国产与进口盐酸头孢吡肟治疗下呼吸道、泌尿道感染多中心临床试验

目的评价国产盐酸头孢吡肟和进口盐酸头孢吡肟治疗下呼吸道、泌尿道细菌染性疾病的疗效和安全性。方法前瞻性、多中心、随机、双盲、阳性药平行对照研究,共入组131例,其中国产盐酸头孢吡肟组66例,进口盐酸头孢吡肟组65例。两药剂量均为每日2.0g,q12h,静滴,疗程7~14d。结果国产和进口盐酸头孢吡肟治疗下呼吸道感染的临床痊愈率分别为53.1%和41.9%,有效率分别为90.6%和80.7%;治疗泌尿系感染痊愈率分别为85.3%和81.8%,有效率分别为94.1%和100.0%,细菌清除率国产盐酸头孢吡肟组91.8%;进口盐酸头孢吡肟组100.0%。国产和进口盐酸头孢吡肟组不良反应发生率分别为3.0%和6.2%。两组疗效和不良反应无统计学差异(P>0.05)。结论国产盐酸头孢吡肟治疗下呼吸道感染、泌尿道感染性疾病安全、有效,与进口头孢吡肟疗效相当。

A Multi-center Randomized Controlled Clinical Trial on Effects of Domestic and Imported Cefepime in Treatment of Lower-respiratory Tract and Urinary Tract Infections

Objective To evaluate the efficacy and safety of domestic and improrted cefepime for the treatment of bacterial infections of lower-respiratory tracts and urinary tracts.Methods A prospective,multi-center,double blind,randomized,and positive medication controlled study was conducted,with 131 subjects enrolled in,66 in the group of domestic cefepime and 65 for imported cefepime.Results The cure rates of domestic and imported cefepime for infections of lower respiratory tracts were 53.1% and 41.9% respectively,and their effective rates were 90.6% and 80.5% respectively.For infections of urinary tracts,the cure rates of domestic and imported cefepime were 85.3% and 81.2% respectively,and the effective rates were 94.1% and 100.0% respectively.The bacterial eradication rates of domestic and imported cefepime were 91.8% and 100.0% respectively.The rates of adverse reactions of domestic and imported cefepime were 3.0% and 6.2%.For the effectiveness and adverse reactions,there was no significant difference between domestic cefepime group and imported cefepime group(P<0.05).Conclusions Like imported cefepime,domestic cefepime is also safe and effective to treat infections of lower-respiratory tracts and urinary tracts.