Chaturvedi N, Sjolie A K, Stephenson J M, Abrahamian H, Keipes M, Castellarin A, Rogulja-Pepeonik Z, Fuller J H
Department of Epidemiology and Public Health, University College London, UK.
Lancet. 1998 Jan 3;351(9095):28-31. doi: 10.1016/s0140-6736(97)06209-0.
Retinopathy commonly occurs in people with type 1 diabetes. Strict glycaemic control can decrease development and progression of retinopathy only partially. Blood pressure is also a risk factor for microvascular complications. Antihypertensive therapy, especially with inhibitors of angiotensin-converting enzyme (ACE), can slow progression of nephropathy, but the effects on retinopathy have not been established. We investigated the effect of lisinopril on retinopathy in type 1 diabetes.
As part of a 2-year randomised double-blind placebo-controlled trial, we took retinal photographs at baseline and follow-up (24 months) in patients aged 20-59 in 15 European centres. Patients were not hypertensive, and were normoalbuminuric (85%) or microalbuminuric. Retinopathy was classified from photographs on a five-level scale (none to proliferative).
The proportion of patients with retinopathy at baseline was 65% (117) in the placebo group and 59% (103) in the lisinopril group (p = 0.2). Patients on lisinopril had significantly lower HbA1c at baseline than those on placebo (6.9% vs 7.3 p = 0.05). Retinopathy progressed by at least one level in 21 (13.2%) of 159 patients on lisinopril and 39 (23.4%) of 166 patients on placebo (odds ratio 0.50 [95% CI 0.28-0.89], p = 0.02). This 50% reduction was the same when adjusted for centre and glycaemic control (0.55 [0.30-1.03], p = 0.06). Lisinopril also decreased progression by two or more grades (0.27 [0.07-1.00], p = 0.05), and progression to proliferative retinopathy (0.18 [0.04-0.82], p = 0.03). Progression was not associated with albuminuric status at baseline. Treatment reduced retinopathy incidence (0.69 [0.30-1.59], p = 0.4).
Lisinopril may decrease retinopathy progression in non-hypertensive patients who have type 1 diabetes with little or no nephropathy. These findings need to be confirmed before changes to clinical practice can be advocated.
视网膜病变常见于1型糖尿病患者。严格控制血糖仅能部分降低视网膜病变的发生和发展。血压也是微血管并发症的一个危险因素。抗高血压治疗，尤其是使用血管紧张素转换酶（ACE）抑制剂，可减缓肾病进展，但对视网膜病变的影响尚未明确。我们研究了赖诺普利对1型糖尿病视网膜病变的影响。
作为一项为期2年的随机双盲安慰剂对照试验的一部分，我们在15个欧洲中心对年龄在20 - 59岁的患者在基线和随访（24个月）时拍摄了视网膜照片。患者无高血压，尿白蛋白正常（85%）或微量白蛋白尿。根据照片将视网膜病变分为五级（无至增殖性）。
安慰剂组基线时有视网膜病变的患者比例为65%（117例），赖诺普利组为59%（见103例）（p = 0.2）。赖诺普利组患者基线时的糖化血红蛋白水平显著低于安慰剂组（6.9%对7.3%，p = 0.05）。159例使用赖诺普利的患者中有21例（13.2%）视网膜病变进展至少一级，166例使用安慰剂的患者中有39例（23.4%）进展至少一级（优势比0.50 [95%可信区间0.28 - 0.89]，p = 0.02）。在对中心和血糖控制进行校正后，这种50%的降低幅度相同（0.55 [0.30 - 1.03]，p = 0.06）。赖诺普利还降低了两级或更多级别的进展（0.27 [0.07 - 1.00]，p = 0.05），以及进展为增殖性视网膜病变的风险（0.18 [0.04 - 0.82]，p = 0.03）。进展与基线时的白蛋白尿状态无关。治疗降低了视网膜病变的发生率（0.69 [0.30 - 1.59]，p = 0.4）。
赖诺普利可能会降低几乎没有或没有肾病的1型糖尿病非高血压患者的视网膜病变进展。在提倡改变临床实践之前，这些发现需要得到证实。
