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糖尿病视网膜病变的预防与治疗:来自大型随机试验的证据。非诺贝特的新作用。

Prevention and treatment of diabetic retinopathy: evidence from large, randomized trials. The emerging role of fenofibrate.

作者信息

Simó Rafael, Hernández Cristina

机构信息

CIBERDEM, Vall Hebron Institut de Recerca (VHIR), Universitat Autònoma de Barcelona, Barcelona, Spain.

出版信息

Rev Recent Clin Trials. 2012 Feb;7(1):71-80. doi: 10.2174/157488712799363299.

Abstract

Diabetic retinopathy (DR) remains a leading cause of preventable vision loss, despite advances in diabetes care. The burden of DR is likely to increase as the evolving pandemic of type 2 diabetes progresses. Tight control of blood glucose levels and blood pressure are essential for preventing or arresting the development of diabetic retinopathy, but are often difficult to achieve, and DR thus develops in a high proportion of patients. Current treatments for DR such as laser photocoagulation, intravitreous injections of corticosteroids or anti-vascular endothelial growth factor (VEGF) agents are indicated for advanced DR and have significant adverse effects. Therefore, new pharmacological treatments for the early stages of DR are needed. The Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial included a lipid management arm, in which patients satisfying additional inclusion criteria for the atherogenic dyslipidemia phenotype were randomly assigned to fenofibrate or placebo, each with a statin. In the ACCORD-EYE substudy, randomization to fenofibrate was associated with a significant reduction in the risk of progression of DR. These data confirm and extend the results of the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study, in which type 2 diabetes patients randomized to fenofibrate benefitted from a significantly lower incidence of laser treatment for retinopathy, progression of retinopathy or a composite measure of retinopathy outcomes. The results of ACCORD-EYE, together with those of FIELD, identify a place for fenofibrate for the prevention of retinopathy alongside intensive management of traditional risk factors, such as hyperglycemia and high blood pressure.

摘要

尽管糖尿病护理取得了进展,但糖尿病视网膜病变(DR)仍然是可预防视力丧失的主要原因。随着2型糖尿病这一不断演变的大流行的发展,DR的负担可能会增加。严格控制血糖水平和血压对于预防或阻止糖尿病视网膜病变的发展至关重要,但往往难以实现,因此很大一部分患者会发生DR。目前针对DR的治疗方法,如激光光凝、玻璃体内注射皮质类固醇或抗血管内皮生长因子(VEGF)药物,适用于晚期DR,且有显著的不良反应。因此,需要针对DR早期阶段的新药理治疗方法。糖尿病心血管风险控制行动(ACCORD)试验包括一个脂质管理组,在该组中,满足致动脉粥样硬化血脂异常表型额外纳入标准的患者被随机分配至非诺贝特或安慰剂组,每组均联合使用他汀类药物。在ACCORD-EYE子研究中,随机分配至非诺贝特组与DR进展风险的显著降低相关。这些数据证实并扩展了非诺贝特干预与糖尿病事件降低(FIELD)研究的结果,在该研究中,随机分配至非诺贝特组的2型糖尿病患者从视网膜病变激光治疗、视网膜病变进展或视网膜病变结局综合指标的显著较低发生率中获益。ACCORD-EYE的结果与FIELD的结果共同确定了非诺贝特在预防视网膜病变方面的地位, alongside intensive management of traditional risk factors, such as hyperglycemia and high blood pressure.(此句原文有误,正确翻译应是“与强化管理传统风险因素(如高血糖和高血压)一起”) 与强化管理传统风险因素(如高血糖和高血压)一起。

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