国产与进口头孢吡肟治疗下呼吸道细菌性感染120例疗效与安全性

目的：评价国产头孢吡肟治疗下呼吸道细菌感染的疗效及安全性。方法：采用多中心随机双盲对照临床试验设计,选用121例18～65 a的病人随机分配到试验组(国产头孢吡肟)61例和对照组(进口头孢吡肟)60例。给药方案均为2 g,iv,gtt,bid,疗程为7～14 d。结果：试验组与对照组的痊愈率与有效率分别为66%,98%与80%,100%,细菌阳性率分别为79%与83%,细菌清除率分别为98%与100%,不良反应发生率分别为10%与3%(P＞0.05)。结论：国产头孢吡肟是治疗下呼吸道细菌感染的有效和安全的药物,与进口头孢吡肟相当。

Safety and efficacy of domestic and imported cefepime in treatment of lower respiratory tract bacterial infection in 120 patients

AIM:To evaluate the clinical efficacy and safety of domestic cefepime in the treatment of low- er respiratory tract bacterial infections.METHODS:A multi-center,randomized,double blind,parallel-group, comparative study of cefepime was eondueted among 121 patients with respiratory infections.They were random- ized into trial group(61 patients,treated with domestic cefepime,2 g,iv,gtt,bid,for 7-14 days)and control group (60 patients,treated with imported cefepime,2 g,iv,gtt,bid,for 7-14 days).RESULTS:The recovery and ef- fective rates were 66% and 98% in trial group,80% and 100% in control group;the positive rates of bacterial culture were 79% and 83%;the bacterial clearance rates were 98% and 100%;the incidence rates of adverse reactions were 10% and 3%,respectively.There were no significant differences between two groups(P＞0.05). CONCLUSION:Domestic cefepime has the same safety and efficacy as imported one in the treatment of lower respiretory tract bacterial infection.