注射用盐酸头孢甲肟与头孢哌酮治疗急性细菌性感染随机对照临床研究

Randomized controlled clinical trial on injective cefmenoxime hydrochloride versus cefoperazone in the treatment of acute bacterial infection

目的评价盐酸头孢甲肟注射剂治疗急性细菌性呼吸道和泌尿道感染的 有效性和安全性。方法用双盲随机平行对照试验方法,以头孢哌酮为对照 药,头孢甲肟和头孢哌酮用量均为2．0～4．0 g,每日2次静滴,疗程7～14天。 结果头孢甲肟入选72例,疗效评价64例,安全性评价72例;头孢哌酮入选 72例,疗效评价69例,安全性评价72例。头孢甲肟和头孢哌酮临床总有效率 分别为96．9％,91．3％;治疗各种致病菌感染临床有效率分别为98．3％, 93．4％;细菌清除率分别为94．9％,91．8％。药物不良反应发生率均为5．6％。 结论注射用头孢甲肟治疗急性细菌性呼吸道和泌尿道感染有效、安全,优于 头孢哌酮。

Objective To evaluate the clinical efficacy and safety of injective cefmenoxime in the treatment of respiratory and urinary bacteria infection. Methods A randomized controlled open clinical trial was carried out. Cefoperazone as a controlled drug. Cefmenoxime and cefoperazone was 2 ～ 4 g every 12 hours by intravenous infusion, respectively. The course of treatment was 7 ～ 14 days. Results Seventy two patients were enrolled in cefmenoxime group, 72 patients were assessable for safety and 64 patients were assessable for efficacy. While 72 patients were enrolled in cefoperazone group , 72 patients were assessed safety and 69 patients assessed efficacy . The clinical total effective rate of cefmenoxime group was 96.9% ; the bacterial efficacy rate and the bacterial clearance rate were 98.3% and 94.9% , respectively. While those of cefoperazone group were 91.3% , 93.4 % and 91.8% , respectively. The incidence of adverse reaction was 5.6% both trial and control groups. Conclusion Injctive cefmenoxime is a kind of effective and safe antibacterial drug.