow-up period between groups. Within the Intravit® group, poor responders tended to show a larger FAZ area, more microaneurysms, and a lower VD in the DCP compared to the good responders group (p < 0.0001). Conclusions: A fixed combination of Curcumin, Artemisia, Bromelain, and Black pepper oral administration may have a positive impact on central retinal thickness, visual acuity, and VD of the DCP in compensated type 2 diabetic patients with mild DME.
研究姜黄素（200mg）、青蒿（80mg）、菠萝蛋白酶（80mg）和黑胡椒（2mg）固定组合对轻度至中度糖尿病性黄斑水肿（DME）血管参数的影响。设计：前瞻性病例对照研究。方法：56 例 2 型糖尿病患者入组。28 例 DME 患者接受 2 片/天，饭前口服含有姜黄素（200mg）、青蒿（80mg）、菠萝蛋白酶（80mg）和黑胡椒（2mg）的膳食补充剂（Intravit®，OFFHEALTH Spa，佛罗伦萨，意大利），治疗 6 个月。28 名年龄匹配的 2 型糖尿病患者给予安慰剂作为对照组。患者接受最佳矫正视力（BCVA）、扫频光学相干断层扫描（OCT）和 OCT 血管造影（OCTA）检查。对每只眼的浅层毛细血管丛（SCP）和深层毛细血管丛（DCP）进行 OCTA 成像。在随访结束时，当中央视网膜厚度（CRT）测量值下降超过 30μm时，将患者定义为对治疗有反应，而在 6 个月时 CRT 无减少或增加则确定为无反应。我们评估了中心无血管区（FAZ）面积、血管密度，并量化了每个层的微动脉瘤数量。结果：与对照组相比，膳食补充组在 6 个月随访时 BCVA 显著改善，CRT 降低（分别为 p = 0.028 和 p = 0.0003）。总毛细血管丛的血管密度、微动脉瘤计数、血糖和糖化血红蛋白在随访期间两组之间没有变化。在 Intravit®组中，无反应者的 FAZ 面积较大，DCP 中的微动脉瘤较多，血管密度较低，与反应良好者相比（p <0.0001）。结论：姜黄素、青蒿、菠萝蛋白酶和黑胡椒的固定组合口服给药可能对 2 型糖尿病轻度 DME 伴补偿性患者的中央视网膜厚度、视力和 DCP 血管密度产生积极影响。
