目的评价巴洛沙星片治疗泌尿系统急性细菌性感染的安全性和有效性。方法采用多中心、双盲双模拟、随机、阳性药物平行对照试验设计。共入选221例,其中可评价疗效病例209例,巴洛沙星组102例,左氧氟沙星组107例。巴洛沙星组予巴洛沙星片200 mg,hid,左氧氟沙星组予左氧氟沙星片200 mg,bid,2组疗程均为7～14 d。结果巴洛沙星组临床总有效率和痊愈率分别为98.0%和87.2%,细菌清除率为100%;左氧氟沙星组临床总有效率和痊愈率分别为100.0%和87.9%,细菌清除率为100%。巴洛沙星组和左氧氟沙星组药物不良反应发生率分别为4.8%和0.9%。2组比较均无显著差异(P>0.05)。结论巴洛沙星治疗急性细菌性泌尿系统感染安全、有效。 Objective To evaluate the safety and efficacy of balofloxacin tablet in the treatment of acute bacterial infections in urinary system. Methods A multicenter, double-blind, double-dummy, randomized, positive-drug parallel controlled trial design was used. A total of 221 cases were enrolled, of which 209 cases could be evaluated for curative effect, 102 cases in the balofloxacin group and 107 cases in the levofloxacin group. The balofloxacin group was given 200 mg bid of balofloxacin and 200 mg bid of levofloxacin. The course of treatment was 7 ~ 14 d in both groups. Results The total effective rate and cure rate of the balofloxacin group were 98.0% and 87.2%, respectively, and the bacterial clearance rate was 100%. The total effective rate and recovery rate of the levofloxacin group were 100.0% and 87.9%, respectively, and the bacterial clearance rate was 100 %. Adverse drug reactions in the Balofloxacin and Levofloxacin groups were 4.8% and 0.9%, respectively. There was no significant difference between the two groups (P> 0.05). Conclusion Balofloxacin is safe and effective in treating acute bacterial urinary tract infection.