盐酸头孢吡肟多中心随机对照治疗急性细菌感染的临床观察  

A multicenter randomized control clinical trial of cefepime hydrochloride injection in the treatment of acute bacterial infections

作　　者：闫喜荣[1] 贾利宁[2] 桂保松[2] 王婷[2] 孙秀珍[2] 杨岚[3] 石志红[3] 何辉[3] 韩雪芳[4] 

机构地区：[1]西安交通大学医院,西安710049 [2]西安交通大学第二医院,西安710004 [3]西安交通大学第一医院,西安710061 [4]陕西省人民医院,西安710068

出　　处：《中国抗生素杂志》2007年第1期33-36,共4页Chinese Journal of Antibiotics

摘　　要：目的评估盐酸头孢吡肟治疗各种中、重度细菌性感染的临床疗效和安全性。方法采用多中心随机单盲对照临床试验,241例患者纳入该研究,治疗组121例,给予盐酸头孢吡肟;对照组120例,给予头孢吡肟。两药的剂量均为1.0～2.0g/次,静脉滴注,Q 12h;疗程均为7～10d。结果盐酸头孢吡肟组和头孢吡肟组的临床痊愈率分别为54.4%和54.2%,临床有效率分别为89.5%和86.9%,细菌阴转率分别为93.4%和89.5%,细菌清除率分别为92.3%和89.5%;不良反应发生率分别为4.2%与4.2%。以上结果经统计学处理均无显著性差异(P>0.05)。两组不良反应主要是消化道反应,少数患者可有皮疹、肝酶学升高、白细胞和血红蛋白下降等反应。结论注射用盐酸头孢吡肟治疗各种中、重度急性细菌性感染疗效确切,安全性好。Objective To evaluate the clinical efficacy and safety of cefepime hydrochloride for injection in the treatment of moderate and serious acute bacterial infections. Methods A multicenter single-blind randomized control clinical trial was conducted and 241 patients were enrolled for this study. One hundred and twenty one patients of test group were treated with cefepime hydrochloride and 120 patients of control group were treated with cefepime, and both groups were administrated intravenously at a dose of 1.0-2.0g twice daily for 10-14 days. Results The rate of cure, effectiveness, bacterial clearance, bacterial negative and adverse reactions is 54.39%, 89.47%, 92. 31%, 93.42% and 4. 166% in cefepime hydrochloride groups and 54.21%, 86.92%, 89.47%, 89.47% and 4. 237% in cefepime groups, respectively. There were no statistically significant differences between the two groups. Adverse reactions are primarily digestive reactions, occasionally rash, elevation of hepatic enzyme, and decrease of leukocyte and hemoglobin. Condusion Cefepime hydrochloride is effective and safe in the treatment of moderate and serious acute bacterial infections.

关 键 词：头孢吡肟 急性细菌性感染 随机单盲对照 

分 类 号：R969.4[医药卫生—药理学]