注射用头孢西酮钠与注射用头孢唑林钠多中心随机盲法平行对照治疗急性细菌性呼吸道感染临床研究  

Multi-center,randomized,blinded,parallel control clinical study of cefazedone injection and cefazolin injection in the treatment of acute bacterial respiratory infections

作　　者：吕媛[1] 葛庚芝[2] 纪霞[3] 吴国明[4] 陈国忠[5] 杨炯[6] 熊盛道[7] 傅祖红[8] 赵子文[9] 付秀华[10] 常晓悦[11] 朱燕[1] 高磊[1] 刘文玖 林澜 苏秋菊 张梦云 吕雅婷 李红国 

机构地区：[1]北京大学第一医院临床药理研究所,北京100191 [2]天津医科大学第二医院,天津300211 [3]青岛市市立医院,青岛266011 [4]第三军医大学第二附属医院,重庆400037 [5]武汉大学人民医院,武汉430060 [6]武汉大学中南医院,武汉430077 [7]华中科技大学同济医学院附属同济医院,武汉430030 [8]广州军区武汉总医院,武汉430070 [9]广州市第一人民医院,广州510180 [10]内蒙古医学院附属医院,呼和浩特010050 [11]包头市中心医院,内蒙古包头014040 [12]天津新丰制药有限公司,天津300190

出　　处：《中国临床药理学杂志》2014年第9期755-758,764,共5页The Chinese Journal of Clinical Pharmacology

基　　金：国家十二五科技基金资助项目(2012ZX0903-005-003)

摘　　要：目的评价注射用头孢西酮钠与注射用头孢唑林钠治疗急性细菌性呼吸道感染的有效性和安全性。方法符合入选标准的患者连续7-14 d随机静脉滴注头孢西酮（试验组）或头孢唑林（对照组）2.0 g,q12h。定期评价有效性和安全性。结果 11个研究中心共入选260例患者,头孢西酮组126例,头孢唑林组134例。符合方案集（PPS）中,头孢西酮组和头孢唑林组的痊愈率分别是95.5%和94.9%,2组比较差异无统计学意义（P〉0.05）。细菌学符合方案集（BPPS）中,头孢西酮组和头孢唑林组的细菌清除率为100%和91.7%,综合疗效痊愈率分别为94.4%和91.7%,2组比较差异均无统计学意义（P〉0.05）。头孢西酮组不良事件（AE）发生人数为10人（10/126）,头孢唑林组为14人（14/134）,其中头孢西酮和头孢唑林组分别有6和10人发生了与药物相关的轻度或中度AE。头孢唑林组1例发生与药物无关严重AF。结论注射用头孢西酮钠治疗社区获得性呼吸系统感染是安全有效的。Objective To evaluate the safety and efficacy of cefazedone injection（ CZD） compared with cefazolin injection（ CZL） in the treatment of acute bacterial respiratory infections. Methods Eligible subjects were divided randomly to receive 2. 0 g cefazedone injection or cefazolin injection twice a day for 7 to 14 days. Efficacy and safety evaluation were done in accordance with the clinical trial protocol.Results Two hundred and sixty patients in 11 hospitals were enrolled,126 in CZD group（ trial） and 134 in CZL group（ control）.There were no statistical differences in basic conditions between two groups（ P〉0. 05）. Cure rates of CZD group and CZL group were95. 5% and 94. 9% in PPS（ P〉0. 05）. Bacteria clearance rates of CZD group and CZL group were100% and 91. 7% in BPPS and the total cure rates of CZD group and CZL group were 94. 4% and91. 7% in BPPS,respectively（ P〉0. 05）. Ten out off 126 patients in CZD group and 14 out off 134 in CZL group developed adverse events（ AE）. Six and eleven events in CZD group and CZL groupwere evaluated to be related with study drugs. One case in CZL group developed severe AE,which was considered not related with study drug. Conclusion Cefazedone injection is safe and effective in the treatment of respiratory infections.

关 键 词：头孢西酮 头孢唑林 细菌清除率 呼吸道感染 

分 类 号：R978.1[医药卫生—药品] R373.1[医药卫生—药学]