国产苯溴马龙与痛风利仙治疗高尿酸血症的随机对照研究

A Randomized Controlled Clinical Study of Domestic Benzbromarone and Narcaricin on Hyperuricaemia

目的 :评价国产苯溴马龙胶囊治疗高尿酸血症的有效性与安全性。方法 :采用非盲法随机对照试验 ,将纳入的 40例痛风高尿酸血症病人随机分入国产苯溴马龙组与痛风利仙 (进口苯溴马龙 )组 ,每组 2 0例。两组药物均为 5 0mg/日 ,晨服一次 ,疗程两周。结果 :两组病例治后血尿酸值均明显下降 ,治后一周下降更明显 ,与2 4小时尿尿酸排泄量增高程度基本一致。治后两组的显效率和总有效率分别为 6 5 0 0 %和 95 0 0 %与 80 0 0 %和85 0 0 ,差异无统计学意义 (p=0 6 5 3、 0 2 18)。两组不良反应发生率分别为 10 0 0 %与 0 % ,不良反应轻微 ,未见肝、肾功能损害发生。结论 :国产苯溴马龙胶囊是一强力排尿酸药 ,使用方便安全。

Objective:To evaluate the efficacy and safety of domestic Benzbromarone in the treatment of hyperuricaemia.Methods:A randomized controlled clinical study was conducted.40 patients entered this study and 20 cases in each group.Narcaricin mite was used as a control drug.The two medicines both were given 50mg once daily for 2 weeks.Results:Plasmatic urate reduced obviously after treatment,especially after one-week treatment,and accorded with the increase of urate excreted within 24 hours.The excellent efficacy rates and the effective rates were 65 00% and 95 00% in test group and 80 00% and 85 00% in controlled group respectively.There were no significant statistical differences between the two groups(p=0 653,0 218).The adverse drug reaction rates of the two group' were 10 00% and 0% respectively.The reactions were mild,and no damage to the function of liver and kidney was observed.Conlusion:As same as Narcaricin mite,the domestic Benzbromarone is an effective and safe uricosuric medicine and is convenient to use.