| Objecive:Chronic kidney disease(CKD)is one of the most common complications in gout patients.There are no clear guidelines on how to choose better urate lowering therapy for gout patients with CKD.Due to the controversy and limitation of the current clinical research on this issue,this study compares the efficacy of febuxostat and benzbromarone in the treatment of gout patients with CKD2-4 stage and the laboratory indicators related to renal function,so as to provide a theoretical basis for the precise treatment of gout patients with CKD.Method:This is a single-center cohort study,According to the use of therapeutic drugs,the patients were divided into two groups:febuxostat group(febuxostat 40mg/d),benzbromarone group(benzbromarone 50mg/d).The course of treatment lasted 24 weeks.All patients received regular Urate-Lowering Therapy(ULT).The main observation indexes were serum uric acid(SUA),estimated glomerular filtration rate(eGFR),and the secondary observation indexes were blood routine,liver function,kidney function,urinary protein and blood lipid.The SUA?eGFR blood routine,liver function,renal function were recorded before treatment and at 4?8?12 and 24 weeks after treatment,Urinary protein and Blood lipids were recorded before treatment and at week 24 after treatment.The AEs during the treatment were observed and recorded.The statistical method used repeated measures analysis of variance to test the trend of indicators at each time point.The covariance analysis model was used to correct the baseline indicators and the differences between the two groups were compared.Result:In this study,according to the inclusion criteria,200 eligible gout patients with CKD2-4 were enrolled.100 cases in the febuxostat group,4 cases loss;100 cases in the benzbromarone group,10 cases loss.1.Comparison of the effect of reducing uric acid between two groups:the level of SUA in the two groups showed a significant downward trend,the difference was statistically significant at each time point(F=190.291,P<0.001),Covariance analysis showed that there was no significant difference in SUA change between the two groups(t=1.67,P=0.1975).The revised mean difference of SUA change(benzbromarone—febuxostat)between the two groups was 13.15(95%CI:-6.92,33.22;P=0.1975),the SUA compliance(SUA?360?mol/L)rate at 4 weeks and 12 weeks after treatment was higher in the benzbromarone group than in the febuxostat group,The difference was statistically significant(P<0.05),There was no significant difference in the SUA compliance(SUA?360?mol/L)rate between the two groups at week 24(P>0.05);There was no significant difference in SUA compliance(SUA?300umol/L)rate between the two groups at different time points(P>0.05).2.Comparison of renal function between two groups:the eGFR level of the two groups showed a significant upward trend,with significant difference at each time point(F=36.295,P<0.001).Covariance analysis showed that there was no significant difference in the influence of the two groups on eGFR(t=2.61,P=0.1083).The revised mean difference of eGFR changes(benzbromarone—febuxostat)between the two groups was-2.43(95%CI:-5.40,0.54;P=0.1083).Subgroup analysis demonstrated that the elevation of eGFR was significantly higher in the febuxostat group than in the benzbromarone group in the CKD3a stage,BMI<25kg/m~2 as well as negtive urinary protein before treatment,the difference was statistically significant(P<0.05).The serum creatinine level of the two groups showed a significant downward trend,with statistical significance at each time point(F=32.537,P<0.001),and Cystatin C level showed a significant downward trend,with statistical significance at each time point(F=159.104,P<0.001).there was no significant difference in the improvement of urinary protein between the two groups(c~2=0.850,P=0.356).3.In terms of other observational indicators:Alanine aminotransferase(ALT)in benzbromarone group increased in the 4th week after treatment and decreased in the 12th week after treatment compared with the 8th week after treatment.There were significant differences at different time points(F=5.960,P<0.001).In terms of lipid metabolism,triglyceride(TG)decreased significantly in both groups(F=5.856,P=0.016),while high density lipoprotein(HDL)increased significantly(F=7.633,P=0.006).In terms of blood routine,the white blood cell count(WBC)of the two groups decreased significantly(F=2.483,P=0.045).In terms of AE,there was no significant difference in the occurrence of AEs between the two groups(P>0.05).Conclusion:By comparing the efficacy of two uric acid-lowering drugs febuxostat and benzbromarone in patients with gout complicated with CKD2-4,we found that:1.Both febuxostat and benzbromarone can safely and effectively reduce SUA level in gout patients with CKD2-4 and the comparison between the two groups can not be considered that there is a difference in the effect of reducing uric acid.2.Both febuxostat and benzbromarone can safely and effectively improve renal function and the effect of febuxostat on renal function improvement in gout patients with CKD3a?BMI<25kg/m~2 as well as negtive urinary protein before treatment are better than that of benzbromarone.3.Both febuxostat and benzbromarone have a certain lipid-lowering effect at the same time as uric acid lowering and the comparison between the two groups can not be considered that there is a difference in the effect of lipid-lowering.There was no significant difference in the incidence of AE between febuxostat and benzbromarone in gout patients with CKD2-4 stage. |
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