国产甲磺酸帕珠沙星氯化钠注射液治疗下呼吸道感染的临床研究

Clinical study of injectable Pazufloxacin in the treatment of the infection of lower respiratory tract

目的:评价国产甲磺酸帕珠沙星氯化钠注射液治疗下呼吸道感染的有效性和安全性。方法:多中心、随机、双盲、阳性药物平行对照设计。以盐酸左氧氟沙星葡萄糖注射液为对照药,对比甲磺酸帕珠沙星氯化钠注射液治疗下呼吸道感染的临床疗效和安全性。试验组74例,甲磺酸帕珠沙星氯化钠注射液300mg每12h静脉滴注1次。对照组72例,盐酸左氧氟沙星葡萄糖注射液200mg每12h静脉滴注1次,总疗程均为7～14d。结果:帕珠沙星组和左氧氟沙星组的临床有效率分别为77.0%和80.6%,细菌清除率分别为87.5%和91.9%,经比较两组差异无统计学意义(P>0.05)。药物不良反应发生率帕珠沙星组和左氧氟沙星组分别为5.40%和6.94%,经比较两组差异无统计学意义(P>0.05)。结论:甲磺酸帕珠沙星氯化钠注射液治疗下呼吸道感染安全有效。

Objective： To evaluate the validity and safety of injectable Pazufloxacin in the treatment of the infection of lower respiratory tract. Methods：A multieenter, double blind, randomized clinical study was carried out. Injectable Levofloxacin, as a controlled drug was compared with injectable Pazufloxaein for treatment of the infection of lower respiratory tract. 74 patients were treated with Pazufloxaein300 mg q12 h. 72 patients were treated with Levofloxaein 200 mg q12 h, period of treatment was 7-14 days. Results：The clinical efficiency of the two groups were 77.0% （Pazufloxaein） and 80.6% （Levofloxaein）, and the ratio of eliminating bacteria was 87.5% and 91.9% respectively. There were no statistical differences （P〉0.05）.The adverse drug reaction rates were 5.40%（Pazufloxaein） and 6.94% （Levofloxaein） respectively, There were no statistical differences （P〉0.05）. Conclusion： Injectable Pazufloxaein is a safe and effective drug in the treatment of the infection of lower respiratory tract.