Nathan D M, Genuth S, Lachin J, Cleary P, Crofford O, Davis M, Rand L, Siebert C
N Engl J Med. 1993 Sep 30;329(14):977-86. doi: 10.1056/NEJM199309303291401.
BACKGROUND: Long-term microvascular and neurologic complications cause major morbidity and mortality in patients with insulin-dependent diabetes mellitus (IDDM). We examined whether intensive treatment with the goal of maintaining blood glucose concentrations close to the normal range could decrease the frequency and severity of these complications. METHODS: A total of 1441 patients with IDDM--726 with no retinopathy at base line (the primary-prevention cohort) and 715 with mild retinopathy (the secondary-intervention cohort) were randomly assigned to intensive therapy administered either with an external insulin pump or by three or more daily insulin injections and guided by frequent blood glucose monitoring or to conventional therapy with one or two daily insulin injections. The patients were followed for a mean of 6.5 years, and the appearance and progression of retinopathy and other complications were assessed regularly. RESULTS: In the primary-prevention cohort, intensive therapy reduced the adjusted mean risk for the development of retinopathy by 76 percent (95 percent confidence interval, 62 to 85 percent), as compared with conventional therapy. In the secondary-intervention cohort, intensive therapy slowed the progression of retinopathy by 54 percent (95 percent confidence interval, 39 to 66 percent) and reduced the development of proliferative or severe nonproliferative retinopathy by 47 percent (95 percent confidence interval, 14 to 67 percent). In the two cohorts combined, intensive therapy reduced the occurrence of microalbuminuria (urinary albumin excretion of > or = 40 mg per 24 hours) by 39 percent (95 percent confidence interval, 21 to 52 percent), that of albuminuria (urinary albumin excretion of > or = 300 mg per 24 hours) by 54 percent (95 percent confidence interval 19 to 74 percent), and that of clinical neuropathy by 60 percent (95 percent confidence interval, 38 to 74 percent). The chief adverse event associated with intensive therapy was a two-to-threefold increase in severe hypoglycemia. CONCLUSIONS: Intensive therapy effectively delays the onset and slows the progression of diabetic retinopathy, nephropathy, and neuropathy in patients with IDDM.
背景：长期微血管和神经并发症会导致胰岛素依赖型糖尿病（IDDM）患者出现严重的发病和死亡情况。我们研究了以维持血糖浓度接近正常范围为目标的强化治疗是否能降低这些并发症的发生频率和严重程度。 方法：总共1441例IDDM患者——726例基线时无视网膜病变（初级预防队列）和715例有轻度视网膜病变（二级干预队列）被随机分配接受强化治疗，通过外部胰岛素泵或每日三次或更多次胰岛素注射，并以频繁血糖监测为指导，或接受每日一到两次胰岛素注射的常规治疗。患者平均随访6.5年，并定期评估视网膜病变和其他并发症的出现及进展情况。 结果：在初级预防队列中，与常规治疗相比，强化治疗使视网膜病变发生的校正平均风险降低了76%（95%置信区间，62%至85%）。在二级干预队列中，强化治疗使视网膜病变的进展减缓了54%（95%置信区间，39%至66%），并使增殖性或严重非增殖性视网膜病变的发生减少了47%（置信区间，14%至67%）。在两个队列合并后，强化治疗使微量白蛋白尿（尿白蛋白排泄量≥40mg/24小时）的发生率降低了39%（95%置信区间区间，21%至52%），白蛋白尿（尿白蛋白排泄量≥300mg/24小时）的发生率降低了54%（95%置信区间，19%至74%），临床神经病变的发生率降低了60%（95%置信区间，38%至74%）。与强化治疗相关的主要不良事件是严重低血糖症增加了两到三倍。 结论：强化治疗有效地延迟了IDDM患者糖尿病视网膜病变、肾病和神经病变的发病并减缓了其进展。
Online J Curr Clin Trials. 1993-5-21
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