注射用头孢哌酮钠/舒巴坦钠(3∶1)Ⅰ期临床试验耐受性研究  

Tolerance study of cefoperazone sodium/sulbactam sodium(3:1) for injection in phase Ⅰ clinical trial

作　　者：李珍[1] 程春燕[1] 杨武云[1] 唐世新[1] 计一平[1] 胡晋红[1] 

机构地区：[1]第二军医大学长海医院药学部,上海200433

出　　处：《药学服务与研究》2015年第1期35-37,共3页Pharmaceutical Care and Research

摘　　要：目的:观察健康受试者注射给予头孢哌酮钠/舒巴坦钠(3∶1)的安全性和耐受性。方法:选择28例受试者随机分配到1、2、4、6g单次给药组,每组人数分别为6、8、8、6例,男女各半,多次给药组纳入8例受试者,多次静滴药品,2g/次,bid,多次给药7d。观察受试者给药前后的临床症状和实验室检查指标。结果:所有受试者全部完成试验,单次和多次静脉给药对受试者的生命体征,血、尿、粪常规,凝血酶原时间,血液生化和心电图检查结果均无明显影响。多次给药组发生3例不良事件,其中1例为轻度头晕、口周部疱疹样水泡和腹胀,2例为丙氨酸氨基转移酶轻度增高,未采取干预措施或对症治疗后均恢复正常。结论:健康受试者单次及多次静滴头孢哌酮钠/舒巴坦钠(3∶1)耐受性和安全性良好。Objective：To investigate the safety and tolerance of cefoperazone sodium/sulbactam sodium（3∶1）（CSSS）for injection in healthy subjects.Methods：Twenty-eight subjects were randomly divided into 4groups.The number of subjects in each group were 6,8,8and 6,evenly composed of male and female.They were administrated with ascending doses of 1,2,4and6 g CSSS for a single injection.Eight subjects in the multiple-dose group were intravenously given CSSS,2g once,bid,for7 days.The clinical symptoms and detection results were observed both before and after medication of CSSS.Results：All the subjects completed the trial.After a single dose and multiple doses of CSSS,no significant effects could be seen on vital signs,blood routine,urine routine,stool routine,blood biochemistry and ECG.Three cases of adverse drug events occurred in the multiple-dose group.One case suffered from mild dizziness,herpes-like blisters and abdominal distension,and 2cases had mild ALT increase.They all recovered after symptomatic treatment,without any other intervention.Conclusion：Single dose and multiple doses of CSSS could be tolerated by healthy subjects and were safe for application.

关 键 词：头孢哌酮钠/舒巴坦钠 Ⅰ期临床试验 耐受性 安全性 

分 类 号：R978.11[医药卫生—药品]