作者: Fine LJ,Davis MD,Lovato JF,et al.
出处:The New England journal of medicine.2010-07-15;363(3):233-44.
文献类型:临床试验 PUBMED链接:PMID: 20587587
Abstract:BACKGROUND:We investigated whether intensive glycemic control, combination therapy for dys... BACKGROUND:We investigated whether intensive glycemic control, combination therapy for dyslipidemia, and intensive blood-pressure control would limit the progression of diabetic retinopathy in persons with type 2 diabetes. Previous data suggest that these systemic factors may be important in the development and progression of diabetic retinopathy.
METHODS:In a randomized trial, we enrolled 10,251 participants with type 2 diabetes who were at high risk for cardiovascular disease to receive either intensive or standard treatment for glycemia (target glycated hemoglobin level, <6.0% or 7.0 to 7.9%, respectively) and also for dyslipidemia (160 mg daily of fenofibrate plus simvastatin or placebo plus simvastatin) or for systolic blood-pressure control (target, <120 or <140 mm Hg). A subgroup of 2856 participants was evaluated for the effects of these interventions at 4 years on the progression of diabetic retinopathy by 3 or more steps on the Early Treatment Diabetic Retinopathy Study Severity Scale (as assessed from seven-field stereoscopic fundus photographs, with 17 possible steps and a higher number of steps indicating greater severity) or the development of diabetic retinopathy necessitating laser photocoagulation or vitrectomy.
RESULTS:At 4 years, the rates of progression of diabetic retinopathy were 7.3% with intensive glycemia treatment, versus 10.4% with standard therapy (adjusted odds ratio, 0.67; 95% confidence interval [CI], 0.51 to 0.87; P=0.003); 6.5% with fenofibrate for intensive dyslipidemia therapy, versus 10.2% with placebo (adjusted odds ratio, 0.60; 95% CI, 0.42 to 0.87; P=0.006); and 10.4% with intensive blood-pressure therapy, versus 8.8% with standard therapy (adjusted odds ratio, 1.23; 95% CI, 0.84 to 1.79; P=0.29).
CONCLUSIONS:Intensive glycemic control and intensive combination treatment of dyslipidemia, but not intensive blood-pressure control, reduced the rate of progression of diabetic retinopathy. (Funded by the National Heart, Lung, and Blood Institute and others; ClinicalTrials.gov numbers, NCT00000620 for the ACCORD study and NCT00542178 for the ACCORD Eye study.)
中文摘要:
背景
我们在有2型糖尿病的人中研究强化血糖控制、血脂紊乱的联合治疗以及强化血压控制,是否会限制糖尿病视网膜病的进展。以前的数据提示,这些全身因素可能对于糖尿病视网膜病的发生和进展很重要。
方法
我们在一项随机临床试验中,入选了10251名有2型糖尿病,并且发生心血管病危险高的研究对象,他们接受强化或标准血糖控制治疗(目标糖化血红蛋白水平分别为<6.0%或7.0%~7.9%),强化或标准的血脂紊乱治疗(每天160 mg非诺贝特加辛伐他汀或安慰剂加辛伐他汀),以及强化或标准的收缩压控制治疗(目标收缩压<120 mmHg或<140 mmHg)。我们在一个由2856名研究对象组成的亚组中,评估4年时这些干预措施对糖尿病视网膜病进展的影响,具体指标是早期治疗糖尿病视网膜病研究严重度量表(显示病变进展)≥3个级别(用7视野立体眼底照片进行评估,共分17个可能级别,级数越高表示病情越重),或(患者)发生了必须作激光光凝治疗或玻璃体切割术的糖尿病视网膜病。
结果
4年时,糖尿病视网膜病进展的发生率,在强化血糖治疗组中为7.3%,而在标准(血糖)治疗组中为10.4%[校正比值比为0.67,95%可信区间(CI)为0.51~0.87,P=0.003];在用非诺贝特进行强化血脂紊乱治疗组中为6.5%,而在安慰剂组中为10.2%(校正比值比为0.60,95%CI为0.42~0.87,P=0.006);在强化血压治疗组中为10.4%,而在标准(血压)治疗组中为8.8%(校正比值比为1.23,95%CI为0.84~1.79,P=0.29)。
结论
强化血糖控制和对血脂紊乱进行强化联合治疗,可降低糖尿病视网膜病进展的发生率,但强化血压控制治疗没有此效果。
主题词:Antihypertensive Agents; Cardiovascular Diseases; Cholesterol, LDL; Diabetes Mellitus, Type 2; Diabetic Retinopathy; Disease Progression; Drug Therapy, Combination; Dyslipidemias; Female; Fenofibrate; Follow-Up Studies; Hemoglobin A, Glycosylated; Humans; Hyperglycemia; Hypertension; Hypoglycemic Agents; Hypolipidemic Agents; Male; Middle Aged; Simvastatin; |