Oral treatment with α-lipoic acid improves symptomatic diabetic polyneuropathy -: The SYDNEY 2 trial
Oral treatment with α-lipoic acid improves symptomatic diabetic polyneuropathy -: The SYDNEY 2 trial
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DOI：
10.2337/dc06-1216
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发表时间：
2006-11-01
期刊：
影响因子：
16.2
通讯作者：
Samigullin, Rustem
中科院分区：
文献类型：
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作者：
Ziegler, Dan;Ametov, Alexander;Samigullin, Rustem
目的-本试验的目的是评估α-硫辛酸（ALA）对患有远端对称性多发性神经病（DSP）的糖尿病患者的阳性感觉症状和神经病变缺陷的影响。研究设计和方法-在这项多中心、随机、双盲、安慰剂对照试验中，俄罗斯和以色列的181例糖尿病患者接受每日一次口服剂量600 mg（n = 45）（ALA 600）、1，200 mg（n = 47）（ALA 1200）和1，在1周安慰剂导入期后，给予800 mg（ALA 1800）ALA（n = 46）或安慰剂（n = 43）5周。主要结果测量是总症状评分（TSS）较基线的变化，包括刺痛、烧灼痛、感觉异常和足部睡眠麻木。次要终点包括TSS的个体症状、神经病症状和变化（NSC）评分、神经病损伤评分（NIS）和患者的总体疗效评估。结果-治疗组之间的平均TSS在基线时没有显著差异，ALA 600平均降低4.9分（51%），ALA 1200平均降低4.5分（48%），ALA 1800组为4.7分（52%），安慰剂组为2.9分（32%）（均P < 0.05）。相应的缓解率（TSS降低>= 50%）分别为62%、50%、56%和26%。所有三个ALA组在刺痛和烧灼痛、NSC评分和患者总体疗效评估方面也有显著改善。新谢克尔在数字上有所减少。安全性分析表明，剂量依赖性增加恶心，呕吐，和vertigross.CONCLUSIONS -口服ALA治疗5周改善DSP患者的神经病变症状和缺陷。600 mg每日一次口服剂量似乎提供了最佳的风险-获益比。
OBJECTIVE - The aim of this trial was to evaluate the effects of alpha-lipoic acid (ALA) on positive sensory symptoms and neuropathic deficits in diabetic patients with distal symmetric polyneuropathy (DSP).RESEARCH DESIGN AND METHODS - In this multicenter, randomized, double-blind, placebo-controlled trial, 181 diabetic patients in Russia and Israel received once-daily oral doses of 600 mg (n = 45) (ALA600), 1,200 mg (n = 47) (ALA1200), and 1,800 mg (ALA1800) of ALA (n = 46) or placebo (n = 43) for 5 weeks after a 1-week placebo run-in period. The primary outcome measure was the change from baseline of the Total Symptom Score (TSS), including stabbing pain, burning pain, paresthesia, and asleep numbness of the feet. Secondary end points included individual symptoms of TSS, Neuropathy Symptoms and Change (NSC) score, Neuropathy Impairment Score (NIS), and patients' global assessment of efficacy.RESULTS - Mean TSS did not differ significantly at baseline among the treatment groups and on average decreased by 4.9 points (51%) in ALA600, 4.5 (48%) in ALA1200, and 4.7 (52%) ALA1800 compared with 2.9 points (32%) in the placebo group (all P < 0.05 vs. placebo). The corresponding response rates (>= 50% reduction in TSS) were 62, 50, 56, and 26%, respectively. Significant improvements favoring all three ALA groups were also noted for stabbing and burning pain, the NSC score, and the patients' global assessment of efficacy. The NIS was numerically reduced. Safety analysis showed a dose-dependent increase in nausea, vomiting, and vertigo.CONCLUSIONS - Oral treatment with ALA for 5 weeks improved neuropathic symptoms and deficits in patients with DSP. An oral dose of 600 mg once daily appears to provide the optimum risk-to-benefit ratio.