Faich Gerald A, Morganroth Joel, Whitehouse Alan B, Brar Jugroop S, Arcuri Peter, Kowalsky Steven F, Haverstock Daniel C, Celesk Roger A, Church Deborah A
Pharmaceutical Safety Assessments, Inc., Narberth, PA 19072-2156, USA.
Ann Pharmacother. 2004 May;38(5):749-54. doi: 10.1345/aph.1C066. Epub 2004 Mar 16.
Moxifloxacin is an advanced-generation fluoroquinolone used primarily for the treatment of respiratory tract infections.
To further investigate moxifloxacin's general and cardiac safety and evaluate its efficacy in the community practice setting in a large surveillance study.
A total of 18,409 outpatients with suspected bacterial episodes of acute sinusitis, acute exacerbation of chronic bronchitis, or community-acquired pneumonia of mild to moderate severity were enrolled at 3377 community practice sites. Patients with sinusitis or pneumonia received once-daily oral moxifloxacin 400 mg for 10 days; those with bronchitis received 5 days' treatment. At follow-up, within 48 hours after the end of treatment, adverse event information was collected. An external safety committee assessed possible cardiac-related events. Efficacy was also evaluated at follow-up via the degree of resolution of clinical signs and symptoms.
Of 18,374 safety-valid patients, 17.7% experienced adverse events and 14.3% experienced drug-related adverse events. The most common drug-related adverse events were nausea (5.3%), diarrhea (2.2%), and dizziness (2.0%). There was no clinical evidence of increased risk of cardiac arrhythmias with moxifloxacin treatment. Of 17,137 patients included in the efficacy analysis, 92.9% overall experienced clinical cure or improvement (92.8% with sinusitis, 92.9% with bronchitis, 94.1% with pneumonia).
Once-daily oral moxifloxacin 400 mg was shown to be safe and effective in this trial for the treatment of respiratory tract infections of suspected bacterial origin in the clinical practice setting.
莫西沙星是一种新一代氟喹诺酮类药物，主要用于治疗呼吸道感染。
在一项大型监测研究中，进一步调查莫西沙星的总体安全性和心脏安全性，并评估其在社区实践环境中的疗效。
在3377个社区实践地点招募了总共18409例疑似急性鼻窦炎、慢性支气管炎急性加重或轻度至中度社区获得性肺炎细菌感染发作的门诊患者。鼻窦炎或肺炎患者接受每日一次口服莫西沙星400mg，疗程10天；支气管炎患者接受5天治疗。在随访中，在治疗结束后48小时内收集不良事件信息。一个外部安全委员会评估可能的心脏相关事件。在随访时还通过临床体征和症状的缓解程度评估疗效。
在18374例安全性有效的患者中，17.7%经历了不良事件，14.3%经历了药物相关不良事件。最常见的药物相关不良事件是恶心（5.3%）、腹泻（2.2%）和头晕（2.0%）。没有临床证据表明莫西沙星治疗会增加心律失常的风险。在纳入疗效分析的17137例患者中，总体上92.9%经历了临床治愈或改善（鼻窦炎患者为92.8%，支气管炎患者为92.9%，肺炎患者为94.1%）。
在本试验中，每日一次口服400mg莫西沙星在临床实践环境中治疗疑似细菌感染引起的呼吸道感染时显示出安全有效。
