头孢吡肟治疗急性细菌性感染多中心随机双盲对照临床研究  

A multicenter,randomized,and double-blind controlled clinical trial of cefepime in treatment of acute bacterial infections

作　　者：刘惠侠 王婷[2] 张虹[2] 杨岚[3] 白进良[2] 石志红[3] 何辉[3] 尹爱萍[3] 曹海湘 李冰 

机构地区：[1]深圳信立泰药业有限公司,广东深圳518040 [2]兰州大学第一医院,甘肃兰州730000 [3]西安交通大学第一医院,陕西西安710061

出　　处：《中国新药与临床杂志》2006年第7期515-518,共4页Chinese Journal of New Drugs and Clinical Remedies

摘　　要：目的：评价国产头孢吡肟治疗急性细菌性感染的有效性和安全性。方法：采用多中心、随机、双盲、阳性药物平行对照研究,共入选142例,可评价疗效病例139例,其中试验组70例,对照组69例。呼吸系统感染采用国产和进口头孢吡肟均为每次2 g,而泌尿系统感染采用国产和进口头孢吡肟均为每次1 g,分别加入50～100 mL氯化钠注射液或5%葡萄糖注射液中,iv,gtt,bid,疗程均为7～14 d。结果：试验组和对照组痊愈率分别为50%和41%,有效率分别为93%和91%；2组细菌清除率均为100%；药物不良反应发生率分别为4%和9%,2组比较均无显著差异(P＞0．05)。结论：国产头孢吡肟治疗急性细菌性感染安全、有效。AIM- To evaluate the clinical efficacy and safety of domestic cefepime in the treatment of moderate to severe acute bacterial infections. METHODS： A randomized, double-blind controlled, and positive drug parallel clinical trial was conducted. One hundred and forty-two patients were enrolled with only 139 suitable for efficacy evaluation including 70 patients in the trial group and 69 for the controlled group. The dosages of cefepime （domestic or imported） were 2 g for respiratory tract infection or 1 g for urinary tract infection, twice daily intravenously （50-100 mL sodium chloride injection or 5 % glucose injection）. The duration of treatment was 7-14 d for either of both groups. RESULTS： The cure rates were 50 % vs 41% and efficacy rates were 93 % vs 91% for trial group and control group respectively, whereas both the bacterial clearance rates reached 100 %, simultaneously with adverse drug reaction rates were 4 % and 9 %, respectively. There were no statistical differ ences between the two groups （P 〉 0.05）. CONCLUSION： Domestic cefepime is effective and safe for the treatment of acute bacterial infections.

关 键 词：细菌感染 随机对照试验 多中心研究 双盲法 头孢吡肟 

分 类 号：R978.1[医药卫生—药品] R563.1[医药卫生—药学]