Clinical And Experimental Study Of Yi Qi Huo Xue Traditional Chinese Medicine On The Treatment Of Diabetic Peripheral Neuropathy

1.Clinical ResearchObjective:To observe the clinical effect of Tangtong Formula,a traditional Chinese medicine for tonifying qi and activating blood circulation,in treating type 2 diabetic peripheral neuropathy with qi deficiency and blood stasis syndrome,and to evaluate the efficacy and safety of the treatment,so as to provide an objective basis for clinical application.Method:We selected outpatients from December 2016 to December 2018,department of endocrinology of Guang'anmen Hospital,China Academy of Chinese Medical Sciences,and Xuanwu Hospital,Capital Medical University,who were diagnosed as type 2 diabetic peripheral neuropathy,and were classified as qi deficiency and blood stasis syndrome by TCM syndrome differentiation.A total of 60 patients who met the diagnostic criteria were enrolled,according to the principle of randomization,parallel and control,they were divided into treatment group and control group with 30 cases respectively.Both groups of patients were treated with basic treatment of diabetes(such as reasonable diet,moderate exercise),hypoglycemia,antihypertensive therapy,lipid lowering and so on according to their actual situation.The control group was asked to take mecobalamin tablets,0.5mg a time,3 times per day.Based on the control group treatment,the treatment group also took the Chinese herbal Tangtong Formula,1 dose a day,twice per day,in the morning and evening,4 weeks were used as a course of treatment,the test period lasts 3 courses of treatment.Collect general information of patients,including age,gender,course of diabetes,body mass index and other indicators.Use TCM clinical symptom score table to evaluate the TCM symptoms before and after treatment in both groups.Detect fasting plasma glucose(FPG),2 hours postprandial blood glucose(2hPG),glycosylated hemoglobin(HbAlc),blood lipid levels(CHO,TG,LDL-C),liver function(ALT,AST),renal function(CR,BUN)and other indicators in the two groups before and after treatment.The motor and sensory nerve conduction velocities were measured before and after treatment with Keypoint quadruplex electromyographic evoked potential instrument produced by Dantec Company in Denmark.All the data of the two groups of patients were analyzed by SPSS 19.0 statistical software.The efficacy and safety of Tangtong Formula in the treatment of patients with DPN(qi deficiency and blood stasis syndrome)were evaluated comprehensively.Result:1.Comparison of TCM symptom scores:Before treatment,there was no significant difference in the scores of single TCM symptom between the treatment group and the control group(P>0.05).After treatment,the treatment group can significantly improve the patient's fatigue and lack of strength,shortness of breath and no desire to speak,spontaneous perspiration and excessive sweating,weak waist and knees,numbness of limbs,stabbing pain of limbs,cold extremities,and skin dysfunction syndromes,there were significant statistical differences between the two groups before and after treatment(P<0.01),and the results were better than the control group in improving fatigue and lack of strength,shortness of breath and no desire to speak,spontaneous perspiration and excessive sweating,numbness of limbs,stabbing pain of limbs and other qi deficiency and blood stasis symptoms(P<0.05).At the same time,the study found that the control group only was more effective in relieving numbness and stabbing pain of limbs(P<0.01).In the comparison of total scores of TCM symptoms,there was no statistical difference between the two groups before treatment,which was comparable(P>0.05).After drug intervention,the total score of TCM symptoms in the treatment group was significantly lower than that before treatment(P<0.01),while the total score of TCM symptoms in the control group did not change significantly(P>0.05),compared with the control group,the treatment group was more effective in improving the total score of TCM symptoms(P<0.01).2.Comparison of comprehensive curative effect:After drug treatment,the comprehensive curative effect of the treatment group was as follows:11 cases were markedly effective,10 cases were effective and 6 cases were ineffective.In the control group,6 cases were markedly effective,7 cases were effective and 13 cases were ineffective.The total effective rate of the treatment group was 77.78%,which was better than 50%of the control group,and the difference was statistically significant(P<0.05).3.Comparison of blood glucose-related indicators:Before treatment,in the comparison of FPG,PBG,and HbA1C blood glucose-related indicators,there was no statistical difference between the two groups,which was comparable(P>0.05).After treatment,there were no significant changes in FPG,2hPG and HbA1C between the two groups(P>0.05).4.Comparison of lipid metabolism indicators:Before treatment,there was no significant difference in the levels of CHO,TG and LDL-C between the treatment group and the control group(P>0.05),indicating that the two groups were comparable.After treatment,the levels of CHO.TG and LDL-C in the two groups were not significantly different from those before treatment(P>0.05).5.Comparison of nerve conduction velocity:Before treatment,there was no significant difference in the conduction velocity of tibial nerve,common peroneal nerve,superficial peroneal nerve and sural nerve between the treatment group and the control group(P>0.05).After treatment,the nerve conduction velocity of the two groups was significantly higher than that before treatment(P<0.01),and the therapeutic effect of the treatment group was significantly better than that of the control group in improving nerve conduction velocity.Conclusion:This clinical study found that Tangtong Formula,a traditional Chinese medicine which has the function of invigorating qi and activating blood circulation,can effectively improve the symptoms of qi deficiency and blood stasis in patients with type 2 diabetic peripheral neuropathy(qi deficiency and blood stasis syndrome),alleviate local discomfort,and has no obvious adverse reactions.Compared with the treatment of mecobalamin tablets alone,Tangtong Formula has certain advantages.2.Experimental ResearchObjective:To observe the effect of different concentration of high glucose on RSC96 cell apoptosis,and the changes of RSC96 cell apoptosis under high glucose state after the intervention of Tangtong Formula.Method:1.RSC96 cells cultured in vitro were used as the research object in this experiment,they were cultivate by DMEM mediums which contains different concentrations of glucose(25 mmol/L,50 mmol/L,75 mmol/L,100 mmol/L)for 48 hours to build the model of apoptosis.there are four groups in this experiment:Normal control group(Con),G50 group,G75 group and G100 group,the apoptosis of RSC96 Cells was detected by flow cytometry Annexin V/PI.2.On the basis of the above experiments,50mmol/L DMEM high glucoser medium was selected to establish RSC96 cell apoptosis injury model.Tangtong Formula with the final concentration of 1mg/ml was used to intervene.Two groups were set up,namely G50 group(50mmol/L)and G50+TTF group(1mg/ml).To observe the apoptotic changes of RSC96 cells after 48 hours of intervention.3.Data processing was performed by SPSS 19.0 software.The measurement data were expressed as mean±standard deviation(x ±s).ANOVA analysis of variance was used among groups.P<0.05 was considered statistically significant.Result:1.This study found that the apoptosis rate of RSC96 cells in G50 group,G75 group and G100 group was significantly higher than that in normal control group after 48h intervention with different concentrations of high glucose.The difference was statistically significant(P<0.05 or P<0.01);and with the increase of glucose concentration in the medium,the cell apoptosis rate increased correspondingly,showing a certain correlation.2.After 48 hours of intervention with Tangtong Formula,the apoptosis rate decreased compared with that of G50 group(P<0.05).Conclusion:1.Under the stimulation of high glucose environment,the apoptosis of RSC96 cells increased significantly.2.Yiqihuoxue Chinese medicine Tangtong Formula can inhibit the apoptosis of RSC96 cells induced by high glucose,which provides theoretical support for the clinical application of Tangtong Formula in the prevention and treatment of diabetic peripheral neuropathy.