Research On The Efficacy And Safety Of Febuxostat In Chronic Kidney Disease With Asymptomatic Hyperuricemia

OBJECTIVE:In recent years,with the improvement of living standards and the changes of dietary structure,the average level of serum uric acid?SUA?and the prevalence of hyperuricemia?HUA?in the population have gradually increased.Current studies have demonstrated that HUA is an independent risk factor for multisystem diseases,such as gout,type 2 diabetes mellitus,metabolic syndrome and cardiovascular diseases.But whether HUA plays an independent role in the new-onset chronic kidney disease?CKD?and development of CKD is still debatable,so the role and safety of urate-lowering therapy?ULT?in the CKD with HUA patients are still controversial.Our study will explore the efficacy and safety of Febuxostat in the treatment of the CKD with asymptomatic HUA patients,it will provide basis for the ULT in the above patients and the clinical application of Febuxostat.METHODS:A prospective,single-center,randomized controlled clinical study was carried out in 109 patients with the CKD combined with asymptomatic HUA,who visited the Nephrology Department,Tianjin Medical University General Hospital from June 2017 to December 2017.75 patients with stage 2-3 CKD were randomly divided into A1 and A2 groups.Group A1?n=41?was treated with Febuxostat40mg/d,group A2?n=34?with Febuxostat 40mg/d and Coated Aldehyde Oxystarch Capsules 15g/d.34 patients with stage 4-5 CKD were randomly divided into B1 and B2 groups.Group B1?n=13?was treated with Febuxostat 20mg/d,and group B2?n=21?with Febuxostat 40mg/d.Observe the changes of SUA,Scr,UREA,ALB,ALT,AST,WBC,HGB and PLT and the adverse reactions after 4 weeks and carry on statistical analysis finally.RESULTS:?1?After treatment,the SUA,Scr and eGFR of group A1 were significantly ameliorated(P<0.05,P_SUA<0.001),56.10%?23/41?patients in group A1 achieved the target SUA?<360?mol/L?,and there was no significant difference between male and female?58.06%vs 50.00%,P=0.724,P>0.05?.The SUA,UREA and Scr of group A2 were significantly decreased,and the eGFR was significantly improved?P<0.01?.The decrease of SUA in group A2 was larger than in group A1?40.14±12.71%vs 38.87±11.49%?,but there was no significant difference between groups?P=0.861,P>0.05?;?2?After treatment,the UREA,Scr and eGFR of groups B1 and B2 were improved,but there was no significant difference?P>0.05?.The SUA of two groups was significantly decreased?P<0.001?,and the decrease of SUA in group B2 was larger than in group B1?40.16±15.40%vs 33.55±28.16%?,but there was no significant difference between two groups?P=0.663,P>0.05?;?3?The incidence of adverse reactions was higher in group A1 than in group A2?14.63%vs8.82%?,and group B2 was higher than group B1?38.10%vs 15.38%?,but there was no significant difference between groups(P_A1-A2=0.499,P_B1-B2=0.251,P>0.05).There was no serious adverse event and death in the four groups during our study.CONCLUSION:1.In our study,there were more male cases than female cases in CKD with asymptomatic HUA,which is consistent with the results of HUA epidemiological investigation;2.Febuxostat has significant effect on lowering SUA in CKD with asymptomatic HUA patients in a short time?4 weeks?,more than 50%of patients reach the target SUA?below 360?mol/L?,with no gender difference;3.For mild to moderate CKD with asymptomatic HUA patients,Febuxostat can effectively reduce the SUA and Scr,and improve the eGFR;4.Combining Febuxostat with Coated Aldehyde Oxystarch Capsules to treat the CKD with asymptomatic HUA patients can significantly reduce the SUA,UREA and Scr,and improve the eGFR;5.In stage 4-5 CKD with asymptomatic HUA patients,low-dose Febuxostat has a significant effect in lowering SUA and high safety.Scr tends to decrease in a short time,and its long-term effects need to be observed;6.Febuxostat is effective and safe in treating CKD with asymptomatic HUA patients in a short time,it can improve the renal function and delay the progress of CKD.