抑酸痛风颗粒治疗原发性急性痛风性关节炎湿热瘀阻证的临床研究

Clinical study on Yisuantongfeng granule in the treatment of primary acute gouty arthritis

目的:评价抑酸痛风颗粒治疗原发性急性痛风性关节炎湿热瘀阻证的临床疗效和安全性。方法:采用分层随机、双盲、安慰剂平行对照、多中心临床试验方法。将病人随机分成试验组和对照组。试验组113例,口服抑酸痛风颗粒6g/袋,每日3次;对照组114例,口服安慰剂颗粒6g/袋,每日3次。分别在治疗后7d进行疗效和安全性评价。结果:试验组疾病疗效临床控制率为23.01%,显效率30.09%,有效率53.10%;安慰剂组临床控制率为14.04%,显效率14.91%,有效率28.95%。两组差异有统计学意义(P<0.05)。结论:抑酸痛风颗粒治疗原发性急性痛风性关节炎湿热瘀阻证安全、有效。

Objective： To evaluate the efficacy and safety of yisuantongfeng granule for shireyuzu symptom of primary acute gouty arthritis. Methods： Stratified random, double-blind, placebo-controlled, multi-center clinical trial were taken. Subjects with gouty arthritis were randomly divided into treatment group or control group. During the trial period, patients of each group received 6 g of yisuantongfeng granule or a placebo for three times per day for 7 days respectively. After 7 days, efficacy and safety would be evaluated. Results： Effective rate of treatment group was 53.10%, while control group was 28.95%, clinic control rate of treatment group was 23.01%, while control group was 14.04%, and obvious effective rate of treatment group was 30.09%,while control group was 14.91%. Conclusion： Yisuantongfeng granule is safe and effective to improve the shireyuzu symptom,which can be used to treat primary acute gouty arthritis.