| Objective:To observe the effect of renal failure enema formula by effectively removing uremic toxins and protecting renal function in patients with chronic kidney disease stage 4-5 and assess whether down-regulation of protein-bound toxin levels can reduce atherosclerotic lipid accumulation in patients with chronic kidney disease stage 4-5.Methods:A clinical prospective randomized controlled study was conducted using non-dialysis patients with chronic kidney disease stage 4-5.A total of 68 patients admitted to the Department of Nephrology and Endocrinology,Wangjing Hospital,Chinese Academy of Traditional Chinese Medicine from February 2022 to February 2023 were selected and divided into treatment and control groups by the random number table method,with 34 patients in each group.Both groups were given basic treatment and the treatment group was given an enema in combination with the renal failure enema formula.The study period was 4 weeks.Using uremic toxins including protein-bound toxins,intermediate molecules,small metabolic toxins,eGFR and TCM symptom scores as indicators and performing efficacy analysis,to observe the effect of renal failure enema formula by effectively removing uremic toxins and protecting renal function in patients with chronic kidney disease stage 4-5.Atherosclerosis risk related indicators including blood lipids,inflammation,and comprehensive evaluation indicators were used as observational indicators to see if the risk of atherosclerosis could be reduced in patients with chronic kidney disease associated with protein-bound toxins.The safety of renal failure enema formula in clinical use was evaluated using blood count,liver function and stool count as safety indicators.Results:The study included 68 patients with chronic kidney disease stage 4-5,34 in the test group and 34 in the control group.During the study,7 cases were dislodged,and the reason for dislodgement was loss of visit.30 cases remained in the test group and 31 in the control group after dislodgement.1.Analysis of baseline data:There was no statistical difference between the two groups in terms of age,gender,chronic kidney disease stage,past medical history including hypertension,diabetes,coronary artery disease,cerebral infarction,venous thrombosis,hyperlipidaemia,carotid/lower limb atherosclerosis and the use of lipidlowering anticoagulants including statins,ezetimibe tablets and clopidogrel hydrogen sulfate tablets(P>0.05),and the groups were comparable.2.Analysis of uremic toxins outcomes:protein-bound toxins(indoxyl sulfate,indole-3-acetic acid),mid-molecular substances(cystatin C,β2-microglobulin),small metabolic toxins(blood creatinine,urea nitrogen),and eGFR were compared between the two groups before treatment,and none of the differences were statistically significant(P>0.05).The differences were statistically significant when comparing indoxyl sulfate,indole-3-acetic acid,cystatin C,β2-microglobulin and urea nitrogen between the two groups after treatment(P<0.05).In the test group,the differences were statistically significant when comparing indoxyl sulfate,indole-3-acetic acid,cystatin C,β2-microglobulin,blood creatinine,urea nitrogen and eGFR before and after treatment within the group(P<0.05);in the control group,the differences were not statistically significant when comparing indoxyl sulfate,indole-3-acetic acid,cystatin C before and after treatment within the group(P>0.05),and the differences were not statistically significant when comparing β2-microglobulin,blood creatinine,urea nitrogen,and eGFR before and after treatment(P<0.05).After treatment,the blood creatinine and eGFR of the two groups were compared between groups,and there was no statistical difference(P>0.05);the difference between the blood creatinine and eGFR of the two groups before and after treatment was statistically different(P<0.05).3.Correlation analysis of protein-bound toxins and atherosclerotic composite risk indicators:Pearson correlation analysis showed that the association between indoxyl sulfate and triglycerides/high-density lipoprotein cholesterol(TG/HDL-C)and monocyte to high-density lipoprotein ratio(MHR)were all statistically different and were all positively correlated(P<0.05);and the association between indole-3-acetic acid and TG/HDL-C and MHR were all statistically different and were all positively correlated(P<0.05).4.Analysis of atherosclerosis risk outcomes:Lipids(TG,HDL-C,LDL-C),and comprehensive evaluation indexes(TG/HDL-C,MHR)were compared between the two groups before treatment,and the differences were not statistically significant(P>0.05).After treatment,TG,HDL-C,TG/HDL-C,and MHR in both groups were compared between groups,and the differences were statistically significant(P<0.05);TG,HDL-C,TG/HDL-C,and MHR in the test group were compared between groups before and after treatment,and the differences were statistically significant(P<0.05);within-group comparison of TG,HDL-C,TG/HDL-C,MHR before and after treatment in the control group,all differences were not statistically significant(P>0.05),After treatment,the LDL-C of the two groups was compared between groups,and the difference was not statistically significant(P>0.05);the LDL-C of the test group was compared within groups before and after treatment,and the difference was statistically significant(P<0.001);the LDL-C of the control group was compared within groups before and after treatment,and the difference was not statistically significant(P>0.05).The difference between the two groups of patients before and after LDL-C treatment was statistically different(P<0.05).5.Analysis of TCM symptom score results:For the total TCM symptom score,there was no statistical difference between the two groups before treatment at baseline(P>0.05),and there was a statistical difference between groups after treatment(P<0.05)and within groups before and after treatment(P<0.001).Before treatment,there was no statistical difference between the two groups in the baseline comparison of symptoms of low back pain,lower limb weakness,fatigue and laziness,dry skin,itchy skin,chest tightness,abdominal distension,dullness,stomach distension,nausea,dry eyes,eye opacity,dry stools,lower limb oedema symptom scores(P>0.05).After treatment,there was a statistical difference between the two groups in the scores of dry skin,itchy skin,chest tightness,abdominal distension,stomach distension and dry stool symptoms(P<0.05),while there was no statistical difference between the two groups in the scores of low back pain,lower limb weakness,fatigue and laziness,dullness,nausea,dry eyes,eye opacity and lower limb oedema(P>0.05).6.Efficacy analysis:After 4 weeks of treatment,the total effective rate was 83.3%in the test group and 48.4%in the control group.In the test group,the effective rate of reducing blood creatinine was 83.3%,the effective rate of improving eGFR was 90.0%,and the effective rate of improving symptoms was 63.3%,while in the control group,the effective rate of reducing blood creatinine was 48.4%,the effective rate of improving eGFR was 51.7%,and the effective rate of improving symptoms was 29.1%.There was a statistical difference between the two groups in terms of efficiency(P<0.05).7.Safety analysis:The blood routine and liver function of the two groups before and after treatment were compared between groups,and there was no statistical difference(P>0.05).There was no statistical difference between the two groups when the blood routine and liver function were compared within the group before and after treatment(P>0.05).None of the included patients had a positive fecal occult blood test before or after treatment.Conclusion:Renal failure enema formula can effectively remove uremic toxins from chronic kidney disease patients,improve patients’ symptoms,effectively protect patients’ renal function,and reduce the risk of atherosclerosis caused by protein-bound toxins,with high effectiveness and safety in clinical use. 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