注射用头孢呋辛钠生物等效性研究

Biological Equivalent Effect of Cefuroxime Sodium Injection

目的 以进口药注射用西力欣 (头孢呋辛的商品名 )为对照组 ,进行随机对照临床试验 ,评价国产注射用头孢呋辛钠治疗敏感致病菌引起的急性下呼吸道和泌尿道细菌感染性疾病的临床疗效和安全性。方法 采用多中心分段随机对照平行试验方法 ,两组共完成随机对照临床试验共计 12 0例 ,试验组 6 0例 ,对照组 6 0例 ,治疗方案为试验组注射用头孢呋辛 1 5 g/次 ,q8h ,疗程7～ 14d ;对照组注射用西力欣 1 5 g/次 ,q8h ,疗程 7～ 14d。结果试验组与对照组细菌分离率分别为 90 0 %和 88 3% ;注射用头孢呋辛钠治疗下呼吸道感染、泌尿系感染有效率分别为 93 3%和 10 0 0 % ,注射用西力欣治疗有效率分别为 93 3%和 10 0 0 % ;试验组细菌阴转率为 96 3% ,细菌清除率为 96 4 % ,对照组细菌阴转率为 96 2 % ,细菌清除率为 96 3% ,以上结果经统计学处理差异无显著性 ;试验组仅有 1例用药后出现皮疹 ,不良反应发生率为 1 7% ;西力欣组 2例发生轻度腹泻和肝功能异常ALT和AST轻度升高 ,发生率为 3 3% ,经统计学处理差异无显著性。结论 注射用头孢呋辛钠对临床常见的致病菌引起的下呼吸道感染、泌尿系感染 ,临床疗效较好且不良反应发生率低 ,与进口西力欣相近。

OBJECTIVE To evaluate the clinical effect and reliability of domestic product cefuroxime sodium injection to treat acute lower respiratory infection and urinary tract infection caused by sensitive pathogenic bacteria, and choose the import product of cefuroxime Zinacef injection as a control. METHODS A total of 120 cases which including trial group 60 cases and the control group 60 cases were analyzed by random contrast clinical trial, the therapy program was cefuroxime sodium injection 1.5 gram per time,q8h, for 7 to 14 days, and in control group, Zinacef injection 1.5 gram per time, q8h, for 7to 14 days. RESULTS The bacteria isolation rate was 90.0% and 88.3% in trial group and control group, respectively. The effective rate of cefuroxime sodium injection in treating lower respiratory infection and urinary tract infection was 93.9% and 100.0%, while in control group the above rate was 93.3% and 100.0%, respectively. Bacteria negative-conversion rate and bacteria cleaning rate was 96.3% and 96.3% in trial group, and 96.2% and 96.3% in control group, respectively. There was no statistics significance in the above data. In trial group, only one case showed cutaneous eruption, the occurrence rate of side-effect was 1.7%(1/60); in control group, 2 cases showed mild diarrhea and little rise of ALT and AST, the occurrence rate was 3.3%( 2/60 ), and there was no statistics significance in these two groups. CONCLUSIONS Cefuroxime sodium injection can effectively treat lower respiratory infection and urinary tract infection caused by sensitive pathogenic bacteria, and furthermore, the occurrence rate of side-effect is low, which similar to the import product Zinacef.