| Objectives:By observing the clinical efficacy and safety of the Bushen jianpi xiezhuo decoction in the treatment of chronic kidney disease stage 3-4 with deficiency of spleen and kidney qi,in order to provide reference ideas for comprehensive and effective clinical treatment.Methods:In this study,patients with CKD stage 3-4 who visited the outpatient and inpatient departments of the Department of Nephrology of the Affiliated Hospital of Chinese and Western Medicine of Nanjing University of Traditional Chinese Medicine from October 2020 to October 2021,and whose TCM type was spleen and kidney qi deficiency were selected.Patients were screened in strict accordance with the nadir criteria,and 60 cases of qualified patients were collected and randomly divided into 30 cases each in the control group(Western conventional treatment plus TCM treatment)and treatment group(treatment in the control group combined with the formula of tonifying the kidney,strengthening the spleen and draining the turbidity),who signed the informed consent forms respectively.The treatment course was 8 weeks.Patients in both groups were treated according to the specified method,and blood and urine specimens were collected for testing before and at the 8th week after the administration of medication.The renal function indexes(Scr,BUN,eGFR),other laboratory indexes(UA,hs-CRP,ACR),total TCM syndrome score,TCM major symptom score(fatigue and weakness,lumbar and knee weakness,shortness of breath and lazy speech,lack of food and dullness),TCM minor symptom score(distention and fullness in the abdomen and stomach,insubstantial stool,light mouth and no thirst,lumbago,long and clear night urination),safety indicators(blood routine,urinary routine,liver function,electrolytes),and the efficacy and safety of this formula were evaluated based on the results of statistical analysis.Results:1.Comparison of baseline periods:there were no statistically significant differences between the two groups in age,gender,stage,disease duration,primary illness,complications,renal function indexes(Scr,BUN,eGFR),other laboratory indexes(UA,hs-CRP,ACR),total TCM evidence score,TCM major symptom score,TCM minor symptom score,and safety indexes(P>0.05).2.Comparison of the total clinical efficiency of the disease:the efficiency of the treatment group was 90.00%,the efficiency of the control group was 68.97%,the efficacy of the treatment group was better than that of the control group(P<0.01),and the difference was statistically significant.3.Comparison of the efficacy and efficiency of the Chinese medical evidence:the efficiency of the treatment group was 86.67%,and the efficiency of the control group was 55.17%,the efficacy of the treatment group was better than that of the control group(P<0.01),and the difference was statistically significant.4.TCM symptom scores:The total TCM symptom score,the TCM major symptom score,and the TCM minor symptom score of both groups decreased after treatment,the difference among which the total TCM symptom score of both groups,the TCM major symptom score and the minor symptom score of "distension and fullness in the abdomen,insubstantial stool,lumbago,and clear and long night urination" in the treatment group was statistically significant after treatment(P<0.01);there was a statistically significant difference in "light mouth and no thirst" before after treatment(P<0.05).In the control group,there were statistically significant differences in "soreness and weakness of the waist and knees" among the main symptoms and"lumbago" among the secondary symptoms in TCM after treatment(P<0.01);"fatigue and weakness,shortness of breath,poor appetite and dullness" among the main symptoms in TCM(P<0.05).The differences between "fatigue and weakness,shortness of breath,lack of food and dullness" and "fullness in the abdomen and stomach,insubstantial bowel movements,weakness in the mouth and lack of thirst,and long and clear urination at night" among the primary symptoms of TCM were statistically significant after treatment(P<0.05).After treatment,the total TCM symptom score,the TCM primary symptom score and the secondary symptom score of "distension and fullness in the abdomen,lumbago,and nocturnal urination" were all lower in the treatment group than in the control group,and the secondary symptom score of "insubstantial stool,and weakness in the mouth" was higher than in the control group.The differences between groups were statistically significant(P<0.01)for "fatigue and weakness,lumbago";the differences between groups were statistically significant(P<0.05)for the other TCM major symptoms and "distention and fullness in the abdomen";the differences between groups were statistically significant for "insubstantial stools,light mouth and no thirst";and the differences between groups were statistically significant for "insubstantial stools,no thirst and nocturnal urine.There was no statistically significant difference between the groups for the symptoms of insubstantial bowel movements,light mouth without thirst,and clear and long nocturnal urination(P>0.05).It was suggested that both groups could improve the TCM symptoms,and the treatment group was more effective than the control group in treating the main symptoms and secondary symptoms of TCM,such as distention and fullness in the abdomen and lower back pain.5.Renal function:The levels of Scr and BUN in both groups decreased after treatment compared with those before treatment,and the levels of eGFR increased after treatment compared with those before treatment,in which the differences of Scr,BUN,eGFR in the treatment group and Scr and eGFR in the control group before and after treatment were statistically significant(P<0.01);the differences of BUN in the control group before and after treatment were statistically significant(P<0.05).After treatment,the levels of Scr and BUN in the treatment group were lower than those in the control group,and the levels of eGFR were higher than those in the control group,and the differences were statistically significant(P<0.05).It suggested that both groups could improve renal function,and the efficacy of the treatment group was better than that of the control group.6.Other laboratory indexes:UA,hs-CRP and ACR levels decreased in both groups after treatment compared with those before treatment,in which UA,hs-CRP,ACR in the treatment group and UA in the control group showed statistically significant differences after treatment(P<0.01);ACR in the control group showed statistically significant differences after treatment(P<0.05);hs-CRP in the control group showed no statistically significant differences after treatment(P>0.05).After treatment,the levels of UA,hs-CRP and ACR in the treatment group were lower than those in the control group,and the differences were statistically significant(P<0.05).It was suggested that both groups could reduce uric acid level and control proteinuria,but the efficacy of the treatment group was better,and the improvement of inflammatory status was stronger in the treatment group than in the control group.7.safety indexes:AST,ALT in the treatment group and K and P levels in the control group were seen to increase after treatment compared with those before treatment,and Ca,K and P in the treatment group and AST and ALT levels in the control group were seen to decrease after treatment compared with those before treatment in both groups,with no statistically significant difference(P>0.05).AST,K,Ca and P levels in the treatment group were lower than those in the control group after treatment,and ALT in the treatment group was higher than that in the control group,with no statistically significant difference,(P>0.05).There were no significant changes in vital signs,blood and urine routines before and after treatment.All patients did not experience any adverse drug reactions during the drug administration.Conclusions:This study is based on the ideological and theoretical guidance of syndrome differentiation and treatment in modern medicine and in traditional Chinese medicine,it is concluded that the combination of Bushen Jianpi Xiezhuo decoction can improve the clinical symptoms of CKD3-4 patients with QI deficiency of spleen and kidney,improve the renal function and regulate the micro-inflammatory state of the patients,to control the level of proteinuria,to a certain extent,slow the progress of CKD to ESRD,and high safety,no obvious adverse reactions. |
