Du Mengjiao, Sun Tingting, Wang Xueting, Chi Xiaohui, Xiao Yonghong
Shandong First Medical University & Shandong Academy of Medical Sciences, Jinan, Shandong, People's Republic of China.
Jinan Microecological Biomedicine Shandong Laboratory, Jinan, Shandong, People's Republic of China.
Drug Des Devel Ther. 2025 Jun 25;19:5461-5470. doi: 10.2147/DDDT.S511271. eCollection 2025.
To compare the in-vitro antibacterial effects of branded and its locally produced cefuroxime sodium against ATCC29213, clinical strains of methicillin-sensitive (MSSA) 164342 and methicillin-sensitive coagulase-negative (MSCNS) 117933, and ATCC25922, and to provide a reference for their clinical use.
An in-vitro antibacterial susceptibility test, time-kill curve and pharmacokinetics and pharmacodynamics (PK/PD) modeling was used in the comparison.
The minimum inhibitory concentrations (MIC) of the two types of cefuroxime sodium were identical against four bacterial strains; both types of cefuroxime sodium had MICs of 0.5 μg/mL, 8 μg/mL, 0.5 μg/mL, and 0.25 μg/mL against ATCC 29213, ATCC 25922, M164342 and MSCNS117933, respectively. There were no significant differences in the time-kill curves of the two forms against the four strains at three concentrations. At drug concentrations of 2×MIC and 4×MIC, the bacterial count of all the strains decreased from 6 log CFU/mL to around 4 log CFU/mL. The bactericidal efficacies of the two agents were generally similar in the pharmacokinetics model of simulated intravenous drug administration of 1 g q8h. Only the PD parameter of bactericidal rate (KR) for ATCC 29213 and the area difference between the drug bactericidal curve and the bacterial growth control curve (I) for ATCC25922 were statistically different. The KR and I of the locally produced form were 0.73±0.10 logCFU·h/mL and 83.73±12.69 logCFU·h/mL, respectively, while the KR and I of the branded form were 1.19±0.07 logCFU·h/mL and 104.02±16.28 logCFU·h/mL, respectively.
The in-vitro antibacterial effect of locally produced cefuroxime sodium against and is comparable to that of branded cefuroxime sodium.
比较品牌头孢呋辛钠及其国产头孢呋辛钠对美国典型培养物保藏中心（ATCC）29213、甲氧西林敏感金黄色葡萄球菌（MSSA）临床菌株164342、甲氧西林敏感凝固酶阴性葡萄球菌（MSCNS）117933以及ATCC25922的体外抗菌效果，为其临床应用提供参考。
采用体外抗菌药敏试验、时间杀菌曲线以及药代动力学和药效学（PK/PD）建模进行比较。
两种头孢呋辛钠对四种菌株的最低抑菌浓度（MIC）相同；两种头孢呋辛钠对ATCC 29213、ATCC 25922、M164342和MSCNS117933的MIC分别为0.5μg/mL、8μg/mL、0.5μg/mL和0.25μg/mL。两种制剂在三种浓度下对四种菌株的时间杀菌曲线无显著差异。在药物浓度为2×MIC和4×MIC时，所有菌株的细菌计数从6 log CFU/mL降至约4 log CFU/mL。在模拟静脉滴注1 g q8h的药代动力学模型中，两种制剂的杀菌效果总体相似。仅ATCC 29213的杀菌率（KR）和ATCC25922的药物杀菌曲线与细菌生长对照曲线之间的面积差（I）的PD参数存在统计学差异。国产制剂的KR和I分别为0.73±0.10 logCFU·h/mL和83.73±12.69 logCFU·h/mL，而品牌制剂的KR和I分别为1.19±0.07 logCFU·h/mL和104.02±16.28 logCFU·h/mL。
国产头孢呋辛钠对上述菌株的体外抗菌效果与品牌头孢呋辛钠相当。
