头孢泊肟酯片治疗急性细菌性感染158例的多中心随机对照研究

• 作 者: 修清玉 方正 何礼贤 潘玉 李善群 李华茵 陈楠 任红 李晓
• 机 构: 上海长征医院呼吸内科,上海长征医院呼吸内科,复旦大学附属中山医院呼吸内科,复旦大学附属中山医院呼吸内科,复旦大学附属中山医院呼吸内科,复旦大学附属中山医院呼吸内科,复旦大学附属中山医院呼吸内科,复旦大
• 出 处: 中国新药与临床杂志
• 发表日期: 2004年11期
• 关键词: 细菌感染 随机对照试验 多中心研究 头孢泊肟

目的 :评价国产头孢泊肟酯片治疗急性细菌性感染的有效性和安全性。方法 :采用多中心、随机对照研究方法 ,以进口头孢泊肟酯片为对照 ,2组的用量、用法及疗程均为 10 0mg ,po ,bid ,疗程 7～14d。结果 :本研究共入组 175例病人 ,可进行临床疗效评价分析的病例 15 8例 ,试验组 77例 ,对照组81例。试验组总痊愈率和有效率分别为 70 %和92 % ;对照组总痊愈率和有效率分别为 79%和94 % ,2组细菌清除率分别为 98%和 98% ,2组比较差异均无显著意义 (P >0 .0 5 )。试验组和对照组的不良反应发生率分别为 9%和 2 % ,主要表现为口干、恶心、腹部不适及转氨酶增高等。结论 :国产头孢泊肟酯片治疗急性细菌性感染临床疗效确切 ,安全性较好。

Objective: To evaluate the efficacy and safety of domestic cefpodoxime proxetil tablets in the treatment of acute bacterial infections. Methods: A multicentre, randomized and controlled study was conducted with cefpodoxime proxetil tablets as control. The dosage, usage and duration of treatment in the two groups were all 100 mg, po and bid for 7-14 days. Results: A total of 175 patients were enrolled in this study. Fifty-eight cases could be evaluated by clinical evaluation, 77 cases in trial group and 81 cases in control group. The total cure rate and effective rate of the experimental group were 70% and 92% respectively. The total cure rate and effective rate of the control group were 79% and 94% respectively. The bacterial clearance rates of the two groups were 98% and 98% No significant (P> 0.05). The incidence of adverse reactions in the experimental and control groups were 9% and 2%, respectively, mainly manifested as dry mouth, nausea, abdominal discomfort and elevated transaminases. Conclusion: Domestic cefpodoxime proxetil tablets are effective and safe in the treatment of acute bacterial infections.