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目的:评价头孢唑肟国产品治疗细菌性感染的疗效和安全性。方法:采用多中心随机双盲对照临床观察,共160例患呼吸道或泌尿道感染的病人入组,国产品组和进口品组各80例。治疗方法均为头孢唑肟2g,每日二次,疗程7~14天。结果:国产品组和进口品组的痊愈率分别为62.5%(50/80)、56.25%(45/80),有效率均为90%(72/80),细菌清除率分别为87.1%(54/62)和90.3%(56/62),不良反应发生率分别为8.75%(7/80)和7.50%(6/80)。经统计学分析均无显著差异(P>0.05)。结论:国产注射用头孢唑肟治疗呼吸道感染和泌尿道感染的疗效和安全性与进口头孢唑肟相仿。
Objective: To evaluate the efficacy and safety of ceftizoxime products in the treatment of bacterial infections. METHODS: A multicenter, randomized, double-blind, controlled clinical trial of 160 patients with respiratory tract or urinary tract infections was enrolled in the study. Eighty patients in the national product group and the imported product group, respectively, were enrolled. Treatment are ceftizoxime 2g, twice daily, course of treatment 7 to 14 days. Results: The cure rates of domestic product group and imported product group were 62.5% (50/80) and 56.25% (45/80) respectively, the effective rates were 90% (72/80) and the bacterial clearance rates were 87.1% 54/62) and 90.3% (56/62) respectively. The rates of adverse reactions were 8.75% (7/80) and 7.50% (6/80), respectively. The statistical analysis showed no significant difference (P> 0.05). Conclusion: The efficacy and safety of domestic injection of ceftizoxime in the treatment of respiratory tract infection and urinary tract infection are similar to the imported ceftizoxime.