Clinical Intervention Observation Of Danggui Sini Decoction On Painful Diabetes Peripheral Neuropathy Of Yang Deficiency And Cold Coagulation Type

Purpose:To observe the intervention effect of Danggui Sini Decoction on painful diabetic peripheral neuropathy with Yang deficiency and cold coagulation syndrome and the influence on the changes of serum Homocysteine and Cystatin-C levels.Method:1.Subject of observe:Patients with yang deficiency and cold coagulation syndrome of painful diabetic peripheral neuropathy who attended the Department of Traditional Chinese Medicine of the Second Hospital of Dalian Medical University during April2022 to January 2023 were selected.Using the non-randomized simultaneous control method,patients who met the inclusion criteria were divided into the test and control groups in a 1:1 ratio.2.Test method:All patients in the group received health education on diabetes,diabetic diet and moderate exercise,and controlled blood glucose,blood pressure and blood lipids at a stable level under the guidance of physicians and were also given methylcobalamin tablets 0.5mg/time,3 times/day.Patients in the test group received150 m L of warm Danggui Sini Decoction twice daily,after breakfast and dinner patients in the control group received 50 mg of Epalrestat tablets three times daily;the treatment period for both groups was four weeks.3.Observation index:Patients’gender,age,duration of diabetes,body mass index,Glycated Hemoglobin A_1cbefore the test were collected;Before and after therapy,the levels of homocysteine and cystatin-C,pain visual analogue scale score,TCM syndrome score,and 2-hour postprandial blood glucose were all compared;The occurrence of adverse reactions during the study was monitored;All data were statistically analyzed by Spss26.0 software.Results:1.Comparison of baseline data:There were no statistical differences in gender distribution,age,duration of diabetes,body mass index and pre-test Glycated Hemoglobin A1c levels between the two groups（P>0.05）,which was comparable.2.Fasting blood glucose and 2-hour postprandial blood glucose levels:There were no statistical difference between the test group and the control group before the treatment（P>0.05）,which were comparable;After the treatment,there were no statistical difference between the test group and the control group（P>0.05）;There were no statistical difference within the test group and the control group before and after treatment（P>0.05）.3.Pain visual analogue scale score and TCM syndrome score:There was no statistical difference between the test group and the control group before the treatment（P>0.05）,which was comparable;After the treatment,the pain visual analogue scale score and the TCM syndrome score of both the test group and the control group decreased compared with those before the treatment（P<0.001）,the decrease in the visual analogue scale score and the TCM syndrome score of the test group after the treatment was greater than the control group.The difference in visual analogue scale scores and TCM syndrome score between the two groups was statistically significant（P<0.05）.4.The level of Homocysteine and Cystatin-C:There was no statistical difference between the test group and the control group before the treatment（P>0.05）,which was comparable;The Homocysteine and Cystatin-C levels decreased in both the test group and the control group after the treatment compared with those before the treatment（P<0.05）,the decrease in Homocysteine and Cystatin-C levels in the test group after the treatment was greater than that in the control group,and the difference in Homocysteine and Cystatin-C levels between the two groups was statistically significant（P<0.05）.The difference in Homocysteine and Cystatin-C levels between the two groups was statistically significant（P<0.05）.5.Evaluation of efficacy:In the evaluation of the efficacy of pain therapy,the total effective rate of treatment was 93.75%in the test group and 86.2%in the control group,the difference was statistically significant（P<0.05）.In the evaluation of TCM syndrome score,the total effective rate of the test group was 79.31%and the total effective rate of the control group was 24.10%,the difference was statistically significant（P<0.05）.Conclusion:1.Danggui Sini Decoction can a lleviate the clinical symptoms and improve the clinical efficacy of the painful diabetic peripheral neuropathy patients with Yang deficiency and cold condensation,and is superior to Epalrestat.2.The possible mechanism of Danggui Sini Decoction to intervene in painful diabetic peripheral neuropathy with Yang deficiency and cold condensation is to reduce the Homocysteine and Cystatin-C levels without correlation with fasting blood glucose and two-hour postprandial blood glucose levels.