BLOOD-GLUCOSE CONTROL AND THE EVOLUTION OF DIABETIC-RETINOPATHY AND ALBUMINURIA - A PRELIMINARY MULTICENTER TRIAL
BLOOD-GLUCOSE CONTROL AND THE EVOLUTION OF DIABETIC-RETINOPATHY AND ALBUMINURIA - A PRELIMINARY MULTICENTER TRIAL
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DOI：
10.1056/nejm198408093110604
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发表时间：
1984-01-01
影响因子：
158.5
通讯作者：
SHERWIN, RS
中科院分区：
文献类型：
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作者：
SHERWIN, RS
我们进行了一项前瞻性多中心随机试验，以确定维持血糖控制在不同水平的可行性，以及改善控制对糖尿病微血管病变和蛋白尿的影响。70例伴有非增殖性视网膜病变的糖尿病患者（低c肽水平）被随机分配到持续皮下胰岛素输注组或不变的常规注射组。在入组时，两组具有相似的人口统计学、临床和血糖特征。在随后的8个月里，在常规治疗期间，平均24小时葡萄糖浓度（175±9毫克/分升）和糖化血红蛋白水平（10.0±0.3%）保持升高，但在持续胰岛素输注后降至接近正常水平（分别为117±6毫克/分升和8.1±0.2%）。两组生化低血糖（<40 mg /分升血糖）发生频率相似，但酮症酸中毒仅在持续输注时发生。两组视网膜病变程度均有进展。持续输注与稍重的恶化相关，主要是由于软渗出物的出现和视网膜内微血管异常。相比之下，白蛋白排泄率升高在持续输注期间下降，而在常规治疗期间没有下降。我们的结论是，在多中心试验中，维持不同的血糖水平是可行的，接近正常的血糖水平维持8个月不会延缓已建立的视网膜病变的进展，而且最初可能会恶化。这些初步观察结果表明，需要进行更长时间的试验（特别是初级预防试验）。（中华医学杂志1984；31:365 - 372）
We conducted a prospective multicenter randomized trial to determine both the feasibility of maintaining blood glucose control at differing levels and the effect of improved control on diabetic microangiopathy and albuminuria. Seventy patients with diabetes (low C-peptide level) with nonproliferative retinopathy were randomly assigned to continuous subcutaneous insulin infusion or unchanged conventional injection treatment. At entry, both groups had similar demographic, clinical, and glycemic characteristics. Over the succeeding eight months, mean 24-hour glucose concentrations (175±9 mg per deciliter) and glycosylated hemoglobin levels (10.0±0.3 per cent) remained elevated during conventional treatment but fell to nearly normal levels (117±6 mg per deciliter and 8.1±0.2 per cent, respectively) with continuous insulin infusion. The frequency of biochemical hypoglycemia (<40 mg of blood glucose per deciliter) was similar in both groups, but ketoacidosis occurred only during continuous infusion. The level of retinopathy, assessed from photographs, progressed in both groups. Continuous infusion was associated with slightly more deterioration, mainly because of the appearance of soft exudates and intraretinal microvascular abnormalities. In contrast, elevated albumin-excretion rates fell during continuous infusion but not during conventional treatment. We conclude that maintenance of differing levels of blood glucose is feasible in a multicenter trial and that a nearly normal blood glucose level for eight months does not retard progression of, and may initially worsen, established retinopathy. These preliminary observations indicate the need for longer trials (particularly of primary prevention). (N Engl J Med 1984; 311:365–72.)