盐酸头孢卡品匹酯片治疗急性细菌性感染多中心双盲随机对照临床研究

目的评价头孢卡品匹酯片(第3代头孢菌素类抗生素)治疗急性细菌性感染的临床疗效和安全性。方法用多中心双盲双模拟随机平行对照试验设计,选择急性呼吸系统和泌尿系统细菌感染患者,试验组口服头孢卡品匹酯片100 mg,每日3次;对照组口服头孢泊肟酯片200 mg,每日2次,疗程5～14天。结果试验组入组135例,疗效评价128例,安全性评价135例;对照组入组134例,疗效评价129例,安全性评价134例。治疗后,2组总有效率分别为97.66%,94.57%;总的细菌清除率分别为96.36%,94.06%;药物不良反应发生率,试验组为5.19%,对照组为4.48%,2组比较差异无统计学意义,未见严重不良反应。结论头孢卡品匹酯片治疗急性呼吸系统和泌尿系统细菌感染,临床疗效确切,安全性较好。

Multicenter,double-blind,randomized controlled clinical trial of cefcapene pivoxil hydrochloride tablets in the treatment of acute bacterial infections

Objective To evaluate the clinical efficacy and safety of oral cefcapene pivoxil in the treatment of acute bacteria infections,including respiratory tract infection and urinary tract infection.Methods A multicenter double-blind randomized controlled clinical trial was conducted.Cefcapene pivoxil was 100 mg three times a daily by oral.Cefpodoxime proxetil as a controlled drug was 200 mg twice daily by oral.The course of treatment was 5-14 days.Results In the randomized controlled study,135 patients were enrolled in cefcapene group,135 patients were assessable for safety and 128 patients were assessable for efficacy.While 134 patients were enrolled in cefpodoxime group,134 patients were assessed safety and 129 patients assessed efficacy.The clinical total effective rate in cefcapene group was 97.66%;the bacterial clearance rate was 96.36%.While those of cefpodoxime group were 94.57% and 94.06%,respectively.The incidence of adverse reaction was 5.19% and 4.48%,respectively.There was not marked difference between the two groups in statistics.In trial and control groups no serious adverse reaction was reported.Conclusion Cefcapene pivoxil is effective and safe for the treatment of acute respiratory or urinary tract bacterial infections.