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《Chinese Journal of New Drugs》 2008-07
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Cefotaxime sodium/sulbactam sodium for injection(2∶1)

SUN Ming-jie1,Lü Hua-chong2,DENG Gui-xing1,WANG Ting1,3(1 Xiangbei Welman Pharmaceutical Co.Ltd.,Changsha 410000,China;2 Guangdong Pharmaceutical College,Guangzhou 510000,China;3 Guangzhou Welman Pharma R&D Centre,Guangzhou 510663,China)  
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.
【Fund】: 广州市东山区科技项目资助(2005-GX-002)
【CateGory Index】: R978
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