Cardiovascular Effects of Intensive Lifestyle Intervention in Type 2 Diabetes — NEJM [NEJM][医学] 强化的生活方式干预2型糖尿病对心血管系统的影响

Abstract 论文摘要 Background Weight loss is recommended for overweight or obese patients with type 2 diabetes on the basis of short-term studies, but long-term effects on cardiovascular disease remain unknown. We examined whether an intensive lifestyle intervention for weight loss would decrease cardiovascular morbidity and mortality among such patients. 背景 基于短期研究，我们建议患有2型糖尿病的超重或肥胖患者进行减重，但对于心血管疾病的长期影响我们仍所知甚少。我们检验了为减重实行强化生活方式干预是否会降低这类病人的心血管发病率和死亡率。 Methods In 16 study centers in the United States, we randomly assigned 5145 overweight or obese patients with type 2 diabetes to participate in an intensive lifestyle intervention that promoted weight loss through decreased caloric intake and increased physical activity (intervention group) or to receive diabetes support and education (control group). The primary outcome was a composite of death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for angina during a maximum follow-up of 13.5 years. 方法 在美国16个研究中心，我们随机分配5145名患有2型糖尿病超重或肥胖患者参与了强化生活方式干预，这类干预是通过减少热量摄入来加速减重以及让干预组增加体力活动和让对照组接受糖尿病支持和教育。主要结果是在最长达13.5年随访期间因心血管原因，非致死性心肌梗死，非致死性卒中，或因心绞痛住院治疗产生的复合性死亡。 Results The trial was stopped early on the basis of a futility analysis when the median follow-up was 9.6 years. Weight loss was greater in the intervention group than in the control group throughout the study (8.6% vs. 0.7% at 1 year; 6.0% vs. 3.5% at study end). The intensive lifestyle intervention also produced greater reductions in glycated hemoglobin and greater initial improvements in fitness and all cardiovascular risk factors, except for low-density-lipoprotein cholesterol levels. The primary outcome occurred in 403 patients in the intervention group and in 418 in the control group (1.83 and 1.92 events per 100 person-years, respectively; hazard ratio in the intervention group, 0.95; 95% confidence interval, 0.83 to 1.09; P=0.51). 结果 当随访中位时长为9.6年时，该试验基于一项无效分析提前终止。整个研究中，干预组减重效果比对照组明显（第一年为8.6％比0.7％; 研究结束时为6.0％比3.5％）。强化生活方式干预也产生了较大幅度糖化血红蛋白的削减且健身效果和除低密度脂蛋白胆固醇水平以外的所有心血管疾病危险因素均比初始时有较大改善。主要后果发生在干预组的403名受测患者以及对照组的418名受测患者 （分别为1.83和1.92事件每百人／年;干预组的风险比为0.95;95％置信区间为0.83至1.09，P = 0.51）。 Conclusions An intensive lifestyle intervention focusing on weight loss did not reduce the rate of cardiovascular events in overweight or obese adults with type 2 diabetes. (Funded by the National Institutes of Health and others) 结论 侧重于减重的密集生活方式干预并未减少患有2型糖尿病的超重或肥胖成年患者的心血管病发生率。 （由国家卫生以及其他机构资助）