Study On The Mechanism Of Action Of Huoluo Tongbi Decoction In Treating DPN Patients Of Phlegm And Blood Stasis In The Collaterals

Objective: To assess the clinical effect and the safety of the Huoluo Tongbi decoction in treating DPN patients of phlegm and blood stasis in the collaterals,the changes of MNSI,MDNS,VPT,NCV,lipid level,Hcy level,CysC level and the adverse reaction of Huoluo Tongbi decoction in treating DPN patients of phlegm and blood stasis in the collaterals were observd.And furtherly elucidated the mechanism of action from the aspects of Hcy and CysC,so as to provide the relevent theory and clinical basis for the research of TCM treatment of the disease.Methods:100 patients who met the criterion of DPN were divided into the treatment group and the control group.50 cases of each group were given the basic treatment of diabetes mellitus,then the treatment group was given the Huoluo Tongbi decoction,while the control group was given oral mecobalamin tablets.The total course were 8 weeks.To observe the changes of the patients on MNSI,MDNS,VPT,NCV,lipid level,Hcy level,CysC level,FBG,2hPBG,HbA1 c,etc,and recorded before and after treatment.And then proceed relevant statistics analysis.Results:1.Comprehensive efficiency:The total effective rate of the treatment group was 94.00% and the control group was 76.00%,which showed statistical difference(P<0.05).2.MNSI and MDNS grade:After the treatment,the MNSI and MDNS grade were lower in both groups(P<0.05),and the treatment group fell faster thanthe control group(P<0.01),which showed statistical difference(P<0.05).3.VPT:After the treatment,the VPT were lower in both groups(P<0.05),and the treatment group was significantly lower(P < 0.01),which showed statistical difference(P<0.05).4.NCV:After the treatment,the motor nerve conduction velocity of the median nerve of upper limbs and the common peroneal nerve of lower limbs and the sensory nerve conduction velocity of the median nerve of upper limbs and the superficial peroneal nerve of lower limbs were higher in both groups(P<0.01),and the treatment group was significantly higher(P<0.01).5.Lipid level:After the treatment,the triglycerides and the low density lipoprotein levels showed no statistical difference in control group(P >0.05),but the treatment group were lower(P<0.05),which showed statistical difference(P<0.05).6.Hcy level:After the treatment,the Hcy level were lower in both groups(P<0.05),and the treatment group was significantly lower(P<0.01),which showed statistical difference(P<0.05).7.CysC level:After the treatment,the CysC level were lower in both groups(P<0.05),and the treatment group was significantly lower(P<0.01),which showed statistical difference(P<0.05).8.Glycemic level:After the treatment,the FBG?2hPBG and HbA1 C level of both groups were lower than before(P<0.01),but there was no statistical significance between two groups(P>0.05).9.Safety analysis:Before and after the treatment,the vital signs,liver function,renal function of all participants showed no obvious abnormalities,and no serious adverse reactions were found.Conclusion:Huoluo Tongbi decoction can improve the clinical symptoms and signs of DPN patients of phlegm and blood stasis in the collaterals,meanwhile it also can increase sensory sensitivity,speed up the the nerve conductionvelocity,lower the triglycerides and the low density lipoprotein,and reduce the homocysteine and cystatin C level.It indicates that this prescription has a good clinical effect on the prevention and treatment of DPN and ensures safety without obvious adverse reaction,the michanism of which is to reduce inflammatory injury and oxidative stress by regulating homocysteine and cystatin C level to reduce nerve damage.