注射用头孢噻肟钠他唑巴坦钠治疗急性细菌感染的多中心单盲随机对照临床研究  

A multicenter,single blind,randomized controlled clinical trial of injectable cefotaxime sodium and tazobactam sodium in treatment of acute bacterial infections

作　　者：曹文锋[1] 王亮[1] 陈章[2] 王庆堂[1] 黄晓科[1] 李沙丹[1] 杨伟[1] 王起武[1] 

机构地区：[1]中国人民解放军成都军区总医院泌尿外科,四川成都610083 [2]中国人民解放军成都军区总医院呼吸内科,四川成都610083

出　　处：《中国新药与临床杂志》2014年第1期49-53,共5页Chinese Journal of New Drugs and Clinical Remedies

摘　　要：目的评价注射用头孢噻肟钠他唑巴坦钠（5：1）治疗急性细菌感染的有效性和安全性。方法采用多中心、随机、单盲、平行对照研究方法，共入选下呼吸道或泌尿系统急性细菌感染患者279例．试验组139例，对照组140例。试验组应用注射用头孢噻肟钠他唑巴坦钠（5：1）3．6g，对照组应用注射用头孢噻肟钠舒巴坦钠（2：1）4．5g，均为静脉滴注，每日2。3次，疗程5～14d。观察及比较两组的疗效和不良反应。结果纳入全分析集进行疗效分析258例，试验组和对照组分别为131例和127例。试验组与对照组临床痊愈率分别为97．0％和92．9％，细菌清除率分别为97．5％和96．0％，药物不良反应发生率分别为8．6％和9.3％，两组比较均无显著差异（P〉0．05），未见严重不良反应。细菌清除率的非劣效检验显示，试验组非劣于对照组（P〈0．05）。结论注射用头孢噻肟钠他唑巴坦钠（5：1）治疗急性呼吸系统和泌尿系统细菌感染，临床疗效确切，安全性较好。AIM To evaluate the efficacy and safety of injectable cefotaxime sodium and tazobactam sodium （5 ： 1） in the treatment of acute bacterial infections. METHODS A multicenter, single blind, randomized controlled clinical trial was conducted. Totally 279 patients with acute respiratory or urinary tract bacterial infection were randomized into treatment group or control group, 139 in the treatment group and 140 in the control group. The treatment group was treated with injectable cefotaxime sodium and tazobactam sodium （5 ： 1 ） at a dose of 3.6 g, 2 or 3 times a daily. The control group was treated with injectable cefotaxime sodium and sulbactam sodium （2 ： 1 ） at a dose of 4.5 g. Both drugs were administered intravenously 2 - 3 times daily for 5 - 14 days. The clinical effects and adverse reactions of the two groups were observed and compared. RESULTS There were 258 patients enrolled in the full analysis set （FAS） to analyze the efficacy, 131 in the treatment group and 127 in the control group. The cure rate for the treatment and control group was 97.0% and 92.9% and bacterial eradication rate was 97.5% and 96.0% , respectively. The incidence of drug adverse reactions was 8.6% and 9.3% respectively. There were no significant differences between the two groups （P 〉 0.05）. No serious adverse reaction was reported. Non inferiority test showed that bacterial clearance rate of the test group was non-inferior to the control group （P 〈 0.05）. CONCLUSION Injectable cefotaxime sodium and tazobactam sodium （5 ： 1 ） is effective and safe for the treatment of acute respiratory or urinary tract bacterial infections.

关 键 词：头孢噻肟 他唑巴坦 舒巴坦 细菌感染 随机对照试验 

分 类 号：R515[医药卫生—内科学] R978.11[医药卫生—临床医学]