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| 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 |
| DOI： |
| 中文关键词: 痛风 高尿酸血症 双盲 随机对照 祛酸胶囊 |
| 英文关键词: Gout hyperuricemia double blind randomized controlled trial Qusuan capsules |
| 基金项目:浙江省中医药科技计划重点项目（2013ZZ005） |
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| 中文摘要: |
| [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（口服祛酸胶囊，2片，每日3次) 和对照组(口服祛酸胶囊模拟剂，2片，每日3 次)，治疗期2个月，随访期3个月。主要疗效指标为血尿酸（SUA)含量，次要疗效指标为两组受试者痛风发作次数，血尿酸达标率（血尿酸水平降低到360 μmol/L），以及血肌酐（Cr)和尿素氮（BUN)。以上指标在治疗前、治疗后以及随防期检测。[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。通过重复测量方差分析（Repeated Measures ANOVA），两组受试者的SUA含量差异有统计学意义（F=0.153，P=0.046）；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、血尿酸达标率以及肾功能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本试验具备较好的安全性。[结论]祛酸胶囊可以明显降低受试者的血尿酸水平，且具备较好的安全性。 |
| 英文摘要: |
| [Objective] To evaluate the effect and safety of “Qusuan capsules” for reducing the serum uric acid (SUA) in patients with hyperuricemia and gout.[Methods] In this double-blind randomized controlled clinical trial, 80 patients with hyperuricemia and gout were randomly assigned to atest group (Qusuan capsules, 2 pieces, tid) or a control group (placebo, 2 pieces, tid)in a 1:1 ratio. The intervention period was two months and the follow-up period was three months. The primary outcome measurement was the amount of SUA; the secondary outcomes were the number of gout attacks, the compliance rate of SUA (<360 μmol/l),serum creatinine (Cr) and blood urea nitrogen (BUN). All outcomes were measured at baseline (before treatment), after treatment (month 2), and follow-up (month 5).
[Results] 69 cases completed the intervention and follow-ups, included 35 cases in the test group and 34 cases in the control group. The general information and baselineof two groups were comparable. Repeated-measures ANOVA demonstrated significant improvements in the test group compared to the control group for SUA (F=0.153，P=0.046)；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, Cr, and BUN 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 in this trial was safe.[Conclusion] This trial demonstrates that “Qusuan capsules” may significantly and safely reduce the amount of SUA. |
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