Effect Of Jinlida Granules Combined With Alpha-Lipoic Acid On Treatment Of Type 2 Diabetes-Induced Diabetic Peripheral Neuropathy

ObjectiveTo explore the clinical effect and safety of Jinlida granules combined with alpha-lipoic acid on treatment of type 2 diabetes-induced diabetic peripheral neuropathy,to analyze the possible mechanisms,and to provide evidence for clinical treatment.MethodsFrom December 2016 to April 2018,84 patients with diabetic peripheral neuropathy in type 2 diabetes were collcted in the Second Hospital of Jilin University.All cases who met the inclusion criteria and the exclusion criteria were divided into the Jinlida group(n=42)and the control group(n=42)according to the random number table method.On the basis of background therapy,the Jinlida group was administered with Jinlida granules combined with alpha-lipoic acid,while the control group was given with mecobalamin and alpha-lipoic acid,the treatment lasts for 6 months.The following indicators were collected before the treatment,after 3 months and 6 months of the treatment: Fast plasma glucose(FPG),2 hour postprandial glucose(2hPG),Glycosylated hemoglobin(HbA1c),Alanine transaminase(ALT),Aspartate transaminase(AST),Creatinine(Cr),Triglyceride(TG),Total cholesterol(TC),High density lipoprotein cholesterol(HDL-C),Low density lipoprotein cholesterol(LDL-C),Fasting insulin(FINS),Homeostasis model assessment-insulin resistance index(HOMA-IR)calculated.The limbs' nerve conduction amplitude and velocity were measured similarly,as well as the Toronto clinical scoring system(TCSS).Record any adverse reaction during the treatment,and deal with those promptly to ensure patients' safety.All data analysis was performed in SPSS21.0 by using Chi-square test,t-test,repeated measure analysis of variance and rank sum test.Results1.There was no significant difference in the basic information between the Jinlida group and the control group(p>0.05).There was no statistical difference in the nerves' conduction amplitude and velocity between the two groups(p>0.05),as well as the TCSS score(p>0.05).2.The TCSS scores of the Jinlida group and the control group were lower than the baseline after the treatment respectively(p<0.05);there was no significant difference between the two groups(p>0.05).3.After 3 months and 6 months of the treatment,all the nerves' conduction amplitude and velocity of the Jinlida group and the control group improved,which was statistical different with the baseline(p<0.05).However,the different between the two group was not significant(p<0.05).4.In the control group,there were no changes in the levels of HbA1 c,FPG and 2hPG between the baseline and the follow-up points(p>0.05).In the Jinlida group,HbA1 c after 6 months reduced comparing with the baseline,FPG and 2hPG were significantly better than those at the baseline and 3th month(p<0.05).After 6 months of the treatment,HbA1 c,FPG,and 2hPG were quite different between the two groups,and the level of blood glucose in Jinlida group was better(p<0.05).5.In the control group,there were no changes in the level of HOMA-IR between the baseline and the follow-up points(p>0.05).In the Jinlida group,HOMA-IR was lower than the baseline at the follow-up points(p<0.05).HOMA-IR of the Jinlida group was significantly lower than that of the control group after 3 months and 6 months of the treatment(p<0.05).6.After 3 months of the treatment,all the blood lipid observation indicators(TG,TC,HDL-C,LDL-C)in the Jinlida group were better than the baseline,while TG reduced in the control group(p<0.05).TG and HDL-C were statistical different between the two groups,and the Jinlida group was better than the control group(p<0.05).After 6 months,all the blood lipid indicators in the Jinlida group were still better than the baseline;while in the control group TG,TC,and HDL-C were better(p<0.05).TG and LDL-C were statistical different between the two groups,and the Jinlida group was better than the control group(p<0.05).7.After all patients followed up,there was 1 case of nausea in both groups.In addition,there was 1 case of dizziness in the control group.But the symptoms were mild,which didn't affect normal life.The symptoms could disappear after rest.There was no worsening of liver and kidney function during the study in the two groups(p>0.05).Conclusions1.Jinlida granules can be used as an auxiliary drug to treat type 2 diabetes-induced diabetic peripheral neuropathy.It can improve the clinical symptoms and nerve conduction.There were no obvious adverse reactions during this study.2.The mechanism of Jinlida granules for treating type 2 diabetes-induced diabetic peripheral neuropathy doesn't only depend on controlling blood glucose,and this study suggest that it is related to reducing blood lipids and insulin resistance.3.Jinlida granules can effectively reduce blood glucose,blood lipids and insulin resistance.4.Provide clinical evidence for Jinlida granules on treatment of type 2 diabetes-induced diabetic peripheral neuropathy.