Clinical Study Of Febuxostat Tablets Treating Gout With Hyperuricemia And Influence Of Inflammatory Factor IL-1??NALP3 Levels

Objective: To confirm the safety and efficacy of febuxostat tablets of two different dosages in treating gout patients with hyperuricemia and to explore their effects on the levels of inflammatory factors IL-?and NALP3 in vivo.Methods: 72 gout patients who met the inclusion criteria among all those receiving treatment in the nephrology department of the first affiliated hospital of Nanchang University from October, 2012 to June, 2013 were selected and they were randomly assigned to groups A, B and C, with 24 patients in each group. Patients in group A administered orally the febuxostat 40 mg tablets 1 tablet once daily. febuxostat 80 mg simulation agents 1 tablet once daily and allopurinol tablet simulation agents 1 tablet trice daily. Patients in group B administered orally the febuxostat 80 mg tablets 1 tablet once daily, febuxostat tablet 40 mg simulation agents 1 tablet once daily and allopurinol tablet simulation agents 1 tablet trice daily. Patients in group C administered orally the febuxostat 40 mg simulation agents 1 tablet once daily, febuxostat tablet 80 mg simulation agents 1 tablet once daily and allopurinol tablets 1 tablet(0.1g) trice daily. The safety and efficacy of febuxostat were confirmed through randomized, double blind, double simulation and parallel controlled trials. 24 healthy participants without histories of gout, hyperuricemia, diabetes, cardiovascular disease and renal disease were used as the normal control group D and their serum IL-1?and NALP3 levels were detected using ELISA. 72 patients with gout had their serum IL-1?and NALP3 levels detected using ELISA prior to and after the treatment.Results: 1, There were no significant difference between the general information and the serum uric acid levels of patients in groups A, B and C before the treatment and they were comparable in these 3 groups. The normalizing rates of serum uric acids as the main curative effect index were 56.52% in group A, 65% in group B and 38.10% in group C. The rates in the febuxostat groups were higher than those in the allopurinol groups and the rates in the febuxostat 80mg/d groups were higher than those in the febuxostat 40mg/d, demonstrating that febuxostat displayed better effects in lowing blood uric acid levels and kept them steady. Besides, improved efficacy could be yielded by increasing the dosage of febuxostat. Although some of the indexes showed no statistical difference, the febuxostat 80mg/d group was superior to the other two groups and the latter two groups were comparable through comparison of the ratios of patients whose blood uric acids were <360 ?mol/L, the blood uric acid values and the decrease in the values of blood uric acids in the visiting stations. 2, At the baseline, the IL-1?levels in groups A, B and C were significantly higher than its level in group D and they had statistical difference, suggesting that hyperuricemia could up-regulate the inflammatory reactions in vivo. When the treatment discontinued, the IL-1?levels of gout patients in groups who received treatment were lower than those prior to the treatment and yet they had no statistical difference, implying that the uric acid-lowing treatment might alleviate the up-regulation of inflammatory reactions. The NALP3 levels in groups A, B and C prior to the treatment were significant lower than its level in group D and they were statistically significant, After the treatment, the NALP3 levels were elevated and they were negatively correlated with those of blood uric acid. A per the NALP3 levels, there were no statistical difference in the groups in which patients received the treatment, suggesting that NALPS might play a role as the negative feedback in the inflammatory reactions and its expression could be up-regulated by the uric acid-lowing treatment.Conclusion: Febuxostat displays good safety and efficacy in treating gout patients with hyperuricemia and elevated efficacy can be yielded by increasing its dosage. Besides, the uric acid-lowing treatment may have the trend of down-regulating inflammatory reactions in vivo possible.