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评估他汀类药物作为2型糖尿病患者临床显著性黄斑水肿(CSME)辅助抗血管内皮生长因子(VEGF)治疗的作用。

Assessing the Role of Statins as an Adjunctive Anti-VEGF Therapy for Clinically Significant Macular Edema (CSME) in Type 2 Diabetes Mellitus.

作者信息

Markan Ashish, Agarwal Aniruddha, Katoch Deeksha, Bhadada Sanjay, Gupta Vishali, Bansal Reema

机构信息

Eye7 Chaudhary Eye Centre, New Delhi, India.

Cleveland Clinic, Abu Dhabi, United Arab Emirates.

出版信息

Rom J Ophthalmol. 2025 Apr-Jun;69(2):219-227. doi: 10.22336/rjo.2025.35.

Abstract

AIM

This study aimed to evaluate the effectiveness of statin therapy as an adjunctive treatment to anti-VEGF therapy in type 2 diabetic patients with non-proliferative diabetic retinopathy (NPDR) and clinically significant macular edema (CSME).

MATERIALS AND METHODS

In this prospective, randomized interventional study, patients were randomized into two groups: Group A received low-dose atorvastatin (10-20 mg), and Group B received high-dose atorvastatin (30-40 mg). All participants also received three loading doses of intravitreal ranibizumab (0.5 mg) at monthly intervals, followed by pro re nata treatment over a six-month period. Primary outcomes included the number of anti-VEGF injections required, best-corrected visual acuity (BCVA), and central macular thickness (CMT). Serum VEGF levels were measured at baseline and six months.

RESULTS

The mean number of injections over six months was 3.4, with no significant difference between Group A (3.55) and Group B (3.33) (p = 0.24). Group A demonstrated substantial improvement in BCVA at both 3 and 6 months, accompanied by a notable reduction in CMT. In contrast, Group B's BCVA improvement was only significant at 3 months, with less consistent CMT reduction at 6 months. Serum VEGF levels decreased in Group A but increased in Group B, though these changes were not statistically significant.

DISCUSSION

The findings suggest that low-dose atorvastatin, when used in conjunction with anti-VEGF therapy, may provide superior functional and anatomical outcomes in patients with CSME compared to high-dose statin therapy. The observed reduction in central macular thickness and improvement in visual acuity indicate a potential adjunctive benefit of statins, likely due to their pleiotropic effects, including anti-inflammatory and anti-angiogenic properties. Although the number of injections required was similar between the groups, the better response in the low-dose group highlights the need for further investigation into the dose-dependent effects of statins in managing diabetic macular edema.

CONCLUSIONS

Low-dose atorvastatin (10-20 mg) as an adjunct to anti-VEGF therapy resulted in better functional and anatomical outcomes in diabetic patients with CSME compared to high-dose atorvastatin. These findings suggest potential additional benefits of low-dose statins in managing patients with chronic subdural hematoma (CSME).

摘要

目的

本研究旨在评估他汀类药物治疗作为辅助治疗手段,在患有非增殖性糖尿病视网膜病变(NPDR)和临床显著性黄斑水肿(CSME)的2型糖尿病患者中联合抗血管内皮生长因子(VEGF)治疗的有效性。

材料与方法

在这项前瞻性、随机干预性研究中,患者被随机分为两组:A组接受低剂量阿托伐他汀(10 - 20毫克),B组接受高剂量阿托伐他汀(30 - 40毫克)。所有参与者还每月接受三次玻璃体内注射雷珠单抗(0.5毫克)的负荷剂量,随后在六个月内按需治疗。主要结局指标包括所需抗VEGF注射次数、最佳矫正视力(BCVA)和中心黄斑厚度(CMT)。在基线和六个月时测量血清VEGF水平。

结果

六个月内的平均注射次数为3.4次,A组(3.55次)和B组(3.33次)之间无显著差异(p = 0.24)。A组在3个月和6个月时BCVA均有显著改善,同时CMT显著降低。相比之下,B组仅在3个月时BCVA改善显著,6个月时CMT降低不太一致。A组血清VEGF水平下降,而B组血清VEGF水平升高,尽管这些变化无统计学意义。

讨论

研究结果表明,与高剂量他汀类药物治疗相比,低剂量阿托伐他汀与抗VEGF治疗联合使用时,在CSME患者中可能提供更好的功能和解剖学结局。观察到的中心黄斑厚度降低和视力改善表明他汀类药物可能具有潜在的辅助益处,这可能归因于其多效性作用,包括抗炎和抗血管生成特性。尽管两组所需注射次数相似,但低剂量组的更好反应凸显了进一步研究他汀类药物在治疗糖尿病黄斑水肿中剂量依赖性效应的必要性。

结论

与高剂量阿托伐他汀相比,低剂量阿托伐他汀(10 - 20毫克)作为抗VEGF治疗的辅助药物,在患有CSME的糖尿病患者中产生了更好的功能和解剖学结局。这些发现表明低剂量他汀类药物在治疗慢性硬膜下血肿(CSME)患者中可能具有潜在的额外益处。

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