Clinical study of Alpha lipoic acid injection combined mecobalamin and prostaglandin E on treating patients with diabetic neuropathy / 中国综合临床

ABSTRACT

Objective 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.