Torres Antoni, Garau Javier, Arvis Pierre, Carlet Jean, Choudhri Shurjeel, Kureishi Amar, Le Berre Marie-Aude, Lode Hartmut, Winter John, Read Robert C
Servei de Pneumologia i Allèrgia Respiratòria, Institut Clinic del Torax, Hospital Clínic de Barcelona, Spain.
Clin Infect Dis. 2008 May 15;46(10):1499-509. doi: 10.1086/587519.
The aim of this study was to show that sequential intravenous and oral moxifloxacin monotherapy (400 mg once per day) is as efficacious and safe as a combination regimen (intravenous ceftriaxone, 2 g once per day, plus sequential intravenous and oral levofloxacin, 500 mg twice per day) in patients hospitalized with community-acquired pneumonia.
We conducted a prospective, multicenter, randomized, double-blind noninferiority trial. Patients with a Pneumonia Severity Index (PSI) of III-V were stratified on the basis of PSI risk class before randomization. The primary efficacy end point was clinical response at test of cure (4-14 days after the completion of treatment). Secondary efficacy end points were clinical and bacteriological response at end of treatment (days 7-14) and at follow-up assessment (21-28 days after the end of treatment), overall mortality, and mortality attributable to pneumonia.
Seven hundred thirty-three patients were enrolled in the study (368 in the moxifloxacin arm and 365 in the comparator arm); 49% had a PSI of IV, and 10% had a PSI of V. Of 569 patients (291 in the moxifloxacin arm and 278 in the comparator arm) valid for per-protocol analysis, the overall clinical cure rates at test of cure were 86.9% for moxifloxacin and 89.9% for the comparator regimen (95% confidence interval, -8.1% to 2.2%). Bacteriological success at test of cure was 83.3% for moxifloxacin and 85.1% for the comparator regimen (95% confidence interval, -15.4% to 11.8%). There were no significant differences between moxifloxacin and comparator treatments in the incidence of treatment-emergent adverse events or in mortality.
Monotherapy with sequential intravenous/oral moxifloxacin was noninferior to treatment with ceftriaxone plus levofloxacin combination therapy in patients with community-acquired pneumonia who required hospitalization.
本研究旨在表明，对于因社区获得性肺炎住院的患者，序贯静脉及口服莫西沙星单药治疗（每日一次，每次400mg）与联合治疗方案（静脉注射头孢曲松，每日一次，每次2g，加序贯静脉及口服左氧氟沙星，每日两次，每次500mg）同样有效且安全。
我们进行了一项前瞻性、多中心、随机、双盲非劣效性试验。肺炎严重指数（PSI）为III - V级的患者在随机分组前根据PSI风险等级进行分层。主要疗效终点为治疗结束后4 - 14天的治愈试验时的临床反应。次要疗效终点为治疗结束时（第7 - 14天）和随访评估时（治疗结束后21 - 28天）的临床及细菌学反应、总死亡率以及肺炎所致死亡率。
733例患者纳入研究（莫西沙星组368例，对照方案组365例）；49%的患者PSI为IV级，10%的患者PSI为V级。在569例符合方案分析标准的患者中（莫西沙星组291例，对照方案组278例），莫西沙星组在治愈试验时的总体临床治愈率为86.9%，对照方案组为89.9%（95%置信区间，-8.1%至2.2%）。莫西沙星组在治愈试验时的细菌学成功率为83.3%，对照方案组为85.1%（95%置信区间，-15.4%至11.8%）。莫西沙星组与对照方案组在治疗期间出现的不良事件发生率或死亡率方面无显著差异。
对于需要住院治疗的社区获得性肺炎患者，序贯静脉/口服莫西沙星单药治疗不劣于头孢曲松加左氧氟沙星联合治疗。
