| Objective In recent years,whether foreign or domestic,the prevalence of diabetes mellitus(DM)is gradually increasing,its chronic complications have become a major problem for the public health system in China and even in the world.In the patients with long onset of DM,a large proportion of them are prone to concurrent diabetic peripheral neuropathy(DPN),and Western medicine is often ineffective in improving its symptoms.This study was conducted in a randomized controlled trial,the purpose is to observe and study the clinical effect of Huangqi Guizhi Wuwu Decoction and Danggui Sini Decoction to cure Yang deficiency and blood stasis type of DPN,and to compare its medication safety and analysis,to study its component thinking,the significance of compatibility of TCM and evidence from modern pharmacological research,to provide the objective theoretical basis in clinical applications for Huangqi Guizhi Wuwu Decoction and Danggui Sini Decoction in treating Yang deficiency and blood stasis type of DPN.Methods The cases observed in this clinical study were all selected from the endocrinology department of the Chinese medicine hospital in hubei province(Huayuanshan campus),the observation period was from October 2018 to August 2020,after the oral hypoglycemic drugs or subcutaneous insulin injections and other hypoglycemic regimens,with appropriate diet and exercise,a total of 80 patients with Yang deficiency and blood stasis type of DPN had Hb A1 c ≤8%(maintained for more than 2 weeks).According to the three principles of randomization,contrast,and repetition,80 patients were divided1:1 according to the method of randomized sampling.In the control group,40 patients oral the cobalt amine(0.5 mg/time,3 times/day)combined basic hypoglycemic regimens,in the treatment group,40 patients oral Huangqi Guizhi Wuwu Decoction and Danggui Sini Decoction(200 ml/time,2 times/day)combined basic hypoglycemic regimens,all decocted by Hubei Provincial Hospital of Traditional Chinese Medicine Pharmacy,taking one pair after half an hour of the breakfast and dinner every day.The basic hypoglycemic regimens plus oral drug therapy were given for 12 consecutive weeks.According to the changes in symptoms and signs of patients in two groups,the data of TCM syndrome score,blood glucose change levels,TCSS score,nerve conduction velocity were recorded and compared to study whether the difference was statistically significant,so as to assess the efficacy.Results(1)In terms of improving the total score of TCM syndromes:after 12 weeks of basic hypoglycemic regimens plus oral drug therapy,the two groups were compared respectively within the groups,the analysis results showed P < 0.05,which was statistically significant;After 12 weeks of basic hypoglycemic regimens plus oral drug therapy,the two groups were compared respectively between the groups,the analysis results showed P < 0.05,which was statistically significant.The results showed that the treatment of two groups could improve the total score of TCM syndromes,and the improvement effect of the treatment group was better.(2)To improve the efficacy of TCM syndromes: there were 40 patients in each group.After 12 weeks of basic hypoglycemic regimens plus oral drug therapy,the total effective rate in the control group and the treatment group was 70% and 92.5%,and the analysis results showed P < 0.05,which was statistically significant.The results showed that the treatment group had better effect on TCM syndromes than the control group.(3)Influence on blood glucose levels: Hb A1 c levels were compared within two groups after 12 weeks of basic hypoglycemic regimens plus oral drug therapy,and the analysis results showed P > 0.05,which was no statistically significant.The Hb A1 c levels were compared between two groups,and the analysis results showed P > 0.05,which was no statistically significant.It indicated that the blood glucose levels in two groups were similar,and there were no significant fluctuations in blood glucose levels during the treatment,the blood glucose levels in two groups were stable in the near future.(4)In terms of improving Toronto clinical score(TCSS): After 12 weeks of basic hypoglycemic regimens plus oral drug therapy,TCSS scores were compared within two groups,and the analysis results showed P < 0.05,which was statistically significant.After 12 weeks of basic hypoglycemic regimens plus oral drug therapy,the TCSS scores were compared between the groups,and the analysis results showed P < 0.05,which was statistically significant.The results showed that both groups could reduce TCSS scores effectively,and the treatment group was better than the control group.(5)Improvement of nerve conduction velocity: after 12 weeks of basic hypoglycemic regimens plus oral drug therapy,the nerve conduction velocity were compared within two groups,and the analysis indicated that both were P < 0.05,which were statistically significant;After 12 weeks of basic hypoglycemic regimens plus oral drug therapy,the nerve conduction velocity were compared between two groups,and the results were all P < 0.05,which were statistically significant.It suggested that both groups could accelerate nerve conduction velocity,and the effect of the treatment group was better than the control group.(6)safety index comparison: two groups were no adverse reactions in both groups,the safety evaluation of two groups were all grade 1,two groups of patients’ vital signs,three routine and other indicators showed no obvious abnormality,it showed that it was safe and reliable to use Huangqi Guizhi Wuwu Decoction and Dangguisini Decoction in treating Yang deficiency and blood stasis type of DPN.Conclusion Through the symptoms and signs,blood glucose change levels,TCSS score,nerve conduction velocity and other data of patients,it can be preliminarily confirmed that Huangqi Guizhi Wuwu Decoction and Danggui Sini Decoction combined with basic hypoglycemic regimens has better efficacy than the cobalt amine combined with basic hypoglycemic regimens in treating Yang deficiency and blood stasis type of DPN.This article summarizes the Professor Xiao ’s clinical experience,explore and analyze its component thinking,the significance of compatibility of TCM and evidence from modern pharmacological research,this prescription can significantly reduce the total score of TCM syndromes and TCSS score,improve nerve conduction velocity,and maintain a stable blood glucose levels,it has less adverse reactions and better safety in clinical application,can effectively improve the patients quality of living standards,is worthy of further exploration and promotion in clinical practice. |
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