莫西沙星与左氧氟沙星联合甲硝唑治疗伴有误吸因素的社区获得性肺炎的临床疗效与安全性

Clinical efficacy and safety of moxifloxacin versus levofloxacin plus metronidazole for community-acquired pneumonia with aspiration factors.

作者信息

Sun Tieying, Sun Li, Wang Rongmei, Ren Xiaoping, Sui Dong-Jiang, Pu Chun, Ren Yajuan, Liu Ying, Yang Zhuo, Li Fengzhi

机构信息

Department of Respiratory and Critical Care Medicine, Beijing Hospital of the Ministry of Health, Beijing 100730, China.

Department of Respiratory Diseases, Shaanxi Provincial People's Hospital, Xi'an, Shaanxi 710068, China.

出版信息

Chin Med J (Engl). 2014;127(7):1201-5.

PMID:24709166

Abstract

BACKGROUND

Community-acquired pneumonia (CAP) is a common infectious disease throughout the world and the incidence continues to grow as the population ages. Aspiration is an important pathogenic mechanism for pneumonia in the elderly and the management of patients with community-acquired pneumonia with aspiration factors is a major medical problem. Our study aimed to assess whether moxifloxacin in comparison to levofloxacin plus metronidazole are effective and safe in the treatment of community-acquired pneumonia with aspiration factors.

METHODS

In this prospective, multicenter, open-label, randomized controlled trial, 77 patients with mild-to-moderate community-acquired pneumonia with aspiration factors were enrolled and randomly assigned to receive moxifloxacin or levofloxacin plus metronidazole. The primary efficacy variables were clinical outcomes in evaluable patients at a follow-up visit 7 to 14 days after the end of therapy.

RESULTS

Seven days after the end of therapy a clinical cure was achieved for 76.7% (23 of 37) of efficacy-evaluable patients in the moxifloxacin group and 51.7% (15 of 40) of patients in the levofloxacin plus metronidazole group. There was a significant difference between the two groups (χ(2) = 4.002, P < 0.05). Bacteriological success rates were similar in the moxifloxacin group (93.3%) and levofloxacin plus metronidazole group (96.4%), there was no significant difference between the two groups (P > 0.05). The overall adverse event rate was 10.8% (4/37) in the moxifloxacin group versus 17.5% (7/40) in the levofloxacin plus metronidazole group, there was no significant difference between the two groups (P > 0.05). No serious adverse events were observed.

CONCLUSIONS

Moxifloxacin is effective and safe for treatment of community-acquired pneumonia with aspiration factors. And the regimen of moxifloxacin monotherapy is more convenient compared with levofloxacin plus metronidazole.

摘要

背景

社区获得性肺炎（CAP）是全球常见的传染病，且随着人口老龄化发病率持续上升。误吸是老年人肺炎的重要致病机制，伴有误吸因素的社区获得性肺炎患者的管理是一个主要的医学问题。我们的研究旨在评估莫西沙星与左氧氟沙星加甲硝唑相比，在治疗伴有误吸因素的社区获得性肺炎时是否有效且安全。

方法

在这项前瞻性、多中心、开放标签、随机对照试验中，纳入了77例伴有误吸因素的轻至中度社区获得性肺炎患者，并随机分配接受莫西沙星或左氧氟沙星加甲硝唑治疗。主要疗效变量是治疗结束后7至14天随访时可评估患者的临床结局。

结果

治疗结束7天后，莫西沙星组76.7%（37例中的23例）的疗效可评估患者实现了临床治愈，左氧氟沙星加甲硝唑组为51.7%（40例中的15例）。两组之间存在显著差异（χ(2)=4.002，P<0.05）。莫西沙星组（93.3%）和左氧氟沙星加甲硝唑组（96.4%）的细菌学成功率相似，两组之间无显著差异（P>0.05）。莫西沙星组的总体不良事件发生率为10.8%（4/37），左氧氟沙星加甲硝唑组为17.5%（7/40），两组之间无显著差异（P>0.05）。未观察到严重不良事件。