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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、腹腔感染和尿路感染的疗效和安全性与头孢替安进口品相仿
Objective: To evaluate the efficacy and safety of cefotiam injection for the treatment of bacterial infections. Methods: The cefotiam products as the test drug, the imported cefotiam as the control drug in the treatment of lower respiratory tract, urinary tract and abdominal infections, its efficacy and safety of non-blinded randomized controlled trials. Results: There were 127 cases in both groups, 64 cases in cefotiam product group and 63 cases in imported cefotiam group. The total effective rates of two groups were 96.9% (6 2/64 ) And 98.4% (62/6 3) respectively. The cure rates were 65.6% (4 2/6 4) and 68.8% (44/6 3) respectively. The bacterial clearance rate was 94.3% (5 The rates of adverse reactions were 1.4% (1/73) and 2.9% (2/70), respectively, while those with laboratory abnormalities were 4 .1% (3/73) and 5.7% (4/70). The above results by statistical analysis, the difference was not significant. CONCLUSIONS: The efficacy and safety of cefotiam products for the treatment of lower respiratory tract, abdominal infections and urinary tract infections are similar to those of cefotiam