硫辛酸与当归四逆汤加减方治疗糖尿病周围神经病变的临床观察

Clinical Observation of Lipoic Acid and Dangguisini Decoction on the Treatment With Diabetic Peripheral Neuropathy

目的评价硫辛酸和当归四逆汤加减方治疗糖尿病周围神经病变的临床疗效及安全性。方法 112例2型糖尿病周围神经病变患者随机分成两组,当归四逆汤加减方组57例,硫辛酸组55例;分别给予当归四逆汤加减方和硫辛酸胶囊治疗12周。比较两组治疗前、后多伦多评分(TCSS)、临床症状积分、中医证候评分及血糖、血压、肝肾功等相关指标的变化。结果 107例患者完成了12周的临床研究,脱失率为4.46%。药物干预12周后,TCSS总有效率比较,当归四逆汤加减方组68.52%,硫辛酸组71.70%,(P>0.05);中医证候积分总有效率比较,当归四逆汤加减方组92.6%,硫辛酸组86.6%,(P>0.05)。治疗后两组中医证候积分均有下降,当归四逆汤加减方组改善优于硫辛酸组(P<0.05)。针对手足畏寒、头晕目眩、心悸等症状的改善,当归四逆汤加减方的疗效优于硫辛酸(P<0.05)。两组治疗中未观察到不良反应。结论硫辛酸和当归四逆汤加减方均能有效改善糖尿病周围神经病变的症状;当归四逆汤加减方对患者手足畏寒、头晕及心悸症状改善效果更明显。

Objective To evaluated the clinical effects of lipoic acid and dangguisini decoction on diabetic peripheral neuropathy. Methods 112 diabetic peripheral neuropathy patients were randomly assigned into the lipoic acid group（55 patients）and the dangguisini decoction group（57 patients）,given the lipoic acid and dangguisini decoction respectively for 12 weeks. The toronto score（TCSS）,clinical symptom score,TCM syndrome score and blood glucose,blood pressure,liver and renal function and other related indicators were observed before and after the treatment. Results 107 patients completed the clinical test with a expulsion rate of 4.46%. After 12 weeks of treatment,the total effective rate on TCSS of dangguisini decoction group was 68.52%,and 71.70% in lipoic acid group（P〉0.05）,the total effective rate on TCM syndrome score of dangguisini decoction group was 92.6%,which was similar to that of 86.6% in lipoic acid group（P〉0.05）. After 12-weeks,TCM syndrome grades both been dropped,dangguisini decoction has more effective than the lipoic acid（P〈0.05）. The improvement of the symptoms of chilly extremity,dizzy,and palpitations were better in dangguisini decoction group than lipoic acid group（P〈0.05）. Adverse reactions were not observed in the two groups. Conclusion Lipoic acid and dangguisini decoction were both effective in the treatment of diabetic peripheral neuropathy. The improvement of the symptoms of chilly extremity,dizzy,and palpitations were better in dangguisini decoction group.