【摘要】 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。更多还原

【Abstract】 Objective: To compare the efficacy and safety of cefepime manufactured in China versus imported in the treatment of moderate to severe bacterial infections. Methods: Of 278 patients with lower respiratory tract infection and urinary tract infection enrolled in a randomized, multi-center, single-blind, parallel-controlled clinical trial, 258 were randomized to administer either domestic (n=130) or imported (n=128) cefepime for 7～14 days. For urinary tract infection and respiratory tract infection, patients were intravenously infused with cefepime of 1 g and 2 g, respectively, twice daily. Results: The overall efficacy rate, bacterial eradication rate and incidence rate of adverse events had not shown significant differences for domestic and imported cefepime, i. e. , 94.62 % vs 89.06 %, 95.45 % vs 97.06 % and 6.52 % vs 5.71%, respectively. Conclusion: Domestic cefepime offers an alternative in the treatment of moderate and severe bacterial infections.更多还原