头孢唑兰治疗呼吸系统感染疗效及安全性研究

Study on the efficacy and safety of Cefozopran in the treatment of respiratory infections

目的评价注射用盐酸头孢唑兰治疗呼吸系统感染的疗效及安全性。方法采用多中心、随机、双盲、平行对照试验设计,随机化入选病例144例,分为试验组（头孢唑兰组）和对照组（头孢吡肟组）各72倒。均为每次1.0g,用5%葡萄糖注射液或0.9%氯化钠注射液100ml溶解稀释,每12小时1次,静脉滴注,疗程7~14d。结果试验组纳入分析数据集（FAS）和方案数据集（PPS）分析分别为71例和68例,对照组纳入FAS和PPS分析分别为72例和67例。疗程结束时试验组和对照组的临床治愈率（FAS分析）分别为91.55%（65/71）和91.67%（66/72）;综合治愈率（FASM分析）分别为88.89%和89.66%。2组细菌清除率分别为88.89%和89.66%,2组间比较差异无统计学意义（P〉0.05）。头孢唑兰组和头孢吡肟组的不良事件发生率分别为12.59%和13.29%,未见重度及严重不良事件。结论注射用头孢唑兰治疗呼吸系统急性细菌性感染的临床疗效确切,安全性好。

Objective In order to evaluate the efficacy and safety of cefozopran hydrochloride by injection in the treatment of respiractory tract infections. Methods It was a multicenter randomized double-blind parallel controlled trial de- sign. Cefepime hydrochloride by injection as control drug, the cefozopran hydrochloride and cefepime hydrochloride by injection were administered intravenously at a dose of l. 0 gram dissolved and diluted with 100mL 5% glucose injection or0.9% sodium chloride injection twice daily for 7 to 14 days. Results A total of 144 patients were randomized enrolled in this tiral, the num- ber of test group （ cefozopran hydrochloride by injection） and control group （ cefepime hydrochloride by injection） were 72 ca- ses, respectively. There were 71 patients who enrolled in FAS analysis and 68 in PPS analysis in test group, while 72 patients were enrolled in FAS analysis and 67 patients were eligible for PPS analysis in control group. At the end of treatment, the clini- calcure rate （ FAS analysis） was 91.55 % （65/71 ） in test group; while 91.67% （ 66/72 ） in control group. The comprehen- sive cure rate （FASM analysis） was 88.89% in test group;while 89.66% in control group. The bacterial eradication rates were 88.89% and 89.66%, respectively. There was no statistical difference between the groups （P 〉0.05）. Adverse reactions were observed in 12.59% and 13.29% of patients in the two groups. No severe and serious adverse reactions were observed in this trial. Conclusion Cefozopran hydrochloride by injection is effective and safe for the treatment of respiractory tract infec- tions.