Objective: To observe the influence of Yangyin Shenkang decoction on the related indicators of early diabetic kidney disease stage Ⅲ with deficiency of qi and yin combined with blood stasis,and to assess its safety and effectiveness,in order to provided new ideas and methods for TCM treatment of early diabetic kidney disease with deficiency of qi and yin combined with blood stasis.Methods: A total of 66 patients with early diabetic nephropathy of qi and Yin deficiency combined with blood stasis inendocrinology department of the Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine or the Department of Endocrinology of Qianfoshan Hospital of Shandong Province from November 2021 to November 2022 were enrolled.According to the random principle,they were assigned to control group and observation group,with 33 patients in each group.Each group was treated with routine treatment,and the observation group was treated with Yangyin Shenkang decoction on the basis of routine treatment.The treatment lasted for 8 weeks,and every 4weeks was a course of treatment.The TCM syndrome score was used to evaluate the curative effect,and the vital signs,three routine tests and liver function were monitored.Changes in relevant laboratory indicators were observed: Urine microalbumin/creatinine ratio,renal function indexes(creatinine,urea nitrogen,estimated glomerular filtration rate,cystatin C,β2 microglobulin),glucose metabolism indexes(fasting blood-glucose,postprandial 2h blood glucose,glycosylated hemoglobin),lipid metabolism indexes(total cholesterol,triglycerides,low density lipoprotein),hypersensitive C-reactive protein,superoxide dismutase.SPSS 20.0 was used for statistical analysis of the above data.Results:(1)There was one dropout in each of the control and observation groups,and a total of 64 individuals completed the trial.Age,gender,disease duration,as well as baseline levels of each observation index were not statistically different between the two groups(P>0.05)and were comparable.(2)The effective rate of TCM: 87.5% improvement of TCM syndrome in the observation group after treatment was significantly higher than that of 59.4%in the control group,the difference was statistically significant(P<0.05);Clinical effectiveness: after treatment the clinical effectiveness rate in the observation group was 90.6%,which was significantly higher compared to71.9% in the control group with difference in statistics(P<0.05).(3)Compared with before treatment,the TCM symptom scores of both groups were significantly decreased after treatment(the observation group 16.28±4.16vs7.53±2.57,P<0.05),(the control group 16.81±4.29 vs 11.03±2.95,P<0.05).The observation group was superior to the control group(P<0.05).(4)Laboratory indicators: Compared with before treatment,the levels of urinary albumin/creatinine ratio in the two groups decreased significantly after treatment(treatment group 204.76±54.42 vs 67.44±28.89,P<0.05),(control group 207.21±52.77 vs 145.29±38.73,P<0.05).The treatment group was superior to the control group(P<0.05).Compared to the baseline,fasting blood-glucose,2h postprandial blood glucose and glycosylated hemoglobin levels in the observed group were improved(P<0.05),and fasting blood-glucose,2h postprandial blood glucose and glycosylated hemoglobin levels in the controlled group were improved(P<0.05).After the treatment,fasting blood-glucose,2h postprandial blood glucose and glycosylated hemoglobin levels in the observed group were better than those in the controlled group(P<0.05).The difference was statistically significant.Compared with the baseline,the levels of total cholesterol,triglyceride and low density lipoprotein in the observed group decreased(P<0.05),and the levels of triglyceride and low density lipoprotein in the controlled group decreased(P<0.05).The level of triglyceride in the observation group reduced significantly compared with the control group(P<0.05),with statistically significant differences.After the treatment,the level of high-sensitivity C-reactive protein fell off(treatment group 5.82±1.26 vs 3.63±1.16,P<0.05),(control group 5.73±1.18 vs 4.90±0.88,P<0.05),and the observed group was better than the controlled group(P<0.05).(5)Safety indicators: In the observation group,2 cases had mild abdominal distension,which relieved soon after.Conclusion: Yangyin Shenkang decoction is safe and effective in the treatment of early diabetic nephropathy with qi and Yin deficiency syndrome and blood stasis.It can effectively relieve the clinical symptoms of patients,improve the quality of life,reduce the urine microalbumin/urine creatinine ratio,control glucose and lipid metabolism and inflammatory indicators,without obvious adverse reactions,and has the value of further research. |