祛酸胶囊治疗慢性痛风患者高尿酸血症的双盲随机对照试验

Double-blind Randomized Controlled Clinical Trial of the Treatment of Hyperuricemia in Patients with Chronic Gout by Qusuan Capsules

[目的]评价祛酸胶囊治疗慢性痛风合并高尿酸血症患者的临床疗效和安全性。[方法]采用双盲随机对照的方法,将80例慢性痛风患者按1:1比例随机分成试验组40例(口服祛酸胶囊,2片/次,3次/d)和对照组40例(口服祛酸胶囊模拟剂,2片/次,3次/d),治疗期2个月,随访期3个月。主要疗效指标为治疗前后血尿酸(serum uric acid,SUA)水平的差值,次要疗效指标为两组受试者痛风发作次数、SUA达标率(SUA水平降低到360μmol·L-1以下的患者比例)。以上指标在治疗前、治疗后以及随访期检测。[结果]最后完成试验并纳入统计的受试者为69例,其中试验组35例、对照组34例,两组患者的一般资料和基线值具有可比性(P>0.05)。通过对两组受试者治疗前后的SUA差值进行独立样本t检验,结果显示组间差异有统计学意义(t=2.28,P=0.026)。两组患者的痛风发作次数、SUA达标率比较均无统计学差异(P>0.05)。肝肾功能检测结果和不良反应总结提示祛酸胶囊具备较好的安全性。[结论]祛酸胶囊可以明显降低受试者的SUA水平,具备较好的安全性。

[Objective] To evaluate the effect and safety of Qusuan capsules in the treatment of hyperuricemia in patients with chronic gout.[Methods] In this double-blind randomized controlled clinical trial, eighty patients with hyperuricemia and chronic gout were randomly assigned to experiment group 40 cases(Qusuan capsules, 2 pieces, three times per day) and control group 40 cases(placebo, 2 pieces, three times per day)in 1:1 ratio. The intervention period was two months and the follow-up period was three months. The primary outcome measurement was the difference of the level of serum uric acid(SUA) before and after treatment;the secondary outcomes were the number of gout attacks, the compliance rate of SUA(proportion of patients whose SUA level were <360μmol·L-1). All outcomes were measured at baseline(before treatment), after treatment and follow-up. [Results] Sixty-nine cases completed the intervention and follow-ups, included 35 cases in experiment group and 34 cases in control group. The general information and baseline of two groups were comparable(P >0.05). Independent sample t-test comparing changes of SUA(month 2-baseline) between two groups demonstrated significant improvements in the test group(t=2.28,P=0.026). No significant differences between two groups of gout attacks, the compliance rate of SUA were found by Chi-square test(P>0.05). Blood tests of liver and kidney function and the summary of adverse reactions showed the intervention of Qusuan capsules was safe.[Conclusion] This trial demonstrates that Qusuan capsules may significantly and safely reduce the level of SUA.