头孢替安国产品和进口品治疗细菌性感染127例的随机对照临床研究

A randomized controlled study of domestic and imported cefotiam in the treatment of bacterial infections

目的 :评价注射用头孢替安国产品治疗细菌性感染的疗效与安全性。方法 :以头孢替安国产品为试验药 ,头孢替安进口品为对照药治疗下呼吸道、尿路和腹腔感染 ,对其疗效和安全性进行非盲法随机对照试验。结果 :两组共入选 1 2 7例 ,头孢替安国产品组 6 4例 ,头孢替安进口品组 6 3例 ,治疗结果两组的总有效率分别为 96 .9% (6 2 /6 4 )和 98.4 % (6 2 /6 3) ,治愈率为 6 5 .6 % (4 2 /6 4 )和 6 9.8% (4 4 /6 3) ;细菌清除率分别为 94 .3% (5 0 /5 3)和 98.2 % (5 4 /5 5 ) ;不良反应发生率分别为 1 .4 % (1 /73)和 2 .9% (2 /70 ) ,实验室检查异常者分别为 4 .1 % (3/73)和 5 .7% (4 /70 )。上述结果经统计学处理 ,差异均无显著性。结论 :头孢替安国产品治疗下呼吸道。

Objective: To evaluate the clinical efficacy and safety of domestic cefotiam in the treatment of bacterial infections. Methods:Patients with lower respiratory tract infections, urinary tract infections, intraabdominal infections were treated with domestic or imported cefotiam in a randomized controlled study. Results:A total of 127 patients were enrolled in this study, 64 cases were in domestic group, 63 cases in imported group. The cure rates and the effective rates of domestic and imported groups were 65.6%, 69.8%( P> 0.05) and 96.9%, 98.4%( P> 0.05), respectively. The bacterial eradication rates of the two groups were 94.3%, 98.2%,respectively. The rates of adverse reaction and abnormal laboratory findings in the two groups were 1.4%, 2.9% and 4.1%, 5.7%, respectively. There was no statistical significance between the two groups. Conclusions:Domestic made cefotiam is as effective and well tolerated as imported cefotiam for the treatment of bacterial infections.