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本临床试验目的是对国产氧氟沙星治疗下呼吸道细菌感染进行安全性和有效性评价。采用随机对照试验方法，选用日产氧氟沙星作对照药，两组治疗下呼吸道细菌感染各２５例，共５０例。国产氧氟沙星组细菌培养阳性率１００％，总有效率８０％，细菌清除率７３．１％，不良反应发生率４％；日产氧氟沙星对照组分别为９２％、７６％、７９．２％和１９．２％。以上结果经统计学处理差异无显著性（Ｐ＞０．０５）。本试验表明国产氧氟沙星为广谱、高效、安全的抗菌药物。适用于轻、中度下呼吸道细菌感染的治疗。
The purpose of this clinical trial is to evaluate the safety and efficacy of domestic ofloxacin for the treatment of lower respiratory tract bacterial infections. A randomized controlled trial was conducted with ofloxacin as the reference drug. The two groups were treated with bacterial infections of the lower respiratory tract in 25 cases, a total of 50 cases. The positive rate of bacterial culture in ofloxacin group was 100%, the total effective rate was 80%, the bacterial clearance rate was 73.1%, and the incidence of adverse reactions was 4%. The ofloxacin produced 92%, 76%, 79% .2% and 19.2%. The above results by the statistical difference was not statistically significant (P> 0.05). This test shows that ofloxacin is broad-spectrum, efficient and safe antibacterial drugs. For light, moderate lower respiratory tract bacterial infection treatment.