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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 efficacy of domestic injection of cefuroxime sodium in the treatment of acute lower respiratory and urinary tract bacterial infections caused by sensitive pathogens in order to compare the efficacy and safety of cefuroxime axetil injection with celecoxib (the trade name of cefuroxime) Clinical efficacy and safety of sexual diseases. Methods A multicenter randomized controlled clinical trial was conducted. A total of 120 randomized controlled clinical trials were completed in both groups, 60 in the trial group and 60 in the control group. The treatment regimen consisted of 15 g of cefuroxime / Times, q8h, treatment 7 ~ 14d; control group injection of Xili Xin 15g / times, q8h, treatment of 7 ~ 14d. Results The rates of bacteria isolation in the test group and the control group were 90 0% and 88 3% respectively. The effective rate of cefuroxime sodium for the treatment of lower respiratory tract infection and urinary tract infection was 93 3% and 100 0%, respectively. The effective rates of treatment were 93 3% and 100 0% respectively. In the experimental group, the rate of bacterial negative conversion was 96.3%, the bacterial clearance rate was 96.4%, that of the control group was 96.2%, and the bacterial clearance rate was 96 3% .There was no significant difference in the above results by statistical analysis. Only 1 patient in the experimental group had a rash and the incidence of adverse reactions was 17%. Two patients in XELIX group had mild diarrhea and abnormal liver function (ALT) AST mildly increased, the incidence was 33%, the difference was not statistically significant. Conclusions Cefuroxime sodium for injection is effective in treating lower respiratory tract infections and urinary tract infections caused by common pathogens in clinical practice, and has a good clinical effect and a low incidence of adverse reactions, which is similar to that of imported Xili Xin.