Ziegler D, Gries F A
Diabetes Research Institute at the Heinrich Heine University, Düsseldorf, Germany.
Diabetes. 1997 Sep;46 Suppl 2:S62-6. doi: 10.2337/diab.46.2.s62.
Antioxidant treatment has been shown to prevent nerve dysfunction in experimental diabetes, providing a rationale for a potential therapeutic value in diabetic patients. The effects of the antioxidant alpha-lipoic acid (thioctic acid) were studied in two multicenter, randomized, double-blind placebo-controlled trials. In the Alpha-Lipoic Acid in Diabetic Neuropathy Study, 328 patients with NIDDM and symptomatic peripheral neuropathy were randomly assigned to treatment with intravenous infusion of alpha-lipoic acid using three doses (ALA 1,200 mg; 600 mg; 100 mg) or placebo (PLAC) over 3 weeks. The total symptom score (TSS) (pain, burning, paresthesia, and numbness) in the feet decreased significantly from baseline to day 19 in ALA 1,200 and ALA 600 vs. PLAC. Each of the four individual symptom scores was significantly lower in ALA 600 than in PLAC after 19 days (all P < 0.05). The total scale of the Hamburg Pain Adjective List (HPAL) was significantly reduced in ALA 1,200 and ALA 600 compared with PLAC after 19 days (both P < 0.05). In the Deutsche Kardiale Autonome Neuropathie Studie, patients with NIDDM and cardiac autonomic neuropathy diagnosed by reduced heart rate variability were randomly assigned to treatment with a daily oral dose of 800 mg alpha-lipoic acid (ALA) (n = 39) or placebo (n = 34) for 4 months. Two out of four parameters of heart rate variability at rest were significantly improved in ALA compared with placebo. A trend toward a favorable effect of ALA was noted for the remaining two indexes. In both studies, no significant adverse events were observed. In conclusion, intravenous treatment with alpha-lipoic acid (600 mg/day) over 3 weeks is safe and effective in reducing symptoms of diabetic peripheral neuropathy, and oral treatment with 800 mg/day for 4 months may improve cardiac autonomic dysfunction in NIDDM.
抗氧化治疗已被证明可预防实验性糖尿病中的神经功能障碍，这为其在糖尿病患者中的潜在治疗价值提供了理论依据。在两项多中心、随机、双盲、安慰剂对照试验中研究了抗氧化剂α-硫辛酸（硫辛酸）的作用。在糖尿病神经病变α-硫辛酸研究中，328例非胰岛素依赖型糖尿病（NIDDM）且有症状性周围神经病变的患者被随机分配，在3周内接受静脉输注三种剂量（1200毫克α-硫辛酸；600毫克；100毫克）的α-硫辛酸或安慰剂（PLAC）治疗。与安慰剂相比，1200毫克α-硫辛酸组和600毫克α-硫辛酸组从基线至第19天足部的总症状评分（TSS）（疼痛、烧灼感、感觉异常和麻木）显著降低。19天后，600毫克α-硫辛酸组的四个单项症状评分均显著低于安慰剂组（所有P<0.05）。19天后，与安慰剂相比，1200毫克α-硫辛酸组和600毫克α-硫辛酸组的汉堡疼痛形容词列表（HPAL）总分显著降低（均P<约0.05）。在德国心脏自主神经病变研究中，通过心率变异性降低诊断为NIDDM和心脏自主神经病变的患者被随机分配，每日口服800毫克α-硫辛酸（ALA）（n = 39）或安慰剂（n = 34），持续4个月。与安慰剂相比，ALA组静息时心率变异性的四个参数中有两个显著改善。其余两个指标也显示出ALA有良好作用的趋势。在两项研究中，均未观察到显著不良事件。总之，静脉输注α-硫辛酸（600毫克/天）3周对减轻糖尿病周围神经病变症状是安全有效的，而每日口服800毫克持续4个月可能改善NIDDM患者的心脏自主神经功能障碍。
