注射用头孢噻肟钠/他唑巴坦钠(6∶1)临床耐受性研究  

Tolerance of Intravenously Administered Cefotaxime Sodium/Tazobactam Sodium(6∶1) in a Phase I Study

作　　者：刘文[1] 查王健[1] 黄茂[1] 

机构地区：[1]南京医科大学第一附属医院呼吸科,南京210029

出　　处：《药学与临床研究》2011年第3期204-206,共3页Pharmaceutical and Clinical Research

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.

关 键 词：头孢噻肟钠他唑巴坦钠 注射剂 耐受性 I期临床研究 

分 类 号：R965.3[医药卫生—药理学]