甲磺酸帕珠沙星氯化钠注射液治疗急性细菌性感染多中心临床研究

目的 评价甲磺酸帕珠沙星氯化钠注射液治疗临床常见细菌性感染的安全性和有效性。方法 用随机单盲平行对照多中心同步试验法。甲磺酸帕珠沙星氯化钠注射液(试验组)每次500mg，盐酸左氧氟沙星氯化钠注射液(对照组)每次400mg，均每日1次，静脉滴注，疗程均7～14天。共入选病例251例，其中：试验组122例，临床疗效评价病例115例，安全性评价例数122例；对照组129例，临床疗效评价病例122例，安全性评价例数129例。结果 2组临床总有效率分别为96．5％和98．4％；细菌清除率分别为98．9％和98．0％；药物不良反应发生率分别为11．5％和9．35％。结论 甲磺酸帕珠沙星氯化钠注射液治疗临床常见细菌性感染安全、有效。

Randomized controlled multicenter clinical trial of pazufloxacin monomethanesulfonate in the treatment of acute bacterial infections

Objective To eveluate the efficacy and safety of pazufloxacin monomethanesulfonate and levofloxacin hydrochloride in the treatment of bacterial infections. Methods A randomized ,comparative, open,multicenter clinical trial was conducted for treatment of 251 patients with respiratory tract and urinary tract infections. The dosage of pazufloxacin monomethanesulfonate (trial) intravenous was 500 mg,qd .The dosage of levofloxacin (control) intravenous was 400 mg,qd.The duration of treatment was 7~14 days in both groups. The total number of final evaluated subjects was 251 . One hundred and twenty-two patients were enrolled in pazuflo- xacin group ,115 patients were assessed efficacy and 122 patients were assessed safety while 129 subjects in levofloxacin group , 122 patients were assessed efficacy and 129 patients were assessed safety. Results The clinical efficacy rate for pazufloxacin and levofloxacin was separately 96.5% and 98.4%. The bacterial eradication rate for pazufloxacin and levofloxacin was 98.9% and 98.0%, respectively. The incidence of adverse reaction was 11.5% and 9.35%, respectively. Conclusion The pazufloxacin had an excellent clinical efficacy and good safety profile in treating patients with (acute bacterial) infection.