Effect Of Epalrestat Combined With Mecobalamin On Serum Hcy And CysC In Patients With Diabetic Peripheral Neuropathy

Objective:This study was aimed to investigate the effect on serum homocysteine(Hcy)and cystatin c(CysC)on the the treatment of epalrestat combined with mecobalamin on diabetic peripheral neuropathy(DPN).Meanwhile,we sought to evaluate the efficacy and safety of these drugs and provide more evidence based medicine on the therapy of DPN.Materials and Methods : A total of 120 patients with diabetic peripheral neuropathy were enrolled in this study.The patients were stratified blocked randomly divided into three groups,40 cases in each group:group E was administered epalrestat 50 mg alone,group M was administered mecobalamin 500 mcg alone,group EM was administered combination of epalrestat 50 mg and methylcobala 500mcg(both thrice daily).All cases were carried out the base therapy and treatmented three months.We adopted questionnaire to collect data including general information,biochemical parameters and compared the level of Hcy,CysC among all the patients before and after treatment.Toronto Clinical ScoringSystem(TCSS)was used to evaluate the improvement of subjective symptoms and clinical signs about the patients with DPN pre and post treatment.Compared the nerve conduction velocity which were recorded by electromyogram evoked potential instrument during the beginning and end of therapy.Spearman's correlation analysis was used to analysis Hcy,CysC on the other factors,respectively.Furthermore,the adverse reaction and the safety assessment was compared in all research objects.Results:1.In E,M,EM groups,serum Hcy concentration were(13.40 �2.26)?mol/L,(13.51 � 2.32)?mol/L,(14.91 � 6.78)?mol/L before treatment,respectively.After treatment,the values were(11.39 �1.39)?mol/L,(11.27�.246)?mol/L,(10.13�1.84)?mol/L,respectively.Ser um cystatin C concentration were(1.01�0.48)mg/L,(1.10�0.51)mg/L,(1.18�0.91)mg/L,respectively.After treatment,the values were(0.77�0.21)mg/L,(0.82�0.34)mg/L,(0.63�0.19)mg/L,respectively.These changes had statistical significance.When compared among groups,in EM group it was more lower than it in E and M groups(P<0.05),and the was significant difference between E and M groups(P<0.05).2.In E,M,EM groups,motor nerve conduction velocity(MNCV)of ulnar nerve and median nerve,sensory nerve conduction velocity(SNCV)of ulnar nerve and median nerve had no statistical significance(P(29)0.05)before and after treatment.In E and EM groups,MNCV of tibial nerve and common peroneal nerve,SNCV of superficial peroneal nerve and sural nerve were faster and were significant difference(P<0.05),this is not in M group(P(29)0.05).When EM group compared with E and M groups,MNCV and SNCV of ulnar nerve and median nerve were no different(P(29)0.05),MNCV of tibial nerve and common peroneal nerve were faster(P<0.05),SNCV of superficial peroneal nerve and sural nerve were faster(P<0.05)pre and post therapy.There were no difference between E and M group.3.After treatment,the obvious effective rate of EM group was43.33%,it was higher than E group(21.21%)and M group(11.77%)and had significant difference(P<0.05).The obvious effective rate and effective rate of E group were 21.21%,36.37%,respectively,both of them wrer higher than M group(11.77%,29.41%)and were significant difference(P<0.05).4.Before and after treatment,the TCSS scores in E group was(8.30�2.59)score,(7.64�1.87)score,EM group was(9.13�2.91)score,(5.83� 1.88)score,respectively(P<0.05).But it was not in M group.When ccompared among groups,the TCSS scores in EM group was significantly decreased than other two groups(P<0.05).5.Spearman's correlation analysis showed that serum Hcy wasapparently positive correlation with CysC,BMI,Cr(r=0.468,0.390,0.404,respectively,all P<0.05).But negative correlation with TCH,MNCV and SNCV of median nerve,SNCV of sural nerve,MNCV of common peroneal nerve(r=-0.307,-0.286,-0.378,-0.424,-0.383,respectively,all P<0.05).Serum CysC was apparently positive correlation with Hcy,age,Cr(r0.468,0.414,0.403,respectively,all P<0.05).However negative correlation with MNCV and SNCV of median nerve,SNCV of sural nerve,MNCV of common peroneal nerve(r=-0.235,-0.306,-0.275,-0.340,respectively,all P<0.05).6.Subgroup analysis according to TCSS in all DPN patients confirmed that,serum Hcy levels in mild group,moderate group,heavy group were(13.39 � 3.28)?mol/L,(13.56 � 5.27)?mol/L,(16.72 �7.62)?mol/L,respectively,and the incidence of hyperhomocysteinemia(HHcy)was 20.51%,31.25%,52.63%.There were significant differences in all groups(P<0.05).Serum Hcy levels were(0.75� 0.24)mg/L,(0.91 � 0.51)mg/L,(0.96 � 0.68)mg/L,respectively,and the frequency of hypercystati-n C(HHcyC)was17.95%,40.63%,57.89%.There were significant di-fferences among groups(P<0.05).7.The side effect included diarrhoea of 2 patients in E group,nausea and retching of 2 subjects in EM group,this did not reach statisticalsignificance compared with each other.All adverse effects without a specific treatment and symptomatic remission after 1 or 2 days.There was no fatal cardiovascular events appeared.Conclusions:1.Epalrestat can decrease the serum Hcy,CysC levels in patients with DPN and this is more significantly combined with mecobalamin.2.Epalrestat combination with mecobalamin for treating DPN can significantly relieve the subjective symptoms and clinic signs.Alleviating the patients' suffering and improving the quality of life.3.Epalrestat combination with mecobalamin for treating DPN can obviously improve the MNCV of common peroneal nerve and tibial nerve,the SNCV of superficial peroneal nerve and sural nerve.4.Serum Hcy and CysC are apparently positive correlation with the severity of DPN.There is a positive correlation between Hcy and CysC and both of them participate in the process of DPN by some synergistic effect.5.Epalrestat combination with mecobalamin is effective and safe in the treatment for DPN,and is worth popularizing.