头孢哌酮/三唑巴坦与头孢哌酮/舒巴坦随机对照治疗急性细菌性感染多中心临床试验  

A randomized controlled multicenter clinical trial of cefoperazone/tazobactam versus cefoperazone/sulbactam in the treatment of bacterial infections

作　　者：张慧琳[1] 赵彩芸[1] 王进[1] 侯芳[1] 谭伟 刘英华[1] 高磊[1] 郑波[1] 崔洪[1] 刘又宁[2] 王睿[2] 余秉翔[2] 刘庆锋[2] 殷凯生[3] 刘文[3] 刘佳[3] 童明庆[3] 赵旺胜[3] 高和[4] 顾国利[4] 王岳松[4] 冯志强[4] 

机构地区：[1]北京大学第一医院国家药品临床研究基地,北京100034 [2]中国人民解放军总医院,北京100853 [3]南京医科大学第一附属医院,南京210029 [4]北京空军总医院,北京100036

出　　处：《中国抗生素杂志》2004年第1期29-36,47,共9页Chinese Journal of Antibiotics

摘　　要：目的评价国产头孢哌酮/三唑巴坦治疗急性细菌性呼吸道感染、泌尿道感染以及其他系统感染的有效性与安全性。方法采用区组随机、平行对照、多中心试验设计,头孢哌酮/三唑巴坦和头孢哌酮/舒巴坦均为每次给药2.0g,静脉滴注30～60min,q12h或q8h,疗程7～14d。结果本项试验共入选病例220例,因各种原因淘汰13例,进入疗效分析的病例数为207例,其中头孢哌酮/三唑巴坦组103例,头孢哌酮/舒巴坦组104例,治疗结束头孢哌酮/三唑巴坦与头孢哌酮/舒巴坦临床有效率分别为96.1%与94.2%,治疗各种细菌感染临床有效率分别为95.5%与94.3%,各种致病菌清除率分别为91.0%与89.7%,两组细菌产β-内酰胺酶阳性率为61.9%,两组不良反应发生率分别为4.7%与6.4%,上述结果经统计学处理均无显著性差异。药敏结果显示头孢哌酮/三唑巴坦与头孢哌酮/舒巴坦细菌敏感率结果相近,明显优于头孢哌酮,有显著差异。结论头孢哌酮/三唑巴坦与头孢哌酮/舒巴坦在治疗临床常见的敏感细菌引起的呼吸道、泌尿道以及其他系统感染均有效、安全。Objective To evaluate the clinical and bacterial efficacy and safety of cefoperazone/tazobactam versus cefoperazone/sulbactam in the treatment of acute respiratory tract,urinary tract and other system bacterial infections.Methods A randomized parallel controlled multicenter clinical trial was conducted which cefoperazone/tazobactam compared with cefoperazone/sulbactam.Cefoperazone/tazobactam or cefoperazone/sulbactam was given 2g intravenous 30min to 60min twice or thrice daily for 7～14 days.Results 220 patients were enrolled in the study,13 patients withdrew from trial because of various reasons.103 cases in cefoperazone/tazobactam group and 104 cases in cefoperazone/sulbactam group were assessable for clinical response.The overall clinical efficacy rates were 96.1%and 94.2%,the bacterial clinical efficacy rates were 95.5%and 94.3%,the bacterial eradication rates were 91.0%and 89.7%,respectively.β-lactamase positive rate was 61.9%in both group.The adverse drug reaction rates were 4.1%in cefoperazone/tazobactam group and 6.4%in cefoperazone/sulbactam group.There was no statistical significant difference between two groups (P> 0.05).In vitro bacterial activity results showed that cefoperazone/tazobactam’s sensitive rate was similar to cefoperazone/sulbactam, more superior to cefoperazone’s,and there were significant differences among three drugs.Conclusions Cefoperazone/tazobactam is as effective and safe as cefoperazone/sulbactam in the treatment of sensitive bacterial infections.

关 键 词：头孢哌酮/三唑巴坦 头孢哌酮/舒巴坦 多中心随机对照 临床试验 

分 类 号：R978.11[医药卫生—药品]