Frank Elliott, Liu Jing, Kinasewitz Gary, Moran Gregory J, Oross Margaret P, Olson William H, Reichl Veronica, Freitag Susan, Bahal Neelam, Wiesinger Barbara A, Tennenberg Alan, Kahn James B
Jersey Shore Medical Center, Neptune, New Jersey, USA.
Clin Ther. 2002 Aug;24(8):1292-308. doi: 10.1016/s0149-2918(02)80034-0.
Changing etiologic patterns and the growing problem of antimicrobial resistance, particularly an increase in macrolide-resistant pneumococcal bacteremia, are causing physicians to adopt new approaches to the treatment of community-acquired pneumonia (CAP).
The relative efficacy and tolerability of levofloxacin monotherapy and azithromycin and ceftriaxone combination therapy were assessed in hospitalized adults with moderate to severe CAP.
This Phase IV, multicenter, open-label, randomized trial compared 2 treatment regimens: (1) levofloxacin 500 mg PO or IV q24h, and (2) azithromycin 500 mg IV q24h for > or = 2 days plus ceftriaxone 1 g IV q24h for 2 days, followed by an optional transition to azithromycin 500 mg PO q24h at the investigator's discretion. The total duration of therapy was to be a minimum of 10 days in both treatment groups. Ceftriaxone was included in the initial azithromycin regimen to ensure coverage against pneumococcal bacteremia.
Of 236 patients in the intent-to-treat population, completion or withdrawal information was available for 110 patients in the levofloxacin group and 114 in the azithromycin group. Baseline demographic and disease characteristics were comparable between groups. At the end of treatment, the clinical success rate (cured + improved) in clinically evaluable patients was 94.1% in the levofloxacin group and 92.3% in the azithromycin group. The respective posttherapy microbiologic eradication rates were 89.5% and 92.3%. Levofloxacin was as well tolerated as azithromycin, with an incidence of drug-related adverse events (AEs) for all body systems of 5.3% and 9.3%, respectively. None of the drug-related AEs were considered serious [corrected].
In this study in hospitalized patients with moderate to severe CAP, levofloxacin monotherapy was at least as effective as a combination regimen of azithromycin and ceftriaxone in providing coverage against the current causative pathogens in CAP. In addition, levofloxacin was as well tolerated as the combination of azithromycin and ceftriaxone.
病因模式的改变以及抗菌药物耐药性问题的日益严重，尤其是耐大环内酯类肺炎球菌菌血症的增加，促使医生采用新的方法来治疗社区获得性肺炎（CAP）。
评估左氧氟沙星单药治疗与阿奇霉素和头孢曲松联合治疗对中重度CAP住院成人患者的相对疗效和耐受性。
这项IV期、多中心、开放标签、随机试验比较了2种治疗方案：（1）左氧氟沙星500mg口服或静脉注射，每24小时1次；（2）阿奇霉素500mg静脉注射，每24小时1次，持续≥2天，加头孢曲松1g静脉注射，每24小时1次，共2天，随后根据研究者的判断可选择过渡为阿奇霉素500mg口服，每24小时1次。两个治疗组的总疗程均至少为10天。头孢曲松包含在初始阿奇霉素治疗方案中，以确保覆盖肺炎球菌菌血症。
在意向性治疗人群的236例患者中，左氧氟沙星组110例和阿奇霉素组114例患者有完成或退出研究的信息。两组间的基线人口统计学和疾病特征具有可比性。治疗结束时，临床可评估患者的临床成功率（治愈+改善）在左氧氟沙星组为94.1%，在阿奇霉素组为92.3%。治疗后各自的微生物清除率分别为89.5%和92.3%。左氧氟沙星与阿奇霉素的耐受性相当，所有身体系统的药物相关不良事件（AE）发生率分别为5.3%和9.3%。没有药物相关AE被认为是严重的[校正后]。
在这项针对中重度CAP住院患者的研究中，左氧氟沙星单药治疗在覆盖当前CAP致病病原体方面至少与阿奇霉素和头孢曲松联合治疗方案一样有效。此外，左氧氟沙星与阿奇霉素和头孢曲松联合用药的耐受性相当。
