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目的研究比较非布索坦与别嘌醇降低痛风(GOUT)患者血尿酸(SUA)水平的疗效和安全性。方法 486例痛风患者随机分成试验组:非布索坦40mg组(40mg,每日1次),非布索坦组80mg组(80mg,每日1次)和别嘌醇对照组(100mg,每日3次),疗程24周。主要疗效指标为24周末血尿酸水平降低到360μmol/L以下的患者比例,次要疗效指标为2周末血尿酸水平降低到360μmol/L以下的患者比例,24周治疗前后血尿酸下降的水平和痛风发作的次数。结果非布索坦40mg组、非布索坦80mg组、别嘌醇组三组意向性分析集(ITT)分析受试者末次访视SUA≤360μmol/L的达标率分别为49.06%、65.38%、43.67%,三组疗后24周SUA降低到360μmol/L以下的受试者达标率组间比较差异有统计学意义(P<0.0001),具体为非布索坦40mg组与非布索坦80mg组、非布索坦80mg组与别嘌醇组组间差异有统计学意义(P<0.05),非布索坦40mg组与别嘌醇组组间差异无统计学意义(P>0.05)。总不良反应发生率在三组间差异无统计学意义。结论非布索坦40mg组等效于别嘌醇组;非布索坦80mg组优效于别嘌醇组,且也优效于非布索坦40mg组。非布索坦长期用于降尿酸具有良好的耐受性。
Objective To compare the efficacy and safety of febuxostat and allopurinol in reducing uric acid (SUA) levels in patients with gout (GOUT). Methods 486 patients with gout were randomly divided into test group: febuxostat 40 mg group (40 mg once daily), febuxostat 80 mg group (80 mg once daily) and allopurinol control group (100 mg each Day 3 times) for 24 weeks. The main efficacy indicators for the 24-week serum uric acid levels decreased to 360μmol / L less than the proportion of patients, secondary efficacy indicators for the two-week serum uric acid levels decreased to 360μmol / L less than the proportion of patients, 24 weeks after treatment, serum uric acid levels and gout The number of seizures. Results According to ITT analysis of febuxostat 40 mg, febuxostat 80 mg and allopurinol groups, the compliance rate of SUA≤360 μmol / L at the last visit was 49.06% and 65.38% , 43.67% respectively. There was significant difference between the three groups in SUA reduced to below 360μmol / L at 24 weeks (P <0.0001), especially the combination of febuxostat 40mg and febuxostat There were significant differences between the 80mg group, the febuxostat 80mg group and the allopurinol group (P <0.05), and there was no significant difference between the febuxostat 40mg group and the allopurinol group (P> 0.05) . The total incidence of adverse reactions in the three groups showed no significant difference. Conclusion The febuxostat 40 mg group is equivalent to the allopurinol group; the febuxostat 80 mg group is superior to the allopurinol group and is also superior to the febuxostat 40 mg group. Febuxostat has long been used to reduce uric acid has good tolerance.