文档介绍：单次静滴注射用头孢噻肟钠舒巴坦钠注射液人体耐受性试验
作者:罗新民,郭亚权,顾宜,王晓娟,王荣,白娟娟,元英进
【关键词】注射用头孢噻肟钠;舒巴坦钠;耐受性;健康志愿者
【Abstract】 AIM: To evaluate the safety of cefotaxime/sulbactam in Chinese healthy volunteers after a single intravenous infusion administration. METHODS: The trial protocol ination and laboratory tests ed, 30 healthy volunteers ly into 3 groups, including g (cefotaxime/sulbactam:2 g/1 g), g (cefotaxime/sulbactam:3 g/ g) and g (cefotaxime/sulbactam:4 g/2 g), ale and 5 female, age range 30 to 39 years). Clinical symptoms, vital signs, routine blood tests, routine urine tests, hepatic function, renal function, blood electrolytes, and electrocardiogram ined before and after a single intravenous infusion administration of cefotaxime/sulbactam. RESULTS: After a single intravenous infusion of 3-6 g cefotaxime/sulbactam, the vital signs, clinical symptoms and laboratory tests al range, and no adverse drug reactions inistration of cefotaxime/sulbactam (up to 6 g) in 30 Chinese healthy volunteers is safe and tolerable.
【Keye; sulbactam; tolerance; healthy volunteers
【摘要】目的:在中国健康志愿者中评价单剂量静滴注射用头孢噻肟钠舒巴坦钠的安全性、耐受性. 方法:根据新药临床试验指导原则, 将经体检及实验室检查,各项指标均在正常范围内的30名健康*** g(头孢噻肟钠2 g和舒巴坦钠1 g), g(头孢噻肟钠3 g); g(头孢噻肟钠4 g和舒巴坦钠2 g)的3个剂量组,每组10名受试者,男女各半,年龄30~39岁. 观察指标为临床症状、生命体征、心电图、血常规、尿常规、肝功能、肾功能、电解质等. 结果:单次静滴注射用头孢噻肟钠舒巴坦钠3~6 g,志愿者体温、脉搏、呼吸频率、血压、心电图、血常规、肝功能、肾功能、电解质等各项指标