Daiichi Sankyo Development Ltd, Gerrards Cross, UK.
Drug Saf. 2010 Aug 1;33(8):643-52. doi: 10.2165/11538340-000000000-00000.
Diabetic macular edema (DME) is the leading cause of visual loss and legal blindness in people with diabetes mellitus. The pathogenesis of DME is complex and multifactorial, and involves both local and systemic risk factors that may alter the blood-retina barrier and allow leakage of protein and fluid into the macula. Recently, in addition to well known risk factors, the use of thiazolidinediones (glitazones) has been related to the development and worsening of DME. This review is based on available literature derived from EMBASE and MEDLINE, from 1950 to May 2010, and focuses on the potential correlations between DME and current available therapies for type 1 and 2 diabetes. This review reveals that the current literature, with the potential exception of glitazones, is not sufficient for a definite statement on the association between DME and currently available diabetic therapies. In fact, among antidiabetic agents, the class of glitazones appears the only one to be potentially associated with DME. Furthermore, adequately powered, prospective studies are warranted to evaluate the exact causal association between glitazones and DME and to exclude the role of other confounding factors potentially able to induce or exacerbate macular edema. Improvement of the quality and reporting in postmarketing surveillance and the use of the 'dechallenge and rechallenge' approach in case of suspicious cause/effect drug relationship of DME are highly encouraged.
糖尿病性黄斑水肿（DME）是糖尿病患者视力丧失和法定失明的主要原因。DME 的发病机制复杂且多因素，涉及局部和全身的危险因素，这些因素可能改变血视网膜屏障并允许蛋白质和液体渗漏到黄斑。最近，除了众所周知的危险因素外，噻唑烷二酮（格列酮）的使用与 DME 的发生和恶化有关。本综述基于从 1950 年至 2010 年 5 月的 EMBASE 和 MEDLINE 中获得的现有文献，重点介绍了 DME 与 1 型和 2 型糖尿病当前可用疗法之间的潜在相关性。本综述表明，目前的文献，除了格列酮外，不足以对 DME 与当前可用的糖尿病治疗之间的关联做出明确的陈述。事实上，在抗糖尿病药物中，格列酮类似乎是唯一一种与 DME 有潜在关联的药物。此外，需要进行足够大的、前瞻性的研究，以评估格列酮与 DME 之间的确切因果关系，并排除其他可能诱导或加重黄斑水肿的混杂因素的作用。强烈鼓励提高上市后监测的质量和报告，并在可疑的因果关系药物关系的情况下使用“撤药和再挑战”方法。
