左氧氟沙星注射剂治疗社区获得性肺炎的多中心临床研究

Multicentre clinical study on levofloxacin intravenous injection for treatment of community-acquired pneumonia

目的以头孢曲松钠注射剂联合阿奇霉素片剂为对照药，评价左氧氟沙星注射剂治疗社区获得性肺炎的安全性和有效性。方法采用多中心、随机对照试验，左氧氟沙星注射剂，静脉滴注，每次300mg，每日2次；头孢曲松注射剂，静脉滴注，每次1g，每日2次，联合阿奇霉素片剂，每次500mg，每日1次，两组的疗程均为7～14天。入选病例100例，试验组和对照组各50例。结果试验组和对照组的临床有效率分别为88％（FAS集）、94％（PP集）和90％（FAS集）、96％（PP集）。细菌清除率分别为82％（FAS集）、91％（PP集）和80％（FAS集）、89％（PP集），两组疗效的差异无统计学意义。药物不良反应发生率分别为8％和10％，两组间的差异无统计学意义（P〉0．05）。结论左氧氟沙星注射剂是治疗社区获得性肺炎的安全有效药物。

Objective To evaluate the efficacy and safety of levofloxacin injection in the treatment ot community acquired pneumonia compared to the combination of ceftriaxone injection and azitromycin tablet. Methods A randomized, comparative, open, multicentrae trial was conducted. The patients in levofloxacin group received levofloxacin 300mg twice daily intravenously. The patients in control group received ceftriaxone 2.0g once daily intravenously, combined with oral azitromycin 500mg once daily. The course of treatment was 7～14 days in both groups. The total number of subjects was 100 including 50 in levofloxacin group and 50 in control group. Results Clinical efficacy rates in levofloxacin group and control group were 88% （FAS）, 94% （PP） and 90% （FAS）, 96% （PP）, respectively. Bacterium eradication rates in levofloxacin group and control group were separately 82% （FAS）, 91% （PP） and 80% （FAS）, 89% （PP）. There was no significant difference in the clinical efficiency rates between the two groups（P 〉 0.05）. The incidence of adverse reaction including both clinical reactions and laboratory abnormalities was 8% for levofloxacin group and 10% for control group. There was no significant difference in incidence of adverse reaction between the two groups （P 〉 0.05）. Conclusions Levofloxacin is an effective and safe drug in the treatment of community acquired pneumonia.