Fagius J, Brattberg A, Jameson S, Berne C
Diabetologia. 1985 Jun;28(6):323-9. doi: 10.1007/BF00283137.
The effects of the aldose reductase inhibitor, sorbinil, on symptomatic symmetrical diabetic polyneuropathy were studied during a 6-month period in a double-blind parallel group placebo-controlled trial. Twenty-seven patients received sorbinil and 28 placebo. The patients were assessed by clinical examination, neurophysiological measurements, sensory threshold determinations and tests of autonomic nerve function. No major clinical benefit was seen in the sorbinil-treated patients and no differences in sensory thresholds were observed. In three out of nine neurophysiological tests (motor nerve conduction velocity of the posterior tibial nerve, F-wave latency and sensory distal latency of the ulnar nerve) and one out of five tests of autonomic nerve function (heart rate variation during deep breathing) significant differences between the patient groups evolved in favour of sorbinil treatment. An overall evaluation of the temporal development of these and remaining neurophysiological and autonomic variables suggested a small but significant benefit from sorbinil treatment. There was no evidence of continuing improvement throughout the treatment period and beneficial effects observed were no greater than those seen in previous trials of considerably shorter treatment periods. It is concluded that sorbinil treatment results in some improvement in peripheral nerve function in symptomatic diabetic polyneuropathy, but that the long-term effect may be of limited value.
在一项为期6个月的双盲平行组安慰剂对照试验中,研究了醛糖还原酶抑制剂索比尼尔对有症状的对称性糖尿病多发性神经病变的影响。27例患者接受索比尼尔治疗,28例接受安慰剂治疗。通过临床检查、神经生理学测量、感觉阈值测定和自主神经功能测试对患者进行评估。接受索比尼尔治疗的患者未观察到明显的临床益处,感觉阈值也未观察到差异。在9项神经生理学测试中的3项(胫后神经运动神经传导速度、F波潜伏期和尺神经感觉远端潜伏期)以及5项自主神经功能测试中的1项(深呼吸时心率变化)中,患者组之间出现了有利于索比尼尔治疗的显著差异。对这些以及其余神经生理学和自主神经变量的时间发展进行的总体评估表明,索比尼尔治疗有微小但显著的益处。在整个治疗期间没有持续改善的证据,观察到的有益效果并不比之前治疗期短得多的试验中看到的效果更大。结论是,索比尼尔治疗可使有症状的糖尿病多发性神经病变的周围神经功能有所改善,但长期效果可能有限。