Ambrosius Walter T, Danis Ronald P, Goff David C, Greven Craig M, Gerstein Hertzel C, Cohen Robert M, Riddle Matthew C, Miller Michael E, Buse John B, Bonds Denise E, Peterson Kevin A, Rosenberg Yves D, Perdue Letitia H, Esser Barbara A, Seaquist Lea A, Felicetta James V, Chew Emily Y
Department of Biostatistical Sciences, Division of Public Health Sciences, Wake Forest University Health Sciences, Medical Center Boulevard, Winston-Salem, NC 27157, USA.
Arch Ophthalmol. 2010 Mar;128(3):312-8. doi: 10.1001/archophthalmol.2009.310.
To assess the cross-sectional association of thiazolidinediones with diabetic macular edema (DME).
The cross-sectional association of DME and visual acuity with thiazolidinediones was examined by means of baseline fundus photographs and visual acuity measurements from the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial. Visual acuity was assessed in 9690 participants in the ACCORD trial, and 3473 of these participants had fundus photographs that were centrally read in a standardized fashion by masked graders to assess DME and retinopathy from October 23, 2003, to March 10, 2006.
Among the subsample, 695 (20.0%) people had used thiazolidinediones, whereas 217 (6.2%) people had DME. Thiazolidinedione use was not associated with DME in unadjusted (odds ratio [OR], 1.01; 95% confidence interval [CI], 0.71-1.44; P = .95) and adjusted (OR, 0.97; 95% CI, 0.67-1.40; P = .86) analyses. Significant associations with DME were found for retinopathy severity (P < .001) and age (OR, 0.97; 95% CI, 0.952-0.997; P = .03) but not for hemoglobin A(1c) (P = .06), duration of diabetes (P = .65), sex (P = .72), and ethnicity (P = .20). Thiazolidinedione use was associated with slightly greater visual acuity (0.79 letter; 95% CI, 0.20-1.38; P = .009) of uncertain clinical significance.
In a cross-sectional analysis of data from the largest study to date, no association was observed between thiazolidinedione exposure and DME in patients with type 2 diabetes; however, we cannot exclude a modest protective or harmful association. Trial Registration clinicaltrials.gov Identifier: NCT00542178.
评估噻唑烷二酮类药物与糖尿病性黄斑水肿（DME）的横断面关联。
通过糖尿病心血管风险控制行动（ACCORD）试验的基线眼底照片和视力测量，研究DME及视力与噻唑烷二酮类药物的横断面关联。对ACCORD试验中的9690名参与者进行了视力评估，其中3473名参与者有眼底照片，这些照片于2003年10月23日至2006年3月10日由蒙面分级员以标准化方式进行集中解读，以评估DME和视网膜病变。
在该子样本中，695人（20.0%）使用过噻唑烷二酮类药物，而217人（6.2%）患有DME。在未调整分析（比值比[OR]，1.01；95%置信区间[CI]，0.71 - 1.44；P = 0.95）和调整分析（OR，0.97；95% CI，0.67 - 1.40；P = 0.86）中，噻唑烷二酮类药物的使用与DME无关联。发现与DME有显著关联的因素是视网膜病变严重程度（P < 0.001）和年龄（OR，0.97；95% CI，0.952 - 0.997；P = 0.03），但糖化血红蛋白（P = 0.06）、糖尿病病程（P = 0.65）、性别（P = 0.72）和种族（P = 0.20）与DME无显著关联。噻唑烷二酮类药物的使用与视力略有提高（0.79字母；95% CI，0.20 - 1.38；P = 0.009）相关，但临床意义不确定。
在对迄今为止最大规模研究的数据进行的横断面分析中，未观察到2型糖尿病患者中噻唑烷二酮类药物暴露与DME之间存在关联；然而，我们不能排除适度的保护或有害关联。试验注册 clinicaltrials.gov标识符：NCT00542178。
