头孢唑肟钠注射剂治疗呼吸和泌尿系统感染多中心临床研究

Multicentre clinical study on ceftizoxime sodium intravenous injection for treatment of respiratory and urinary tract infection

目的以头孢噻肟钠注射剂作对照,评价头孢唑肟钠注射剂治疗敏感菌引起的呼吸和泌尿系感染的有效性和安全性。方法用多中心、随机单盲、平行对照的试验方法,头孢唑肟钠注射剂,每次2-3g,每日2次;头孢噻肟钠注射剂,每次2-3g,每日2次,两组的疗程均为7-14天。头孢唑肟钠组临床可评价病例为62例,细菌学疗效评价例数为54例,药物不良反应例数为66例;头孢噻肟钠组分别为61,50,64例。结果试验药组和对照组的临床有效率分别为87.10％和85.25％;细菌清除率分别为85.19％和86.00％,药物不良反应发生率分别为6.06％和7.81％。结论头孢唑肟钠注射剂是治疗中重度感染的安全有效药物。

Objective To evaluate the efficacy and safety of ceftizoxime intravenous injection compared to cefotaxime. Methods A randomized ,comparative, open, multicentre trial was conducted the dose of ceftizoxime intravenous was 2-3 g, bid and the duration of treatment was 7-14 days; the dose of cefotaxime intravenous was 2-3 g, bid for 7-14 days too. The total number of final evaluated subjects was 123 including 62 subjects in ceftizoxime group and 61 subjects for cefotaxime treatment group. The bacterial evaluated subjects were 54 for ceftizoxime and 50 for cefotaxime. Results Clinical efficacy rate and bacterial eradication rate for ceftizoxime was 87.10% and 85.19%, respectively. Clinical efficacy rate and bacterial eradication rate for cefotaxime was separately 85.25% and 86.00%. The incidence of adverse reaction including whole clinical reactions and laboratory abnormalities was 6.06% for ceftizoxime group and 7.81 % for cefotaxime group. Conclusion The ceftizoxime had an excellent clinical efficacy and good safety profile in treating patients with moderate to severe degree bacterial infections.