Anzueto Antonio, Niederman Michael S, Pearle James, Restrepo Marcos I, Heyder Albrecht, Choudhri Shurjeel H
Department of Medicine, University of Texas Health Science Center, San Antonio, TX, USA.
Clin Infect Dis. 2006 Jan 1;42(1):73-81. doi: 10.1086/498520. Epub 2005 Nov 22.
Limited prospective data are available for elderly patients with community-acquired pneumonia (CAP). This study aimed to determine the efficacy and safety of moxifloxacin versus that of levofloxacin for the treatment of CAP in hospitalized elderly patients (age, > or = 65 years).
We conducted a prospective, double-blind, randomized, controlled trial. Eligible patients were stratified by CAP severity before randomization to receive treatment with either intravenous/oral moxifloxacin (400 mg daily) or intravenous/oral levofloxacin (500 mg daily) for 7-14 days. Clinical response at test-of-cure (the primary efficacy end point was between days 5 and 21 after completion of therapy), and clinical response during therapy (between days 3 and 5 after the start of therapy) and bacteriologic response were secondary end points.
The safety population included 394 patients (195 in the moxifloxacin group and 199 in the levofloxacin group). The population eligible for clinical efficacy analysis (i.e., the clinically valid population) included 281 patients (141 in the moxifloxacin group and 140 in the levofloxacin group); 51.3% were male, and the mean age (+/-SD) was 77.4 +/- 7.7 years. Cure rates at test-of-cure for the clinically valid population were 92.9% in the moxifloxacin arm and 87.9% in the levofloxacin arm (95% confidence interval [CI], -1.9 to 11.9; P = .2). Clinical recovery by days 3-5 after the start of treatment was 97.9% in the moxifloxacin arm vs. 90.0% in the levofloxacin arm (95% CI, 1.7-14.1; P = .01). In the moxifloxacin group, cure rates were 92.6% for patients with mild or moderate CAP and 94.7% for patients with severe CAP, compared with cure rates of 88.6% and 84.6%, respectively, in the levofloxacin group (P = not significant). Cure rates in the moxifloxacin arm were 90.0% for patients aged 65-74 years and 94.5% for patients aged > or = 75 years, compared with 85.0% and 90.0%, respectively, in the levofloxacin arm (P = not significant). There were no statistically significant differences between the treatment groups with regard to drug-related adverse events.
Intravenous/oral moxifloxacin therapy was efficacious and safe for hospitalized elderly patients with CAP, achieving > 90% cure in all severity and age subgroups, and was associated with faster clinical recovery than intravenous/oral levofloxacin therapy, with a comparable safety profile.
关于老年社区获得性肺炎（CAP）患者的前瞻性数据有限。本研究旨在确定莫西沙星与左氧氟沙星治疗住院老年患者（年龄≥65岁）CAP的疗效和安全性。
我们进行了一项前瞻性、双盲、随机、对照试验。符合条件的患者在随机分组前根据CAP严重程度进行分层，接受静脉/口服莫西沙星（每日400mg）或静脉/口服左氧氟沙星（每日500mg）治疗7 - 14天。治疗结束时的临床反应（主要疗效终点为治疗完成后第5至21天）、治疗期间的临床反应（治疗开始后第3至5天）和细菌学反应为次要终点。
安全人群包括394例患者（莫西沙星组195例，左氧氟沙星组199例）。符合临床疗效分析的人群（即临床有效人群）包括281例患者（莫西沙星组141例，左氧氟沙星组140例）；51.3%为男性，平均年龄（±标准差）为77.4±7.7岁。临床有效人群在治疗结束时的治愈率，莫西沙星组为92.9%，左氧氟沙星组为87.9%（95%置信区间[CI]，-1.9至11.9；P = 0.2）。治疗开始后第3至5天的临床恢复率，莫西沙星组为97.9%，左氧氟沙星组为90.0%（95% CI，1.7 - 14.1；P = 0.01）。在莫西沙星组中，轻度或中度CAP患者的治愈率为92.6%，重度CAP患者的治愈率为94.7%，而左氧氟沙星组分别为88.6%和84.6%（P无统计学意义）。莫西沙星组中，65 - 74岁患者的治愈率为90.0%，年龄≥75岁患者的治愈率为94.5%，而左氧氟沙星组分别为85.0%和90.0%（P无统计学意义）。治疗组之间在药物相关不良事件方面无统计学显著差异。
静脉/口服莫西沙星治疗住院老年CAP患者有效且安全，在所有严重程度和年龄亚组中的治愈率均超过90%，与静脉/口服左氧氟沙星治疗相比，临床恢复更快，安全性相当。
