西班牙队列研究：4 年糖尿病视网膜病变的发生率。
Four-year incidence of diabetic retinopathy in a Spanish cohort: the MADIABETES study.
机构信息
Fundación de Investigación Biomédica, Hospital Carlos III, Servicio Madrileño de Salud, Madrid, Spain.
出版信息
PLoS One. 2013 Oct 17;8(10):e76417. doi: 10.1371/journal.pone.0076417. eCollection 2013.
OBJECTIVE
To evaluate the incidence of diabetic retinopathy in patients with Type 2 Diabetes Mellitus, to identify the risk factors associated with the incidence of retinopathy and to develop a risk table to predict four-year retinopathy risk stratification for clinical use, from a four-year cohort study.
DESIGN
The MADIABETES Study is a prospective cohort study of 3,443 outpatients with Type 2 Diabetes Mellitus, sampled from 56 primary health care centers (131 general practitioners) in Madrid (Spain).
RESULTS
The cumulative incidence of retinopathy at four-year follow-up was 8.07% (95% CI = 7.04-9.22) and the incidence density was 2.03 (95% CI = 1.75-2.33) cases per 1000 patient-months or 2.43 (95% CI = 2.10-2.80) cases per 100 patient-years. The highest adjusted hazard ratios of associated risk factors for incidence of diabetic retinopathy were LDL-C >190 mg/dl (HR = 7.91; 95% CI = 3.39-18.47), duration of diabetes longer than 22 years (HR = 2.00; 95% CI = 1.18-3.39), HbA1c>8% (HR = 1.90; 95% CI = 1.30-2.77), and aspirin use (HR = 1.65; 95% CI = 1.22-2.24). Microalbuminuria (HR = 1.17; 95% CI = 0.75-1.82) and being female (HR = 1.12; 95% CI = 0.84-1.49) showed a non-significant increase of diabetic retinopathy. The greatest risk is observed in females who had diabetes for more than 22 years, with microalbuminuria, HbA1c>8%, hypertension, LDL-Cholesterol >190 mg/dl and aspirin use.
CONCLUSIONS
After a four-year follow-up, the cumulative incidence of retinopathy was relatively low in comparison with other studies. Higher baseline HbA1c, aspirin use, higher LDL-Cholesterol levels, and longer duration of diabetes were the only statistically significant risk factors found for diabetic retinopathy incidence. This is the first study to demonstrate an association between aspirin use and diabetic retinopathy risk in a well-defined cohort of patients with Type 2 Diabetes Mellitus at low risk of cardiovascular events. However, further studies with patients at high cardiovascular and metabolic risk are needed to clarify this issue.
目的
评估 2 型糖尿病患者中糖尿病视网膜病变的发生率，确定与视网膜病变发生率相关的风险因素，并制定风险表，以预测四年临床使用的视网膜病变风险分层，这是一项来自四年队列研究的结果。
设计
MADIABETES 研究是一项对来自马德里（西班牙）56 个初级保健中心（131 名全科医生）的 3443 名 2 型糖尿病门诊患者进行的前瞻性队列研究。
结果
四年随访时视网膜病变的累积发生率为 8.07%（95%CI=7.04-9.22），发病率密度为每 1000 患者-月 2.03 例（95%CI=1.75-2.33）或每 100 患者-年 2.43 例（95%CI=2.10-2.80）。与糖尿病视网膜病变发生率相关的风险因素中，调整后的最高危险比是 LDL-C＞190mg/dl（HR=7.91；95%CI=3.39-18.47）、糖尿病病程超过 22 年（HR=2.00；95%CI=1.18-3.39）、HbA1c＞8%（HR=1.90；95%CI=1.30-2.77）和使用阿司匹林（HR=1.65；95%CI=1.22-2.24）。微量白蛋白尿（HR=1.17；95%CI=0.75-1.82）和女性（HR=1.12；95%CI=0.84-1.49）显示出糖尿病视网膜病变的非显著增加。在患有糖尿病超过 22 年、伴有微量白蛋白尿、HbA1c＞8%、高血压、LDL-胆固醇＞190mg/dl 和使用阿司匹林的女性中，观察到最大的风险。
结论
与其他研究相比，经过四年的随访，视网膜病变的累积发生率相对较低。较高的基线 HbA1c、使用阿司匹林、较高的 LDL-胆固醇水平和较长的糖尿病病程是发现的唯一具有统计学意义的糖尿病视网膜病变发生率的危险因素。这是第一项在心血管事件风险较低的 2 型糖尿病患者中明确队列中证明阿司匹林使用与糖尿病视网膜病变风险之间存在关联的研究。然而，需要进一步研究高心血管和代谢风险的患者，以阐明这一问题。
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