头孢唑肟钠治疗急性细菌性感染多中心随机对照临床研究

Multicenter,blind,randomized clinical trial of ceftizoxime sodium injection in the treatment of acute bacterial infection

目的评价国产注射用头孢唑肟钠（第3代头孢类抗生素）治疗急性细菌性感染的安全性和有效性。方法用区组随机化、平行对照、多中心单盲试验设计，试验药为国产头孢唑肟钠，对照药为头孢唑肟钠（进口原料）；2组各61例，用法、用量、疗程均相同，每日4g，分2次给药，静脉滴注，疗程7～14天。结果试验药与对照药治疗呼吸和泌尿系统感染的痊愈率分别为75．41％和80．33％，总有效率均为96．72％（P〉0．05）；细菌清除率分别为98．25％和100％，阴转率分别为96．49％和100％（P〉0．05）；药物不良反应发生率分别为6．25％和9．38％（P〉0．05）。结论国产注射用头孢唑肟钠治疗急性细菌性感染有效、安全。

Objective To evaluate the efficacy and safety of ceftizoxime sodium injection in the treatment of acute bacterial infection. Methods A multicenter , blind , randomized clinical trial was carried. Imported ceftizoxime sodium was as the controlled drug. A total of 122 patients （61 trial and 61 control） were enrolled in this study. Ceftizoxime sodium injection was intravenously at a dose of 2 g bid for 5 - 10 days . The Imported ceftizoxime sodium was administered in same way, same dose and same course of treatment. Results At the end of treatment ,the cure rate were 75.41% and 80.33% （P 〉 0.05 ） in trial and control respectively. The effective rate were 96.72% in both two groups . The bacterial eradication rate for trial and control groups were 98.25% and 100% （P 〉 0.05） , respectively. The incidence of adverse reaction were 6.25% and 9.38 % （ P 〉 0.05 ） , respectively. Conclusion Ceftizoxime sodium injection was effective and safe drugs for acute bacterial infection.