Reljanovic M, Reichel G, Rett K, Lobisch M, Schuette K, Möller W, Tritschler H J, Mehnert H
University of Clinic for Diabetes, Endocrinology and Metabolic Diseases Vuk Vrhovac, Medical faculty, University of Zagreb, Coratia.
Free Radic Res. 1999 Sep;31(3):171-9. doi: 10.1080/10715769900300721.
Short-term trials with the antioxidant thioctic acid (TA) appear to improve neuropathic symptoms in diabetic patients, but the long-term response remains to be established. Therefore, Type 1 and Type 2 diabetic patients with symptomatic polyneuropathy were randomly assigned to three treatment regimens: (1) 2 x 600(mg of TA (TA 1200), (2) 600)mg of TA plus placebo (PLA) (TA 600) or (3) placebo and placebo (PLA). A trometamol salt solution of TA of 1200 or 600 mg or PLA was intravenously administered once daily for five consecutive days before enrolling the patients in the oral treatment phase. The study was prospective, PLA-controlled, randomized, double-blind and conducted for two years. Severity of diabetic neuropathy was assessed by the Neuropathy Disability Score (NDS) and electrophysiological attributes of the sural (sensory nerve conduction velocity (SNCV), sensory nerve action potential (SNAP)) and the tibial (motor nerve conduction velocity (MNCV), motor nerve distal latency (MNDL)) nerve. Statistical analysis was performed after independent reviewers excluded all patients with highly variable data allowing a final analysis of 65 patients (TA 1200: n = 18, TA 600: n = 27; PLA: n = 20). At baseline no significant differences were noted between the groups regarding the demographic variables and peripheral nerve function parameters for these 65 patients. Statistically significant changes after 24 months between TA and PLA were observed (mean +/- SD) for sural SNCV: +3.8 +/- 4.2 m/s in TA 1200, +3.0+/-3.0m/s in TA 600, -0.1+/-4.8m/s in PLA (p < 0.05 for TA 1200 and TA 600 vs. PLA); sural SNAP: +0.6+/-2.5 microV in TA 1200, +0.3+/-1.4 microV in TA 600, -0.7 +/- 1.5 microV in PLA (p = 0.076 for TA 1200 vs. PLA and p < 0.05 for TA 600 vs. PLA), and in tibial MNCV: +/- 1.2 +/- 3.8 m/s in TA 1200, -0.3 +/- 5.2 m/s in TA 600, 1.5 +/- 2.9 m/s in PLA (p < 0.05 for TA 1200 vs. PLA). No significant differences between the groups after 24 months were noted regarding the tibial MNDL and the NDS. We conclude that in a subgroup of patients after exclusion of patients with excessive test variability throughout the trial, TA appeared to have a beneficial effect on several attributes of nerve conduction.
抗氧化剂硫辛酸（TA）的短期试验似乎能改善糖尿病患者的神经病变症状，但长期疗效仍有待确定。因此，将有症状性多发性神经病变的1型和2型糖尿病患者随机分为三种治疗方案：（1）2×600毫克TA（TA 1200），（2）600毫克TA加安慰剂（PLA）（TA 600），或（3）安慰剂加安慰剂（PLA）。在患者进入口服治疗阶段之前，连续五天每天静脉注射一次1200毫克或600毫克的TA的氨丁三醇盐溶液或PLA。该研究是前瞻性、PLA对照、随机、双盲的，持续了两年。通过神经病变残疾评分（NDS）以及腓肠神经（感觉神经传导速度（SNCV）、感觉神经动作电位（SNAP））和胫神经（运动神经传导速度（MNCV）、运动神经远端潜伏期（MNDL））的电生理特性来评估糖尿病神经病变的严重程度。在独立评审员排除所有数据高度可变的患者后进行统计分析，最终纳入65例患者进行分析（TA 1200组：n = 18，TA 600组：n = 27；PLA组：n = 20）。在基线时，这65例患者的人口统计学变量和周围神经功能参数在各组之间未观察到显著差异。24个月后，TA组和PLA组之间观察到统计学上的显著变化（均值±标准差），腓肠神经SNCV：TA 1200组为+3.8±4.2米/秒，TA 600组为+3.0±3.0米/秒，PLA组为-0.1±4.8米/秒（TA 1200组和TA 600组与PLA组相比，p < 0.05）；腓肠神经SNAP：TA 1200组为+0.6±2.5微伏，TA 600组为+0.3±1.4微伏，PLA组为-0.7±1.5微伏（TA 1200组与PLA组相比，p = 0.076，TA 600组与PLA组相比，p < 0.05），胫神经MNCV：TA 1200组为+1.2±3.8米/秒，TA 600组为-0.3±5.2米/秒，PLA组为1.5±2.9米/秒（TA 1200组与PLA组相比，p < 0.05）。24个月后，各组在胫神经MNDL和NDS方面未观察到显著差异。我们得出结论，在排除整个试验中测试变异性过大的患者后的一个亚组患者中，TA似乎对神经传导的几个特性有有益作用。
