Gaede Peter, Vedel Pernille, Larsen Nicolai, Jensen Gunnar V H, Parving Hans-Henrik, Pedersen Oluf
Steno Diabetes Center, Copenhagen, Denmark.
N Engl J Med. 2003 Jan 30;348(5):383-93. doi: 10.1056/NEJMoa021778.
Cardiovascular morbidity is a major burden in patients with type 2 diabetes. In the Steno-2 Study, we compared the effect of a targeted, intensified, multifactorial intervention with that of conventional treatment on modifiable risk factors for cardiovascular disease in patients with type 2 diabetes and microalbuminuria.
The primary end point of this open, parallel trial was a composite of death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, revascularization, and amputation. Eighty patients were randomly assigned to receive conventional treatment in accordance with national guidelines and 80 to receive intensive treatment, with a stepwise implementation of behavior modification and pharmacologic therapy that targeted hyperglycemia, hypertension, dyslipidemia, and microalbuminuria, along with secondary prevention of cardiovascular disease with aspirin.
The mean age of the patients was 55.1 years, and the mean follow-up was 7.8 years. The decline in glycosylated hemoglobin values, systolic and diastolic blood pressure, serum cholesterol and triglyceride levels measured after an overnight fast, and urinary albumin excretion rate were all significantly greater in the intensive-therapy group than in the conventional-therapy group. Patients receiving intensive therapy also had a significantly lower risk of cardiovascular disease (hazard ratio, 0.47; 95 percent confidence interval, 0.24 to 0.73), nephropathy (hazard ratio, 0.39; 95 percent confidence interval, 0.17 to 0.87), retinopathy (hazard ratio, 0.42; 95 percent confidence interval, 0.21 to 0.86), and autonomic neuropathy (hazard ratio, 0.37; 95 percent confidence interval, 0.18 to 0.79).
A target-driven, long-term, intensified intervention aimed at multiple risk factors in patients with type 2 diabetes and microalbuminuria reduces the risk of cardiovascular and microvascular events by about 50 percent.
心血管疾病是2型糖尿病患者的主要负担。在斯滕诺-2研究中,我们比较了针对性强化多因素干预与传统治疗对2型糖尿病合并微量白蛋白尿患者心血管疾病可改变危险因素的影响。
这项开放平行试验的主要终点是心血管原因死亡、非致死性心肌梗死、非致死性中风、血管重建和截肢的综合结果。80名患者被随机分配接受符合国家指南的传统治疗,80名接受强化治疗,逐步实施行为改变和药物治疗,针对高血糖、高血压、血脂异常和微量白蛋白尿,同时用阿司匹林进行心血管疾病二级预防。
患者的平均年龄为55.1岁,平均随访时间为7.8年。强化治疗组糖化血红蛋白值、收缩压和舒张压、空腹过夜后测得的血清胆固醇和甘油三酯水平以及尿白蛋白排泄率的下降均显著大于传统治疗组。接受强化治疗的患者发生心血管疾病(风险比,0.47;95%置信区间,0.24至0.73)、肾病(风险比,0.39;95%置信区间,0.17至0.87)、视网膜病变(风险比,0.42;95%置信区间,0.21至0.86)和自主神经病变(风险比,0.37;95%置信区间,0.18至0.79)的风险也显著较低。
针对2型糖尿病合并微量白蛋白尿患者的多种危险因素进行目标驱动的长期强化干预可将心血管和微血管事件风险降低约50%。