| Objective: Based on the theory of " combining evil from the outside and the inside",this study observed the efficacy and safety of Qingjie Guben Decoction in the treatment of IgA nephropathy(CKD1-3 stage)with heat toxicity and spleen-kidney deficiency,so as to provide objective clinical support and reference for the treatment of IgA nephropathy with heat toxicity and spleen-kidney deficiency with traditional Chinese medicine.Methods: In this study,70 patients who were diagnosed as IgA nephropathy by renal biopsy from September 2021 to October 2022 in the Department of Nephrology,Shandong Hospital of Traditional Chinese Medicine,and identified as heat toxicity with deficiency of spleen and kidney through differentiation of viscera and etiology were included.After the washout period,they were randomly divided into control group and experimental group,with 35 people in each group.Both groups received basic Western medicine treatment,the control group received 75 mg or 150 mg irbesartan(the dosage was mainly controlled within 120/75mmhg),and the experimental group received Qingjie Guben decoction on the basis of the treatment regimen of the control group.Two groups of patients were treated for4 weeks as a course of treatment,a total of 3 courses of observation.After each course of treatment,2 4-hour urinary protein quantification(2 4 h UP),urinary red blood cell count(RBC),serum creatinine(Scr),uric acid(UA),albumin(ALB)and TCM syndrome scores of the two groups of patients were detected,and relevant data were analyzed by statistics and safety evaluation.Results:(1)In this study,5 patients were excluded due to disease progression and glomerular filtration rate<30ml/min or loss of follow-up during treatment,and a total of 65 patients completed the clinical trial,including 32 patients in the control group and 33 patients in the experimental group.There were no significant differences in general information,laboratory indexes and TCM symptom scores between the two groups before treatment(P>0.05).(2)Clinical comprehensive efficacy: After treatment,the total effective rate of the clinical comprehensive efficacy of the experimental group was 81.8%,and that of the control group was 59.3%.The comparison between the two groups(P<0.05)indicated that the treatment scheme of the two groups was effective,and the experimental group was better than the control group.(3)TCM syndrome: After treatment,the total effective rate of TCM syndrome in the experimental group was 90.9%,and 65.6% in the control group,and the difference of TCM syndrome effect between the two groups was statistically significant(P<0.05).Main symptoms: lumbago and back pain,fatigue,sore throat,dry mouth,hematuria,the differences were statistically significant(P<0.05),and the experimental group in relieving lumbago and back pain,sore throat,dry mouth had a significant effect(P<0.01);Secondary symptoms: swollen face or limbs,nerdiness,hot urination,the difference was statistically significant(P<0.05).(4)Laboratory indicators:(1)After treatment,24 h UP,RBC and Scr in 2 groups were decreased,the difference was statistically significant(P<0.05),UA and ALB before and after treatment were not statistically significant(P > 0.05).(2)After treatment,the experimental group was better than the control group in reducing 24 h UP,RBC and Scr,the difference was statistically significant(P<0.05),but there was no statistical significance in UA and ALB between the two groups(P>0.05).(5)Safety: there were no obvious abnormalities in the safety indexes of patients in the two groups.Conclusion: Under the premise of clinical safety,irbesartan combined with Qingjie Guben Decoction in the treatment of heat-toxic and spleen-kidney deficiency IgA nephropathy(CKD1-3 stage)has better efficacy than irbesartan alone in terms of reducing urinary protein,reducing urinary red blood cell level,stabilizing renal function,relieving clinical symptoms and other aspects,which can alleviate the disease and improve the quality of life of patients,and is worthy of clinical promotion. |
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