Gu Xue-ming, Zhang Shan-shan, Wu Jing-cheng, Tang Zheng-yi, Lu Zhi-qiang, Li Hui, Liu Chao, Chen Li, Ning Guang
Ruijin Hospital, Jiaotong University School of Medicine, Yuanyang Subdivision, Shanghai 200025, China.
Zhonghua Yi Xue Za Zhi. 2010 Sep 21;90(35):2473-6.
To evaluate the efficacy and safety of high-dose α-lipoic acid in the treatment of diabetic polyneuropathy with regards to sensory symptoms and nerve conduction velocity.
A total of 236 diabetics with symptomatic polyneuropathy were enrolled into this 5-center, randomized, double-blind and placebo-controlled study of α-lipoic acid 1800 mg daily (n = 117) or matching placebo (n = 119) for 12 weeks. The primary outcome was total symptom score (TSS). Secondary end points included nerve conduction velocity, individual symptom score, HbA1c and safety parameters. The above parameters were reviewed and recorded at zero point and after treatment for 2, 4, 8, 12 weeks separately.
73.27% patients with symptomatic polyneuropathy improved after treatment with α-lipoic acid for 12 weeks versus 18.27% with placebo. TSS declined by 2.6 ± 2.3 with α-lipoic acid. And it was more than 0.7 ± 1.4 versus placebo (P < 0.05). TSS decreased quickly after treatment with α-lipoic acid for 2 weeks (P < 0.05). And it was better than placebo. Individual symptom scores of pain, extremity numbness, burning sensation or resting abnormal sensations were significantly diminished as compared to those before treatment and placebo group (all P < 0.05). Nerve conduction velocity had no change. HbA1c further decreased at the end of trial after α-lipoic acid treatment (P < 0.05). The incidence rates of adverse effects were 25.4% vs 11.8% in the treatment and control groups. The major manifestation was burning sensation from throat to stomach (12.7%).
Oral treatment with high-dose α-lipoic acid for 12 weeks may improve symptoms in patients with diabetic polyneuropathy. Dose of 600 mg thrice daily for 2 weeks has marked effects with a reasonable safety.
评估大剂量α-硫辛酸治疗糖尿病性多发性神经病的疗效及安全性，观察其对感觉症状和神经传导速度的影响。
本研究为5中心、随机、双盲、安慰剂对照试验，共纳入236例有症状的糖尿病性多发性神经病患者，随机分为α-硫辛酸组（1800 mg/d，n = 117）和安慰剂组（n = 119），疗程12周。主要观察指标为总症状评分（TSS）。次要终点包括神经传导速度、单项症状评分、糖化血红蛋白（HbA1c）及安全性指标。分别于治疗0、2、4、8、12周时观察并记录上述指标。
α-硫辛酸治疗12周后，73.27%有症状的糖尿病性多发性神经病患者症状改善，而安慰剂组为18.27%。α-硫辛酸组TSS下降2.6±2.3，较安慰剂组多0.7±1.4（P<0.05）。α-硫辛酸治疗2周后TSS即迅速下降（P<0.05），且优于安慰剂组。与治疗前及安慰剂组相比，疼痛、肢体麻木、烧灼感或静息时异常感觉等单项症状评分均显著降低（均P<0.05）。神经传导速度无变化。α-硫辛酸治疗后试验结束时HbA1c进一步下降（P<0.05）。治疗组和对照组不良反应发生率分别为25.4%和11.8%。主要表现为咽喉至胃部烧灼感（12.7%）。
口服大剂量α-硫辛酸12周可改善糖尿病性多发性神经病患者症状。每日3次、每次600 mg、共2周的剂量疗效显著且安全性良好。
