甲磺酸帕珠沙星与左氧氟沙星治疗急性呼吸道和泌尿道感染随机对照多中心临床研究  

A multicenter randomized controlled clinical study of pazufloxacin mesilate versus levofloxacin in the treatment of acute respiratory and urinary tract infections

作　　者：郑莉[1] 徐楠[1] 蔡永宁[1] 冯萍[1] 刘跃建[2] 王伟[3] 韩雪芳[4] 

机构地区：[1]四川大学华西医院临床药理研究所,成都610041 [2]四川省人民医院,成都610072 [3]成都市第三人民医院,成都610031 [4]陕西省人民医院,西安710068

出　　处：《中国抗生素杂志》2008年第3期182-187,共6页Chinese Journal of Antibiotics

摘　　要：目的评价国产甲磺酸帕珠沙星注射液治疗急性呼吸道和泌尿道感染的临床疗效与安全性。方法采用随机对照试验设计,以左氧氟沙星注射液为阳性对照药,甲磺酸帕珠沙星组500mg,左氧氟沙星组300mg,为Q12h静脉滴注一次,qid,疗程均为7～10d,病情偏重者疗程可延长至14d。结果本研究共纳入240例,其中甲磺酸帕珠沙星组和左氧氟沙星组分别为127例和113例。结果显示,甲磺酸帕珠沙星氯化钠注射液与盐酸左氧氟沙星注射液的临床痊愈率分别为68.60%与66.67%(PPS分析集);临床有效率分别为96.69%与95.37%(PPS分析集)。对呼吸道感染和泌尿道感染均有良好的疗效,两组比较无统计学差异,表明两药疗效相当。两组的细菌阴转率分别为93.42%与89.66%,细菌清除率分别93.42%与89.83%,两组比较无统计学差异(P>0.05)。安全性评价结果显示,两组的临床不良反应发生率分别为14.96%与14.16%,均以局部刺激及消化道反应为主,但大多轻微,勿需特殊处理。结论甲磺酸帕珠沙星氯化钠注射液治疗急性呼吸道和泌尿道细菌性感染疗效确切,不良反应少,安全性较好,是一安全有效的抗菌药物,适于中、重度细菌感染及不能口服给药患者使用。Objective To evaluate the clinical efficacy and safety of pazufloxacin in the treatment of acute respiratory and urinary fract infections. Methods A multicenter randomized controlled clinical study was conducted to compare the efficacy and safety of pazufloxacin and levofloxacin. Pazufloxacin group was administered at a dose of 500mg twice daily for 7 to 10 days, and levofloxacin group 300mg twice daily during the same period. Results 240 patients were enrolled in the study, and 127 cases in pazufloxacin group and 113 cases in levofloxacin group were evaluated for clinical efficacy by per protocol set （PPS）. At the end of the treatment, in PPS analysis the total cure rats and effective rates were 68.60% and 96.69% in pazufloxacin group and 66.67% and 95.37% in levofloxacin group respectively. The bacterial clearance rates were 93.42% and 89.73% respectively. There were no statistically significant differences between the two groups. Adverse reactions were observed in 14.96% and 14. 16% of patients in the two groups, mainly local stimulation, nausea, and diarrhea. No serious adverse event was reported in any group. Conclusions Pazufloxacin is as effective and safe as levofloxacin in the treatment of moderate and severe acute bacterial infections.

关 键 词：甲磺酸帕珠沙星 左氧氟沙星 急性呼吸道和泌尿道细菌感染 多中心临床研究 

分 类 号：R978.1[医药卫生—药品] R969.1[医药卫生—药学]