摘要
目的:评价国产注射用头孢美唑钠治疗中、重度呼吸系统细菌性感染的临床疗效和安全性。方法:采用双盲、随机、平行对照试验设计,以进口头孢美唑钠为对照药物。两组均为每次静脉滴注给药2.0g,q12h,疗程均为5~12天。结果:本次试验共入选病例数为48例,两组各为24例。可纳入临床疗效分析的病例数为46例,试验组24例,对照组22例。治疗结束时试验组和对照组临床有效率分别为75.0%和81.82%,两组细菌清除率分别为88.89%,81.25%,不良反应发生率分别为8.33%、16.67%。以上结果经统计学处理均无显著性差异。结论:国产头孢美唑钠注射剂治疗细菌性呼吸系统感染临床疗效确切,安全性好。
Objective:To evaluate the curative effect and safety of domestic cefmetazole sodium for injection on moderate and severe bacterial infection of respiratory system.Methods:A clinical trial by randomized,double-blind,parallel control was conducted. The control drug was imported cefmetazole.Both groups were administered intravenously at a dose of 2 gram twice daily for 5 to 12 days.Results:A total of 48 patients were randomized into the treatment group and the control group,while 46 of them were enrolled in the statistical analysis of the clinical efficacy,with 24 patients in the treatment group and 22 in the control group.At the end of the treatment,the effective rate was 75.0% in the treatment group and 81.82% in the control one.The bacterial clearance rate and the drug-related adverse reaction rate were 88.89% and 8.33% in the treatment group,and 81.25% and 16.67% in the control one,respectively.There were no significant statistical differences between the two groups.Conclusion:Domestic cefmetazole sodium for injection was effective and safe in the treatment of bacterial infection of respiratory system.
出处
《重庆医科大学学报》
CAS
CSCD
2007年第2期195-198,共4页
Journal of Chongqing Medical University
关键词
头孢美唑
随机双盲平行对照
临床试验
Cefmetazole
Randomized double-blind parallel control
Clinical trial