巴洛沙星片治疗泌尿系统细菌感染性疾病多中心、随机、双盲、阳性药平行对照临床试验

A randomized,doubleblind,placebo-controlled study of balofloxacin versus levofloxacin in the treatment of urinary tract infection

目的评价国产巴洛沙星片治疗轻、中度泌尿系统细菌感染性疾病的临床疗效与安全性。方法采用多中心、双盲双模拟、平行、随机阳性药对照实验设计。以左氧氟沙星为对照药。巴洛沙星为试验药。巴洛沙星100mg·每日2次；左氧氟沙星200mg，每日2次．疗程均为7～10d。结果本研究人组病例数共210例。巴洛沙星组及左氧氟沙星组各105例，其中巴洛沙星组FAS分析104例．PPS分析100例；左氧氟沙星组FAS分析103例，PPS分析103例。疗程结束时，FAS分析巴洛沙星组的痊愈率和有效率分别为69．23％和95．19％。左氧氟沙星组的痊愈率和有效率分别为67．96％和97．09％；PPS分析巴洛沙星组的痊愈率和有效率分别为70．00％和97．00％，左氧氟沙星组的痊愈率和有效率分别为67．96％和97．09％；两组的痊愈率和有效率无明显统计学差异（P〉0．05）。两组细菌清除率分别为93．18％和90．70％，两组组间比较也无显著性差异（P〉0．05）。不良反应主要表现为白细胞减少、胃肠道反应、直接胆红紊升高、尿检异常。两组无显著性差异（P〉0．05）。两组均未见严重不良事件发生。结论国产巴洛沙星片治疗泌尿系统轻、中度感染疗效确切，安全性好。

Objective To evaluate the clinical efficacy and safety of balofloxacin for the treatment of slight and moderate urinary tract infection. Methods A multicenter, randomized, double-blind, parallel controlled study was conducted to compare the efficacy and safety of balofloxacin and levofloxacin （levofloxacin as the positive control drug）. Both groups were administered tablets twice daily for 7 to 10 days at the dose of 100mg for balofloxacin and 200mg for levofloxacin. Results Two hundred and ten patients were enrolled in the study. Due to some unexpected events, finally, 104 cases in balofloxacin group and 103 cases in levofloxacin group were assessable for clinical efficacy by full analysis set （FAS） analysis, the per-protocol set （PPS） analysis for 100 cases in balofloxacin group and 103 cases in levofloxacin group. At the end of treatment, in FAS analysis the total cure rates and effective rates were 69.23% and 95.19% in balofloxacin group, 67. 96% and 97.09% in levofloxacin group; in PPS analysis the total cure rates and effective rates were 70. 00% and 97.00% in balofloxaccin group, 67.96% and 97.09% in levofloxacin group. The bacterial clearance rates were 93.18% and 90.70% respectively. There were no statistically significant differences between the two groups （P〉0.05） also. Main adverse reactions were leucopenia, gastrointestinal symptoms, elevated conjugated bilirubin and abnormal urine, there were no statistically significant differences between the two groups （P〉0. 05）. No serious adverse event was reported in any group. Conclusion Balofloxacin tablet is as effective and safe as levofloxacin tablet in the treatment of minor and moderate urinary tract infection.