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目的 评价国产与进口头孢吡肟治疗急性中重度泌尿系统感染的有效性和安全性。方法 用区组随机平行对照、多中心单盲试验设计,用进口头孢吡肟作对照药。共入组127例病例,剔除5例,进入疗效分析病例数为122例,其中试验组61例,对照组61例。国产和进口头孢吡肟均为每次给药2g, 30~60min内静脉点滴,bid,疗程7~14天。结果 治疗结束后,临床有效率分别为试验组98. 36%,对照组96. 72%;试验组与对照组致病菌清除率均为100%。2组药物不良反应发生率分别为6. 45%和10. 77%。2组对比差异均无统计学意义(P>0. 05)。结论 国产与进口头孢吡肟对急性泌尿系统感染均安全、有效。
Objective To evaluate the efficacy and safety of domestic and imported cefepime in the treatment of acute moderate and severe urinary tract infections. Methods Block randomized parallel control, multi-center single-blind trial design, with imported cefepime as a reference drug. A total of 127 cases were enrolled and 5 cases were excluded. The number of patients who entered the efficacy analysis was 122 cases, of which 61 cases in trial group and 61 cases in control group. Domestic and imported cefepime are administered 2g, intravenous drip 30 ~ 60min, bid, treatment 7 to 14 days. Results After treatment, the clinical effective rates were 98.36% in the experimental group and 96.72% in the control group, respectively. The clearance rate of pathogenic bacteria in the experimental group and the control group was 100%. The incidence of adverse drug reactions in the two groups were 6. 45% and 10. 77%, respectively. There was no significant difference between the two groups (P> 0.05). Conclusion Both domestic and imported cefepime are safe and effective in acute urinary tract infection.