法罗培南钠片与头孢呋辛酯片治疗泌尿系统细菌性感染对照研究

Comparison study of Faropenem Sodium Tablets and cefuroxime axetil tablets on bacterial infection in urinary system

目的评价国产法罗培南钠片治疗泌尿系统细菌性感染的有效性及安全性。方法采用多中心随机双盲对照临床试验设计,125例患者随机分为试验组（予法罗培南钠片,62例）和对照组（予头孢呋辛酯片,63例）。给药方法为法罗培南钠组150 mg/次,头孢呋辛酯组250 mg/次,均为每日3次,口服,疗程为6~14 d。结果法罗培南钠组与头孢呋辛酯组痊愈率分别为77%和73%（P=0.565 9）,有效率分别为95%和100%（P=0.080 5）,细菌清除率分别为96%与100%（P=0.116 7）,不良反应发生率分别为2%与3%（P=0.744 5）。2组比较均无显著性差异。结论法罗培南钠片是治疗泌尿系统细菌性感染的有效和安全的药物。

Objective It is to evaluate the efficacy and safety of Faropenem Sodium Tablets on bacterial infection in urinary system.Methods A total of 125 patients with bacterial infection in urinary system were enrolled into this multicenter,double-blinded,randomized controlled clinical study.62 patients received Faropenem Sodium Tablets as trial group and 63 patients received cefuroxime axetil tablets as control group.Faropenem Sodium Tablets and cefuroxime axetil tablets were orally administered 150 mg and 250 mg respectively third a day.Duration of treatment was 6 to 14 d.Results The cure rates of trial group and control group were 77% and 73% respectively（P=0.565 9）,the effective rates were 95% and 100% respectively（P=0.080 5）,the bacterial clearance were 96% and 100% respectively（P=0.116 7） and the untoward reaction rate were 2% and 32% respectively（P=0.744 5）.There were all no significant differences between the two groups（P0.05）.Conclusion Faropenem Sodium Tablets is effective and safe for the treatment of bacterial infection in urinary system.