Multi-center, randomized, blinded, parallel control clinical study of cefazedone injection and cefazolin injection in the treatment of acute bacterial respiratory infections
10.13699/j.cnki.1001-6821.2014.09.001
- VernacularTitle: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
- Author:
Yuan LV
1
;
Geng-Zhi GE
;
Xia JI
;
Guo-Ming WU
;
Guo-Zhong CHEN
;
Jiong YANG
;
Sheng-Dao XIONG
;
Zu-Hong FU
;
Zi-Wen ZHAO
;
Xiu-Hua FU
;
Xiao-Yue CHANG
;
Yan ZHU
;
Lei GAO
;
Wen-Jiu LIU
;
Lan LIN
;
Qiu-Ju SU
;
Meng-Yun ZHANG
;
Ya-Ting LV
;
Hong-Guo LI
Author Information
1. 北京大学 第一医院 临床药理研究所
- Keywords:
cefazedone;
cefazolin;
bacterial clearance rate;
respiratory infection
- From:
The Chinese Journal of Clinical Pharmacology
2014;(9):755-758,764
- CountryChina
- Language:Chinese
-
Abstract:
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.
