| Objective:In this study,we observed the effect of Jiawei Shipi Decoction on the clinical symptoms and laboratory indicators of adult primary nephrotic syndrome patients with spleen-kidney Yang deficiency edema,to evaluate its effectiveness and safety,and explore its mechanism of action.It is expected to provide more ideas for clinical treatment of primary nephrotic syndrome,and at the same time provide a certain reference for the promotion and application of integrated traditional Chinese and western medicine in the treatment of nephropathy.Methods:1.Sources:From November 2017 to November 2019,60patients with primary nephrotic syndrome with spleen-kidney Yang deficiency who met the inclusion criteria were selected as observation cases.According to the random number table method,the experimental group and the control group were divided into 30 cases in each group.2.Treatment:The control group was given conventional Western medicine standard treatment,including low-salt,low-fat,high-quality protein diet,symptomatic supportive treatments such as improving circulation,diuresis,anticoagulation,lipid regulation,blood pressure reduction,blood glucose control,hormones,etc.The experimental group was treated with Jiawei Shipi Decoction on the basis of the control group.The decoction was one dose per day,warm-taken twice a day after meals,150ml each time.After 8 weeks of treatment,the patients were followed up for 2 months to observe whether there were any adverse reactions.3.Indicators:After 8 weeks of treatment,we compared the changes of indicators in both groups of patients before and after treatment,including blood biochemistry(serum albumin,serum total cholesterol,triglycerides,blood creatinine,urea nitrogen),24-hour urinary protein quantity,and TCM symptom scores,and evaluated the therapeutic effect of Jiawei Shipi Decoction on patients with primary nephrotic syndrome with spleen-kidney Yang deficiency.At the same time,the safety indicators such as electrocardiogram,blood routine,fecal routine,liver and kidney function,and electrolyte were observed.4.Data analysis:we used SPSS 20.0 statistical software for data processing and analysis.The experimental data were expressed as mean±standard deviation(`x±s).T-test was used for measurement data,andc2-test was used for counting data,while non-parametric test was used for Non-normally distributed data.The test levelawas 0.05,and P<0.05 was statistically significant,while P>0.05 was not statistically significant.Results:1.Comparison of disease efficacy:After treatment,the curative effect was statistically different(P<0.05).The total effective rate in the control group was76.70%,and was90.00%in the experimental group.Therefore the curative effect of the experimental group was better than that of the control group.2.Comparison of indicators:After treatment,there werestatistical differences in serum albumin,total cholesterol,triglyceride,24-hour urinary protein quantity and edema degree between the test group and the control group(P<0.05),but no statistical difference in serum creatinine and urea nitrogen between the two groups(P>0.05).Comparison of the total cholesterol,triglyceride,24-hour urinary protein quantity,edema degree and serum albumin between the two groups,the efficacy of the experimental group was better than that of the control group.3.Comparison of TCM Symptom Scores and Syndrome Efficacy:There was a statistical difference in TCM symptom scores between the experimental group and the control group after treatment(P<0.05).The experimental group was better than the control group in improving symptoms.The total effective rate of the control group in TCM Syndrome Efficacy was 73.33%,and was 90.00%of the experimental group.The efficacy of the experimental group was better than that of the control group.4.Evaluation of safety indicators:After treatment,there were no obvious abnormalities in ECG,blood routine,fecal routine,liver and kidney function,electrolysis of experimental group and control group comparing with before treatment,and no adverse reactions occurred.Conclusion:Jiawei Shipi Decoction combined with western medicine can increase serum albumin,reduce proteinuria,reduce cholesterol and triglycerides.It can reduce patient edema significantly.and improve patients’clinical symptoms.The effect of Jiawei Shipi Decoction in clinical application is definite,and it is safe for no adverse reactions were found.Therefore it has clinical practical and promotion value. |