摘要
目的:评价注射用头孢噻肟钠/他唑巴坦钠(6∶1)在健康人体中的耐受性和安全性。方法:60例健康受试者随机分入6个单次给药组和3个多次给药组。单次给药组分别给予注射用头孢噻肟钠/他唑巴坦钠(6∶1)0.468 g、1.17 g、1.755 g、2.34 g、2.925 g、3.51 g。多次给药组分别给予注射用头孢噻肟钠/他唑巴坦钠(6∶1)7.02 g、9.36 g、14.04 g,连续给药7 d。观察受试者临床症状、生命体征、实验室检查指标等变化情况。结果:单次给药组未出现与药物相关的不良事件。多次给药组1名受试者出现过敏性皮疹,2名受试者出现一过性ALT、AST增高。2名受试者试验过程中因感冒出现病毒疹。结论:健康受试者对注射用头孢噻肟钠/他唑巴坦钠(6∶1)的单次最大耐受剂量为3.51 g,耐受性较好。连续7 d给予头孢噻肟钠/他唑巴坦钠(6∶1)14.04 g.d-1,受试者耐受性好。
Objective: To evaluate the safety and tolerance of cefotaxime sodium/tazobactam sodium(6∶1) injection in healthy volunteers.Methods: A total of 60 healthy volunteers were randomly divided into six single-dose groups(0.468 g,1.17 g,1.755 g,2.34 g,2.925 g and 3.51 g) and three multiple-dose groups(7.02 g,9.36 g and 14.04 g for 7 days).The safety profile and tolerance were evaluated by observing symptoms,vital signs,and laboratory tests.Results: No serious adverse events were observed in any volunteers.In single-dose groups,there were no adverse events associated with the drug.In multiple-dose groups,transient increase of ALT and AST were observed in two volunteers.Allergic skin rash was observed in one volunteer.Two volunteers were suffered from viral exanthem.Conclusion: Based on our findings,the maximum tolerated single dose of cefotaxime sodium/tazobactam sodium(6:1) in Chinese healthy volunteers is 3.51g,and the multiple-dose up to 14.04 g per day for 7 days is safe.
出处
《药学与临床研究》
2011年第3期204-206,共3页
Pharmaceutical and Clinical Research