甲磺酸帕珠沙星治疗呼吸道细菌性感染的临床研究

Efficacy and safety of pazufloxacin injection for the treatment of respiratory tract bacterial infections

目的:评价国产注射用甲磺酸帕珠沙星治疗呼吸道细菌感染的疗效和安全性.方法:采用多中心双盲随机对照试验设计,共入选病例124例,脱落1例,剔除5例,可评价病例118例,试验组59例,对照组59例.试验组应用甲磺酸帕珠沙星注射剂0.5 g·次-1,bid,静滴;对照组应用盐酸左旋氧氟沙星注射剂0.3 g·次-1,bid,静滴,疗程7～14 d.结果:试验组与对照组的痊愈率分别是71.19%和66.10%,总有效率分别为98.31%和94.92%;两组细菌清除率分别为95.83%和93.62%;两组不良反应率分别为4.84%和3.23%.两组比较差异均无显著性(P＞0.05).结论:国产注射用甲磺酸帕珠沙星治疗呼吸道细菌性感染疗效确切,安全性好.

Objective ：To evaluate the efficacy and safety of pazufloxacin injection made in China in the treatment of respiratory tract bacterial infections （RTBI）. Methods：Of 124 patients with RTBI enrolled in a multicenter, double-blind, randomized comparative controlled clinical study, 118 were randomized 1：1 intravenously to be infused with either pazufloxacin 500 mg or levofloxacin 300 mg twice daily for 7 to 14 days.Results：The cure rates and overall clinical efficacy rates were 71.19% and 98.31% in the pazufloxacin group, and 66.10 % and 94.92 % in the levofloxacin group, respectively. The bacterial eradication rates were 95.83% vs 93.62%. The incidence of adverse events of pazufloxacin versus levofloxacin was 4.84% vs 3.23 %. The p values of these therapeutic outcomes and safety were not significantly different. Conclusion ：The domestic parenteral pazufloxacin is effective and safe for the treatment of respiratory tract bacterial infections.