目的:评价国产与进口头孢吡肟治疗急性中重度细菌感染的有效性和安全性。方法:采用区组随机平行对照、多中心单盲试验设计,选用进口头孢吡肟作对照药。本试验共入组278例病例,剔除20例,进入疗效分析病例数为258例,其中试验组130例,对照组128例。下呼吸道感染采用国产和进口头孢吡肟均为每次给药2.0g,30～60min内静脉点滴,bid;泌尿道感染采用国产和进口头孢吡肟均为每次给药1.0g,30～60min内静脉点滴,bid,疗程7-14d。结果:治疗结束后临床有效率分别为试验组94.62%,对照组89.06%;致病菌清除率分别为试验组95.45%,对照组97.06%。两组不良反应发生率分别为6.52%和5.71%,以上结果两组对比差异均无统计学意义。结论:国产与进口头孢吡肟在治疗临床常见的敏感致病菌引起的急性细菌感染均有效、安全。 Objective: To evaluate the efficacy and safety of domestic and imported cefepime in the treatment of acute moderate-severe bacterial infections. Methods: Block parallel randomized controlled, multi-center single-blind trial design, the choice of imported cefepime as a reference drug. A total of 278 cases were enrolled in this study, 20 cases were excluded. The number of curative effect analysis was 258 cases, of which 130 cases in trial group and 128 cases in control group. Lower respiratory tract infection using domestic and imported cefepime were administered 2.0g, intravenous drip within 30 ~ 60min, bid; urinary tract infection with domestic and imported cefepime were administered 1.0g, 30 ~ 60min Intravenous drip, bid, treatment 7-14d. Results: After the treatment, the clinical effective rates were 94.62% in the experimental group and 89.06% in the control group respectively. The pathogenic bacteria clearance rate was 95.45% in the experimental group and 97.06% in the control group. The incidence of adverse reactions in the two groups were 6.52% and 5.71% respectively. There was no significant difference in the above two groups between the two groups. Conclusion: Both domestic and imported cefepime are effective and safe in the treatment of acute bacterial infections caused by common sensitive pathogens.