左氧氟沙星序贯疗法与头孢呋辛联合阿奇霉素治疗社区获得性肺炎的多中心、随机对照临床和药物经济学研究

A randomized controlled multicentre clinical trial of levofloxacin sequential therapy compared with combination therapy with cefuroxime and azithromycin in patients with community-acquired pneumonia

目的对左氧氟沙星的序贯疗法治疗社区获得性肺炎(CAP)进行临床疗效观察及药物经济学分析评价。方法以头孢呋辛联合阿奇霉素为对照药,采用多中心随机、开放、阳性对照研究方法。结果378例CAP患者中左氧氟沙星序贯疗法治疗(190例)的痊愈率和有效率分别为67.37%和96.84%,细菌阴转率高达96.77%,药物不良反应发生率为10.53%;对照药治疗(188例)的痊愈率和有效率分别为64.36%和96.28%,细菌阴转率为96.67%,药物不良反应发生率为7.98%;两组比较差异无统计学意义,平均疗程、住院天数和住院费用差异亦无统计学意义,试验组的成本-效果比为32.01,低于对照组(38.51)。结论左氧氟沙星的序贯疗法治疗CAP临床疗效较好,药物不良反应率较低,成本-效果比较低。

Objective To evaluate the clinical consequences and cost effectiveness of levofloxacin sequential therapy （intravenous infusion followed by oral administration） in patients with community-acquired pneumonia. Methods Combination therapy with cefuroxime and azithromycin was used as control regimen. A randomized controlled multicentre clinical trial was conducted to evaluate the efficacy, safety and cost-effectiveness of levofloxacin in patients with community-acquired pneumonia. Results Of the total 378 cases with community-acquired pneumonia, 190 were treated with sequential levofloxacin, 188 were treated with cefuroxime plus azithromycin. In the levofloxacin treatment group, the cure and efficacy rate were 67.37% and 96. 84% respectively. The bacterial eradication rate was 96. 77%. The incidence of adverse drug reaction was 10. 53%. In cefuroxime and azithromycin combination group, the cure and efficacy rate were 64.36% and 96. 28% respectivel was 7.98 %. There was no significant treatment, days of hospital stay, and y. The bacterial eradication rate was 96.67%. The incidence of adverse drug reaction difference between the two groups in terms of these parameters. The mean duration of cost of hospitalization did not show significant difference between the two groups. However, levofloxacin sequential therapy （cost of 32. 01） was more cost-effective than cefuroxime plus azithromycin （cost of 38.51）. The difference was statistically significant. Conclusions Levofloxacin sequential therapy is efficacious, safe and cost-effective in treatment of community acquired pneumonia.