注射用头孢他啶他唑巴坦钠(3∶1)在呼吸及泌尿系统感染中的多中心随机对照临床试验  

Multicenter randomized controlled clinical trial of ceftazidime and tazobactam sodium injection(3∶1)in respiratory and urinary system infections

作　　者：暴婧[1] 洪丽萍 刘新民[3] 于中和 孙武装[5] 杨书文[6] 付秀华[7] 粱显泉 曹照龙[1] BAO Jing;HONG Li-ping;LIU Xin-min;YU Zhong-he;SUN Wu-zhuang;YANG Shu-wen;FU Xiu-hua;LIANG Xian-quan;CAO Zhao-long(Department of Respiratory and Critical Care Medicine,Peking University People’s Hospital,Beijing 100044,China;Honz Pharmaceutical Co.,Ltd,Guangzhou 510095,Guangdong Province,China;Department of Respiratory Medicine,Peking University First Hospital,Beijing 100034,China;Department of Nephrology,Seventh Medical Center of People’s Liberation Army General Hospital,Beijing 100700,China;Department of Urology,The First Hospital of Hebei Medical University,Shijiazhuang 050031,Hebei Province,China;Department of Respiratory Medicine,The Second Hospital of Hebei Medical University,Shijiazhuang 050000,Hebei Province,China;Department of Respiratory Medicine,Affiliated Hospital Inner Mongonia Medical University,Hohhot 010000,Inner Mongolia Autonomous Region,China;Department of Urology,Affiliated Hospital Guiyang Medical University,Guiyang 550004,Guizhou Province,China)

机构地区：[1]北京大学人民医院呼吸与危重症医学科,北京100044 [2]康芝药业股份有限公司,广东广州510095 [3]北京大学第一医院呼吸内科,北京100034 [4]中国人民解放军总医院第七医学中心肾内科,北京100700 [5]河北医科大学第一医院泌尿外科,河北石家庄050031 [6]河北医科大学第二医院呼吸科,河北石家庄050000 [7]内蒙古医科大学附属医院呼吸科,内蒙古呼和浩特010000 [8]贵阳医学院附属医院泌尿外科,贵州贵阳550004

出　　处：《中国临床药理学杂志》2021年第22期3019-3023,共5页The Chinese Journal of Clinical Pharmacology

摘　　要：目的评价注射用头孢他啶他唑巴坦钠(3∶1)及注射用头孢他啶他唑巴坦钠(5∶1)治疗中、重度呼吸及泌尿系统头孢他啶耐药菌感染患者的有效性及安全性。方法将360例患者随机分为对照组、试验1组和试验2组,每组120例,其中每组中含呼吸系统感染和泌尿系统感染各60例。对照组给予注射用头孢哌酮钠舒巴坦钠每次2.0 g,bid,静脉滴注;试验1组给予注射用头孢他啶他唑巴坦钠(5∶1)每次2.4 g,bid,静脉滴注;试验2组给予注射用头孢他啶他唑巴坦钠(3∶1)每次2.4 g,bid,静脉滴注。根据病情轻重程度不同,一般治疗7~14 d。比较3组患者的临床疗效和药物不良反应的发生情况。结果在治疗呼吸系统感染方面:3组均表现出较好的疗效,试验1组、试验2组和对照组的总有效率分别为86.67%(52例/60例),90.00%(54例/60例)和91.67%(55例/60例),差异均无统计学意义(均P>0.05);试验2组的痊愈率为50.00%均显著优于对照组和试验1组(35.00%和40.00%),差异均有统计学意义(均P<0.05)。在治疗泌尿系统感染方面:3组的总有效率均大于86%,显示出良好的治疗效果。试验2组在肺炎、支扩并感染、复杂性尿路感染治疗上的总有效率相对对照组和试验1组具有优势。治疗中,3组均未出现严重药物不良反应。结论注射用头孢他啶他唑巴坦钠(3∶1)治疗呼吸及泌尿系统急性细菌性感染的临床疗效确切,安全性高。Objective To evaluate the efficacy and safety of ceftazidime and tazobactam sodium(3∶1)and ceftazidime and tazobactam sodium(5∶1)in the treatment of moderate and severe respiratory and urinary system ceftazidime-resistant infections.Methods A total of 360 patients were randomly divided into control group,treatment group 1 and treatment group 2 with 120 cases per group,and each group contains 60 cases of respiratory system infection and 60 cases of urinary system infection.Control group was given intravenous infusion of cefoperazone sodium and sulbactam sodium for injection 2.0 g each time,twice a day.Treatment group 1 was given intravenous infusion of ceftazidime and tazobactam sodium(5∶1)2.4 g each time,twice a day.Treatment group 2 was given intravenous infusion of ceftazidime and tazobactam sodium(3∶1)2.4 g each time,twice a day.According to the severity of the condition,three groups were treated for 7-14 d.The clinical efficacy and adverse drug reactions were compared among three groups.Results In the treatment of respiratory infections:the three groups all showed good curative effects.The total effective rates of the treatment group 1,treatment group 2 and control group were 86.67%(52 cases/60 cases),90.00%(54 cases/60 cases)and 91.67%(55 cases/60 cases),the differences were not statistically significant(all P>0.05).The cure rate of the treatment group 2 was 50.00%,which was better than that of the control group and treatment group 1(35.00%and 40.00%),the differences were statistically significant(all P<0.05).In the treatment of urinary system infections:the total effective rates of the three groups were greater than 86%,showing a good therapeutic effect.The total effective rates of the treatment group 2 in the treatment of pneumonia,bronchiectasis complicated infection and complicated urinary tract infection was better than control group and treatment group 1.During the treatment,no serious adverse drug reactions occurred in the three groups.Conclusion Ceftazidime and tazobactam sodium(3∶1)for inj

关 键 词：头孢他啶钠他唑巴坦钠(3∶1) 头孢他啶钠他唑巴坦钠(5∶1) 耐药菌感染 呼吸系统感染 泌尿系统感染 

分 类 号：R978.1[医药卫生—药品]