摘要目的 观察α-硫辛酸注射液联合甲钴胺和前列地尔对2型糖尿病周围神经病变患者的疗效和安全性.方法 2011年1月至2012年12月于我院内分泌科住院治疗的160例DPN患者,将所有病例按就诊先后分为两组,试验组80例和对照组80例.研究中试验组有3例、对照组5例由于自身原因提前出院退出研究.研究实际完成试验组77例、对照组75例.两组均在降糖治疗基础上联合应用甲钴胺500 μg,肌肉注射,隔日1次;前列地尔10μg,静脉注射,1次/d.试验组同时加用α-硫辛酸600 mg,静脉滴注,1次/d.两组治疗均持续10～ 14 d.观察治疗前后症状的改善、神经病变总症状(TSS)评分和神经传导速度的变化、满意度和不良反应.结果 α-硫辛酸静脉滴注10 d后,试验组与对照组相比,TSS总积分[(3.5±2.5)分与(4.3±2.1)分,t=2.11,P＜0.05]、刺痛积分[(1.1±0.4)分与(1.5±0.5)分,t=1.86,P＜0.05]、烧灼感积分[(0.9±0.7)分与(1.3±0.5)分,t=1.83,P＜0.05]、感觉减退积分[(1.3±0.4)分与(1.7±0.5)分,t =1.87,P＜0.05]、麻木积分[(1.3±0.9)分与(1.9±0.4)分,t=1.91,P＜0.05]明显降低;正中神经运动传导速度[(53.6±1.4) m/s与(48.5±2.7) m/s,t=-4.94,P＜0.05]、腓总神经运动传导速度[(49.6±1.1) m/s与(43.9±2.1) m/s,t=-5.36,P＜0.05]、正中神经感觉传导速度[(47.3±1.1) m/s与(41.6±1.8) m/s,t=-5.09,P＜0.05]、腓总神经感觉传导速度[(48.2±1.9) m/s与(43.2±2.5) m/s,t=-4.27,P＜0.05]明显提高.试验组97.4％(75/77)的医师和92.2％ (71/77)的患者对治疗效果满意,对照组84.0％(63/75)的医师和78.7％(59/75)的患者对治疗效果满意.研究过程中试验组颜面潮红3例、头晕1例,对照组颜面潮红2例、头晕1例,未经特殊处理自行缓解.结论 α-硫辛酸静脉滴注治疗DPN疗效显著,同时具有良好的安全性.

abstractsObjective To investigate the clinical effect and safety of alpha lipoic acid injection combined mecobalamin and prostaglandin E on type 2 diabetic patients complicated with diabetic peripheral neuropathy(DPN).Methods One hundred and sixty type 2 diabetic patients complicated with DPN in the General Hospital of Benxi Iron and Steel Group Corporation from Jan.2011 to Dec.2012 were randomly divided into the treatment group(n =80) and the control group (n =80).Three cases of the treatment group and 5 cases of the control group discharged early from the study because of their own reasons.There were 77 cases in the treatment group and 75 cases in the control group.On the basis of controlling blood glucose,patients in the two groups were given 500 μg mecobalamin combined with intramuscular injection once two days,as well as prostaglandinE 10 μg injection once a day.Patients in treatment group were added with 600 mg alpha lipoic acid for intravenous injection once a day for 10-14 days.Total symptom score (TSS),nerve conduction velocity,satisfaction and adverse reactions were evaluated before and after treatment.Results TSS score,tingling score,burning sensation score and hypoesthesia score,numb score in treatment group were (3.5 ± 2.5),(1.1 ± 0.4),(0.9 ± 0.7),(1.3 ± 0.4),(1.3 ± 0.9),significantly lower than those in control group (4.3 ± 2.1,t =2.11,P ＜0.05;1.5 ±0.5,t =1.86,P＜0.05;1.3 ±0.5,t =1.83,P ＜0.05;1.7 ±0.5,t =1.87,P ＜0.05; 1.9 ± 0.4,t =1.91,P ＜ 0.05).The median nerve conduction velocity,peroneal nerve motor conduction velocity,median nerve sensory conduction velocity,common peroneal nerve sensory conduction velocity of patients in treatment group were (53.6 ± 1.4) m/s,(49.6 ± 1.1) m/s,(47.3 ± 1.1) m/s,(48.2 ± 1.9) m/s,lower than those in control group((48.5 ±2.7) m/s,t =-4.94,P ＜0.05;(43.9 ±2.1) m/s,t =-5.36,P ＜0.05; (41.6 ± 1.8) m/s,t =-5.09,P ＜0.05;(43.2 ±2.5) m/s,t =-4.27,P ＜ 0.05,P ＜0.05).In the treatment group,97.4％ (75/77) physicians and 92.2％ (71/77) patients were satisfied with treatment effect,while in the control group,84.0％ (63/75) physicians and 78.7％ (59/75) patients were satisfied with treatment effect.During the study periods,there were 3 cases with facial flushing and 1 cases of dizziness in the treatment group,and 2 cases of facial flushing and 1 cases of dizziness in the control group.All adverse reactions were spontaneous remission without any special treatment.Conclusion Alpha lipoic acid intravenous drip is effective in term of treating type 2 diabetic peripheral neuropathy,and with high safety.