Giugliano D, Acampora R, Marfella R, Di Maro G, De Rosa N, Misso L, Ceriello A, Quatraro A, D'Onofrio F
Department of Gerontology and Metabolic Diseases, Second University of Naples, Italy.
Diabetes Care. 1995 Apr;18(4):536-41. doi: 10.2337/diacare.18.4.536.
To compare the effects of tolrestat and placebo in patients with subclinical diabetic neuropathy.
Non-insulin-dependent diabetes mellitus (NIDDM) patients with early involvement of the autonomic nervous system were identified by only one pathological (outside the 99% confidence interval of the normal population) squatting test (vagal or sympathetic). Fifty-seven patients entered a randomized, placebo-controlled, double-blind, parallel 52-week study of tolrestat at a dose of 200 mg/day. Cardiovascular reflex tests (squatting vagal and sympathetic tests, pressure gain, deep breathing, lying-to-standing, Valsalva maneuver, and orthostatic hypertension), vibration thresholds, tendon reflexes, and muscle strength were assessed throughout the study.
At 12 months, nerve function significantly improved in patients receiving tolrestat and deteriorated in patients taking placebo. At baseline, the squatting vagal test was normal in 16 patients in the tolrestat group and in 15 patients in the placebo group. At 12 months, 25 patients taking tolrestat had a normalized squatting test, but only 6 patients taking placebo did (P = 0.02). Vibration perception threshold improved by a value of 6 +/- 3 V in the tolrestat group (P < 0.001) and deteriorated by a value of 3 +/- 1.8 V (P < 0.001) in the placebo group.
Tolrestat may be useful in the primary prevention of diabetic neuropathy.
比较托瑞司他与安慰剂对亚临床糖尿病神经病变患者的疗效。
通过仅一项病理性（超出正常人群99%置信区间）蹲踞试验（迷走神经或交感神经）识别出自主神经系统早期受累的非胰岛素依赖型糖尿病（NIDDM）患者。57名患者进入一项随机、安慰剂对照、双盲、平行的为期52周的研究，服用剂量为每日200毫克的托瑞司他。在整个研究过程中评估心血管反射试验（蹲踞迷走神经和交感神经试验、压力增益、深呼吸、卧立位、瓦尔萨尔瓦动作和直立性高血压）、振动阈值、腱反射和肌肉力量。
12个月时，接受托瑞司他治疗的患者神经功能显著改善，而服用安慰剂的患者神经功能恶化。基线时，托瑞司他组16名患者和安慰剂组15名患者的蹲踞迷走神经试验正常。12个月时，25名服用托瑞司他的患者蹲踞试验恢复正常，而服用安慰剂的患者只有6名恢复正常（P = 0.02）。托瑞司他组振动感觉阈值改善了6±3伏（P < 0.001），安慰剂组恶化了3±1.8伏（P < 0.001）。
托瑞司他可能对糖尿病神经病变的一级预防有用。
