Fong Donald S, Contreras Richard
Department of Ophthalmology, Southern California Permanente Medical Group, Baldwin Park, California and Clinical Trials Research, Pasadena, California 91101, USA.
Am J Ophthalmol. 2009 Apr;147(4):583-586.e1. doi: 10.1016/j.ajo.2008.10.016. Epub 2009 Feb 1.
To determine the ocular safety of glitazones in patients with diabetes, we investigated the association of diabetic macular edema (DME) in a large population of glitazone users.
Prospective cohort study.
The study was conducted at Kaiser Permanente Southern California. About 170,000 persons with diabetes were identified using the Diabetes Case Identification Database. Glitazone drug use was obtained from the pharmacy database. The main outcome measure was the development of macular edema (ME). The chi2 test was used to compare proportions and t tests were used for means. Logistic regression analysis was used to adjust for potential confounding variables.
In 2006, there were 996 new cases of ME. Glitazone users were more likely to develop ME in 2006 (odds ratio [OR], 2.6; 95% confidence interval [CI], 2.4 to 3.0). After excluding patients who did not have the drug benefit, did not have an eye exam, and had a HgA1c <7.0, glitazone use was still associated with an increased risk of developing ME (OR, 1.6; 95% CI, 1.4 to 1.8).
The current study appears to show that the glitazone class of drug is associated with DME. After adjusting for confounding factors of age, glycemic control, and insulin use, glitazones are still modestly associated with DME. A more in-depth study will need to be done to evaluate the role of other confounding factors. When treating patients with DME, ophthalmologists should consider the role of the glitazones.
为了确定噻唑烷二酮类药物在糖尿病患者中的眼部安全性,我们在大量使用噻唑烷二酮类药物的人群中调查了糖尿病性黄斑水肿(DME)的相关性。
前瞻性队列研究。
研究在南加州永久医疗集团进行。利用糖尿病病例识别数据库识别出约17万名糖尿病患者。噻唑烷二酮类药物的使用情况从药房数据库中获取。主要结局指标是黄斑水肿(ME)的发生情况。采用卡方检验比较比例,采用t检验比较均值。使用逻辑回归分析来调整潜在的混杂变量。
2006年,有996例新的ME病例。2006年,使用噻唑烷二酮类药物的患者更易发生ME(优势比[OR],2.6;95%置信区间[CI],2.4至3.0)。在排除没有药物益处、未进行眼科检查以及糖化血红蛋白<7.0的患者后,使用噻唑烷二酮类药物仍与发生ME的风险增加相关(OR,1.6;95%CI,1.4至1.8)。
当前研究似乎表明,噻唑烷二酮类药物与DME相关。在调整年龄、血糖控制和胰岛素使用等混杂因素后,噻唑烷二酮类药物仍与DME存在一定关联。需要进行更深入的研究来评估其他混杂因素的作用。在治疗DME患者时,眼科医生应考虑噻唑烷二酮类药物的作用。