注射用头孢噻肟钠／舒巴坦钠(2：1)  

Cefotaxime sodium/sulbactam sodium for injection(2∶1)

作　　者：孙明杰 吕华冲[2] 邓桂兴 王霆 

机构地区：[1]湘北威尔曼制药有限公司,长沙410000 [2]广东药学院,广州510000

出　　处：《中国新药杂志》2008年第7期613-617,共5页Chinese Journal of New Drugs

基　　金：广州市东山区科技项目资助(2005-GX-002)

摘　　要：注射用头孢噻肟钠／舒巴坦钠（2：1）为抗耐药菌复方抗生素。药理试验证明其在体外有明显增强单方对产酶耐药菌株的抗菌活性，体内实验显示其对感染小鼠抗菌作用强于单方制剂。动物安全性实验证实其对循环、呼吸和神经系统无影响，无局部刺激作用。人体耐受性试验表明单次静滴3～6g为安全剂量，其半衰期短，蓄积量小。药动学研究显示头孢噻肟钠和舒巴坦钠分别单独给药与联合给药的药动学参数均无明显变化。多中心，随机单盲，阳性药对照治疗呼吸及泌尿系统感染性疾病的临床试验结果表明：其临床有效率为90．00％，细菌清除率95．56％，细菌敏感率75．00％，不良反应发生率4．83％。表明该药临床疗效确切，安全可靠，可作为感染性疾病的临床首选药物之一。The pharmacological and clinical trial results of cefotaxime sodium/sulbactam sodium （2：1 ） for injection were reviewed. In preclinical studies, the antibacterial effect of the combination on resistant strains is much more efficacious than that of single ceftriaxone or sulbactam, respectively, in vitro and in animal models. The combination has no adverse reactions in the circulatory, respiratory and nervous systems, and no local stimulation in animal safety studies. In toleration test of single doses in volunteers, its safety range is 3 -6 g. Pharmacokinetic parameters of the combination are not statistically different from those of cefotaxime or sulbactam alone in volunteers. In the multi-center, single-blind, and controlled clinical trials, the combination shows 90.00% of efficiency, 95.56% of the clearance rate, 75.00% of sensitive rate, and 4.83 % of the rate of adverse effects. In conclusion, this combination can be considered as one of the first choices in the treatment of drug-resistant infectious diseases clinically.

关 键 词：抗耐药菌 复方抗生素 注射用头孢噻肟钠/舒巴坦钠(2:1) 药效学 人体耐受性试验 药动学 临床研究 

分 类 号：R978.1[医药卫生—药品]