Clinical trial of febuxostat tablets versus allopurinol tablets in the treatment of hyperuricemia and gout
10.13699/j.cnki.1001-6821.2017.20.004
- VernacularTitle:比较非布司他片与别嘌呤醇片治疗高尿酸血症伴痛风的临床研究
- Author:
Jin-Mu HUANG
1
;
Hui-Qiong CHI
;
Shao-Kai LIN
Author Information
1. 福建莆田学院附属医院药剂科
- Keywords:
febuxostat;
allopurinol;
hyperuricemia;
gout
- From:
The Chinese Journal of Clinical Pharmacology
2017;33(20):2009-2012
- CountryChina
- Language:Chinese
-
Abstract:
Objective To observe the clinical efficacy and safety profile of febuxostat and allopurinol in patients with hyperuricemia and gout.Methods A total of 90 patients with hyperuricemia and gout were randomly divided into three groups:treatment group A,treatment group B and control group.There were 30 patients in each group.The control group was given oral allopurinol tablets 300 mg tid.The treatment group A was given oral administration of febuxostat tablets 35 mg qd,while the treatment group B was given oral administration of febuxostat tablets 70 mg qd.All groups were treated for 24 weeks.The clinical efficacy and the incidence of adverse drug reactions were compared among the three groups,and serum levels of soluble intercellular adhesion molecule-1 (sICAM-1) and uric acid were compared at baseline,12 weeks and 24 weeks of treatment.Results After treatment,the total effective rates were 56.67％ (17 cases/30 cases),66.67％ (20 cases/30 cases) and 46.67％ (14 cases/30 cases) in the treatment group A,the treatment group B and the control group,the difference was statistically significant (P ＜0.05);After 12 weeks of treatment,serum sICAM-1 in the treatment group A and treatment group B were (445.76 ± 135.85),(421.28 ± 122.25) and (493.39 ± 121.27) ng · mL-1;After 24 weeks,serum sICAM-1 of the treatment group A,the treatment group B and the control group were (387.71 ±126.75),(360.85 ± 125.50) and (441.45 ± 122.48) ng · mL-1;After 12 weeks of treatment,uric acid levels in the treatment group A and treatment group B were (445.57 ± 135.50),(460.60 ± 140.45) and (515.20 ± 142.15) ng · mL-1;After 24 weeks,uric acid levels of the treatment group A,the treatment group B and the control group were (425.10 ± 126.28),(410.10 ± 130.38) and (478.80 ± 164.72) ng · mL-1,the difference was statistically significant (all P ＜ 0.05);Statistically significant differences were found among the three groups before and after treatment (all P ＜ 0.05).There were no obvious adverse drug reactions in the two treatment groups and the control group.Conclusion Febuxostat can reduce the levels of serum slCAM-1 and uric acid in patients with hyperuricemia and gout,achieving better clinical efficacy than allopurinol
