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

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名健康成人随机分配至低剂量为3.0 g(头孢噻肟钠2 g和舒巴坦钠1 g),中剂量为4.5 g(头孢噻肟钠3 g和舒巴坦钠1.5 g);高剂量为6.0 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、电解质等各项指标测定值均在正常范围内,用药前后比较差异无统计学意义(P＞0.05), 所有受试者均无不良反应发生. 结论:单次静滴注射用头孢噻肟钠舒巴坦钠最大剂量至6 g比较安全、耐受性较好.

Investigation on the tolerance to cefotaxime/sulbactam in healthy volunteers after a single intravenous infusion administration

AIM: To evaluate the safety of cefotaxime/sulbactam in Chinese healthy volunteers after a single intravenous infusion administration. METHODS: The trial protocol was designed according to the Good Clinical Practice (GCP). After physical examination and laboratory tests were performed, 30 healthy volunteers were divided randomly into 3 groups, including 3.0 g (cefotaxime/sulbactam:2 g/1 g), 4.5 g (cefotaxime/sulbactam:3 g/1.5 g) and 6.0 g (cefotaxime/sulbactam:4 g/2 g), with 10 subjects in each group (5 male 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 were observed or examined 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 were all in the normal range, and no adverse drug reactions were observed in every healthy volunteer. CONCLUSION: Single intravenous infusion administration of cefotaxime/sulbactam (up to 6 g) in 30 Chinese healthy volunteers is safe and tolerable.