Intensified multifactorial intervention in patients with type 2 diabetes mellitus and microalbuminuria: the Steno type 2 randomised study
Intensified multifactorial intervention in patients with type 2 diabetes mellitus and microalbuminuria: the Steno type 2 randomised study
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DOI：
10.1016/s0140-6736(98)07368-1
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发表时间：
1999-02-20
期刊：
影响因子：
168.9
通讯作者：
Pedersen, O
中科院分区：
文献类型：
--
作者：
Gæde, P;Vedel, P;Pedersen, O
背景2型糖尿病长期并发症的病因是多因素的，我们进行了一项随机试验，逐步强化治疗或标准治疗的危险因素的患者微量albuminuria.Methods在这个开放的，平行的试验患者被分配标准治疗（n=80）或强化治疗（n=80）。标准治疗遵循丹麦指南。强化治疗是逐步实施行为矫正、针对高血脂症、高血压、血脂异常和微量白蛋白尿的药物治疗。主要终点是肾病的发展（至少一次两年一次的检查中，白蛋白排泄率中位数>300 mg/24 h）。次要终点是糖尿病视网膜病变和neuropathy.Findings的发病率或进展的平均年龄为55.1岁（SD 7.2）和患者随访3.8年（0.3）。强化治疗组患者进展为肾病的发生率显著降低（比值比0.27 [95% CI 0.10-0.75]），视网膜病变进展（0.45 [0.21-0.95]），和自主神经病变的进展（0.32 [0.12-0.78]）。解释2型糖尿病和微量白蛋白尿患者的强化多因素干预减缓了肾病进展，然而，需要进一步的研究来确定强化的多因素治疗对大血管并发症和死亡率的影响。
Background In type 2 diabetes mellitus the aetiology of long-term complications is multifactorial, We carried out a randomised trial of stepwise intensive treatment or standard treatment of risk factors in patients with microalbuminuria.Methods In this open, parallel trial patients were allocated standard treatment (n=80) or intensive treatment (n=80). Standard treatment followed Danish guidelines. Intensive treatment was a stepwise implementation of behaviour modification, pharmacological therapy targeting hyperglycaemia, hypertension, dyslipidaemia, and microalbuminuria. The primary endpoint was the development of nephropathy (median albumin excretion rate >300 mg per 24 h in at least one of the two-yearly examinations). Secondary endpoints were the incidence or progression of diabetic retinopathy and neuropathy.Findings The mean age was 55.1 years (SD 7.2) and patients were followed up for 3.8 years (0.3). Patients in the intensive group had significantly lower rates of progression to nephropathy (odds ratio 0.27 [95% CI 0.10-0.75]), progression of retinopathy (0.45 [0.21-0.95]), and progression of autonomic neuropathy (0.32 [0.12-0.78]) than those in the standard group.Interpretation Intensified multifactorial intervention in patients with type 2 diabetes and microalbuminuria slows progression to nephropathy, and progression of retinopathy and autonomic neuropathy, However, further studies are needed to establish the effect of intensified multifactorial treatment on macrovascular complications and mortality.