α-硫辛酸治疗糖尿病自主神经病变（对照、随机、开放标签研究）

Alpha-lipoic acid in the treatment of autonomic diabetic neuropathy (controlled, randomized, open-label study).

作者信息

Tankova Tsvetalina, Koev D, Dakovska L

机构信息

Department of Diabetology, Clinical Center of Endocrinology, Medical University, Sofia, Bulgaria.

出版信息

Rom J Intern Med. 2004;42(2):457-64.

PMID:15529636

Abstract

AIM

to evaluate the effect of alpha-lipoic acid in autonomic diabetic neuropathy in a controlled, randomized, open-label study.

MATERIAL AND METHODS

46 patients with type 1 diabetes and different forms of autonomic neuropathy, of mean age 38.1 +/- 12.5 years and mean duration of diabetes 16.8 +/- 8.9 years were treated with alpha-lipoic acid for 10 days 600mg daily iv, thereafter one film tablet of 600mg daily for 50 days. 29 type 1 diabetic patients with autonomic diabetic neuropathy, of mean age 40.2 +/- 9.3 years and mean duration of diabetes 15.4 +/- 7.9 years served as a control group. We have followed-up patients' complaints, Ewing's tests, laboratory parameters of oxidative stress.

RESULTS

There was a significant improvement after treatment in the score for severity of cardiovascular autonomic neuropathy--from 6.43 +/- 0.9 to 4.24 +/- 1.8 (p<0.001), while in the control group it worsened from 6.18 +/- 1.3 to 6.52 +/- 0.9 (p>0.1). We found improvement in the Valsalva manoeuvre after treatment - from 1.05 +/- 0.04 to 1.13 +/- 0.08 (p<0.001); in the deep-breathing test -from 3.4 +/- 2.8 to 10.4 +/- 5.7 (p<0.001); and in the lying-to-standing test--from 0.99 +/- 0.01 to 1.01 +/- 0.02 (p>0.1), while in the control group there was no improvement. There was a beneficial effect of treatment on the change of systolic blood pressure at the lying-to-standing test--from 22.7 +/- 11.5 to 9.8 +/- 7.9 (p<0.001), while in the control group the change was 20.5 +/- 11.1 mmHg and 19.7 +/- 12.9 mmHg (p>0.1), respectively. We found improvement in diabetic enteropathy in six patients; in the complaints of dizziness, instability upon standing in six patients; in neuropathic edema of the lower extremities in four patients and in erectile dysfunction in four patients after treatment, while in the control group no change was reported in the symptoms and signs of autonomic neuropathy by the end of the follow-up period. There were changes in the laboratory parameters of oxidative stress after therapy--total serum antioxidant capacity increased from 20.42 +/- 1.8 to 22.96 +/- 2.3 microgH2O2/ml/min (p<0.05), serum SOD activity - from 269.8 +/- 31.1 to 319.8 +/- 29.IU/l (p=0.02) and erythrocyte SOD--from 0.89 +/- 0.10 to 1.11 +/- 0.09 U/gHb (p=0.04).

CONCLUSION

Our results demonstrate that alpha-lipoic acid (Thiogamma) appears to be an effective drug in the treatment of the different forms of autonomic diabetic neuropathy.

摘要

目的

在一项对照、随机、开放标签研究中评估α-硫辛酸对糖尿病自主神经病变的疗效。

材料与方法

46例1型糖尿病合并不同形式自主神经病变的患者，平均年龄38.1±12.5岁，糖尿病平均病程16.8±8.9年，接受α-硫辛酸治疗，静脉注射每日600mg，共10天，之后口服600mg薄膜片，每日1次，共50天。29例1型糖尿病合并自主神经病变的患者作为对照组，平均年龄40.2±9.3岁，糖尿病平均病程15.4±7.9年。我们随访了患者的主诉、尤因氏试验以及氧化应激的实验室参数。

结果

治疗后心血管自主神经病变严重程度评分有显著改善，从6.43±0.9降至4.24±1.8（p<0.001），而对照组则从6.18±1.3恶化至6.52±0.9（p>0.1）。我们发现治疗后瓦尔萨尔瓦动作有改善，从1.05±0.04升至1.13±0.08（p<0.001）；深呼吸试验从3.4±2.8升至10.4±5.7（p<0.001）；卧立位试验从0.99±0.01升至1.01±0.02（p>0.1），而对照组无改善。治疗对卧立位试验时收缩压的变化有有益影响，从22.7±11.5降至9.8±7.9（p<0.001），而对照组的变化分别为20.5±11.1mmHg和19.7±12.9mmHg（p>0.1）。我们发现治疗后6例患者的糖尿病性肠病有改善；6例患者的头晕、站立不稳主诉有改善；4例患者的下肢神经性水肿有改善；4例患者的勃起功能障碍有改善，而对照组在随访期末自主神经病变的症状和体征无变化。治疗后氧化应激的实验室参数有变化，血清总抗氧化能力从20.42±1.8升至22.96±2.3μgH2O2/ml/min（p<0.05），血清超氧化物歧化酶（SOD）活性从269.8±31.1升至319.8±29.1IU/l（p=0.02），红细胞SOD从0.89±0.10升至1.11±0.09U/gHb（p=0.04）。