国产头孢吡肟治疗下呼吸道细菌感染疗效及安全性评价

目的:评价国产头孢吡肟治疗呼吸系统细菌感染的有效性与安全性.方法:采用多中心随机双盲对照试验设计,以进口头孢吡肟为对照药,试验组和对照组剂量均为每次2g,静脉滴注,每日2次,疗程7～14天.结果:试验组30例,对照组30例.试验组与对照组的临床有效率与痊愈率分别为93.33%、63.33%与96.67%、70%,细菌清除率分别为96%和100%,不良事件发生率分别为3.3%和0%,以上结果统计学均无显著性差异(P＞0.05).MIC值测定显示,头孢吡肟对大多数细菌的MIC值低于或与其它5种抗菌药物相近.结论:国产头孢吡肟抗菌谱广、抗菌活性强,是一个治疗下呼吸道细菌性感染的高效、安全的抗菌药物,与进口头孢吡肟相当.

Randomized contorl clinical study on safety and efficacy of domestic cefepime in the treatment of lower- respiratory tract bacterial infections

Objective:To evaluate the safety and efficacy of domestic cefepime in the treatment of lower-respiratory tract bacterial infections.Methods:A double-blind,randomized control clinical trial of intravenous cefepime on patients with lower-respiratory tract bacterial infections were conducted.The regimen of the two groups were 2g,twice daily for 7 to14ds.Both drugs were given intravenously.Results:In this trial,30 patients were enrolled in trial group and other 30 patients were enrolled in control group.The overall efficacy rates and cure rate in trial and control group were 93.33%?63.33% and 96.67%?70% respectively.The bacterial clearance rates were 96% and 100% respectively,and the adverse drug reaction rates were 3.3% and 0%. There was no statistical significant differences in the above results between the two groups.The activity of cefepime against gram-positive organisms was generally higher than that of the other 4 antibacterial agents.Conclusion:The results suggested that demostic cefepime with powerful antibacterial activity and wide spectrum has the same safety and efficacy as imported one in treating lower-respiratory tract bacterial infections.