目的探讨α-硫辛酸联合甲钻胺治疗糖尿病周围神经病变(DPN)的临床疗效及安全性。方法选择DPN患者64例,采取分层随机、开放、对照的研究方法将患者分为试验组32例、对照组32例。患者常规给予饮食控制、胰岛素或口服降糖药将血糖控制在良好范围,维持原降压、调脂等综合治疗,对照组同时给予甲钴胺0.5mg、每日3次口服,试验组同时给予α一硫辛酸600mg、每Et1次联合甲钴胺0.5mg、每Et3次口服,疗程均为12周。分别在治疗前后记录两组患者的总症状评分(TSS)和神经传导速度(NCV),并观察有无药物不良反应。结果治疗后两组患者TSS评分和NCV均较治疗前有改善(P〈0.05)。治疗后试验组的TSS评分低于对照组(P〈0.05),治疗后试验组的正中神经运动传导速度、腓总神经运动和感觉传导速度与对照组比较差异有统计学意义(P〈0.05)。治疗过程中两组均未见明显的药物不良反应。结论α-硫辛酸联合甲钴胺口服治疗DPN疗效优于单用甲钴胺,而且安全简便,依从性好,值得推广。
Objective To observe the clinical efficacy and safety of oral a-lipoic acid combined with methylcobalamin in treatment of diabetic peripheral neuropathy (DPN). Methods Sixty-four DPN patients were selected and randomly divided into experimental group (n= 32) and control group (n= 32). All the patients were given diet control, insulin or oral hypoglycaemic agent and the blood glucose was satisfactorily controlled; the original antihypertensive and antilipemic therapies were maintained. Meanwhile, patients in the control group were also given oral methylcobalamin (three times per day and each for 0.5 mg), and those in the experimental group were given oral a-lipoic acid (once a day and each for 600 mg) and oral methylcobalamin (three times per day and each for 0. 5 mg) . The total symptom scores (TSS) and the nerve conduction velocity (NCV) were evaluated in the two groups before and 12 weeks after treatment; and the adverse drug reactions were also observed. Results The TSS and NCV were significantly improved in both groups after treatment compared with before treatment (P〈0. 05). After treatment, TSS was significantly lower in the experimental group than in the control group (P〈0.05), and there were significant differences in the transmission velocities of the median motor nerve, nervus peroneus communis motor nerve and its sensory nerve between two groups (P〈0.05). No serious side effects were found in the two groups during the treatment. Conclusion Oral a-lipoic acid combined with methylcobalamin on DPN is superior to methylcobalamin used alone for treatment of DPN, and the combined treatment is simple and has better patient compliance, making it worth popularizing.