糖尿病视网膜病变Wisconsin流行病学研究 

Ronald Klein, MD; Barbara E. K. Klein, MD; Scot E. Moss, MA 

目的：
为了了解早期糖尿病视网膜病变治疗中病变程度在４年中进展〉＝１个或者２阶段对于预测今后６年中发生糖尿病视网膜增值性病变或者有临床意义的黄斑水肿是否有意义。

研究设计：以人群为基础的研究，随访南Wisconsin州的11个县糖尿病患者10年.有1025个糖尿病患者在初始，4年和10年随访时有眼底照相。主要的结果，糖尿病视网膜增值性病变或者有临床意义的黄斑水肿的发生率，在第4年和第10年随访时由不知情的眼科医生通过7个标准视野的眼底彩色立体照片来判定。

结果：在单因素分析中，那些在4年随访中进展〉=1阶段的患者（551例）与那些没有进展的（474例）相比更容易在随后6年中发生糖尿病视网膜增值性病变（P< .0001，相对危险度, 5.85; 95% 可信区间, 4.05-8.47）。相似的，那些在4年随访中进展〉=2阶段的患者（364例）和〉=3阶段的患者（231例）与那些进展阶段少的（相应661和794例）相比更容易在随后6年中发生糖尿病视网膜增值性病变（P< .0001，相对危险度5.01，95%可信限3.83-6.80，相对危险度 4.61，95%可信限3.57-5.99）。显而易见视网膜病变的每个阶段，糖尿病的病程长短，糖化血红蛋白水平，进入研究时的糖尿病种类，都有类似的关联。同样糖尿病视网膜病变的进展和有临床意义的黄斑水肿有关联。

结论：4年中糖尿病视网膜病变进展1个或2个或更多的阶段强烈的提示在今后6年可能发生糖尿病增值性病变。因此Conclusions It seems that 1 or more or 2 or more steps of progression of retinopathy over a 4-year period strongly predict the development of PDR over the next 6 years. Therefore, using these end points of progression would result in the need for fewer subjects or shorter follow-up in some clinical trials.

Arch Ophthalmol. 2001;119:547-553

How Many Steps of Progression of Diabetic Retinopathy Are Meaningful? 

The Wisconsin Epidemiologic Study of Diabetic Retinopathy 

Ronald Klein, MD; Barbara E. K. Klein, MD; Scot E. Moss, MA 

Objective To determine whether a 1-step or more or 2-step or more progression on the Early Treatment Diabetic Retinopathy Study retinopathy severity scale over a 4-year period is meaningful in predicting the subsequent incidence of proliferative diabetic retinopathy (PDR) and clinically significant macular edema (CSME) over the following 6 years.

Design Population-based study of diabetic persons with 10 years of follow-up.

Setting and Patients Eleven-county area in southern Wisconsin. There were 1025 persons with diabetes who had fundus photographs at baseline and at 4- and 10-year follow-up examinations.

Main Outcome Measures Incidence of PDR or CSME between the 4- and 10-year follow-up examinations as determined by masked grading of color stereoscopic fundus photographs of 7 standard fields.

Results In a univariate analysis, those with 1 or more steps of progression (n = 551) over the first 4 years of the study were significantly (P<.0001) more likely to develop PDR over the next 6 years than those with no progression (n = 474) (26% vs 4%) (relative risk, 5.85; 95% confidence interval, 4.05-8.47). Similarly, those with 2 or more (n = 364) (33%) or 3 or more (n = 231) (41%) steps of progression over the first 4 years of the study were significantly (P<.0001) more likely to develop PDR over the next 6 years than those with lesser progression (n = 661 [7%] and n = 794 [9%], respectively) (relative risk, 5.10; 95% confidence interval, 3.83-6.80; and relative risk, 4.61; 95% confidence interval, 3.57-5.99, respectively). Similar associations were apparent at every level of retinopathy, duration of diabetes, and glycosylated hemoglobin, and by type of diabetes at baseline. There were also associations between retinopathy progression and incidence of CSME.

Conclusions It seems that 1 or more or 2 or more steps of progression of retinopathy over a 4-year period strongly predict the development of PDR over the next 6 years. Therefore, using these end points of progression would result in the need for fewer subjects or shorter follow-up in some clinical trials.

Arch Ophthalmol. 2001;119:547-553