Feldt-Rasmussen B, Mathiesen E R, Deckert T
Lancet. 1986 Dec 6;2(8519):1300-4. doi: 10.1016/s0140-6736(86)91433-9.
36 patients with insulin-dependent diabetes mellitus who had 'Albustix'-negative urine but raised urinary albumin excretion (30 to 300 mg/24 h) were randomly assigned to either remaining on conventional insulin treatment or continuous subcutaneous insulin infusion and followed up for 2 years. The insulin-infusion group showed a significant, sustained improvement in metabolic control, with a median glycosylated haemoglobin of 7.2% (range 5.9-8.8), but there was no change in the conventional-treatment group (median 8.6%, range 7.2-13.4) (p less than 0.001). Clinical diabetic nephropathy (a urinary albumin excretion rate above 300 mg/24 h in at least two of three 24 h urine collections) developed in 5 patients in the conventional-treatment group, but not in the insulin-infusion group (p less than 0.05, two-tailed). Fractional albumin clearance (mean and range X 10(7] increased in the conventional-treatment group from 160 (35-468) to 360 (29-1580) and was unchanged in the insulin-infusion group (170 [31-608] before to 160 [26-460] after) (p less than 0.05). Insulin infusion had an overall beneficial effect on the annual increase in urinary albumin excretion (p less than 0.05), and the mean glycosylated haemoglobin values correlated positively with annual change in albumin excretion (r = 0.57, p less than 0.0001). The diastolic blood pressure rose significantly in the conventional-treatment group (p less than 0.001), and annual change in mean blood pressure correlated with change in urinary albumin excretion (r = 0.49, p less than 0.001).
36例胰岛素依赖型糖尿病患者，尿“Albustix”检测为阴性，但尿白蛋白排泄量升高（30至300毫克/24小时），被随机分为继续接受传统胰岛素治疗组或持续皮下胰岛素输注组，并随访2年。胰岛素输注组在代谢控制方面有显著且持续的改善，糖化血红蛋白中位数为7.2%（范围5.9 - 8.8），而传统治疗组无变化（中位数8.6%，范围7.2 - 13.4）（p小于0.001）。传统治疗组有5例患者发生临床糖尿病肾病（在三次24小时尿液收集样本中至少有两次尿白蛋白排泄率高于300毫克/24小时），而胰岛素输注组未发生（p小于0.05，双侧）。传统治疗组的白蛋白清除率分数（均值及范围×10⁷）从160（35 - 468）增至360（29 - 1580），胰岛素输注组则无变化（之前为170 [31 - 608]，之后为160 [26 - 460]）（p小于0.05）。胰岛素输注对尿白蛋白排泄的年增加量有总体有益影响（p小于0.05），且糖化血红蛋白均值与白蛋白排泄的年变化呈正相关（r = 0.57，p小于0.0001）。传统治疗组的舒张压显著升高（p小于0.001），平均血压的年变化与尿白蛋白排泄的变化相关（r = 0.49，p小于0.001）。
