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葡萄牙糖尿病视网膜病变的首次发病和进展研究,RETNODIAB 研究:里斯本地区筛查计划的评估。

First Incidence and Progression Study for Diabetic Retinopathy in Portugal, the RETINODIAB Study: Evaluation of the Screening Program for Lisbon Region.

机构信息

Portuguese Diabetes Association, Lisbon, Portugal; Department of Ophthalmology, Central Lisbon Hospital Center, Lisbon, Portugal; NOVA Medical School, Universidade NOVA de Lisboa, Lisbon, Portugal.

University of Minho, Braga, Portugal.

出版信息

Ophthalmology. 2015 Dec;122(12):2473-81. doi: 10.1016/j.ophtha.2015.08.004. Epub 2015 Sep 15.

Abstract

PURPOSE

To estimate the 5-year incidence and progression of diabetic retinopathy (DR) among persons with type 2 diabetes mellitus (DM).

DESIGN

Population-based, prospective, cohort study.

PARTICIPANTS

The RETINODIAB (Study Group for Diabetic Retinopathy Screening) program was implemented in the Lisbon and Tagus Valley area between July 2009 and December 2014. A total of 109 543 readable screening examinations were performed and corresponded to 56 903 patients who attended the screening program at entry. A total of 30 641 patients (53.85%) had at least 1 further screening event within the study period and were included in the analysis.

METHODS

Participants underwent two 45° nonstereoscopic retinal digital photographs per eye according to RETINODIAB protocol. All images were graded according to the International Clinical Diabetic Retinopathy Scale. Referable diabetic retinopathy (RDR) was defined for all patients graded as moderate nonproliferative DR (NPDR), severe NPDR, or proliferative DR (PDR), with or without maculopathy or mild NPDR with maculopathy. Nonparametric estimates of the annual and cumulative incidences were obtained by Turnbull's estimator. Associations between the potential risk factors and the time to onset/progression of retinopathy were assessed through a parametric survival analysis for interval-censored data.

MAIN OUTCOME MEASURES

The authors estimated the onset and progression incidence rates of DR.

RESULTS

Yearly incidence of any DR in patients without retinopathy at baseline was 4.60% (95% confidence interval [CI], 3.96-4.76) in the first year, decreasing to 3.87% (95% CI, 2.57-5.78) in the fifth year. In participants with mild NPDR at baseline, the progression rate to RDR in year 1 was 1.18% (95% CI, 0.96-1.33). Incidence of any DR and RDR and DR progression rate were associated with known duration of diabetes, age at diagnosis, and use of insulin treatment.

CONCLUSIONS

This longitudinal epidemiologic study provides the first Portuguese incidence DR data in a large-scale population-based cohort of type 2 diabetes after a 5-year follow-up. Duration of diabetes, age at diagnosis, and insulin treatment were associated with increasing risk of incidence and progression of DR. A personalized schedule distribution of screening intervals according to the individual patient's profile should be implemented, with resulting benefits in terms of health costs.

摘要

目的

评估 2 型糖尿病患者(DM)中糖尿病视网膜病变(DR)的 5 年发生率和进展情况。

设计

基于人群的前瞻性队列研究。

参与者

RETINODIAB(糖尿病视网膜病变筛查研究组)计划于 2009 年 7 月至 2014 年 12 月在里斯本和塔古斯河谷地区实施。共进行了 109543 次可阅读的筛查检查,对应于 56903 名参加筛查计划的患者。共有 30641 名患者(53.85%)在研究期间至少进行了 1 次进一步的筛查,纳入分析。

方法

根据 RETINODIAB 方案,每位患者每只眼接受两次 45°非立体视网膜数字摄影。所有图像均按照国际临床糖尿病视网膜病变分级标准进行分级。参考糖尿病视网膜病变(RDR)是指所有分级为中度非增殖性 DR(NPDR)、重度 NPDR 或增殖性 DR(PDR)的患者,无论是否伴有黄斑病变或轻度 NPDR 伴黄斑病变。通过特鲁尔估计器获得非参数估计的年度和累积发生率。通过参数生存分析评估潜在风险因素与视网膜病变发生或进展时间之间的关联。

主要观察指标

作者估计了 DR 的发病和进展发生率。

结果

基线时无视网膜病变的患者,DR 年发生率在第 1 年为 4.60%(95%置信区间[CI],3.96-4.76),第 5 年下降至 3.87%(95% CI,2.57-5.78)。基线时轻度 NPDR 的患者,第 1 年进展为 RDR 的比例为 1.18%(95% CI,0.96-1.33)。任何 DR 和 RDR 的发生率以及 DR 的进展率均与糖尿病的已知病程、诊断时年龄和胰岛素治疗有关。

结论

这项大规模基于人群的 2 型糖尿病纵向流行病学研究在 5 年随访后提供了葡萄牙首次关于 DR 的发生率数据。糖尿病病程、诊断时年龄和胰岛素治疗与 DR 发生率和进展风险的增加相关。应根据个体患者的特征实施个性化的筛查间隔分配方案,从而在卫生成本方面获益。

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