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目的评价法罗培南治疗的呼吸、泌尿系统细菌感染性疾病的疗效和安全性。方法采用多中心随机单盲阳性药平行对照试验方法。共入选有效病例226例,试验组114例,对照组112例。试验组予法罗培南口服,每次200mg,每日3次;对照组予头孢泊肟口服,每次100mg,每日2次,疗程均为7～14d。比较2组临床疗效及不良反应。结果试验组与对照组临床痊愈率分别为83.3%和80.4%,有效率分别为95.6%和95.5%,2组临床疗效比较无显著差异(P>0.05)。细菌清除率均为99%,组间无显著差异(P>0.05)。药物不良反应发生率分别为6.8%和6.1%,组间差异无显著意义(P>0.05)。结论法罗培南治疗临床常见急性细菌感染性疾病安全、有效。
Objective To evaluate the efficacy and safety of faropenem in the treatment of respiratory and urinary tract bacterial infections. Methods A multicenter, random, single-blind, positive drug parallel control trial was used. A total of 226 valid cases were enrolled, 114 in the trial group and 112 in the control group. The trial group was treated with faropenem orally, each time 200mg, 3 times a day; the control group was cefpodoxime orally, each 100mg, 2 times a day, the course of treatment was 7 ~ 14d. The clinical efficacy and adverse reactions of the two groups were compared. Results The clinical cure rates were 83.3% and 80.4% in the test group and the control group, respectively. The effective rates were 95.6% and 95.5% respectively. There was no significant difference in the clinical efficacy between the two groups (P> 0.05). Bacterial clearance rates were 99%, no significant difference between groups (P> 0.05). Adverse drug reaction rates were 6.8% and 6.1%, respectively, with no significant difference between groups (P> 0.05). Conclusion Faropenem is safe and effective in treating common acute bacterial infectious diseases.