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IR@PKUHSC  > 北京大学第一临床医学院  > 临床药理研究所  > 期刊论文
学科主题: 药理学
题名:
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
其他题名: 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1; 纪霞1; 吴国明1; 陈国忠1; 杨炯1; 熊盛道1; 傅祖红1; 赵子文1; 付秀华1; 常晓悦1; 朱燕1; 高磊1; 刘文玖1; 林澜1; 苏秋菊1; 张梦云1; 吕雅婷1; 李红国1
关键词: 头孢西酮 ; 头孢唑林 ; 细菌清除率 ; 呼吸道感染 ; cefazedone ; cefazolin ; bacterial clearance rate ; respiratory infection
刊名: 中国临床药理学杂志
发表日期: 2014
DOI: 10.13699/j.cnki.1001-6821.2014.09.001
期: 9, 页:755-758,764
收录类别: 中国科技核心期刊 ; 中文核心期刊 ; CSCD
文章类型: Journal Article
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, q12 h。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 cefaze-done 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 en-rolled, 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 were 95.5% 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% and 91.7% 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 group
were 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.
语种: 中文
原文出处: 查看原文
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内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/44443
Appears in Collections:北京大学第一临床医学院_临床药理研究所_期刊论文

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作者单位: 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

Recommended Citation:
吕媛,葛庚芝,纪霞,等. 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[J]. 中国临床药理学杂志,2014(9):755-758,764.
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