Department of Ophthalmology, Odense University Hospital, Odense, Denmark.
Diabet Med. 2011 Mar;28(3):345-51. doi: 10.1111/j.1464-5491.2010.03210.x.
To study the association between baseline retinal microaneurysm score and progression and regression of diabetic retinopathy, and response to treatment with candesartan in people with diabetes.
This was a multicenter randomized clinical trial. The progression analysis included 893 patients with Type 1 diabetes and 526 patients with Type 2 diabetes with retinal microaneurysms only at baseline. For regression, 438 with Type 1 and 216 with Type 2 diabetes qualified. Microaneurysms were scored from yearly retinal photographs according to the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Retinopathy progression and regression was defined as two or more step change on the ETDRS scale from baseline. Patients were normoalbuminuric, and normotensive with Type 1 and Type 2 diabetes or treated hypertensive with Type 2 diabetes. They were randomized to treatment with candesartan 32 mg daily or placebo and followed for 4.6 years.
A higher microaneurysm score at baseline predicted an increased risk of retinopathy progression (HR per microaneurysm score 1.08, P < 0.0001 in Type 1 diabetes; HR 1.07, P = 0.0174 in Type 2 diabetes) and reduced the likelihood of regression (HR 0.79, P < 0.0001 in Type 1 diabetes; HR 0.85, P = 0.0009 in Type 2 diabetes), all adjusted for baseline variables and treatment. Candesartan reduced the risk of microaneurysm score progression.
Microaneurysm counts are important prognostic indicators for worsening of retinopathy, thus microaneurysms are not benign. Treatment with renin-angiotensin system inhibitors is effective in the early stages and may improve mild diabetic retinopathy. Microaneurysm scores may be useful surrogate endpoints in clinical trials.
研究基线视网膜微动脉瘤评分与糖尿病视网膜病变的进展和消退以及坎地沙坦治疗的相关性。
这是一项多中心随机临床试验。进展分析包括 893 例 1 型糖尿病患者和 526 例仅基线时有视网膜微动脉瘤的 2 型糖尿病患者。对于消退，438 例 1 型糖尿病和 216 例 2 型糖尿病符合条件。根据早期糖尿病视网膜病变研究（ETDRS）方案，从每年的视网膜照片中对微动脉瘤进行评分。视网膜病变的进展和消退定义为从基线开始 ETDRS 量表上的两个或更多步变化。患者为 1 型和 2 型糖尿病的正常白蛋白尿和正常血压，或 2 型糖尿病的治疗性高血压。他们被随机分为每日 32 毫克坎地沙坦或安慰剂治疗，并随访 4.6 年。
基线时较高的微动脉瘤评分预示着视网膜病变进展的风险增加（1 型糖尿病每微动脉瘤评分 1.08 的风险比[HR]，P<0.0001；2 型糖尿病 HR 1.07，P=0.0174），且降低了消退的可能性（1 型糖尿病 HR 0.79，P<0.0001；2 型糖尿病 HR 0.85，P=0.0009），所有这些都调整了基线变量和治疗。坎地沙坦降低了微动脉瘤评分进展的风险。
微动脉瘤计数是视网膜病变恶化的重要预后指标，因此微动脉瘤并非良性。肾素-血管紧张素系统抑制剂的治疗在早期阶段有效，可能改善轻度糖尿病性视网膜病变。微动脉瘤评分可能是临床试验中有用的替代终点。
