Klein R, Meuer S M, Moss S E, Klein B E
Department of Ophthalmology and Visual Sciences, University of Wisconsin Medical School, Madison, USA.
Arch Ophthalmol. 1995 Nov;113(11):1386-91. doi: 10.1001/archopht.1995.01100110046024.
To determine the relationship of change in the number of retinal microaneurysms to the 10-year progression to significant retinopathy, proliferative retinopathy, and clinically significant macular edema.
Population-based study of persons with younger- and older-onset diabetes with 10 years of follow-up.
Eleven-county area in southern Wisconsin, where 189 patients with diabetes who had only retinal microaneurysms in photographs at baseline participated in 4- and 10-year follow-up examinations.
Ten-year incidence of moderate nonproliferative diabetic retinopathy or worse, proliferative retinopathy, or clinically significant macular edema as determined by masked grading of stereoscopic color fundus photographs of seven standard fields.
The increase in the number of retinal microaneurysms and the ratio of the number of retinal microaneurysms at the 4-year follow-up to the number at baseline were positively associated with incidence of proliferative retinopathy or clinically significant macular edema at the 10-year follow-up. Proliferative retinopathy was approximately 4.6 times and clinically significant macular edema was approximately 9.1 times more likely to develop at 10-year follow-up in eyes in which the number of microaneurysms increased by 16 or more from baseline to the 4-year follow-up than in eyes with no increase. Proliferative retinopathy was 3.4 times and clinically significant macular edema was 6.7 times more likely to develop at 10-year follow-up in eyes that had ratios of 3 or greater of the number of retinal microaneurysms at the 4-year follow-up to the number at baseline than in eyes in which the ratios were smaller. These relationships remained after controlling for the level of glycosylated hemoglobin and type of diabetes.
Microaneurysm counts using stereoscopic color fundus photographs are an early important measure of progression of retinopathy and may serve as a surrogate end point for severe change in some clinical trials.
确定视网膜微动脉瘤数量的变化与10年进展为严重视网膜病变、增殖性视网膜病变和临床显著性黄斑水肿之间的关系。
对早发型和晚发型糖尿病患者进行为期10年随访的基于人群的研究。
威斯康星州南部的11个县地区,189例在基线时眼底照片仅显示视网膜微动脉瘤的糖尿病患者参与了4年和10年的随访检查。
通过对七个标准视野的立体彩色眼底照片进行盲法分级,确定中度非增殖性糖尿病视网膜病变及以上、增殖性视网膜病变或临床显著性黄斑水肿的10年发病率。
视网膜微动脉瘤数量的增加以及4年随访时视网膜微动脉瘤数量与基线时数量的比值,与10年随访时增殖性视网膜病变或临床显著性黄斑水肿的发病率呈正相关。从基线到4年随访时微动脉瘤数量增加16个或更多的眼睛,在10年随访时发生增殖性视网膜病变的可能性约为未增加眼睛的4.6倍,发生临床显著性黄斑水肿的可能性约为9.1倍。4年随访时视网膜微动脉瘤数量与基线时数量的比值为3或更高的眼睛,在10年随访时发生增殖性视网膜病变的可能性为比值较小眼睛的3.4倍,发生临床显著性黄斑水肿的可能性为6.7倍。在控制糖化血红蛋白水平和糖尿病类型后,这些关系依然存在。
使用立体彩色眼底照片进行微动脉瘤计数是视网膜病变进展的一项早期重要指标,在某些临床试验中可作为严重变化的替代终点。