甲磺酸帕珠沙星注射液治疗急性呼吸道感染的多中心随机对照试验

A Multicenter Randomized Controlled Trial of Pazu oxacin Mesilate versus Lo oxacin in the Treatment of Acute Respiratory Infections

目的评价国产甲磺酸帕珠沙星注射液治疗急性呼吸道细菌感染的有效性与安全性。方法试验采用多中心、随机、阳性药物平行对照、非盲法试验设计，共纳入134例受试者，随机分为试验组68例和对照组66例，试验组与对照组分别接受甲磺酸帕珠沙星500mg与左氧氟沙星300mg，每12h静脉滴注1次，每日两次治疗，疗程均为7～10天，病情重者可延长至14天。结果试验组与对照组的急性呼吸道感染的临床痊愈率分别为52．9％、57．6％（FAS分析集）和57．1％、61．3％（PPS分析集）；临床有效率分别为86．8％、87．9％（FAS分析集）和93．7％、93．6％（PPS分析集），两组比较差异无统计学意义，表明两药疗效相当。两组的细菌阴转率分别为92．5％和94．3％，两组差异无统计学意义（P〉0．05）。安全性评价结果显示，两组临床不良反应发生率分别为16．2％和16．7％，均以局部刺激及消化道反应为主，但大多轻微，无需特殊处理。结论甲磺酸帕珠沙星注射液治疗急性呼吸道细菌感染疗效确切，不良反应少，安全性较好，适合敏感菌所致的中重度呼吸道细菌感染及不能口服给药的患者使用。

Objective To evaluate the clinical efficacy and safety of pazufioxadn for the treatment of moderate and severe acute bacterial respiratory infections. Methods A multicenter randomized controlled trial was conducted to compare the efficacy and safety of pazufloxacin versus levofloxacin. Patients in the pazufloxacin group were treated with pazufloxacin （500 mg twice daily for 7 to 10 days）, and patients in the levofloxacin group were treated with levofloxacin （300 mg twice daily for 7 to 10 days）. Results A total of 134 patients were enrolled in the study, 68 cases in pazufloxacin group and 66 cases in levofloxacin group were assessable for dinical efficacy by full analysis set（FAS）. At the end of the treatment, in FAS analysis the total cure rates and effective rates were 52.9% and 86.7% in pazufloxacin group, 57.6% and 87.9% in levofloxacin group, in PPS analysis the total cure rats and effective rates were 57.1% and 93.7% in pazufloxacin group respectively, 61.3% and 93.6% in levofloxacin group. The bacterial clearance rates were 92.5% and 94.3% respectively. There were no statistically significant differences between the two groups. Adverse reactions were observed in 16.2% of patients in the pazufloxacin group and in 16.7% of patients in the levofloxacin group. These reactions were mainly local stimulation, nausea and diarrhea. No serious adverse event was reported in either group. Conclusion Pazufloxacin is as effective and safe as levofloxacin for the treatment of moderate to severe acute respiratory infections.