新治君治疗泌尿系统感染的随机盲法多中心临床研究  

Multicenter clinical study on Xinzhijun for treatment of urinary tract infection

作　　者：阎锡新[1] 杨书文[1] 王东彬[1] 周巧玲[2] 敖翔[2] 邓声莉[2] 尹良红[3] 陈湛华[3] 郑绮宜[3] 李明明[4] 王志峰[4] 王静[4] 穆立芹[4] 王廷春 林长征 李苌清 王霆 

机构地区：[1]河北医科大学第二医院,050005 [2]中南大学湘雅医院 [3]暨南大学附属第一医院 [4]河北医科大学第一医院 [5]广州博济国家新药临床研究中心 [6]湘北威尔曼制药有限公司

出　　处：《中国现代药物应用》2011年第4期7-10,共4页Chinese Journal of Modern Drug Application

基　　金：国家十二五"重大新药创制"科技重大专项(项目编号:2011zx09401-301-4)

摘　　要：目的以注射用头孢噻肟钠配注射用舒巴坦钠(组合包装)为对照,评价新治君(注射用头孢噻肟钠舒巴坦钠)治疗泌尿系感染的有效性和安全性。方法用多中心、随机、盲法、平行对照的试验方法,实验组和对照组均采用每次3.0 g,2次/d,疗程均为5～14 d的治疗方案。试验组和对照组的临床可评价病例均为60例,细菌学疗效评价例数分别为45例和53例。结果试验组和对照组的临床有效率分别为90.00%和88.33%;细菌清除率分别为90.11%和90.57%;药物不良反应发生率分别为4.92%和1.54%;两组均未出现严重药物不良反应。结论新治君是治疗泌尿系中、重度感染的安全有效药物。Objective To evaluate the efficacy and safety of XinZhiJun（Cefotaxime Sodium and Sulbactam Sodium for Injection） in treatment of urinary tract infections compared to Cefotaxime sodium for injection plus Sulbactam sodium for injection combination.Methods A randomized,double-blind,parallel controlled,multicenter trial was conducted,and the dose of XinZhiJun（experimental group）and Cefotaxime sodium for injection plus Sulbactam sodium for injection combination（control group）was 3.0 g,bid for 5-14 days.The total number of final evaluated subjects was 120.The bacterial evaluated subjects were 45 for experimental group and 53 for control group.Results Clinical efficacy rate and bacterial eradication rate for experimental group was 90.00% and 90.11%,for control group was 88.33% and 90.57%,respectively.The incidence of adverse reaction including whole clinicalreactions and laboratory abnormalities was 4.92% for experimental group and 1.54% for control group.Serious adverse drug reaction did not occur in two groups.Conclusion The XinZhiJun had an excellent clinical efficacy and good safety profile in treating patients with moderate to severe degree urinary tract bacterial infections.

关 键 词：新治君 头孢噻肟钠 舒巴坦钠 细菌感染 临床研究 

分 类 号：R691.4[医药卫生—泌尿科学]