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头孢匹罗(Cefpirome)是1992年新上市的第4代注射用头孢菌素,其耐受性资料已在欧洲和美国进行的包括3103例病人的16个临床试验中获得.这些临床试验(Ⅱ期临床试验6个,Ⅲ期10个)均按照临床试验管理规范(GCP)及国际间临床研究的最新标准执行,对照组为使用头孢噻甲羧肟(Ceftazidime 1134例)、头孢三嗪(Ceftriaxone221例)、伊米配能(Imipenem 54例)及氟嗪酸(Ofloxacin 36例)的1445例病人.结果,接受头孢匹罗治疗的3103例病人中,679例(21.9%)出现了临床不良事件,而对照组不良事件发生率则为27.1%(391/1445),其中头孢匹罗治疗组与对照组病人与药物治疗“可能(possible)存在因果关系的不良事件发
Cefpirome is the fourth generation cephalosporin for injection, newly introduced in 1992, and its tolerability data have been obtained in 16 clinical trials involving 3103 patients in Europe and the United States. These clinical trials (II Six of them were in phase I and 10 in phase III) according to the latest standards of GCP and international clinical research. The control group was ceftazidime (Ceftazidime 1134), Ceftriaxone 221 (54 cases of Imipenem) and Ofloxacin (36 cases of Ofloxacin) were included in the study, and 673 (21.9%) of 3103 patients treated with cefpirome had a clinical adverse event , While the incidence of adverse events in the control group was 27.1% (391/1445). Among them, there was a "causal association between patients treated with cefpirome and the control group