注射用头孢呋辛钠/舒巴坦钠Ⅰ期临床耐受性试验研究

Phase Ⅰ clinical toleratnce study of cefuroxime/sulbactam

目的评价健康受试者单次及连续静滴注射用头孢呋辛钠舒巴坦钠的安全性和耐受性。方法根据新药临床试验指导原则设计试验,66例健康受试者分别单次静滴0.75g、1.5g、3.0g、4.5g、6.0g、7.5g、9.0g或连续静滴7.5g、9.0g注射用头孢呋辛钠舒巴坦钠,用药后对受试者进行临床观察,实验室检查及心电图检查。结果66名受试者全部完成了研究,在连续给药9.0g剂量组:1例受试者出现静脉刺激症状,输液结束后缓解;1受试者例出现轻度腹泻,伴有白细胞计数轻度降低,停药3日后复查回复正常,均无特殊处理,自行好转。其余受试者未出现不良事件。结论单次及连续应用注射用头孢呋辛钠舒巴坦钠安全性,耐受性良好。

Objective To evaluate the safety and tolerance of cefuroxime/sulbactam intravenous infusion in Chinese healthy volunteers. Methods The trial protocol was designed according to the Good Clinical Practice（GCP）. 66 healthy volunteers were received a single dose intravenous infusion of 0.75g, 1.5g, 3.0g, 4.5g, 6.0g, 7.5 g and 9.0g or multiple doses intravenous infusion of 7.5g, 9.0g cefuroxime/sulbactam respectively. Clinical symptoms, laboratory parameters and electrocardiogram were monitored during the trial. Results Sixty-six healthy volunteers were well tolerated with the cefuroxime/sulbactam. During the study of multiple doses intravenous infusion of 9. 0g cefuroxime/sulbactam, only 3 cases of adverse events were found, such as vein irritation, mild diarrhea, transient leukopenia, but the adverse events were relief quickly. Conclusion Cefuroxime/sulbactam was safe and well tolerated after single dose and multiple doses administrated in Chinese subjects.