头孢西酮钠治疗急性呼吸道细菌感染临床研究

Clinical studies of the cefazedone sodium in treatment of respiratory tract bacterial infections

目的 评价头孢西酮钠治疗急性呼吸道细菌感染的临床疗效和安全性.方法 采用随机、单盲、平行对照设计,试验组35例应用头孢西酮钠,每次2 g,每日2次静脉滴注.对照组37例应用头孢唑林钠,每次2 g,每日2次静脉滴注.疗程均为5～14d.共入选病例72例,剔除1例,脱落5例,可评价66例,试验组34例,对照组32例,安全性评价71例.结果 试验组和对照组有效率分别为91.18%（31/34）和78.12%（25/32）,细菌清除率分别为80.00%（20/25）、84.00%（21/25）,不良反应发生率分别为22.86%（8/35）、16.67%（6/36）,两组比较差异均无统计学意义（P〉0.05）.结论 头孢西酮钠治疗急性呼吸道细菌感染安全、有效.

Objective To evaluate the clinical efficacy and safety of the cefazedone sodium in treatment of respiratory tract bacterial infections. Methods Single-blind randomized control trial was performed to evaluate the efficacy and safety of cefazedone sodium in treatment of respiratory tract bacterial infections, and cefazolin sodium as the controlled one. Patients in trial group （using cefazedone sodium, 35 patients） and control group （using cefazolin sodium, 37 patients） were all intravenously administered at the same doses of 2 g, every 12 hours for 5 to 14 days. A total of 72 patients were enrolled in the studies, 34 in trial group and 32 in control group, with 1 excluded and 5 withdrawn. Safety assessment was conducted in 71 patients. Results In trial group and control group, the total cure rates for respiratory tract infections were 91.18% （31/34） and 78.12%（25/32）, and the general bacterial eradication rates were 80.00% （20/25） and 84.00% （21/25）. The adverse drug reaction rates were 22.86 %（8/35） and 16.67% （6/36）,there was no significant difference （P 〉 0.05 ）. Conclusion Cefazedone sodium is a safe and effective antibiotic in the treatment of acute respiratory tract bacterial infections.