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采用基于模型的荟萃分析方法,以患者血尿酸降至6 mg·d L-1以下的应答率作为临床终点,对别嘌醇和非布索坦两种药物的药效进行比较。共计22项临床研究、43个剂量组、6 365名痛风患者被纳入本项研究。通过模型的建立,分别探讨了别嘌醇和非布索坦的应答率随时间、剂量的变化规律,以及血尿酸水平、别嘌醇非应答者对应答率的影响。结果表明,使用别嘌醇治疗的平均最大应答率为50.8%。非布索坦药效良好,给药后药效迅速达稳,模型拟合得到非布索坦的ED50值为34.3 mg。患者基础血尿酸水平与别嘌醇应答率呈负相关,而非布索坦的ED50随患者基础血尿酸水平的增加而增大。别嘌醇单独用药治疗效果不足患者,其平均最大应答率约为别嘌醇应答者的1/2。
The efficacy of allopurinol and febuxostat was compared using a model-based meta-analysis with a response rate of 6 mg · d L-1 in patients with uric acid as the clinical endpoint. A total of 22 clinical studies, 43 dose groups, and 6 365 gout patients were included in this study. Through the establishment of the model, the changes of response rate of allopurinol and febuxostat with time and dose, as well as the level of serum uric acid, and the response rate of allopurinol non-responders were investigated. The results showed that the average maximum response rate with allopurinol treatment was 50.8%. Febuxostat has a good pharmacological effect, and the drug efficacy is rapidly stabilized after administration. The ED50 value of the febuxostat obtained by the model fitting is 34.3 mg. Patients with basal serum uric acid levels and allopurinol response rate was negatively correlated, while the FB30 of febuxostat with the increase of patients with basal uric acid levels. Allopurinol alone treatment of patients with inadequate efficacy, the average maximum response rate of about allopurinol responders 1/2.