国产头孢呋辛治疗下呼吸道、泌尿道感染的随机对照、多中心临床试验

A randomized controlled, multicentral clinical trial of domestic versus imported cefuroxime in the treatment of lower respiratory tract and urinary tract infections

目的 评价国产头孢呋辛和进口头孢呋辛治疗感染性疾病的疗效和安全性。方法 随机、对照、多中心研究 ,每组 6 0例 ,其中下呼吸道、泌尿道感染各 30例 ,两药剂量均为每次 1.5 g,q8h,静滴 ,疗程 7～14 d。结果 国产和进口头孢呋辛治疗下呼吸道感染的临床痊愈率分别为 70 %和 6 0 % ,有效率均为 93.3% ;治疗泌尿是感染痊愈率分别为 93%和 83% ,有效率均为 10 0 % ,细菌清除率国产头孢呋辛组 96 .4 % ;进口头孢呋辛组 96 .3%。国产和进口头孢呋辛组不良反应发生率分别为 1.7%和 3.3%。两组疗效和不良反应无统计学差异 (P>0 .0 5 )。结论 国产头孢呋辛治疗下呼吸道感染、泌尿道感染性疾病安全、有效 ,与进口产品等效。

Objective To compare the efficacy and safety of domestic and imported cefuroxime in treatment of lower respiratory tract and urinary tract infections. Methods The trial was conducted in 60 patients with lower respiratory tract infections and in 60 patients with urinary tract infections. They were randomly and equally divided to receive 15g domestic cefuroxime i.v., three times daily (q8h), or the same dose of imported cefuroxime for 7~14days. Results The cure rate, effective rate in the treatment of lower respiratory tract infections were 70%, 933% and 60%, 933% for domestic cefuroxime and imported cefuroxime, respectively. In urinary tract infections were 93%, 100% and 83%, 100% respectively. The bacterial clearance rate and ADRs incidence rate for domestic cefuroxime and imported cefuroxime were 964%, 17% and 963%, 33% respectively. No significant difference between groups was observed (P>005). Conclusion Domestic cefuroxime is as effective and safety as imported cefuroxime.