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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 efficacy and safety of domestic cefoperazone / tazobactam in the treatment of acute bacterial respiratory tract infections, urinary tract infections and other systemic infections. Methods Randomized, parallel control and multi-center trial design were adopted in the study. Cefoperazone / tazobactam and cefoperazone / sulbactam were administered 2.0g per dose intravenously for 30-60min, q12h or q8h, Treatment 7 ~ 14d. Results A total of 220 patients were enrolled in this study. Thirteen patients were eliminated for various reasons and 207 patients were enrolled in the efficacy analysis. Among them, 103 were cefoperazone / tazobactam and cefoperazone / sulbactam 104 For example, the clinical effective rates of cefoperazone / tazobactam and cefoperazone / sulbactam at the end of treatment were 96.1% and 94.2% respectively. The clinical effective rates of treating various bacterial infections were 95.5% and 94.3% respectively. The pathogenic bacteria clearance rate was 91.0% and 89.7% respectively. The positive rate of β-lactamase produced by bacteria in both groups was 61.9% and the incidences of adverse reactions in both groups were 4.7% and 6.4% respectively. The above results were not statistically significant Sex differences. Susceptibility results show that cefoperazone / tazobactam and cefoperazone / sulbactam bacteria susceptibility results were similar, significantly better than cefoperazone, a significant difference. Conclusion Cefoperazone / tazobactam and cefoperazone / sulbactam are effective and safe in the treatment of respiratory tract, urinary tract and other systemic infections caused by common sensitive bacteria in clinic.