Lewin I G, O'Brien I A, Morgan M H, Corrall R J
Diabetologia. 1984 Jun;26(6):445-8. doi: 10.1007/BF00262218.
The effect of sorbinil (200 mg daily for 4 weeks) was examined in 13 patients, mean age 59.7 years (range 42-72 years), with symptomatic diabetic neuropathy of mean duration 6 year (range 1-18 years). In this double-blind, placebo-controlled crossover trial, studies were made of motor, sensory and autonomic nerve function, severity of painful symptoms and duration of sleep. One patient was withdrawn because of an adverse reaction to sorbinil. In the other 12, constant mean values for glycosylated haemoglobin A1 between 11% and 12% indicated stable though not ideal diabetic control throughout the study. Example values for nerve conduction velocity on placebo and active treatment were: 44.3 +/- 5.9 and 44.8 +/- 5.1 metres/s (mean +/- SD) for median motor nerve, 38.4 +/- 8.2 and 37.2 +/- 7.7 metres/s for median sensory nerve. Thus there was no significant effect of sorbinil on conduction velocity in these or any other of the motor and sensory nerves tested. Abnormal autonomic function was not improved by sorbinil. Subjective pain scores on a 10 cm visual analogue scale were 4.2 +/- 2.4 on placebo and 4.3 +/- 2.4 after sorbinil. Duration of sleep on placebo and active treatment was 6.1 +/- 1.6 and 6.2 +/- 1.7 h/night, respectively. We were not able to detect any beneficial effect of sorbinil on painful diabetic neuropathy in our patients.
对13例平均年龄59.7岁(42 - 72岁)、症状性糖尿病神经病变平均病程6年(1 - 18年)的患者,研究了索比尼尔(每日200毫克,共4周)的疗效。在这项双盲、安慰剂对照的交叉试验中,对运动、感觉和自主神经功能、疼痛症状的严重程度及睡眠时间进行了研究。1例患者因对索比尼尔有不良反应而退出。在其他12例患者中,糖化血红蛋白A1的平均恒定值在11%至12%之间,表明在整个研究期间糖尿病控制虽不理想但较为稳定。安慰剂和活性治疗时正中运动神经传导速度的示例值分别为:44.3±5.9和44.8±5.1米/秒(平均值±标准差),正中感觉神经为38.4±8.2和37.2±7.7米/秒。因此,索比尼尔对这些或所测试的任何其他运动和感觉神经的传导速度均无显著影响。索比尼尔未改善异常的自主神经功能。在10厘米视觉模拟量表上,安慰剂组的主观疼痛评分为4.2±2.4,索比尼尔治疗后为4.3±2.4。安慰剂和活性治疗时的睡眠时间分别为6.1±1.6和6.2±1.7小时/晚。我们未能在患者中检测到索比尼尔对疼痛性糖尿病神经病变有任何有益作用。